BREIZH-PARPi: Survival Data and Characteristics of Finisterian Patients Treated With PARP Inhibitors for Ovarian Cancer Between 2014 and 2019.

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT04573933
Collaborator
(none)
54
4
2
13.5
6.7

Study Details

Study Description

Brief Summary

Ovarian cancer is a relatively uncommon but serious disease. It ranks 10th for female cancers, 5th for mortality, and its origin is still imperfectly known. It has a silent history for a long time, is often diagnosed late, and the prognosis is poor with a high relapse rate. It is therefore necessary to assess and prevent the risk of relapse, in order to establish a diagnosis as early as possible, and thus set up the appropriate treatment. Poly-ADP-Ribose Polymerase (PARP) inhibitors such as OLAPARIB and NIRAPARIB are effective in maintenance to prevent the risk of relapse in patients with recurrent platinum-sensitive ovarian cancer, as proved by recent data from the medical literature. Nevertheless, there may be a difference between "real life" and clinical trial data. Thus, the objective of this cohort is to assess whether the efficacy and safety of PARP inhibitors is the same in Finistère patients as in the scientific literature.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Ovarian cancer is a relatively uncommon but serious disease. It ranks 10th for female cancers and 5th for mortality (4,720 new cases in France in 2017, for 3,111 deaths), and its origin is still imperfectly known. Several risk factors have been identified, the main ones being genetic (importance of heredity, BRCA mutations) and environmental (taking hormone replacement therapy based on estrogen at menopause, exposure to tobacco, asbestos…). Epithelial tumors are the most frequent (85%), with different subtypes: serous (40 to 50%); endometrioid (20%); mucinous (15%); clear cell (5%); or with transitional, undifferentiated and mixed cells. The classification used in clinical practice is the TNM classification which establishes the stage of the disease (FIGO). Initial treatment is based on surgery and chemotherapy. The standard scheme combines CARBOPLATIN and PACLITAXEL for 6 cycles. For advanced stages, IIIB, IIIC and IV, BEVACIZUMAB can be administered every 3 weeks in combination with CARBOPLATIN and PACLITAXEL, and is then continued as monotherapy for 15 months The management of recurrences depends on their time of occurrence. Before 6 months, it is a resistance to platinum, a monochemotherapy without platinum is then indicated, associated with BEVACIZUMAB, if it was not given initially and in the absence of contraindication. After 6 months, polychemotherapy with platinum must be administered, possibly associated with BEVACIZUMAB, again if it was not given initially and in the absence of a contraindication. This treatment is then continued after stopping chemotherapy, until progression or toxicity .The arrival of PARP (Poly-ADP-Ribose-Polymerase) inhibitors, such as OLAPARIB, NIRAPARIB, or even RUCAPARIB, has considerably modified the treatment regimen of these relapses known as "platinum-sensitive" These molecules act on the DNA repair system, in synergy with the loss of BRCA function by tumor cells, causing significant genetic instability leading to cell death. This is the principle of synthetic lethality. These treatments will also in the very near future modify the management of patients with ovarian cancer as soon as they are managed. In fact, the SOLO 1 study published in 2018 showed the benefit of OLAPARIB prescribed as maintenance treatment in BRCA mutated patients, in complete or partial response after chemotherapy based on platinum The PRIMA and VELIA studies, published in 2019, have shown the effectiveness of NIRAPARIB and VELIPARIB respectively, prescribed as maintenance therapy, regardless of the patients' BRCA status.The benefit of the treatment was greater in the group of patients with a defect in homologous recombination. Finally, the PAOLA study published in 2019, showed the benefit of OLAPARIB versus placebo, in combination with BEVACIZUMAB, as maintenance treatment in patients with ovarian cancer in full or partial response after chemotherapy with PLATINUM-PACLITAXEL-BEVACIZUMAB, regardless of their BRCA status PARP inhibitors are effective in maintenance to prevent the risk of relapse, in patients with recurrent ovarian cancer sensitive to platinum (relapse> 6 months after the last course of platinum), as proved by recent data from the medical literature. On the one hand, the SOLO 2 study showed an improvement in progression-free survival in patients with a BRCA constitutional or somatic mutation, in relapse of platinum-sensitive ovarian cancer, treated with OLAPARIB in maintenance (19.1 months versus 5.5 months) On the other hand, the NOVA (2016) and ARIEL 3 (2017) studies showed an improvement in progression-free survival in relapsed patients with platinum-sensitive ovarian cancer, treated with maintenance by NIRAPARIB or by RUCAPARIB respectively, regardless of their mutational status for BRCA (probable action on other homologous recombination pathways than BRCA, still unknown to date) All these molecules are now part of our therapeutic arsenal, from the 2nd line of treatment.

    In this context of major progress in the management of ovarian cancer, we decided to set up a Finistère study, aiming to analyze the characteristics and survival data of patients treated with PARP inhibitor for a recurrent platinum-sensitive ovarian cancer, as well as their tolerance to these treatments. This is a retrospective study, using data from Finistère in comparison with data from the literature. Nevertheless, there may be a difference between "real life" and clinical trial data. Thus, the objective of this cohort is to assess whether the efficacy (survival) and safety (side effects) of PARP inhibitors is the same in Finistère patients as in the scientific literature.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    54 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Survival Data and Characteristics of Finisterian Patients Treated With PARP Inhibitors for Ovarian Cancer Between 2014 and 2019. Study of Efficacy and Safety Based on Finisterian Data Compared to Data in the Literature.
    Actual Study Start Date :
    Jun 29, 2020
    Actual Primary Completion Date :
    Jul 29, 2020
    Actual Study Completion Date :
    Aug 29, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival [Through study completion, assessed up to 80 months]

      Time from date of start of parp inhibitor therapy to date of first documented progression

    Secondary Outcome Measures

    1. - Overall survival [Through study completion, assessed up to 80 months]

      Time from date of start of parp inhibitor therapy to date of death of any cause

    2. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [through study completion, an average of 1 year]

      % of patient with a grade ≥1 adverse event during treatment, according to CTCAE

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ≥ 18 years old

    • High grade serous or clear cell ovarian cancer or endometrioid, including primary peritoneal cancer and fallopian tubes

    • Treatment with PARP inhibitor (OLAPARIB, NIRAPARIB) in maintenance after sensitive platinum relapse

    • No objection made

    Exclusion Criteria:
      • Patients under judicial protection (guardianship)
    • Refusal to participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique Pasteur Brest France 29200
    2 Clinique Pasteur Brest France 29229
    3 CH des pays de Morlaix Morlaix France 29672
    4 CHIC Quimper France 29000

    Sponsors and Collaborators

    • University Hospital, Brest

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Brest
    ClinicalTrials.gov Identifier:
    NCT04573933
    Other Study ID Numbers:
    • BREIZH-PARPi (29BRC20.0092)
    First Posted:
    Oct 5, 2020
    Last Update Posted:
    Oct 5, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Brest
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 5, 2020