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    Association details:
    Biomarker:BRCA1 mutation
    Cancer:Fallopian Tube Cancer
    Drug:Rubraca (rucaparib) (PARP inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies.
    Test:
    BRACAnalysis CDx™
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    Lancet Oncol
    Title:

    Rucaparib for patients with platinum-sensitive, recurrent ovarian carcinoma (ARIEL3): post-progression outcomes and updated safety results from a randomised, placebo-controlled, phase 3 trial

    Excerpt:
    Between April 7, 2014, and July 19, 2016, 564 patients were enrolled and randomly assigned to rucaparib (n=375) or placebo (n=189). Median follow-up was 28·1 months (IQR 22·0-33·6). In the intention-to-treat population, median CFI was 14·3 months (95% CI 13·0-17·4) in the rucaparib group versus 8·8 months (8·0-10·3) in the placebo group (hazard ratio [HR] 0·43 [95% CI 0·35-0·53]; p<0·0001), median TFST was 12·4 months (11·1-15·2) versus 7·2 months (6·4-8·6; HR 0·43 [0·35-0·52]; p<0·0001), median PFS2 was 21·0 months (18·9-23·6) versus 16·5 months (15·2-18·4; HR 0·66 [0·53-0·82]; p=0·0002), and median TSST was 22·4 months (19·1-24·5) versus 17·3 months (14·9-19·4; HR 0·68 [0·54-0·85]; p=0·0007). CFI, TFST, PFS2, and TSST were also significantly longer with rucaparib than placebo in the BRCA-mutant and homologous recombination-deficient cohorts.In these exploratory analyses over a median follow-up of more than 2 years, rucaparib maintenance treatment led to a clinically meaningful delay in starting subsequent therapy and provided lasting clinical benefits versus placebo in all three analysis cohorts.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients

    Excerpt:
    ...biopsy is optional for patients known to harbor a BRCA1/2 mutation...
    Trial ID:
    ARIEL4
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study

    Excerpt:
    ...Sex, age, mutational status (BRCA 1/2 [germline/somatic] and in other homologous recombination repair (HRR) genes), number of previous relapses, number of previous chemotherapy regimens, types of treatments received (chemotherapy, targeted therapies [bevacizumab, PARP inhibitors (PARPi)]), prior maintenance or with maintenance, treatment-free interval (platinum-based chemotherapy, non-platinum-based chemotherapy, targeted therapy).`...
    Trial ID:
    GEICO
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ASCO 2022
    Title:

    Clinical insights from the rucaparib access program in Spain: A sub-analysis of long-term responders by GEICO.

    Published date:
    05/26/2022
    Excerpt:
    Adult women with HGOC, fallopian tube, or primary peritoneal cancer were included and received rucaparib (600 mg BID) in the MTN, Tx Pt-sensitive or Tx Pt-resistant setting....In the Tx group, 10 patients (30.3%) were LTR, with a median age of 71 years (47-86). All of them harbored BRCA and/or RAD51C mutations.
    DOI:
    10.1200/JCO.2022.40.16_suppl.e17562