Scientific publications

Tolerability of maintenance olaparib in newly diagnosed patients with advanced ovarian cancer and a BRCA mutation in the randomized phase III SOLO1 trial

Aug 2, 2021 | Magazine: Gynecological Oncology

Nicoletta Colombo 1 , Kathleen Moore 2 , Giovanni Scambia 3 , Ana Oaknin 4 , Michael Friedlander 5 , Alla Lisyanskaya 6 , Anne Floquet 7 , Alexandra Leary 8 , Gabe S Sonke 9 , Charlie Gourley 10 , Susana Banerjee 11 , Amit Oza 12 , Antonio González-Martín 13 , Carol Aghajanian 14 , William H Bradley 15 , Jae-Weon Kim 16 , Cara Mathews 17 , Joyce Liu 18 , Elizabeth S Lowe 19 , Ralph Bloomfield 20 , Paul DiSilvestro 17

Objectives: In 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.

Methods: Eligible 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).

Results: Median 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.

Conclusions: Maintenance 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.

CITATION  Gynecol Oncol. 2021 Oct;163(1):41-49.
doi: 10.1016/j.ygyno.2021.07.016. Epub 2021 Aug 2.