Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial.

Autor:	DiSilvestro P; Program in Women's Oncology, Women & Infants Hospital, Providence, RI., Banerjee S; The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom., Colombo N; University of Milan-Bicocca and Istituto Europeo di Oncologia IRCCS, Milan, Italy., Scambia G; Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Kim BG; Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea., Oaknin A; Gynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain., Friedlander M; University of New South Wales Clinical School, Prince of Wales Hospital, Randwick, New South Wales, Australia., Lisyanskaya A; St Petersburg City Oncology Dispensary, St Petersburg, Russia., Floquet A; Institut Bergonié, Comprehensive Cancer Center, Bordeaux, France.; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Paris, France., Leary A; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Paris, France.; Institut Gustave-Roussy, Villejuif, France., Sonke GS; The Netherlands Cancer Institute, Amsterdam, the Netherlands., Gourley C; Cancer Research UK Scotland Center, University of Edinburgh, Edinburgh, United Kingdom., Oza A; Princess Margaret Cancer Center, Toronto, ON, Canada., González-Martín A; Clínica Universidad de Navarra, Madrid, Spain.; Program In Solid Tumours, CIMA, Pamplona, Spain., Aghajanian C; Memorial Sloan Kettering Cancer Center, New York, NY., Bradley W; Froedtert and the Medical College of Wisconsin, Milwaukee, WI., Mathews C; Program in Women's Oncology, Women & Infants Hospital, Providence, RI., Liu J; Dana-Farber Cancer Institute, Boston, MA., McNamara J; Biostatistics, Oncology Biometrics, Oncology R&D, AstraZeneca, Cambridge, United Kingdom., Lowe ES; Global Medicines Development, Oncology, AstraZeneca, Gaithersburg, MD., Ah-See ML; Oncology R&D, Late-stage Development, AstraZeneca, Cambridge, United Kingdom., Moore KN; Stephenson Oklahoma Cancer Center, Oklahoma City, OK.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2023 Jan 20; Vol. 41 (3), pp. 609-617. Date of Electronic Publication: 2022 Sep 09.
DOI:	10.1200/JCO.22.01549
Abstrakt:	Purpose: In SOLO1/GOG 3004 (ClinicalTrials.gov identifier: NCT01844986), maintenance therapy with the poly(ADP-ribose) polymerase inhibitor olaparib provided a sustained progression-free survival benefit in patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 (BRCA) mutation. We report overall survival (OS) after a 7-year follow-up, a clinically relevant time point and the longest follow-up for any poly(ADP-ribose) polymerase inhibitor in the first-line setting. Methods: This double-blind phase III trial randomly assigned patients with newly diagnosed advanced ovarian cancer and a BRCA mutation in clinical response to platinum-based chemotherapy to maintenance olaparib (n = 260) or placebo (n = 131) for up to 2 years. A prespecified descriptive analysis of OS, a secondary end point, was conducted after a 7-year follow-up. Results: The median duration of treatment was 24.6 months with olaparib and 13.9 months with placebo, and the median follow-up was 88.9 and 87.4 months, respectively. The hazard ratio for OS was 0.55 (95% CI, 0.40 to 0.76; P = .0004 [ P < .0001 required to declare statistical significance]). At 7 years, 67.0% of olaparib patients versus 46.5% of placebo patients were alive, and 45.3% versus 20.6%, respectively, were alive and had not received a first subsequent treatment (Kaplan-Meier estimates). The incidence of myelodysplastic syndrome and acute myeloid leukemia remained low, and new primary malignancies remained balanced between treatment groups. Conclusion: Results indicate a clinically meaningful, albeit not statistically significant according to prespecified criteria, improvement in OS with maintenance olaparib in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation and support the use of maintenance olaparib to achieve long-term remission in this setting; the potential for cure may also be enhanced. No new safety signals were observed during long-term follow-up.
Databáze:	MEDLINE
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