Trial Outcomes & Findings for A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC) (NCT NCT04317599)

NCT ID: NCT04317599

Last Updated: 2026-01-02

Results Overview

First-line SACT treatment patterns in BRAFV600E mutant mCRC patients described by agent or combination of agents received

Recruitment status

COMPLETED

Target enrollment

274 participants

Primary outcome timeframe

time from treatment initiation (for mCRC) up to 31 December 2020

Results posted on

2026-01-02

Participant Flow

Participant milestones

Participant milestones
Measure
Non Interventional
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Overall Study
STARTED
274
Overall Study
COMPLETED
255
Overall Study
NOT COMPLETED
19

Reasons for withdrawal

Reasons for withdrawal
Measure
Non Interventional
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Overall Study
ineligible due to inclusion/exclusion criteria
15
Overall Study
treatment outside standard of care
4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Non Interventional
n=255 Participants
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Age, Customized
≤ 60 years
87 Participants
n=255 Participants
Age, Customized
61-70 years
68 Participants
n=255 Participants
Age, Customized
> 70 years
100 Participants
n=255 Participants
Sex: Female, Male
Female
149 Participants
n=255 Participants
Sex: Female, Male
Male
106 Participants
n=255 Participants
Region of Enrollment
Austria
4 Participants
n=255 Participants
Region of Enrollment
Belgium
28 Participants
n=255 Participants
Region of Enrollment
Italy
52 Participants
n=255 Participants
Region of Enrollment
United Kingdom
17 Participants
n=255 Participants
Region of Enrollment
France
74 Participants
n=255 Participants
Region of Enrollment
Germany
45 Participants
n=255 Participants
Region of Enrollment
Spain
35 Participants
n=255 Participants
Anthropometry - Body Mass Index (BMI)
25.42 kg/m²
STANDARD_DEVIATION 5.44 • n=255 Participants
Disease stage at initial diagnosis
I
4 Participants
n=226 Participants • Data not available for all patients.
Disease stage at initial diagnosis
II
24 Participants
n=226 Participants • Data not available for all patients.
Disease stage at initial diagnosis
III
48 Participants
n=226 Participants • Data not available for all patients.
Disease stage at initial diagnosis
IV
150 Participants
n=226 Participants • Data not available for all patients.
Histology at initial diagnosis
Adenocarcinoma
252 Participants
n=253 Participants • Data not available for all patients.
Histology at initial diagnosis
Other carcinoma
1 Participants
n=253 Participants • Data not available for all patients.
Primary tumor location
left and/or rectum
83 Participants
n=255 Participants
Primary tumor location
right only
134 Participants
n=255 Participants
Primary tumor location
other (left and right or transverse or right and rectum or not applicable)
38 Participants
n=255 Participants
Number of metastatic sites
1 site
115 Participants
n=255 Participants
Number of metastatic sites
2 sites
82 Participants
n=255 Participants
Number of metastatic sites
≥3 sites
58 Participants
n=255 Participants
Characterization of metastasis
4.75 months
STANDARD_DEVIATION 12.25 • n=255 Participants
Location of metastasis
Liver
148 Participants
n=255 Participants
Location of metastasis
Liver only
48 Participants
n=255 Participants
Location of metastasis
Lungs
68 Participants
n=255 Participants
Location of metastasis
Lymph nodes
89 Participants
n=255 Participants
Location of metastasis
Bone
8 Participants
n=255 Participants
Location of metastasis
Peritoneum
112 Participants
n=255 Participants
Location of metastasis
Central Nervous System
2 Participants
n=255 Participants
Location of metastasis
Abdomen (including 7 patients with "ovaries")
12 Participants
n=255 Participants
Location of metastasis
Other
25 Participants
n=255 Participants
Performance Status
ECOG 0
80 Participants
n=150 Participants • ECOG performance status score at mCRC diagnosis was recorded for 150 patients
Performance Status
ECOG 1
56 Participants
n=150 Participants • ECOG performance status score at mCRC diagnosis was recorded for 150 patients
Performance Status
ECOG 2
10 Participants
n=150 Participants • ECOG performance status score at mCRC diagnosis was recorded for 150 patients
Performance Status
ECOG 3
4 Participants
n=150 Participants • ECOG performance status score at mCRC diagnosis was recorded for 150 patients
Patients with at least one comorbidity
129 Participants
n=253 Participants • Data not available for all patients.
Number of comorbidities
0.8 comorbidities
STANDARD_DEVIATION 1.0 • n=253 Participants • Data not available for all patients.
Types of comorbidity
Treated hypertension
100 Participants
n=253 Participants • Data not available for all patients.
Types of comorbidity
Heart rhythm disorder
19 Participants
n=253 Participants • Data not available for all patients.
Types of comorbidity
Peripheral vascular disease
15 Participants
n=253 Participants • Data not available for all patients.
Types of comorbidity
Ischemic cardiac disorder
12 Participants
n=253 Participants • Data not available for all patients.
Types of comorbidity
Chronic pulmonary disease
12 Participants
n=253 Participants • Data not available for all patients.
Types of comorbidity
Rheumatic or connective tissue disease
12 Participants
n=253 Participants • Data not available for all patients.
Types of comorbidity
Diabetes mellitus with end-organ damage
9 Participants
n=253 Participants • Data not available for all patients.
Types of comorbidity
Moderate or severe liver disease
6 Participants
n=253 Participants • Data not available for all patients.
Types of comorbidity
Congestive heart failure
4 Participants
n=253 Participants • Data not available for all patients.
Types of comorbidity
Moderate or severe renal disease
4 Participants
n=253 Participants • Data not available for all patients.
Types of comorbidity
Cerebrovascular disease
1 Participants
n=253 Participants • Data not available for all patients.
Types of comorbidity
Acquired immunodeficiency syndrome (AIDS)
1 Participants
n=253 Participants • Data not available for all patients.
1st line therapy received for the mCRC
monotherapy +/- Targeted Therapy (TT)
17 Participants
n=255 Participants
1st line therapy received for the mCRC
Doublet chemotherapy (CT)
72 Participants
n=255 Participants
1st line therapy received for the mCRC
Doublet CT + TT
118 Participants
n=255 Participants
1st line therapy received for the mCRC
Triplet CT
8 Participants
n=255 Participants
1st line therapy received for the mCRC
Triplet CT + TT
40 Participants
n=255 Participants
Number of patients with at least one surgery for either CRC or mCRC
163 Participants
n=255 Participants
Number of patients receiving radiotherapy for CRC or mCRC
29 Participants
n=255 Participants
Number of patients with at least one SACT (Systemic anti-cancer therapy) treatment
40 Participants
n=254 Participants • Analysis done for 254 patients
RAS testing
Mutated
16 Participants
n=234 Participants • 234 patients had at least one RAS testing.
RAS testing
Wild type
217 Participants
n=234 Participants • 234 patients had at least one RAS testing.
RAS testing
Unknown
1 Participants
n=234 Participants • 234 patients had at least one RAS testing.
Method of RAS testing
Next generation sequencing (NGS)
89 Participants
n=230 Participants • 230 patients had this information available.
Method of RAS testing
Polymerase chain reaction (PCR)
81 Participants
n=230 Participants • 230 patients had this information available.
Method of RAS testing
Other
60 Participants
n=230 Participants • 230 patients had this information available.
Microsatellite instability (MSI) testing
MSI low
10 Participants
n=153 Participants • 153 patients had at least one MSI testing.
Microsatellite instability (MSI) testing
MSI stable
103 Participants
n=153 Participants • 153 patients had at least one MSI testing.
Microsatellite instability (MSI) testing
MSI high
36 Participants
n=153 Participants • 153 patients had at least one MSI testing.
Microsatellite instability (MSI) testing
MSI unknown
4 Participants
n=153 Participants • 153 patients had at least one MSI testing.
MMR gene (if MSI was measured)
dMMR
29 Participants
n=119 Participants • 119 patients had this information available.
MMR gene (if MSI was measured)
pMMR
90 Participants
n=119 Participants • 119 patients had this information available.
Serum albumin levels
10.17 g/dL
STANDARD_DEVIATION 14.43 • n=96 Participants • Data not available for all patients.
Hemoglobin levels
11.93 g/dL
STANDARD_DEVIATION 1.91 • n=167 Participants • Data not available for all patients.
Hemoglobin levels - normal/abnormal
Abnormal
79 Participants
n=167 Participants • Data not available for all patients.
Hemoglobin levels - normal/abnormal
Normal (between [12 ;16] g/dL)
88 Participants
n=167 Participants • Data not available for all patients.
Platelet levels
342.64 10^9 platelets/L
STANDARD_DEVIATION 142.86 • n=166 Participants • Data not available for all patients.
Leucocyte levels
9.07 10^9 cells/L
STANDARD_DEVIATION 3.33 • n=165 Participants • Data not available for all patients.
Neutrophil (absolute count)
6.19 10^9 cells/L
STANDARD_DEVIATION 2.96 • n=151 Participants • Data not available for all patients.
Neutrophil (differential count)
67.75 percentage of total blood cells
STANDARD_DEVIATION 11.77 • n=145 Participants • Data not available for all patients.
C-reactive protein levels
13.99 mg/L
STANDARD_DEVIATION 12.45 • n=61 Participants • This data was not available for all patients.
Carcinoembryonic antigen (CEA) levels
16.20 ng/mL
STANDARD_DEVIATION 18.46 • n=109 Participants • This data was not available for all patients.
Carbohydrate antigen 19-9 (CA 19.9) levels
149.18 U/mL
STANDARD_DEVIATION 220.75 • n=79 Participants • This data was not available for all patients.

PRIMARY outcome

Timeframe: time from treatment initiation (for mCRC) up to 31 December 2020

Population: \*treated as doublet CT + anti-EGFR for analysis.

First-line SACT treatment patterns in BRAFV600E mutant mCRC patients described by agent or combination of agents received

Outcome measures

Outcome measures
Measure
Non Interventional
n=255 Participants
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT + TT : Doublet CT + anti-VEGF : FOLFIRI / Aflibercept
2 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT + TT : Doublet CT + anti-VEGF : FOLFIRI / Bevacizumab
20 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT + TT : Doublet CT + anti-VEGF : FOLFOX / Bevacizumab
69 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT + TT : Doublet CT + anti-EGFR
19 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT + TT : Doublet CT + anti-EGFR : FOLFIRI / Cetuximab
3 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT + TT : Doublet CT + anti-EGFR : FOLFIRI / Panitumumab
2 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT + TT : Doublet CT + anti-EGFR : Tomiri / Panitumumab
1 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT + TT : Doublet CT + anti-EGFR : FOLFOX / Cetuximab
5 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT + TT : Doublet CT + anti-EGFR : FOLFOX / Panitumumab
7 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT + TT : Doublet CT + anti-EGFR : FOLFOX / Cetuximab + Avelumab*
1 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Triplet CT
8 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Triplet CT : : FOLFIRINOX
2 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Triplet CT : : FOLFOXIRI
6 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Triplet CT + TT
40 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Triplet CT + TT : Triplet + anti-VEGF
38 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Triplet CT + TT : Triplet + anti-VEGF : FOLFIRINOX / Bevacizumab
4 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Triplet CT + TT : Triplet + anti-VEGF : FOLFOXIRI / Bevacizumab
34 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Triplet CT + TT : Triplet + anti-EGFR
2 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Triplet CT + TT : Triplet + anti-EGFR : FOLFOXIRI / Cetuximab
1 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Triplet CT + TT : Triplet + anti-EGFR : FOLFOXIRI / Panitumumab
1 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet chemotherapy (CT)
72 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Monotherapy +/- targetted therapy (TT)
17 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Monotherapy +/- TT : : Fluropyrimidine monotherapy
6 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Monotherapy +/- TT : : Fluropyrimidine monotherapy / Bevacizumab
10 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Monotherapy +/- TT : : Fluropyrimidine monotherapy / Panitumumab
1 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT : : CAPOX
11 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT : : FOLFIRI
7 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT : : FOLFOX
49 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT : : Fluoropyrimidine + (Irinotecan or Folic Acid)
3 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT : : XELIRI
2 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT + TT
118 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT + TT : Doublet CT + anti-VEGF
99 Participants
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Doublet CT + TT : Doublet CT + anti-VEGF : CAPOX / Bevacizumab
8 Participants

PRIMARY outcome

Timeframe: time from treatment initiation (for mCRC) up to 31 December 2020

Population: A total of 255 patients were included in the full analysis set (FAS). Data for 2 patients were not available.

First-line SACT treatment patterns in BRAFV600E mutant mCRC patients described by Duration of Treatment

Outcome measures

Outcome measures
Measure
Non Interventional
n=253 Participants
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Duration of Treatment for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
6.04 months
Standard Deviation 5.79

PRIMARY outcome

Timeframe: time from treatment initiation (for mCRC) up to 31 December 2020

Switch in mCRC first-line SACT treatment in BRAFV600E mutant mCRC patients.

Outcome measures

Outcome measures
Measure
Non Interventional
n=255 Participants
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Reason for switch: toxicity
24 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Reason for switch: lack of response
13 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Reason for switch: other
13 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch to: FOLFOX
21 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch to: CAPOX
1 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch to: FOLFIRI
16 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch to: Fluoropyrimidine monotherapy
27 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch to: FOLFOXIRI
4 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch to: FOLFIRINOX
3 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch to: BRAFi + Other
1 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
If switch with FOLFOX, CAPOX, FOLFIRI, Fluoropyrimidine or FOLFIXIRI -
53 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
- then, in combination with: Panitumumab
4 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
- then, in combination with: Cetuximab
1 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
- then, in combination with: Bevacizumab
48 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: CAPOX / Bevacizumab
1 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: FOLFIRI
6 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: FOLFIRI / Bevacizumab
8 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: FOLFIRI / Cetuximab
1 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: FOLFIRI / Panitumumab
1 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: FOLFIRINOX
2 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: FOLFIRINOX / Bevacizumab
1 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: FOLFOX
6 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: FOLFOX / Bevacizumab
14 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: FOLFOX / Panitumumab
1 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: FOLFOXIRI / Bevacizumab
4 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: Tomiri
1 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch to other treatment
80 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch to other treatment: maintenance
30 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch to: Tomiri
1 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch to: Fluoropyrimidine + (Leucovorin or Folinic Acid)
2 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch to: Other
4 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: BRAFi + Other
1 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: Fluoropyrimidine monotherapy
6 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: Fluoropyrimidine monotherapy / Bevacizumab
19 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: Fluoropyrimidine monotherapy / Panitumumab
2 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: Fluoropyrimidine + (Leucovorin or Folinic Acid)
1 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: Fluoropyrimidine + (Leucovorin or Folinic Acid) / Bevacizumab
1 Participants
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch regiment: Other
4 Participants

SECONDARY outcome

Timeframe: from the date of the start of first-line treatment for mCRC up to 31 December 2020

Population: Disease stage at initial diagnosis of CRC by first line treatment regimen Data were available for 226 of the 255 patients included in the FAS

Description of the demographic and clinical profile of patients at the time of treatment initiation (for mCRC) TNM stage of colorectal cancer. Stage I: Cancer is still in the inner lining, but has grown through the mucosa of the colon and invaded the muscle layer. Stage II: The cancer has grown beyond the mucosa of the colon but has not spread to the lymph nodes Stage III: The cancer has spread to the lymph nodes near the colon, it has not spread further. Stage IV: The cancer has spread outside of the colon and has been carried through the lymph and blood systems to distant parts of the body, this is known as metastasis.

Outcome measures

Outcome measures
Measure
Non Interventional
n=226 Participants
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Demographic and Clinical Characteristics
Doublet CT · TNM Stage IV
41 Participants
Demographic and Clinical Characteristics
Triplet CT · TNM Stage I
0 Participants
Demographic and Clinical Characteristics
Monotherapy +/- TT · TNM Stage I
0 Participants
Demographic and Clinical Characteristics
Monotherapy +/- TT · TNM Stage II
3 Participants
Demographic and Clinical Characteristics
Monotherapy +/- TT · TNM Stage III
4 Participants
Demographic and Clinical Characteristics
Monotherapy +/- TT · TNM Stage IV
8 Participants
Demographic and Clinical Characteristics
Doublet CT · TNM Stage I
1 Participants
Demographic and Clinical Characteristics
Doublet CT · TNM Stage II
7 Participants
Demographic and Clinical Characteristics
Doublet CT · TNM Stage III
10 Participants
Demographic and Clinical Characteristics
Doublet CT + TT · TNM Stage I
2 Participants
Demographic and Clinical Characteristics
Doublet CT + TT · TNM Stage II
10 Participants
Demographic and Clinical Characteristics
Doublet CT + TT · TNM Stage III
26 Participants
Demographic and Clinical Characteristics
Doublet CT + TT · TNM Stage IV
75 Participants
Demographic and Clinical Characteristics
Triplet CT · TNM Stage III
2 Participants
Demographic and Clinical Characteristics
Triplet CT · TNM Stage IV
4 Participants
Demographic and Clinical Characteristics
Triplet CT + TT · TNM Stage I
1 Participants
Demographic and Clinical Characteristics
Triplet CT + TT · TNM Stage II
4 Participants
Demographic and Clinical Characteristics
Triplet CT + TT · TNM Stage III
6 Participants
Demographic and Clinical Characteristics
Triplet CT + TT · TNM Stage IV
22 Participants
Demographic and Clinical Characteristics
Triplet CT · TNM Stage II
0 Participants

SECONDARY outcome

Timeframe: from the date of the start of first-line treatment for mCRC up to 31 December 2020

the length of time between initiation of first-line treatment for mCRC and the first documented disease progression or death. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure
Non Interventional
n=255 Participants
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Progression-free Survival (PFS)
5.98 months
Interval 5.32 to 6.67

SECONDARY outcome

Timeframe: from the date of the start of first-line treatment for mCRC up to 31 December 2020

length of time between first-line treatment initiation (for mCRC) and death (due to any cause)

Outcome measures

Outcome measures
Measure
Non Interventional
n=255 Participants
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Overall Survival (OS)
12.68 months
Interval 11.6 to 14.13

SECONDARY outcome

Timeframe: from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020

Population: Data were available for 221 of the 255 patients included in the FAS

complete response (CR) or partial response (PR), during the first line treatment Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Outcome measures
Measure
Non Interventional
n=221 Participants
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Overall Response Rate (ORR)
37.1 percentage of participants
Interval 30.7 to 43.5

SECONDARY outcome

Timeframe: from the date of the start of first-line treatment for mCRC until the documented disease progression up to 31 December 2020

the length of time between initiation of first-line treatment for mCRC and documented disease progression (or start of subsequent Line Of Treatment (LOT), if disease progression is not well documented in patient medical record), treatment discontinuation or switch to another treatment (defined as change from one treatment regimen to another treatment regimen, e.g., change from FOLFOX-based regimen to FOLFIRI or irinotecan-based regimen)

Outcome measures

Outcome measures
Measure
Non Interventional
n=255 Participants
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Time to Treatment Cessation
4.83 months
Interval 4.01 to 5.32

SECONDARY outcome

Timeframe: from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020

Population: Data not available for all patients.

Description of testing procedures of BRAF mutation testing since mCRC diagnosis and since first-line treatment for mCRC

Outcome measures

Outcome measures
Measure
Non Interventional
n=255 Participants
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
If tumor sample, tumor sample tested: archival
175 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
If tumor sample, tumor sample tested: fresh
53 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Method used: PCR
104 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Method used: NGS
86 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Method used: Other
10 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Method used: high resolution melting
4 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Method used: mass spectrometry
22 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Number of BRAF testing: 1
244 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Number of BRAF testing: 2
11 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Timing of 1st BRAF testing: before 1L (2 to 38 months before 1st line initiation)
62 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Timing of 1st BRAF testing: before 1L (less than 2 months before 1st line initiation)
140 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Timing of 1st BRAF testing: during 1L
21 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Timing of 1st BRAF testing: after 1L and before 2L
1 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Timing of 1st BRAF testing: during 2L
1 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
BRAF test sample: tumor sample
252 Participants
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
BRAF test sample: ctDNA
3 Participants

SECONDARY outcome

Timeframe: from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020

Population: Data not available for all patients.

Time to BRAF mutation testing since mCRC diagnosis and since first-line treatment for mCRC

Outcome measures

Outcome measures
Measure
Non Interventional
n=255 Participants
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Description of BRAF Mutation Testing Timing in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Time from metastatic diagnosis to 1st BRAF mutation testing (if after metastatic diagnosis)
0.6 months
Standard Error 1.7
Description of BRAF Mutation Testing Timing in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Time from metastatic diagnosis to 1st BRAF mutation testing (if before metastatic diagnosis)
6.1 months
Standard Error 7.9

OTHER_PRE_SPECIFIED outcome

Timeframe: from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020

Population: \*due to other reasons than progression or toxicity.

Description of reasons for alteration or discontinuation of first-line treatment for mCRC in BRAFV600E Mutant mCRC Patients

Outcome measures

Outcome measures
Measure
Non Interventional
n=255 Participants
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Patient with treatment alteration
137 Participants
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Most important reason for treatment alteration: Planned alteration
10 Participants
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Most important reason for treatment alteration: Toxicity
100 Participants
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Most important reason for treatment alteration: Poor performance status of patient
6 Participants
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Most important reason for treatment alteration: Other
16 Participants
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Patient with treatment discontinuation
248 Participants
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Most important reason for treatment discontinuation: Progression
158 Participants
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Most important reason for treatment discontinuation: Toxicity
19 Participants
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Most important reason for treatment discontinuation: BRAF test available
5 Participants
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Most important reason for treatment discontinuation: Planned discontinuation
21 Participants
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Most important reason for treatment discontinuation: Patient choice
6 Participants
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Most important reason for treatment discontinuation: Poor performance status of patient
16 Participants
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Most important reason for treatment discontinuation: Death*
4 Participants
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients
Most important reason for treatment discontinuation: Other
9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020

Population: Not all patients went through all lines of treatment.

Description of the types of treatments after first-line SACT treatment (2nd-line to 7th-line) in BRAFV600E Mutant mCRC Patients.

Outcome measures

Outcome measures
Measure
Non Interventional
n=255 Participants
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · BRAFi / Cetuximab
7 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · BRAFi / Cetuximab + Irinotecan
4 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · BRAFi / MEKi / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · CAPOX
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · Cetuximab monotherapy
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · FOLFIRI
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · FOLFIRI / Aflibercept
4 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · FOLFIRI / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · FOLFIRI / Cetuximab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · FOLFIRI / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · FOLFOX
4 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · FOLFOX / Bevacizumab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · FOLFOX / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · FOLFOX / Panitumumab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · FOLFOXIRI
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · BRAFi+ Fluoropyrimidine + (Leucovorin or Folinic Acid) / Cetuximab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · BRAFi / MEKi / Cetuximab
16 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · BRAFi / MEKi / Panitumumab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · CAPOX
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · Cetuximab monotherapy
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · FOLFIRI
19 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · FOLFIRI / Aflibercept
7 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · FOLFIRI / Bevacizumab
20 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · FOLFIRI / Cetuximab
8 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · FOLFIRI / Panitumumab
5 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · FOLFOX
4 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · FOLFIRI / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · FOLFOX
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · FOLFOX / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · FOLFOX / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · FOLFOX / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · FOLFOXIRI
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · FOLFOX / Bevacizumab
7 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · FOLFOX / Cetuximab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · FOLFOX / Panitumumab
3 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · FOLFOXIRI
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · FOLFOXIRI / Bevacizumab
6 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · Fluoropyrimidine monotherapy
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · Fluoropyrimidine monotherapy / Bevacizumab
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · Fluoropyrimidine + (Leucovorin or Folinic Acid)
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · FOLFOXIRI / Bevacizumab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · Fluoropyrimidine + (Leucovorin or Folinic Acid) / Cetuximab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · Irinotecan
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · Irinotecan / Cetuximab
4 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · Irinotecan / Panitumumab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · Other
7 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · Panitumumab monotherapy
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · XELIRI / Bevacizumab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · BRAFi
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · Fluoropyrimidine monotherapy / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · Fluoropyrimidine + (Leucovorin or Folinic Acid) / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · BRAFi / Cetuximab
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · BRAFi / Cetuximab + Irinotecan
5 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · Fluoropyrimidine monotherapy
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · Fluoropyrimidine monotherapy / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · Fluoropyrimidine + (Leucovorin or Folinic Acid)
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · BRAFi+ Fluoropyrimidine + (Leucovorin or Folinic Acid) / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · BRAFi / MEKi / Cetuximab
6 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · BRAFi / MEKi / Panitumumab
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · CAPOX
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · Cetuximab monotherapy
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · FOLFIRI
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · FOLFIRI / Aflibercept
4 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · FOLFIRI / Bevacizumab
9 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · FOLFIRI / Cetuximab
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · FOLFIRI / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · FOLFOX
4 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · FOLFOX / Bevacizumab
5 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · FOLFOX / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · FOLFOX / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · FOLFOXIRI
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · FOLFOXIRI / Bevacizumab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · Fluoropyrimidine monotherapy
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · Fluoropyrimidine monotherapy / Bevacizumab
3 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · Fluoropyrimidine + (Leucovorin or Folinic Acid)
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · Fluoropyrimidine + (Leucovorin or Folinic Acid) / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · Irinotecan
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · Irinotecan / Cetuximab
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · Irinotecan / Panitumumab
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · Other
20 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · Panitumumab monotherapy
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · XELIRI / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · BRAFi
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · CAPOX / Bevacizumab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · Fluoropyrimidine monotherapy / Panitumumab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
3rd · Fluoropyrimidine + (Leucovorin or Folinic Acid) / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · BRAFi / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · BRAFi / Cetuximab + Irinotecan
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · BRAFi+ Fluoropyrimidine + (Leucovorin or Folinic Acid) / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · BRAFi / MEKi / Cetuximab
3 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · BRAFi+ Fluoropyrimidine + (Leucovorin or Folinic Acid) / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · BRAFi / MEKi / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · BRAFi / MEKi / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · CAPOX
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · Cetuximab monotherapy
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · FOLFIRI
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · FOLFIRI / Aflibercept
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · FOLFIRI / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · FOLFIRI / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · FOLFIRI / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · FOLFOX
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · FOLFOX / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · FOLFOX / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · FOLFOX / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · FOLFOXIRI
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · FOLFOXIRI / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · Fluoropyrimidine monotherapy
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · Fluoropyrimidine monotherapy / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · Fluoropyrimidine + (Leucovorin or Folinic Acid)
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · Fluoropyrimidine + (Leucovorin or Folinic Acid) / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · Irinotecan
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · Irinotecan / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · Irinotecan / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · Other
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · Panitumumab monotherapy
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · XELIRI / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · BRAFi
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · CAPOX / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · Fluoropyrimidine monotherapy / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · Fluoropyrimidine + (Leucovorin or Folinic Acid) / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · Fluoropyrimidine + (Leucovorin or Folinic Acid) / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · Irinotecan
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · Irinotecan / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · Other
15 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · Panitumumab monotherapy
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · XELIRI / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · BRAFi
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · CAPOX / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · Fluoropyrimidine + (Leucovorin or Folinic Acid) / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · BRAFi / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · BRAFi / Cetuximab + Irinotecan
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · BRAFi+ Fluoropyrimidine + (Leucovorin or Folinic Acid) / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · BRAFi / MEKi / Cetuximab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · BRAFi / MEKi / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · CAPOX
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · Cetuximab monotherapy
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · FOLFIRI / Aflibercept
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · FOLFIRI / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · FOLFIRI / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · FOLFIRI / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · FOLFOX
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · FOLFOX / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · FOLFOX / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · FOLFOX / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · FOLFOXIRI
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · FOLFOXIRI / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · Fluoropyrimidine monotherapy
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · Fluoropyrimidine monotherapy / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · Fluoropyrimidine + (Leucovorin or Folinic Acid)
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · Fluoropyrimidine + (Leucovorin or Folinic Acid) / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · Irinotecan
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · Irinotecan / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · Irinotecan / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · FOLFOXIRI / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · Fluoropyrimidine monotherapy
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · Fluoropyrimidine monotherapy / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · Fluoropyrimidine + (Leucovorin or Folinic Acid)
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · Fluoropyrimidine + (Leucovorin or Folinic Acid) / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · Irinotecan
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · Irinotecan / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · Irinotecan / Panitumumab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · Other
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · Panitumumab monotherapy
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · XELIRI / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · Fluoropyrimidine monotherapy / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · Fluoropyrimidine + (Leucovorin or Folinic Acid) / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · BRAFi / Cetuximab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
7th line · BRAFi / Cetuximab + Irinotecan
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
2nd · CAPOX / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · Irinotecan / Cetuximab
2 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
4th line · Fluoropyrimidine monotherapy / Panitumumab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · FOLFIRI
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · Other
8 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · Panitumumab monotherapy
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · CAPOX / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · Fluoropyrimidine monotherapy / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · CAPOX
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · FOLFIRI / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · BRAFi
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · CAPOX / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · XELIRI / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · BRAFi
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · FOLFIRI / Bevacizumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
5th line · Fluoropyrimidine + (Leucovorin or Folinic Acid) / Bevacizumab
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · BRAFi / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · BRAFi / Cetuximab + Irinotecan
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · BRAFi+ Fluoropyrimidine + (Leucovorin or Folinic Acid) / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · BRAFi / MEKi / Cetuximab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · BRAFi / MEKi / Panitumumab
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · Cetuximab monotherapy
1 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · FOLFIRI
0 Participants
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients
6th line · FOLFIRI / Aflibercept
0 Participants

Adverse Events

Non Interventional

Serious events: 40 serious events
Other events: 104 other events
Deaths: 206 deaths

Serious adverse events

Serious adverse events
Measure
Non Interventional
n=255 participants at risk
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Blood and lymphatic system disorders
Blood and lymphatic system disorders
2.7%
7/255 • Number of events 9 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Cardiac disorders
Cardiac disorders
0.78%
2/255 • Number of events 2 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Gastrointestinal disorders
Gastrointestinal disorders
7.1%
18/255 • Number of events 26 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
General disorders
General disorders and administration site conditions
1.6%
4/255 • Number of events 4 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Hepatobiliary disorders
Hepatobiliary disorders
1.2%
3/255 • Number of events 3 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Immune system disorders
Immune system disorders
0.39%
1/255 • Number of events 1 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Infections and infestations
Infections and infestations
1.2%
3/255 • Number of events 4 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
0.39%
1/255 • Number of events 1 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Investigations
Investigations
0.39%
1/255 • Number of events 1 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Metabolism and nutrition disorders
Metabolism and nutrition disorders
1.6%
4/255 • Number of events 5 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Nervous system disorders
Nervous system disorders
0.39%
1/255 • Number of events 1 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Renal and urinary disorders
Renal and urinary disorders
1.2%
3/255 • Number of events 4 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
0.78%
2/255 • Number of events 2 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Vascular disorders
Vascular disorders
0.78%
2/255 • Number of events 2 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).

Other adverse events

Other adverse events
Measure
Non Interventional
n=255 participants at risk
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country Non Interventional study: Non Interventional study
Blood and lymphatic system disorders
Blood and lymphatic system disorders
9.0%
23/255 • Number of events 24 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Cardiac disorders
Cardiac disorders
0.39%
1/255 • Number of events 1 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Gastrointestinal disorders
Gastrointestinal disorders
14.5%
37/255 • Number of events 51 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
General disorders
General disorders and administration site conditions
9.8%
25/255 • Number of events 28 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Hepatobiliary disorders
Hepatobiliary disorders
0.78%
2/255 • Number of events 2 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Immune system disorders
Immune system disorders
0.39%
1/255 • Number of events 1 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Infections and infestations
Infections and infestations
0.39%
1/255 • Number of events 1 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
0.39%
1/255 • Number of events 1 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Investigations
Investigations
0.78%
2/255 • Number of events 2 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Metabolism and nutrition disorders
Metabolism and nutrition disorders
1.2%
3/255 • Number of events 3 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
0.78%
2/255 • Number of events 2 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Nervous system disorders
Nervous system disorders
16.5%
42/255 • Number of events 44 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Renal and urinary disorders
Renal and urinary disorder
0.39%
1/255 • Number of events 1 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal
2.4%
6/255 • Number of events 6 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
5.1%
13/255 • Number of events 15 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).
Vascular disorders
Vascular disorders
1.6%
4/255 • Number of events 4 • Time from treatment initiation (for mCRC) up to 31 December 2020
Since this is a retrospective study only relevant adverse events (AEs) have been collected. Definition of relevant AE: AE leading to first-line treatment switch, dose adaptation or discontinuation, or leading to death. Relevant AEs were assessed by System Organ Class (SOC).

Additional Information

Project leader

Pierre Fabre

Phone: +33(0)1 49 10 81 84

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place