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Colombo, N; Gadducci, A; Sehouli, J; Rulli, E; Mäenpää, J; Sessa, C; Montes, A; Ottevanger, N B; Berger, R; Vergote, I; D'Incalci, M; Churruca Galaz, C; Chekerov, R; Nyvang, G B; Riniker, S; Herbertson, R; Fossati, R; Barretina-Ginesta, M P; Deryal, M; Mirza, M R; Biagioli, E; Iglesias, M; Funari, G; Romeo, M; Tasca, G; Pardo, B; Tognon, G; Rubio-Pérez, M J; DeCensi, A; De Giorgi, U; Zola, P; Benedetti Panici, P; Aglietta, M; Arcangeli, V; Zamagni, C; Bologna, A; Westermann, A; Heinzelmann-Schwarz, V; Tsibulak, I; Wimberger, P; Poveda, A
British journal of cancer, 04/2023, Volume: 128, Issue: 8Journal Article
This trial investigated the hypothesis that the treatment with trabectedin/PLD (TP) to extend the platinum-free interval (TFIp) can improve overall survival (OS) in patients with recurrent ovarian cancer (OC). Patients with OC (up to two previous platinum-based lines), with a TFIp of 6-12 months, were randomised to receive carboplatin/PLD (CP) or TP followed by platinum therapy at relapse. The primary endpoint was OS (HR: 0.75). The study enrolled 617 patients. The median TFIp was 8.3 months and 30.3% of patients had received two previous platinum lines. 74% and 73.9% of patients, respectively, received a subsequent therapy (ST) in the CP and TP arm; in the latter TP arm 87.2% of ST was platinum-based, as per protocol. The median OS was 21.4 for CP and 21.9 months for TP (HR 1.13; 95% CI: 0.94-1.35; p = 0.197). Grade 3-5 adverse reactions occurred in 37.1% of patients in the CP arm and 69.7% of patients in the TP arm, and the most frequent were neutropenia (22.8% CP, 39.5% TP), gastrointestinal (7.1% CP, 17.4% TP), hepatic (0.7% CP, 19.1% TP). This study did not meet the primary endpoint. CP combination remains the standard for patients with recurrent OC and a 6-12 months TFIp; TP is an effective treatment in patients suffering from persistent platinum toxicities. ClinicalTrials.gov, number NCT01379989.
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