The recommendations were based on a review of 17 clinical trials, FDA approvals, and consensus where evidence was lacking.
The American Society for Clinical Oncology (ASCO) published new guidelines on the use of PARP inhibitors in the management of ovarian cancer.1
“The purpose of this guideline is to provide clinicians, other health care practitioners, patients, and caregivers with recommendations regarding the role of [PARP inhibitors] in the management of [epithelial ovarian, tubal, or primary peritoneal cancer; EOC] based on the best available evidence,” the authors of the guidelines wrote.
The guidelines, published in the Journal of Clinical Oncology, identified 17 randomized, controlled, and open-labeled eligible trials published from 2011 through 2020. Recommendations were based on a review of the evidence, FDA approvals, and consensus where evidence was lacking. Importantly, the guidelines refer to patients naïve to PARP inhibitors.
Per the guidelines, all patients with newly diagnosed, stage III-IV EOC whose disease is in complete or partial response to first-line, platinum-based chemotherapy with high-grade serous or endometrioid EOC should be offered PARP inhibitor maintenance therapy with niraparib. Moreover, patients with germline or somatic pathogenic or likely pathogenic variants in BRCA1 or BRCA2 genes should be treated with olaparib.
Further, ASCO recommends that the addition of olaparib to bevacizumab may be offered to patients with stage III-IV EOC with germline or somatic BRCA1/2 and/or genomic instability and a partial or complete response to chemotherapy plus bevacizumab combination. Maintenance therapy (second line or more) with single agent PARP inhibitors may also be offered for patients with EOC who have not received a PARP inhibitor and have responded to platinum-based therapy regardless of BRCA mutation status.
Additionally, treatment with a PARP inhibitor should be offered to patients with recurrent EOC that has not recurred within 6 months of platinum-based therapy, who have not received a PARP inhibitor, and have a germline or somatic BRCA1/2, or whose tumor demonstrates genomic instability, according to ASCO.
However, the authors of the guidelines indicated that PARP inhibitors are not recommended for use in combination with chemotherapy, other targeted agents, or immune-oncology agents in the recurrent setting outside the context of a clinical trial.
“Preclinical development is moving rapidly and some empirical and some data-driven clinical trials have begun. Reuse of a [PARP inhibitor] should only be considered in such a trial situation until data develop to guide evidence-based clinical care,” the authors concluded. “Future clinical trials that examine [PARP inhibitor] timing within the treatment life cycle and optimal duration of treatment could help establish the best risk-benefit balance practice pattern for [PARP inhibitor] use in the management of EOC.”
Of note, the guidelines specifically cited the myChoice CDx as the sole companion diagnostic to be used in this space.2 The use of the myChoice CDx was recommended in both newly diagnosed and recurrent ovarian cancer.
“We are thrilled to be a part of the rapidly changing landscape in guiding treatment for patients with ovarian cancer,” Thomas Slavin, MD, FACMG, DABCC, senior vice president of Medical Affairs for Myriad Oncology, the developer of the diagnostic, said in a press release. “The new ASCO guidelines highlight the large number of recent studies that have gone into improving ovarian cancer patient outcomes.”
1. Tew WP, Lacchetti C, Ellis A, et al. PARP Inhibitors in the Management of Ovarian Cancer: ASCO Guideline. Journal of Clinical Oncology. doi: 10.1200/JCO.20.01924
2. American Society of Clinical Oncology Exclusively Cites myChoice® CDx in New Recommendations for Patients with Advanced Ovarian Cancer [news release]. Salt Lake City. Published August 21, 2020. Accessed August 28, 2020. https://finance.yahoo.com/news/american-society-clinical-oncology-exclusively-110500791.html