1. In women with BRCA-associated, newly diagnosed advanced ovarian cancer, olaparib significantly prolonged progression-free survival (PFS) at three years compared to placebo.
2. The majority of adverse events reported in the olaparib group were low-grade. Among high-grade adverse events, anemia and neutropenia were the most common.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Though many women with advanced (stage III or IV) ovarian cancer achieve clinical remission with first-line surgical cytoreduction and platinum-based chemotherapy, the majority will relapse within three years. The poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor olaparib has been approved as maintenance therapy in BRCA-associated cancers after failure with several chemotherapy agents; however, its use earlier in treatment is under investigation. This study reports results from the SOLO1 trial, which assessed the PARP inhibitor olaparib as maintenance therapy in women with newly diagnosed, BRCA-associated, advanced ovarian cancer. At three years, there was a significantly prolonged PFS – the primary outcome – for women treated with olaparib compared to placebo. Among secondary endpoints, olaparib significantly prolonged the rate of second PFS and time to first subsequent therapy or death. The results suggest that olaparib may become a standard of care following platinum-based chemotherapy in this patient population.
This was the first phase III trial to evaluate a PARP inhibitor as maintenance therapy in BRCA-associated, newly diagnosed advanced ovarian cancer, and the results demonstrate a clear benefit with olaparib in this population. However, since most patients had a germline BRCA mutation and a complete response to initial chemotherapy, more data is needed before the results can be generalized to the entire ovarian cancer population. In addition, longer-term analysis is required to determine the impact on overall survival and provide more toxicity data.
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