A randomized multicenter phase III study comparing weekly versus every 3 weeks carboplatin (C) plus paclitaxel (P) in patients with advanced ovarian cancer (AOC): Multicenter Italian Trials in Ovarian Cancer (MITO-7)—European Network of Gynaecological Oncological Trial Groups (ENGOT-ov-10) and Gynecologic Cancer Intergroup (GCIG) trial.

Gynecologic Cancer
Session Type and Session Title: 
Oral Abstract Session, Gynecologic Cancer
Abstract Number: 
J Clin Oncol 31, 2013 (suppl; abstr LBA5501)
Sandro Pignata, Giovanni Scambia, Rossella Lauria, Francesco Raspagliesi, Pierluigi Benedetti Panici, Gennaro Cormio, Dionyssios Katsaros, Roberto Sorio, Giovanna Cavazzini, Gabriella Ferrandina, Enrico Breda, Viviana Murgia, Cosimo Sacco, Nuria Maria Asensio Sierra, Carmela Pisano, Vanda Salutari, Beatrice E. Weber, Eric Pujade-Lauraine, Ciro Gallo, Francesco Perrone; National Cancer Institute, Napoli, Italy; Catholic University of the Sacred Heart, Roma, Italy; AOU Federico II, Naples, Italy; IRCCS Istituto Nazionale Tumori, Milan, Italy; "Sapienza" University, Roma, Italy; University of Bari, Bari, Italy; Sant'Anna Hospital - University of Torino, Turin, Italy; National Cancer Institute CRO, Aviano, Italy; “C.Poma” Hospital, Mantova, Italy; Catholic University of the Sacred Heart, Campobasso, Italy; Fatebenefratelli Hospital, Roma, Italy; Santa Chiara Hospital, Trento, Italy; University Hospital, Udine, Italy; Arcispedale “S. Maria Nuova” IRCCS, Reggio Emilia, Italy; Catholic University of the Sacred Heart, Rome, Italy; Centre Alexis Vautrin, Vandoeuvre-lès-Nancy, France; Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Hôtel-Dieu, Paris, France; Medical Statistics, Department of Medicine and Public Health, Second University, Napoli, Italy; National Cancer Institute, G.Pascale Foundation, Napoli, Italy

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Abstract Disclosures


Background: Three-weekly (3w) CP is standard first-line chemotherapy for AOC pts. Weekly (w) P combined with 3w C prolonged PFS and OS in a JGOG phase III trial. MITO-7 is an academic randomized phase III study, comparing 3w vs. w CP. Methods: AOC chemonaive pts, stage IC-IV, age≤75, ECOG PS≤2, were randomized to 3wCP (C AUC6 + P 175mg/m², d1q21) for 6 cycles or to wCP (C AUC2 + P 60mg/m²) for 18 administrations. Coprimary endpoints were PFS and quality of life (QoL), measured by FACT-O and FACT/GOG-Ntx. With 80% power in detecting HR of 0.75, 2-sided α=0.05, 383 events were needed for PFS analysis. The arms were compared with a log-rank test and in a Cox model adjusted by stage, PS, residual disease, age and size of institution, following intention-to-treat. QoL was measured at baseline and weekly for 9 wks. Interaction between arm and QoL time was tested in a linear mixed model. Toxicity was coded by NCI-CTCAE v3.0. Results: 822 pts were enrolled by MITO, MANGO, and GINECO. Median age was 60; stage III (66%) and IV (18%) were prevalent. As of March 18, 2013, with median follow-up 20 months, 410 PFS events were recorded. Median PFS was 18.8 months with wCP and 16.5 months with 3wCP (HR 0.88, 95%CI 0.72-1.06, p=0.18). Lack of significant difference was confirmed (HR 0.87, 95%CI 0.71-1.05) in Cox model. For all scores, QoL course was significantly different between arms (p<0.0001). With 3wCP, QoL scores clearly worsened after each chemotherapy course (weeks 1, 4, 7), whilst with wCP, after a small and transient worsening at week 1, scores remained stable. Considering severe grades (≥3), wCP produced significantly less neutropenia, febrile neutropenia, thrombocytopenia, renal toxicity, and neuropathy. Conclusions: Compared to standard CP every 3 weeks, weekly CP did not demonstrate a significant benefit in PFS, but was associated with better QoL and toxicity. Clinical trial information: NCT00660842.