Back to Search Start Over

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

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

Authors :
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
Source :
Journal of Clinical Oncology. 31:LBA5501-LBA5501
Publication Year :
2013
Publisher :
American Society of Clinical Oncology (ASCO), 2013.

Abstract

LBA5501 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

Subjects

Subjects :
Cancer Research
Oncology

Details

ISSN :
15277755 and 0732183X
Volume :
31
Database :
OpenAIRE
Journal :
Journal of Clinical Oncology
Accession number :
edsair.doi...........616fdedeb6c448523a14bd6181a91aad
Full Text :
https://doi.org/10.1200/jco.2013.31.18_suppl.lba5501