Abstract
Poly(ADP-ribose) polymerase (PARP) inhibitors emerged as the first targeted treatment for ovarian cancer, and are selectively active for women with mutations in BRCA1 and BRCA2 (mBRCA). On the basis of data showing activity (measured by the proportion of patients who achieved an objective response), 1 Kim G Ison G McKee AE et al. FDA approval summary: olaparib monotherapy in patients with deleterious germline BRCA-mutated advanced ovarian cancer treated with three or more lines of chemotherapy. Clin Cancer Res. 2015; 21: 4257-4261 Crossref PubMed Scopus (379) Google Scholar the PARP inhibitor olaparib received US Food and Drug Administration (FDA) approval in 2014 specifically for women with germline mBRCA-associated (gBRCA) recurrent ovarian cancer. 2 US Food and Drug AdministrationFDA approves Lynparza to treat advanced ovarian cancer. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427554.htm Google Scholar However, subsequent findings from clinical trials of PARP inhibitors have suggested that the importance of mBRCA as a predictive biomarker has diminished. For instance, among women without a germline mBRCA, predictors of PARP activity include a somatic (tumour) mutation in BRCA (sBRCA) and evidence of homologous recombination deficiency. 3 Swisher EM Lin KK Oza AM et al. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol. 2017; 18: 75-87 Summary Full Text Full Text PDF PubMed Scopus (785) Google Scholar , 4 Mirza MR Monk BJ Herrstedt J et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016; 375: 2154-2164 Crossref PubMed Scopus (1490) Google Scholar Indeed, FDA approval of the PARP inhibitor rucaparib in 2016 broadened the eligibility for PARP inhibitor treatment beyond gBRCA and included patients with sBRCA-associated ovarian cancers. 5 US Food and Drug AdministrationFDA grants accelerated approval to new treatment for advanced ovarian cancer. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm533873.htmDate: Dec 19, 2016 Google Scholar Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trialAcross all primary analysis groups, rucaparib significantly improved progression-free survival in patients with platinum-sensitive ovarian cancer who had achieved a response to platinum-based chemotherapy. ARIEL3 provides further evidence that use of a poly(ADP-ribose) polymerase inhibitor in the maintenance treatment setting versus placebo could be considered a new standard of care for women with platinum-sensitive ovarian cancer following a complete or partial response to second-line or later platinum-based chemotherapy. Full-Text PDF
Published Version
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