Olaparib Trial Supports 2-Year Treatment Duration in Ovarian Cancer

William H. Bradley, MD, a gynecologic oncologist at the Medical College of Wisconsin, discusses the 5-year follow-up of the SOLO-1 trial (NCT01844986) of olaparib (Lynparza) maintenance in patients with BRCA1/2-mutated advanced ovarian cancer.

One important observation from the SOLO-1 trial was its duration of treatment; patients received 300 mg of olaparib twice daily for up to 2 years or until disease progression, and physicians were allowed to continue treatment beyond 2 years.

According to Bradley, the study’s outcome establishes that this is a tolerable approach that could be used as standard of care with olaparib. While the treatment duration was longer than in the SOLO-2 trial (NCT01874353) and other trials of PARP inhibitors in the relapsed setting, the safety profile was similar. The rate of treatment discontinuation due to adverse events (AEs) in SOLO-1 was relatively low at 12%. Rare but dangerous AEs such as the development of acute myeloid leukemia did not occur at a higher rate than in other trials with a shorter treatment duration.

TRANSCRIPTION:

0:08 | One of the discussions that was held was the duration of therapy, and that's a really interesting point. On this trial, patients received the drug for 2 years. There were some patients, a subset [who] were allowed to continue if they had a measurable disease after that 2-year period and the physician that was treating them thought that that was in their benefit, but this is really a very small number.

0:27 | I actually think that the point about duration therapy off study, if you're going to use this as a standard of care, seems to be that 2-year window is actually a very reasonable one that the patient will receive a benefit. There's no reason to continue it past that unless there's something specific for that individual patient.