Trial Outcomes & Findings for Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study (NCT NCT04539327)
NCT ID: NCT04539327
Last Updated: 2026-03-18
Results Overview
Rucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching). Rucaparib drug exposure in months Patient 14-001 has been eliminated for not following the treatment scheme
COMPLETED
51 participants
0-24 months
2026-03-18
Participant Flow
Participant milestones
| Measure |
Rucaparib - Treatment
The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
18
|
|
Overall Study
COMPLETED
|
33
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Weight data from all particpants could not be retrieved
Baseline characteristics by cohort
| Measure |
Rucaparib - Treatment
n=33 Participants
The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib Maintenance
n=18 Participants
The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 11.8 • n=33 Participants
|
65.9 years
STANDARD_DEVIATION 9.3 • n=18 Participants
|
62.4 years
STANDARD_DEVIATION 11.2 • n=51 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=33 Participants
|
18 Participants
n=18 Participants
|
51 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=33 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=33 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=33 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=33 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=33 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=33 Participants
|
18 Participants
n=18 Participants
|
51 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=33 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=33 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=51 Participants
|
|
Region of Enrollment
Spain
|
33 Participants
n=33 Participants
|
18 Participants
n=18 Participants
|
51 Participants
n=51 Participants
|
|
Existence of measurable disease before treatment
|
28 Participants
n=33 Participants
|
9 Participants
n=18 Participants
|
37 Participants
n=51 Participants
|
|
ECOG
0
|
12 Participants
n=33 Participants
|
7 Participants
n=18 Participants
|
19 Participants
n=51 Participants
|
|
ECOG
1
|
15 Participants
n=33 Participants
|
10 Participants
n=18 Participants
|
25 Participants
n=51 Participants
|
|
ECOG
2
|
3 Participants
n=33 Participants
|
0 Participants
n=18 Participants
|
3 Participants
n=51 Participants
|
|
ECOG
UNK
|
3 Participants
n=33 Participants
|
1 Participants
n=18 Participants
|
4 Participants
n=51 Participants
|
|
Weight
|
61 Kilograms
STANDARD_DEVIATION 12.2 • n=30 Participants • Weight data from all particpants could not be retrieved
|
66.2 Kilograms
STANDARD_DEVIATION 14.2 • n=16 Participants • Weight data from all particpants could not be retrieved
|
62.8 Kilograms
STANDARD_DEVIATION 13 • n=46 Participants • Weight data from all particpants could not be retrieved
|
|
Brain metastasis
|
0 participants
n=33 Participants
|
1 participants
n=18 Participants
|
1 participants
n=51 Participants
|
|
Relevant comorbidities
|
15 Participants
n=33 Participants
|
12 Participants
n=18 Participants
|
27 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: 0 months - Measurements were done at baselinePatient characteristics and medical history Detected diseases include: arterial hypertension, diabetes melliutus, COPD, ischemic cardiomyopathy, cerebrovascular disease, obesity, etc. Measurements were done at baseline
Outcome measures
| Measure |
Rucaparib - Treatment
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Number of Participants With Relevant Co-morbidities
|
15 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 0 months - Measurements were done at baselinePatient characteristics and medical history. Descriptive statistics: Other cancers present during trial including endometrial, breast , colorrectal, lung or other cancers Measurements were done at baseline
Outcome measures
| Measure |
Rucaparib - Treatment
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Other Previous Cancers?
|
8 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 0 months - Measurements were done at baselinePatient characteristics and medical history Family history of other cancers including ovarian, breast and others Measurements were done at baseline
Outcome measures
| Measure |
Rucaparib - Treatment
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Family History of Cancers?
|
22 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 0 months - Measurements were done at baselineStage = tumor size and location; higher stage = more spread metastasis I Tumor confined to the corpus uteri IA No or less than half myometrial invasion IB Invasion equal to or more than half of the myometrium IC IA+IB + ascites IC1 surgical spill IC2 Capsule rupture before surgery or tumor on ovarian surface II Tumor invades cervical stroma, but does not extend beyond the uterus III Local and/or regional spread of the tumor IIIA Tumor invades the serosa of the corpus uteri and/or adnexae IIIA2 involvement of uterine subserosa or spread through uterine serosa IIIB Vaginal involvement and/or parametrial involvement IIIC Metastases to pelvic and/or para-aortic lymph nodes IIIC1 Positive pelvic nodes IIIC2 Positive para-aortic nodes with or without positive pelvic lymph nodes IV Tumor invades bladder and/or bowel mucosa, and/or distant metastases IVA Tumor invasion of bladder and/or bowel mucosa IVB Distant metastasis (intra-abdominal metastases and/or inguinal nodes)
Outcome measures
| Measure |
Rucaparib - Treatment
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
FIGO STAGE
IB
|
0 Participants
|
1 Participants
|
|
FIGO STAGE
IC1
|
0 Participants
|
1 Participants
|
|
FIGO STAGE
IC2
|
1 Participants
|
0 Participants
|
|
FIGO STAGE
IIIA2
|
1 Participants
|
0 Participants
|
|
FIGO STAGE
IIIB
|
2 Participants
|
2 Participants
|
|
FIGO STAGE
IIIC
|
11 Participants
|
22 Participants
|
|
FIGO STAGE
IVA
|
0 Participants
|
4 Participants
|
|
FIGO STAGE
IVB
|
1 Participants
|
1 Participants
|
|
FIGO STAGE
II
|
1 Participants
|
0 Participants
|
|
FIGO STAGE
III
|
0 Participants
|
1 Participants
|
|
FIGO STAGE
IIIB-C
|
1 Participants
|
0 Participants
|
|
FIGO STAGE
unk
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 0 months - Measurements were done at baselinePatient characteristics and medical history Tumor histology history Measurements were done at baseline
Outcome measures
| Measure |
Rucaparib - Treatment
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Tumor Histology
Endometroid ovarian carcinoma (others)
|
1 Participants
|
0 Participants
|
|
Tumor Histology
High grade fallopian tube cancer
|
2 Participants
|
0 Participants
|
|
Tumor Histology
Clear-cell (others)
|
1 Participants
|
0 Participants
|
|
Tumor Histology
High grade serious ovarian cancer
|
28 Participants
|
17 Participants
|
|
Tumor Histology
High grade primary peritoneal cancer
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 0 months - Measurements were done at baselinePatient characteristics and medical history mutational status (BRCA 1/2 \[germline/somatic\] and in other HRR genes) Measurements were done at baseline
Outcome measures
| Measure |
Rucaparib - Treatment
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
BCRA Status
BCRA Mutation
|
28 Participants
|
3 Participants
|
|
BCRA Status
BCRA unk
|
2 Participants
|
2 Participants
|
|
BCRA Status
BCRA wild type
|
3 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 0 months - Measurements were done at baselinePatient characteristics and medical history Other HRR deficiencies including RAD51C, RAD51D, PALBB2, BRIP1, CHEK1, CHEK2, BARD1, FAM175A, NEN, ATM, EMSY and others Measurements were done at baseline
Outcome measures
| Measure |
Rucaparib - Treatment
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Deficiencies in Other Genes Involved in Homologous Recombination
|
19 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 0 months - Measurements were done at baselinePatient characteristics and medical history Total number of surgeries per patient before treatment started Measurements were done at baseline
Outcome measures
| Measure |
Rucaparib - Treatment
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Surgeries Before Rucaparib
0
|
1 Participants
|
0 Participants
|
|
Surgeries Before Rucaparib
1
|
25 Participants
|
13 Participants
|
|
Surgeries Before Rucaparib
2
|
4 Participants
|
5 Participants
|
|
Surgeries Before Rucaparib
3
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 0-24 monthsPatient characteristics and medical history: Prior lines of platinum-based chemotherapy
Outcome measures
| Measure |
Rucaparib - Treatment
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Previous Lines
|
4.7 Treatment lines
Standard Deviation 2.1
|
3.1 Treatment lines
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: 0 months - Measurements were done at baselinePatient characteristics and medical history: PARPi treatment before rucaparib Measurements were done at baseline
Outcome measures
| Measure |
Rucaparib - Treatment
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
PARPi Before Rucaparib
|
13 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 0-12 monthsRucaparib dosing data Descrption: average dose of rucaparib administered (mg/12h)
Outcome measures
| Measure |
Rucaparib - Treatment
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Average Dose of Rucaparib Received Per 12 Hours
|
545.5 mg/12h
Standard Deviation 72.2
|
513.5 mg/12h
Standard Deviation 105.1
|
PRIMARY outcome
Timeframe: 0-24 monthsRucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching). Rucaparib drug exposure in months Patient 14-001 has been eliminated for not following the treatment scheme
Outcome measures
| Measure |
Rucaparib - Treatment
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=15 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Rucaparib Drug Exposure
From 0-12 months
|
30 Participants
|
12 Participants
|
|
Rucaparib Drug Exposure
From 12-24 months
|
1 Participants
|
3 Participants
|
|
Rucaparib Drug Exposure
More than 24 months
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 0-12 monthsRucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching). Specific description: How many dose reductions had to be conducted on each patient \*Patient 14-001 from treatment group has been eliminated by not following the tratment scheme
Outcome measures
| Measure |
Rucaparib - Treatment
n=32 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Dose Reductions
0
|
18 Participants
|
7 Participants
|
|
Dose Reductions
1
|
11 Participants
|
5 Participants
|
|
Dose Reductions
2
|
3 Participants
|
5 Participants
|
|
Dose Reductions
3
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 0-12 monthsRucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching). Specific description: How many dose interruptions had to be conducted on each patient \*Patient 14-001 from treatment group has been eliminated by not following the tratment scheme
Outcome measures
| Measure |
Rucaparib - Treatment
n=32 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Number of Dose Interruptions
1
|
13 Participants
|
8 Participants
|
|
Number of Dose Interruptions
0
|
12 Participants
|
8 Participants
|
|
Number of Dose Interruptions
2
|
7 Participants
|
0 Participants
|
|
Number of Dose Interruptions
3
|
0 Participants
|
0 Participants
|
|
Number of Dose Interruptions
4
|
0 Participants
|
1 Participants
|
|
Number of Dose Interruptions
5
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 0-36 monthsRucaparib efficacy data: best response rates in the treatment indication patients, duration of response and PFS in the treatment indication patients, PFS in the maintenance indication patients, radiological response to chemotherapy in maintenance patients (and impact of response on patient evolution). For maintenance patients: Duration of response has been calculated taking into account the date of CR or RP prior to RAP until progression (on last follow date) during Rucaparib as a maintenance treatment. For treatment patients: Duration of response has been calculated taking into account the best response date (PR or CR) during Rucaparib until progression of follow-up date (Only patients with PR or CR as best overall response)
Outcome measures
| Measure |
Rucaparib - Treatment
n=6 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Duration of Response (DoR)
|
5.7 months
Standard Deviation 4
|
13.2 months
Standard Deviation 9.2
|
PRIMARY outcome
Timeframe: 0-24 monthsRucaparib dosing data: mean starting dose, number of dose reductions, reasons for reductions, number of treatment discontinuations, reasons for discontinuations, duration of treatment, and switching of maintenance therapy to another PARP inhibitor (including reasons for switching). Description: Rucaparib exposure termination (reasons)
Outcome measures
| Measure |
Rucaparib - Treatment
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
End of Treatment
Progression
|
23 Participants
|
13 Participants
|
|
End of Treatment
Doctor's decision
|
1 Participants
|
1 Participants
|
|
End of Treatment
Toxicity
|
4 Participants
|
1 Participants
|
|
End of Treatment
Patient's decision
|
1 Participants
|
0 Participants
|
|
End of Treatment
Other
|
2 Participants
|
0 Participants
|
|
End of Treatment
No EoT (Ongoing treatment)
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 0-24 monthsRucaparib efficacy data ORR: Confirmed best overall tumor response of CR or PR according to RECIST v1.1 or Response and normalization or Response according to Rustin criteria. The RECIST v1.1 answer prevailed over the Rustin criterion answer except where RECIST is 'Not assessable' and Rustin criterion is different than 'Not assessable'. ORR was calculated only on the treatment population and not on the maintenance population. \*This measurement was only taken in participants from the treatment group as these present an active disease, therefore Rucaparib was administered in order to reduce tumoral charge or control tumor progression. On the other hand, participants from the maintenance group have already responded to previous treatments, and rucaparib was administered I order to maintain response rate and/or delay progression, which was measured using "free-progression survival".
Outcome measures
| Measure |
Rucaparib - Treatment
n=28 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Objective Response Rate (ORR)
Progressive Disease
|
11 Participants
|
—
|
|
Objective Response Rate (ORR)
Stable Disease
|
4 Participants
|
—
|
|
Objective Response Rate (ORR)
Complete Response
|
4 Participants
|
—
|
|
Objective Response Rate (ORR)
Partial Response
|
0 Participants
|
—
|
|
Objective Response Rate (ORR)
Not asssessable
|
9 Participants
|
—
|
PRIMARY outcome
Timeframe: 0-24 monthsRucaparib efficacy data: best response rates in the treatment indication patients, duration of response and PFS in the treatment indication patients, PFS in the maintenance indication patients, radiological response to chemotherapy in maintenance patients (and impact of response on patient evolution). It represents the length of time during and after treatment that a patient lives with the disease, but without it getting worse.
Outcome measures
| Measure |
Rucaparib - Treatment
n=33 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Progression-free Survival (PFS)
|
2.8 months
Interval 2.0 to 6.4
|
9.1 months
Interval 4.2 to 11.6
|
PRIMARY outcome
Timeframe: 0-24 monthsRucaparib efficacy data Radiological best overall response - Only 19 radiologically evaluable patients (treatment group only) \*This measurement was only taken in participants from the treatment group as these present an active disease, therefore Rucaparib was administered in order to reduce tumoral charge or control tumor progression. On the other hand, participants from the maintenance group have already responded to previous treatments, and rucaparib was administered I order to maintain response rate and/or delay progression, which was measured using "free-progression survival".
Outcome measures
| Measure |
Rucaparib - Treatment
n=19 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Radiological Best Overall Response
first progression (PD)
|
11 Participants
|
—
|
|
Radiological Best Overall Response
Stable Disease (SD)
|
4 Participants
|
—
|
|
Radiological Best Overall Response
Partial Response (PR)
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: 0-24 monthsRucaparib efficacy data: best response rates in the treatment indication patients, duration of response and PFS in the treatment indication patients, PFS in the maintenance indication patients, radiological response to chemotherapy in maintenance patients (and impact of response on patient evolution). Biological best overall response - Only 16 assessable patients (Treatment arm only) \*This measurement was only taken in participants from the treatment group as these present an active disease, therefore Rucaparib was administered in order to reduce tumoral charge or control tumor progression. On the other hand, participants from the maintenance group have already responded to previous treatments, and rucaparib was administered I order to maintain response rate and/or delay progression, which was measured using "free-progression survival".
Outcome measures
| Measure |
Rucaparib - Treatment
n=16 Participants
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
"The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response"
|
|---|---|---|
|
Biological Best Overall Response
Progression
|
6 Participants
|
—
|
|
Biological Best Overall Response
Stabilization
|
7 Participants
|
—
|
|
Biological Best Overall Response
Response
|
3 Participants
|
—
|
Adverse Events
Rucaparib - Treatment
Rucaparib - Maintenance
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rucaparib - Treatment
n=33 participants at risk
The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Platinum-sensitive BRCA-mutated patients after progression, and BRCA-mutated patients who are currently platinum-resistant.
|
Rucaparib - Maintenance
n=18 participants at risk
The population will include all patients who received at least one dose of rucaparib as part of the RAP in GEICO-associated hospitals. The sample size will be based on the accrual rate of the RAP and the date of rucaparib launch in Spain.
Studied patients were the ones recruited between July 2020 and February 2021
Inclusion criteria:
1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccesible patients (dead, lost, etc.) according to ethics committee permisions and applicable law for retrospective studies in Spain.
2. Histological diagnosis of high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain.
3. Adult women (18 years or more at the time of diagnosis).
Exclusion criteria:
1\. Patients without medical record available (lost, empty or unretrievable clinical information).
Rucaparib was given as maintenance or Pt-resistant and Pt-sensitive treatment
This group includes: Maintenance therapy in patients after a platinum-sensitive relapse in response
|
|---|---|---|
|
General disorders
Fatigue
|
21.2%
7/33 • Number of events 7 • 1 year
Retrospective study
|
27.8%
5/18 • Number of events 6 • 1 year
Retrospective study
|
|
Endocrine disorders
Hyponatremia
|
3.0%
1/33 • Number of events 7 • 1 year
Retrospective study
|
0.00%
0/18 • 1 year
Retrospective study
|
|
Gastrointestinal disorders
Intestinal obstruction
|
3.0%
1/33 • Number of events 1 • 1 year
Retrospective study
|
0.00%
0/18 • 1 year
Retrospective study
|
|
Blood and lymphatic system disorders
Anemia
|
39.4%
13/33 • Number of events 18 • 1 year
Retrospective study
|
11.1%
2/18 • Number of events 5 • 1 year
Retrospective study
|
|
Hepatobiliary disorders
GGT increased
|
0.00%
0/33 • 1 year
Retrospective study
|
5.6%
1/18 • Number of events 1 • 1 year
Retrospective study
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.1%
3/33 • Number of events 4 • 1 year
Retrospective study
|
11.1%
2/18 • Number of events 3 • 1 year
Retrospective study
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
30.3%
10/33 • Number of events 12 • 1 year
Retrospective study
|
5.6%
1/18 • Number of events 1 • 1 year
Retrospective study
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
2/33 • Number of events 2 • 1 year
Retrospective study
|
11.1%
2/18 • Number of events 3 • 1 year
Retrospective study
|
|
Hepatobiliary disorders
ALT increased
|
12.1%
4/33 • Number of events 7 • 1 year
Retrospective study
|
27.8%
5/18 • Number of events 6 • 1 year
Retrospective study
|
|
Renal and urinary disorders
ALP increased
|
9.1%
3/33 • Number of events 4 • 1 year
Retrospective study
|
11.1%
2/18 • Number of events 2 • 1 year
Retrospective study
|
|
Hepatobiliary disorders
AST increased
|
12.1%
4/33 • Number of events 5 • 1 year
Retrospective study
|
27.8%
5/18 • Number of events 7 • 1 year
Retrospective study
|
|
General disorders
Asthenia
|
9.1%
3/33 • Number of events 3 • 1 year
Retrospective study
|
5.6%
1/18 • Number of events 1 • 1 year
Retrospective study
|
|
Gastrointestinal disorders
Colonic obstruction
|
3.0%
1/33 • Number of events 1 • 1 year
Retrospective study
|
0.00%
0/18 • 1 year
Retrospective study
|
|
Gastrointestinal disorders
Constipation
|
6.1%
2/33 • Number of events 2 • 1 year
Retrospective study
|
5.6%
1/18 • Number of events 1 • 1 year
Retrospective study
|
|
Renal and urinary disorders
Creatinine increased
|
3.0%
1/33 • Number of events 1 • 1 year
Retrospective study
|
22.2%
4/18 • Number of events 6 • 1 year
Retrospective study
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33 • Number of events 1 • 1 year
Retrospective study
|
22.2%
4/18 • Number of events 5 • 1 year
Retrospective study
|
|
Nervous system disorders
Dysgeusia
|
3.0%
1/33 • Number of events 1 • 1 year
Retrospective study
|
11.1%
2/18 • Number of events 3 • 1 year
Retrospective study
|
|
Blood and lymphatic system disorders
Myelodysplastic syndrome
|
3.0%
1/33 • Number of events 1 • 1 year
Retrospective study
|
0.00%
0/18 • 1 year
Retrospective study
|
|
Gastrointestinal disorders
Nausea
|
15.2%
5/33 • Number of events 5 • 1 year
Retrospective study
|
38.9%
7/18 • Number of events 8 • 1 year
Retrospective study
|
|
Respiratory, thoracic and mediastinal disorders
Pleural efussion
|
3.0%
1/33 • Number of events 1 • 1 year
Retrospective study
|
0.00%
0/18 • 1 year
Retrospective study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
1/33 • Number of events 1 • 1 year
Retrospective study
|
5.6%
1/18 • Number of events 3 • 1 year
Retrospective study
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
3/33 • Number of events 3 • 1 year
Retrospective study
|
11.1%
2/18 • Number of events 2 • 1 year
Retrospective study
|
Additional Information
President
Grupo Español de Investigación en Cáncer de Ovario
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60