TY - JOUR
T1 - INOVATYON/ ENGOT-ov5 study
T2 - Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line
AU - Colombo, N.
AU - Gadducci, A.
AU - Sehouli, J.
AU - Rulli, E.
AU - Mäenpää, J.
AU - Sessa, C.
AU - Montes, A.
AU - Ottevanger, N. B.
AU - Berger, R.
AU - Vergote, I.
AU - D'Incalci, M.
AU - Churruca Galaz, C.
AU - Chekerov, R.
AU - Nyvang, G. B.
AU - Riniker, S.
AU - Herbertson, R.
AU - Fossati, R.
AU - Barretina-Ginesta, M. P.
AU - Deryal, M.
AU - Mirza, M. R.
AU - Biagioli, E.
AU - Iglesias, M.
AU - Funari, G.
AU - Romeo, M.
AU - Tasca, G.
AU - Pardo, B.
AU - Tognon, G.
AU - Rubio-Pérez, M. J.
AU - DeCensi, A.
AU - de Giorgi, U.
AU - Zola, P.
AU - Benedetti Panici, P.
AU - Aglietta, M.
AU - Arcangeli, V.
AU - Zamagni, C.
AU - Bologna, A.
AU - Westermann, A.
AU - Heinzelmann-Schwarz, V.
AU - Tsibulak, I.
AU - Wimberger, P.
AU - INOVATYON study group
AU - Poveda, A.
N1 - Publisher Copyright: © 2023. The Author(s).
PY - 2023/4/1
Y1 - 2023/4/1
N2 - BACKGROUND: 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). METHODS: 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). RESULTS: 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). CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT01379989.
AB - BACKGROUND: 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). METHODS: 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). RESULTS: 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). CONCLUSIONS: 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT01379989.
UR - http://www.scopus.com/inward/record.url?scp=85152160334&partnerID=8YFLogxK
U2 - https://doi.org/10.1038/s41416-022-02108-7
DO - https://doi.org/10.1038/s41416-022-02108-7
M3 - Article
C2 - 36759720
SN - 0007-0920
VL - 128
SP - 1503
EP - 1513
JO - British journal of cancer
JF - British journal of cancer
IS - 8
ER -