Trial Outcomes & Findings for FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine (NCT NCT02827201)
NCT ID: NCT02827201
Last Updated: 2024-07-09
Results Overview
The primary endpoint was the rate of patients alive and progression-free 6 months after randomization. Progression was assessed by the investigator and defined radiologically according to RECIST v1.1 criteria and/or clinically as deterioration of general condition not related to treatment, palpable tumor masses on clinical examination (adenopathy, tumor hepatomegaly, peritoneal carcinosis), pleural effusion, ascites. Patients who progressed or died before 6 months were considered to have failed the primary endpoint at 6 months. The 6-month imaging was the imaging done at 6 months with a +/- 1 month window.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
127 participants
Primary outcome timeframe
6 months after randomization
Results posted on
2024-07-09
Participant Flow
Between November 2015 and November 2016, 127 patients were enrolled in the trial by 36 french centres .
Participant milestones
| Measure |
Nab-paclitaxel + Gemcitabine/FOLFIRI.3
Alternance of :
* 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free)
* follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression
FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
Nab-paclitaxel + Gemcitabine
nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
|
Overall Study
COMPLETED
|
62
|
60
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Nab-paclitaxel + Gemcitabine/FOLFIRI.3
Alternance of :
* 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free)
* follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression
FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
Nab-paclitaxel + Gemcitabine
nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Patients not treated
|
1
|
1
|
Baseline Characteristics
FIrst Line Treatment of Metastatic Pancreatic Cancer: Sequential Nab-paclitaxel + Gemcitabine/FOLFIRI.3 VS Nab-paclitaxel + Gemcitabine
Baseline characteristics by cohort
| Measure |
Nab-paclitaxel + Gemcitabine/FOLFIRI.3
n=64 Participants
Alternance of :
* 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free)
* follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression
FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
Nab-paclitaxel + Gemcitabine
n=63 Participants
nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Age, Continuous
|
65.20 years
n=99 Participants
|
65.99 years
n=107 Participants
|
65.33 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
64 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Region of Enrollment
France
|
64 participants
n=99 Participants
|
63 participants
n=107 Participants
|
127 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 months after randomizationPopulation: The primary endpoint was analysed on the mITT population meaning all the randomized patients with at least one dose of study drug taken
The primary endpoint was the rate of patients alive and progression-free 6 months after randomization. Progression was assessed by the investigator and defined radiologically according to RECIST v1.1 criteria and/or clinically as deterioration of general condition not related to treatment, palpable tumor masses on clinical examination (adenopathy, tumor hepatomegaly, peritoneal carcinosis), pleural effusion, ascites. Patients who progressed or died before 6 months were considered to have failed the primary endpoint at 6 months. The 6-month imaging was the imaging done at 6 months with a +/- 1 month window.
Outcome measures
| Measure |
Nab-paclitaxel + Gemcitabine/FOLFIRI.3
n=62 Participants
Alternance of :
* 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free)
* follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression
FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
Nab-paclitaxel + Gemcitabine
n=60 Participants
nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
|---|---|---|
|
Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization
|
28 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years after the treatment startPopulation: Endpoint was analyzed on the ITT population
Overall survival was defined as the time from the date of randomization to the patient's death (all causes). For alive patients, the date of last news was taken into account
Outcome measures
| Measure |
Nab-paclitaxel + Gemcitabine/FOLFIRI.3
n=64 Participants
Alternance of :
* 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free)
* follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression
FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
Nab-paclitaxel + Gemcitabine
n=63 Participants
nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
|---|---|---|
|
Overall Survival (OS):
|
11.71 months
Interval 7.92 to 14.55
|
10.94 months
Interval 8.18 to 12.39
|
SECONDARY outcome
Timeframe: Up to the end of treatment on the average of 12 monthsPopulation: Endpoint was analysed on mITT population meaning all randomized patients having at least one dose of treatment
Best response is defined as the best response for each patient regarding imagerie taken during the treatment. Response was evalauted according to RECIST v1.1 over the entire treatment period according the investigator
Outcome measures
| Measure |
Nab-paclitaxel + Gemcitabine/FOLFIRI.3
n=62 Participants
Alternance of :
* 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free)
* follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression
FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
Nab-paclitaxel + Gemcitabine
n=60 Participants
nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
|---|---|---|
|
Best Response
Death without any imagery
|
12 Participants
|
5 Participants
|
|
Best Response
Complete response
|
1 Participants
|
0 Participants
|
|
Best Response
Partial Response
|
24 Participants
|
16 Participants
|
|
Best Response
Stability
|
20 Participants
|
26 Participants
|
|
Best Response
Progression
|
5 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: up to 12 months after randomizationIt was defined as the time between t randomization and the date of the first radiological progression (RECIST 1.1 criteria) and/or clinical progression according to the investigator or death (whatever the cause is); Patients alive without progression were censored at date of last news
Outcome measures
| Measure |
Nab-paclitaxel + Gemcitabine/FOLFIRI.3
n=64 Participants
Alternance of :
* 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free)
* follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression
FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
Nab-paclitaxel + Gemcitabine
n=63 Participants
nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
5.72 months
Interval 3.68 to 7.59
|
4.21 months
Interval 2.43 to 6.01
|
Adverse Events
Nab-paclitaxel + Gemcitabine/FOLFIRI.3
Serious events: 30 serious events
Other events: 63 other events
Deaths: 53 deaths
Nab-paclitaxel + Gemcitabine
Serious events: 19 serious events
Other events: 58 other events
Deaths: 54 deaths
Serious adverse events
| Measure |
Nab-paclitaxel + Gemcitabine/FOLFIRI.3
n=64 participants at risk
Alternance of :
* 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free)
* follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression
FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
Nab-paclitaxel + Gemcitabine
n=58 participants at risk
nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
3.4%
2/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Nervous system disorders
Transient Ischemic Attack
|
1.6%
1/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
0.00%
0/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
5/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
1.7%
1/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Blood and lymphatic system disorders
Hypocellular bone marrow
|
3.1%
2/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
1.7%
1/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Vascular disorders
Venous thromboembolic event
|
1.6%
1/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
3.4%
2/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Vascular disorders
Thromboembolic event
|
1.6%
1/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
1.7%
1/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Infections and infestations
Catheter infection
|
6.2%
4/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
3.4%
2/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Hepatobiliary disorders
Biliary tract infection
|
3.1%
2/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
3.4%
2/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Infections and infestations
Septicemia
|
7.8%
5/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
10.3%
6/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Metabolism and nutrition disorders
Hypokaliemia
|
4.7%
3/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
0.00%
0/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
General disorders
Multivisceral failure
|
1.6%
1/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
0.00%
0/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
General disorders
Fatigue
|
7.8%
5/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
8.6%
5/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
General disorders
Thrills
|
0.00%
0/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
3.4%
2/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
Other adverse events
| Measure |
Nab-paclitaxel + Gemcitabine/FOLFIRI.3
n=64 participants at risk
Alternance of :
* 2 months with nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m², 30 min in IV, 3 injections follow by 1 week free)
* follow by 2 months with FOLFIRI.3 (irinotecan: 90 mg/m² at D1, acid folinic 400 mg/m², 5Fu continus: 2000 mg/m² IV 46 hours, and irinotecan at D3, 90 mg/m²) This alternance continus until progression
FOLFIRI.3: For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
Nab-paclitaxel + Gemcitabine
n=58 participants at risk
nab-paclitaxel (125 g/m² - 30 min in IV) + gemcitabine (1000 mg/m² - 30 min in IV) 3 injections follow by 1 week free, until progression
nab-paclitaxel+ gemcitabine: For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
7.8%
5/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
1.7%
1/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
48.4%
31/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
55.2%
32/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Skin and subcutaneous tissue disorders
Palmo-palmar syndrome
|
12.5%
8/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
5.2%
3/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Immune system disorders
Allergic reaction
|
9.4%
6/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
6.9%
4/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Nervous system disorders
Cephalgia
|
6.2%
4/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
12.1%
7/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Nervous system disorders
Paresthesia
|
34.4%
22/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
39.7%
23/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Nervous system disorders
Dysgueusia
|
7.8%
5/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
8.6%
5/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Gastrointestinal disorders
Constipation
|
23.4%
15/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
31.0%
18/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Gastrointestinal disorders
Diarrhea
|
70.3%
45/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
60.3%
35/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Gastrointestinal disorders
Mucitis
|
21.9%
14/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
20.7%
12/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Gastrointestinal disorders
Nausea
|
65.6%
42/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
51.7%
30/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Gastrointestinal disorders
Vomiting
|
46.9%
30/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
36.2%
21/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Gastrointestinal disorders
Abdominal pain
|
39.1%
25/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
27.6%
16/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Blood and lymphatic system disorders
Anemia
|
90.6%
58/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
94.8%
55/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Nervous system disorders
Sensitive neuropathie peripheral
|
23.4%
15/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
27.6%
16/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.4%
6/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
5.2%
3/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Vascular disorders
Venous thromboembolic event
|
15.6%
10/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
10.3%
6/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
Metabolism and nutrition disorders
Anorexia
|
59.4%
38/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
44.8%
26/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
General disorders
Fatigue
|
89.1%
57/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
84.5%
49/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
General disorders
Fever
|
37.5%
24/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
31.0%
18/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
|
General disorders
Inferior members oedema
|
25.0%
16/64 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
|
24.1%
14/58 • Both deaths and adverse events were assessed up to 2 years
Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. Two patients randomized in the Nab-paclitaxel + Gemcitabine arm received Nab-paclitaxel + Gemcitabine - Folfiri. So, these patient wereanalyzed in the Nab-paclitaxel + Gemcitabine/FOLFIRI.3 arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
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Additional Information
Karine Le Malicot
Fédération Francophone de Cancérologie Digestive
Phone: +33 3 80 39 34 79
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place