Tumor Treating Fields therapy in platinum-resistant ovarian cancer: Results of the ENGOT-ov50/GOG-3029/INNOVATE-3 pivotal phase 3 randomized study.
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Vergote Ignace, Copeland Larry J, Van Gorp Toon, Laenen Annouschka, Scambia Giovanni, Thaker Premal H, Cibula David, Colombo Nicoletta, Lea Jayanthi, Gonzalez-Martin Antonio, Korach Jacob, Sehouli Jalid, Monk Bradley J, Heinzelmann-Schwarz Viola, Berger Regina, Buscema Joseph, Lau Susie, Mądry Radoslaw, Denys Hannelore, Pepin Jessica Thomes, Salutari Vanda, Bagaméri Andrea, Ardizzoia Antonio, Henry Stéphanie, Cecere Sabrina Chiara, Hruda Martin, Iglesias David A, Manso Luis, Shai Ayelet, O'Malley David M, ENGOT-ov50/GOG-3029/INNOVATE-3 Study Investigators
Аннотация
PATIENTS AND METHODS: Adult patients with PROC with ≤ 5 total prior lines of therapy (LOT), including ≤ 2 prior LOT for platinum-resistant disease, and ECOG PS of 0-1 were randomized 1:1 to receive TTFields (200 kHz; ≥ 18 h/day) + PTX (80 mg/m2 weekly) or PTX. Primary endpoint was overall survival (OS). Exploratory post-hoc analyses assessed OS in pegylated liposomal doxorubicin (PLD)-naive patients.
RESULTS: Between March 2019 and November 2021, 558 patients (ECOG PS 0, 60.2 %; median [range] age, 62 [22-91] years) were assigned TTFields+PTX (n = 280) or PTX (n = 278). 24.4 % had 4 + prior LOT. Median OS was 12.2 months with TTFields+PTX vs 11.9 months with PTX (HR, 1.01; 95 % CI, 0.83-1.24; p = 0.89). Grade ≥ 3 adverse events (AEs) were similar between treatment groups. Grade 1/2 device-related skin AEs occurred in 83.6 % of patients receiving TTFields therapy. In exploratory post-hoc analysis in PLD-naive patients, median OS was 16 months with TTFields+PTX (n = 113) vs 11.7 months with PTX (n = 88; nominal HR, 0.67; 95 % CI, 0.49-0.94; p = 0.03).
CONCLUSIONS: No new safety signals were identified. TTFields+PTX did not significantly improve OS compared with PTX in the intent-to-treat population. An exploratory post-hoc analysis suggests a potentially favorable benefit-risk profile for TTFields therapy in PLD-naive patients.