Abstract
ObjectivesIn the phase III SOLO1 trial (NCT01844986), maintenance olaparib provided a substantial progression-free survival benefit in patients with newly diagnosed, advanced ovarian cancer and a BRCA mutation who were in response after platinum-based chemotherapy. We analyzed the timing, duration and grade of the most common hematologic and non-hematologic adverse events in SOLO1. MethodsEligible patients were randomized to olaparib tablets 300 mg twice daily (N = 260) or placebo (N = 131), with a 2-year treatment cap in most patients. Safety outcomes were analyzed in detail in randomized patients who received at least one dose of study drug (olaparib, n = 260; placebo, n = 130). ResultsMedian time to first onset of the most common hematologic (anemia, neutropenia, thrombocytopenia) and non-hematologic (nausea, fatigue/asthenia, vomiting) adverse events was <3 months in olaparib-treated patients. The first event of anemia, neutropenia, thrombocytopenia, nausea and vomiting lasted a median of <2 months and the first event of fatigue/asthenia lasted a median of 3.48 months in the olaparib group. These adverse events were manageable with supportive treatment and/or olaparib dose modification in most patients, with few patients requiring discontinuation of olaparib. Of 162 patients still receiving olaparib at month 24, 64.2% were receiving the recommended starting dose of olaparib 300 mg twice daily. ConclusionsMaintenance olaparib had a predictable and manageable adverse event profile in the newly diagnosed setting with no new safety signals identified. Adverse events usually occurred early, were largely manageable and led to discontinuation in a minority of patients.
Highlights
The first event of anemia, neutropenia, thrombocytopenia, nausea and vomiting lasted a median of
In women with newly diagnosed, advanced ovarian cancer who are in response to first-line platinum-based chemotherapy, maintenance therapy with the poly(ADP-ribose) polymerase (PARP) inhibitor olaparib is approved in the USA, the EU, China, Japan and other countries worldwide for women with a BRCA1 and/or BRCA2 mutation (BRCAm) [1,2,3,4] and maintenance olaparib plus bevacizumab is approved in the USA, the EU and Japan for women who test positive for homologous recombination deficiency (BRCAm and/or genomic instability) [1,2,5]
In the phase III SOLO1 trial (NCT01844986; GOG-3004), maintenance olaparib provided a substantial progression-free survival (PFS) benefit in women with newly diagnosed, advanced ovarian cancer and a BRCAm who were in response after platinum-based chemotherapy [6]
Summary
Given that following cytoreductive surgery and platinum-based chemotherapy, patients with newly diagnosed, advanced ovarian cancer will receive maintenance olaparib for a planned 2 years in the setting of no or minimal disease, it is important to establish that olaparib does not add a significant safety or toxicity burden. In the phase III SOLO1 trial (NCT01844986; GOG-3004), maintenance olaparib provided a substantial progression-free survival (PFS) benefit in women with newly diagnosed, advanced ovarian cancer and a BRCAm who were in response after platinum-based chemotherapy [6]. With longer-term follow-up, 48.3% of olaparib patients versus 20.5% of placebo patients were progression free at 5 years (Kaplan-Meier estimates) [7]. The safety profile of maintenance olaparib in the newly diagnosed setting [6] was consistent with that previously reported in the relapsed disease setting [8,9]
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