Publicaciones científicas

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

20-ene-2023 | Revista: Journal of Clinical Oncology

Paul DiSilvestro  1 , Susana Banerjee  2 , Nicoletta Colombo  3 , Giovanni Scambia  4 , Byoung-Gie Kim  5 , Ana Oaknin  6 , Michael Friedlander  7 , Alla Lisyanskaya  8 , Anne Floquet  9   10 , Alexandra Leary  10   11 , Gabe S Sonke  12 , Charlie Gourley  13 , Amit Oza  14 , Antonio González-Martín  15   16 , Carol Aghajanian  17 , William Bradley  18 , Cara Mathews  1 , Joyce Liu  19 , John McNamara  20 , Elizabeth S Lowe  21 , Mei-Lin Ah-See  22 , Kathleen N Moore  23 , SOLO1 Investigators

Purpose: In SOLO1/GOG 3004 ( 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.

CITA DEL ARTÍCULO  J Clin Oncol. 2023 Jan 20;41(3):609-617. doi: 10.1200/JCO.22.01549.  Epub 2022 Sep 9.