SOLO3 Highlights Toxicities With Olaparib in Ovarian Cancer

Richard T. Penson, MD, clinical director, Medical Gynecologic Oncology, Massachusetts General Hospital, discusses the toxicities that were demonstrated in the long-term follow-up of the phase III SOLO3 trial. This multicenter, open-label trial investigated single-agent olaparib (Lynparza) in patients with platinum-sensitive, relapsed, BRCA-mutated ovarian cancer who have received at least 2 prior lines of chemotherapy.

The long-term analysis demonstrated no new safety signals, says Penson. Toxicities were similar to what had been previously demonstrated, including gastrointestinal constitutional and hematologic toxicities. Patients experienced nausea, vomiting, fatigue, and anemia.

Physicians worry about myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) in this patient population, but there no association between the PARP inhibitor and these complications appeared. Moreover, Penson adds that AML may relate to the harboring of a BRCA mutation, sensitivity, and chemotherapy agents.

Based on these findings from SOLO3 and results from SOLO2, there was less BRCA mutations with the PARP inhibitor. MDS and AML occurred about 2% of the time in these patients versus 4% in the chemotherapy arm.

These data are exciting, Penson concludes. Next steps for PARP inhibitors may include prevention studies, which were previously placed on hold due to concerns of toxicity.