Electronic Resource
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
| العنوان: | 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 |
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| المؤلفون: | Colombo, N, Gadducci, A, Sehouli, J, Rulli, E, Mäenpää, J, Sessa, C, Montes, A, Ottevanger, N, Berger, R, Vergote, I, D'Incalci, M, Churruca Galaz, C, Chekerov, R, Nyvang, G, Riniker, S, Herbertson, R, Fossati, R, Barretina-Ginesta, M, Deryal, M, Mirza, M, Biagioli, E, Iglesias, M, Funari, G, Romeo, M, Tasca, G, Pardo, B, Tognon, G, Rubio-Pérez, M, 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, Ottevanger, N B, Nyvang, G B, Barretina-Ginesta, M P, Mirza, M R, Rubio-Pérez, M J, DeCensi, A |
| بيانات النشر: | Nature Publishing Group country:GB 2023 |
| نوع الوثيقة: | Electronic Resource |
| مستخلص: | 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. |
| مصطلحات الفهرس: | platinum-free interval, info:eu-repo/semantics/article |
| URL: | info:eu-repo/semantics/altIdentifier/pmid/36759720 info:eu-repo/semantics/altIdentifier/wos/WOS:000962948100001 volume:128 issue:8 firstpage:1503 lastpage:1513 numberofpages:11 journal:BRITISH JOURNAL OF CANCER |
| الاتاحة: | Open access content. Open access content info:eu-repo/semantics/openAccess |
| ملاحظة: | STAMPA English |
| Other Numbers: | ITBAO oai:boa.unimib.it:10281/403595 10.1038/s41416-022-02108-7 info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85152160334 1376722302 |
| المصدر المساهم: | BICOCCA OPEN ARCH From OAIster®, provided by the OCLC Cooperative. |
| رقم الانضمام: | edsoai.on1376722302 |
| قاعدة البيانات: | OAIster |
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