Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomised, multicentre, open-label, phase 3 trial
| Autor: | Pignata, S, Scambia, G, Katsaros, D, Gallo, C, Pujade Lauraine, E, De Placido, S, Bologna, A, Weber, B, Raspagliesi, F, Panici, Pb, Cormio, G, Sorio, R, Cavazzini, Mg, Ferrandina, G, Breda, E, Murgia, V, Sacco, C, Cinieri, S, Salutari, V, Ricci, C, Pisano, C, Greggi, S, Lauria, R, Lorusso, D, Marchetti, C, Selvaggi, L, Signoriello, S, Piccirillo, Mc, DI MAIO, Massimo, Perrone, F, Multicentre Italian Trials in Ovarian cancer, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens et du sein, Mario Negri Gynecologic Oncology, European Network of Gynaecological Oncological Trial Groups, Gynecologic Cancer InterGroup Investigators |
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| Přispěvatelé: | Pignata, S, Scambia, G, Katsaros, D, Gallo, C, Pujade-Lauraine, E, De Placido, S, Bologna, A, Weber, B, Raspagliesi, F, Panici, Pb, Cormio, G, Sorio, R, Cavazzini, Mg, Ferrandina, G, Breda, E, Murgia, V, Sacco, C, Cinieri, S, Salutari, V, Ricci, C, Pisano, C, Greggi, S, Lauria, R, Lorusso, D, Marchetti, C, Selvaggi, L, Signoriello, S, Piccirillo, Mc, Di Maio, M, Perrone, F |
| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
medicine.medical_specialty
Carboplatin plus Paclitaxel medicine.medical_treatment Phases of clinical research law.invention chemistry.chemical_compound paclitaxel Randomized controlled trial law Medicine Chemotherapy Intention-to-treat analysis advanced ovarian cancer business.industry Hazard ratio medicine.disease Carboplatin Surgery Regimen ovarian cancer Settore MED/40 - GINECOLOGIA E OSTETRICIA Oncology chemistry carboplatin business Febrile neutropenia |
| Popis: | Background: Carboplatin plus paclitaxel administered every 3 weeks is standard first-line chemotherapy for patients with advanced ovarian cancer. A weekly paclitaxel schedule combined with carboplatin every 3 weeks prolonged progression-free survival and overall survival in a Japanese phase 3 trial. The aim of our study was to assess whether a weekly schedule of carboplatin plus paclitaxel is more effective than the same drugs given every 3 weeks. Methods: We did a multicentre, randomised, phase 3 study at 67 institutions in Italy and France. Women with FIGO stage IC-IV ovarian cancer, an ECOG performance status of 2 or lower, and who had never received chemotherapy were randomly allocated in a 1:1 ratio to receive either carboplatin (AUC 6 mg/mL per min) plus paclitaxel (175 mg/m2) every 3 weeks for six cycles or carboplatin (AUC 2 mg/mL per min) plus paclitaxel (60 mg/m2) every week for 18 weeks. Randomisation was done by computer-based minimisation, stratified by centre, residual disease after surgery, and ECOG performance status. The study was not blinded. Coprimary endpoints were progression-free survival and quality of life (assessed by the Functional Assessment of Cancer Therapy Ovarian Trial Outcome Index [FACT-O/TOI] score), and analysis was by modified intention to treat. This report presents the final analysis. The study is registered with ClinicalTrials.gov, number NCT00660842. Findings: 822 patients were enrolled into the study between Nov 20, 2008, and March 1, 2012; 12 withdrew their consent immediately after randomisation and were excluded, and 810 were eligible for analysis. 404 women were allocated treatment every 3 weeks and 406 were assigned to the weekly schedule. After median follow-up of 22·3 months (IQR 16·2-30·9), 449 progression-free survival events were recorded. Median progression-free survival was 17·3 months (95% CI 15·2-20·2) in patients assigned to treatment every 3 weeks, versus 18·3 months (16·8-20·9) in women allocated to the weekly schedule (hazard ratio 0·96, 95% CI 0·80-1·16; p=0·66). FACT-O/TOI scores differed significantly between the two schedules (treatment-by-time interaction p |
| Databáze: | OpenAIRE |
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