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- INOVATYON/ ENGOT-ov5 study: 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
INOVATYON/ ENGOT-ov5 study: 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
Fecha de publicación:
Autores de IIS La Fe
Participantes ajenos a IIS La Fe
- Colombo, N.
- Gadducci, A.
- Sehouli, J.
- Mäenpää, J.
- Sessa, C.
- Férnández-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.
- De Giorgi, U.
- Zola, P.
- Panici, P.
- Aglietta, M.
- Arcangeli, V.
- Zamagni, C.
- Bologna, A.
- Westermann, A.
- Heinzelmann-Schwarz, V.
- Tsibulak, I.
- Wimberger, P.
- Poveda, A.
- Rulli, E.
- Carlucci, L.
- Poli, D.
- Caudana, M.C.
- Nicoletto, M.O.
- DeCensi, A.
- Katsaròs, D.
- Palaia, I.
- Bertolini, A.
- Caroti, C.
- Bruzzone, M.
- Donadello, N.
- Di Costanzo, G.
- Zaniboni, A.
- Surico, D.
- Buosi, R.
- Cortesi, E.
- Zafarana, E.
- Fusco, V.
- Zavallone, L.
- Gamucci, T.
- Narducci, F.
- Musacchi, V.
- Babilonti, L.
- Ferrero, A.
- Cavanna, L.
- Sabbatini, R.
- Tamberi, S.
- Gentili, M.R.
- Artioli, G.
- Ardizzoia, A.
- Caldara, A.
- Sirotovà, Z.
- Casartelli, C.
- Aieta, M.
- Cinieri, S.
- de Marino, E.
- Gori, S.
- Ferraú, F.
- Blasi, L.
- Alù, M.
- De Placido, S.
- Milandri, C.
- Bover, I.
- Márquez, R.
- Alarcón, J.
- Caballero-Diaz, C.
- Ruiz-Miravet, N.
- Ortega, E.
- Arcusa Lanza, M.A.
- Catot Tort, S.
- García-Martínez, E.
- Gironés Sarrió, R.
- Garcia Garcia, Y.
- Mendiola, C.
- Sánchez, A.B.
- Heinrich, G.
- Runnebaum, I.
Abstract
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. © The Author(s) 2023.
Datos de la publicación
- ISSN/ISSNe:
- 0007-0920, 1532-1827
- Tipo:
- Article
- Páginas:
- 1503-1513
- PubMed:
- 36759720
- Enlace a otro recurso:
- www.scopus.com
- Factor de Impacto:
- 2,272 SCImago ℠
- Cuartil:
- Q1 SCImago ℠
BRITISH JOURNAL OF CANCER SPRINGERNATURE
Citas Recibidas en Web of Science: 21
Citas Recibidas en Scopus: 25
Documentos
- No hay documentos
Filiaciones
Keywords
- antineoplastic metal complex; bevacizumab; carboplatin; dexamethasone; doxorubicin; olaparib; trabectedin; antineoplastic agent; macrogol; platinum; adult; aged; Article; cancer growth; cancer patient; cancer recurrence; controlled study; febrile neutropenia; female; gastrointestinal disease; human; leukopenia; liver disease; liver toxicity; maintenance therapy; major clinical study; monotherapy; multiple cycle treatment; myelodysplastic syndrome; nausea; neurotoxicity; neutropenia; open study; ovary cancer; overall survival; patient history of chemotherapy; phase 3 clinical trial; pleura effusion; progression free survival; randomized controlled trial; sepsis; stomatitis; thrombocytopenia; vomiting; clinical trial; ovary tumor; tumor recurrence; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Carcinoma, Ovarian Epithelial; Doxorubicin; Female; Humans; Neoplasm Recurrence, Local; Ovarian Neoplasms; Platinum; Polyethylene Glycols; Trabectedin
Campos de Estudio
Cita
Colombo N,Gadducci A,Sehouli J,Mäenpää J,Sessa C,Férnández A,Ottevanger NB,Berger R,VERGOTE I,D’Incalci M,Churruca C,Chekerov R,Nyvang GB,Riniker S,Herbertson R,Fossati R,Barretina MP,Deryal M,Mirza MR,Biagioli E,Iglesias M,Funari G,Romeo M,Tasca G,Pardo B,Tognon G,Rubio MJ,De Giorgi U,Zola P,Panici P,Aglietta M,Arcangeli V,Zamagni C,Bologna A,Westermann A,Heinzelmann V,Tsibulak I,Wimberger P,Poveda A,Rulli E,Carlucci L,Poli D,Caudana MC,Nicoletto MO,DeCensi A,Katsaròs D,Palaia I,Bertolini A,Caroti C,Bruzzone M,Donadello N,Di G,Zaniboni A,Surico D,Buosi R,Cortesi E,Zafarana E,Fusco V,Zavallone L,Gamucci T,Narducci F,Musacchi V,Babilonti L,Ferrero A,Cavanna L,Sabbatini R,Tamberi S,Gentili MR,Artioli G,Ardizzoia A,Caldara A,Sirotovà Z,Casartelli C,Aieta M,Cinieri S,de Marino E,Gori S,Ferraú F,Blasi L,Alù M,De Placido S,Milandri C,Bover I,SANTABALLA A,Márquez R,Alarcón J,Caballero C,Ruiz N,Ortega E,Arcusa MA,Catot S,García E,Gironés R,Garcia Y,Mendiola C,Sánchez AB,Heinrich G,Runnebaum I. INOVATYON/ ENGOT-ov5 study: 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. Br. J. Cancer. 2023. 128. (8):p. 1503-1513. IF:6,400. (1).