التفاصيل البيبلوغرافية
| العنوان: |
Tolerability of maintenance olaparib in newly diagnosed patients with advanced ovarian cancer and a BRCA mutation in the randomized phase III SOLO1 trial. |
| المؤلفون: |
Colombo, Nicoletta1 (AUTHOR) nicoletta.colombo@ieo.it, Moore, Kathleen2 (AUTHOR), Scambia, Giovanni3 (AUTHOR), Oaknin, Ana4 (AUTHOR), Friedlander, Michael5 (AUTHOR), Lisyanskaya, Alla6 (AUTHOR), Floquet, Anne7,8 (AUTHOR), Leary, Alexandra8,9 (AUTHOR), Sonke, Gabe S.10 (AUTHOR), Gourley, Charlie11 (AUTHOR), Banerjee, Susana12 (AUTHOR), Oza, Amit13 (AUTHOR), González-Martín, Antonio14 (AUTHOR), Aghajanian, Carol15 (AUTHOR), Bradley, William H.16 (AUTHOR), Kim, Jae-Weon17 (AUTHOR), Mathews, Cara18 (AUTHOR), Liu, Joyce19 (AUTHOR), Lowe, Elizabeth S.20 (AUTHOR), Bloomfield, Ralph21 (AUTHOR) |
| المصدر: |
Gynecologic Oncology. Oct2021, Vol. 163 Issue 1, p41-49. 9p. |
| مصطلحات موضوعية: |
*OVARIAN cancer, *OLAPARIB, *BRCA genes, *DIAGNOSIS, *PROGRESSION-free survival, *NEUTROPENIA |
| مستخلص: |
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. 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). 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. 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. • Detailed safety data from the SOLO1 trial of maintenance olaparib in newly diagnosed, advanced BRCA-mutated ovarian cancer. • Maintenance olaparib had a predictable tolerability profile with no new safety signals identified. • Adverse events usually occurred early, were largely manageable and led to discontinuation in a minority of patients. • Risk of MDS/AML with maintenance olaparib in the newly diagnosed setting remained <1.5% with long-term follow-up of 5 years. • The majority of patients were able to remain on the recommended starting dose of olaparib 300 mg twice daily. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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