Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Conditions
Keywords
Rucaparib
Brief summary
The study consists of a retrospective observational, multicenter study in which the fundamental exposure factor being investigated is a drug (rucaparib). A clinical database will be built including clinical data in three scenarios of rucaparib treatment: (1) platinum-sensitive BRCA-mutated patients after progression, (2) maintenance therapy in patients after a platinum-sensitive relapse in response, and (3) treatment therapy in BRCA-mutated patients who are currently platinum-resistant. The specific objectives of the study are: * To describe patient characteristics/medical history, safety, efficacy, and dosing of on-label treatment with rucaparib in real-world patients (real-world data). * To describe patient characteristics/medical history, safety, efficacy, and dosing of all patients treated with rucaparib (including patients with on-label treatment and others) in real-world patients (real-world data). * To show that data obtained in clinical trials could be reproduced in non-screened patients.
Detailed description
An observational study (GEICO 87-R) was performed in high-grade ovarian cancer patients treated within the rucaparib access program (RAP) in Spain. The aim was to better understand rucaparib's management in real-life setting, to optimize future use, considering Pt-sensitive and Pt-resistant BRCAmut treatment and maintenance patients. A retrospective study was performed at 22 GEICO hospitals in Spain that treated patients within RAP (600 mg BID) since September 2018. Adult women with high-grade epithelian ovarian, fallopian tube, or primary peritoneal cancer, with medical record available, were included. Patient characteristics, medical history, safety, efficacy, and dosing data were collected. The setting of this observational study was rucaparib's access program (RAP) in Spain, in the context of real-life use of the product.
Interventions
DRUGRucaparib
Participating local sites (GEICO-associated hospitals with expertise in gynecological cancer management) will enter clinical data of those patients who have previously participated in the rucaparib access program (RAP) in Spain and have given their consent.
Sponsors
Grupo Español de Investigación en Cáncer de Ovario
Clovis Oncology, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 unaccessible patients (dead, lost, etc.) according to ethics committee permissions and applicable law for retrospective studies in Spain. 2. Histological diagnosis of high-grade epithelial 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Relevant Co-morbidities | 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 |
| Other Previous Cancers? | 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 |
| Family History of Cancers? | 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 |
| FIGO STAGE | 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) |
| Tumor Histology | 0 months - Measurements were done at baseline | Patient characteristics and medical history Tumor histology history Measurements were done at baseline |
| BCRA Status | 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 |
| Deficiencies in Other Genes Involved in Homologous Recombination | 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 |
| Surgeries Before Rucaparib | 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 |
| Previous Lines | 0-24 months | Patient characteristics and medical history: Prior lines of platinum-based chemotherapy |
| PARPi Before Rucaparib | 0 months - Measurements were done at baseline | Patient characteristics and medical history: PARPi treatment before rucaparib Measurements were done at baseline |
| Average Dose of Rucaparib Received Per 12 Hours | 0-12 months | Rucaparib dosing data Descrption: average dose of rucaparib administered (mg/12h) |
| Rucaparib Drug Exposure | 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 |
| Dose Reductions | 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 |
| Number of Dose Interruptions | 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 |
| Duration of Response (DoR) | 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) |
| End of Treatment | 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) |
| Objective Response Rate (ORR) | 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". |
| Progression-free Survival (PFS) | 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. |
| Radiological Best Overall Response | 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". |
| Biological Best Overall Response | 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". |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORAlfonso Yubero, Dr.
Hospital Clínico Universitario Lozano Blesa
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 11.8 |
| Brain metastasis | 0 participants |
| ECOG 0 | 7 Participants |
| ECOG 1 | 25 Participants |
| ECOG 2 | 3 Participants |
| ECOG UNK | 1 Participants |
| Existence of measurable disease before treatment | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment Spain | 33 Participants |
| Relevant comorbidities | 12 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight | 66.2 Kilograms STANDARD_DEVIATION 14.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 24 / 33 | 8 / 18 |
| other Total, other adverse events | 28 / 33 | 16 / 18 |
| serious Total, serious adverse events | 0 / 33 | 0 / 18 |
Outcome results
None listed