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

Recruitment status

COMPLETED

Target enrollment

51 participants

Primary outcome timeframe

0-24 months

Results posted on

2026-03-18

Participant Flow

Participant milestones

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

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 baseline

Patient 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

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 baseline

Patient 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

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 baseline

Patient characteristics and medical history Family history of other cancers including ovarian, breast and others Measurements were done at baseline

Outcome measures

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 baseline

Stage = 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

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 baseline

Patient characteristics and medical history Tumor histology history Measurements were done at baseline

Outcome measures

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 baseline

Patient characteristics and medical history mutational status (BRCA 1/2 \[germline/somatic\] and in other HRR genes) Measurements were done at baseline

Outcome measures

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 baseline

Patient 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

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 baseline

Patient characteristics and medical history Total number of surgeries per patient before treatment started Measurements were done at baseline

Outcome measures

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 months

Patient characteristics and medical history: Prior lines of platinum-based chemotherapy

Outcome measures

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 baseline

Patient characteristics and medical history: PARPi treatment before rucaparib Measurements were done at baseline

Outcome measures

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 months

Rucaparib dosing data Descrption: average dose of rucaparib administered (mg/12h)

Outcome measures

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 months

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

Outcome measures

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 months

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). 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

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 months

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). 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

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 months

Rucaparib 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

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 months

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). Description: Rucaparib exposure termination (reasons)

Outcome measures

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 months

Rucaparib 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

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 months

Rucaparib 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

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 months

Rucaparib 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

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 months

Rucaparib 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

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

Serious events: 0 serious events
Other events: 28 other events
Deaths: 24 deaths

Rucaparib - Maintenance

Serious events: 0 serious events
Other events: 16 other events
Deaths: 8 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 648495298

Results disclosure agreements

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

Restriction type: LTE60