Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: The MITO-2 randomized phase III trial

Maria Rosaria Valerio, Vittorio Gebbia, Pietro Musso, Antonella Ferro, Laura Scaltriti, Alba Brandes, Massimo Di Maio, Vittorio Gebbia, Luigi Frigerio, Paolo Scollo, Alberto Ravaioli, Alessandra Vernaglia Lombardi, Stefano Tamberi, Pietro Del Medico, Francesco Legge, Vanda Salutari, Antonio Febbraro, Enrico Aitini, Carmela Pisano, Roberto SorioSandro Pignata, Enrico Breda, Stefano Greggi, Antonella Savarese, Gabriella Ferrandina, Alessandro Morabito, Domenica Lorusso, Francesco Perrone, Giovanni Scambia, Ciro Gallo, Donato Natale

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Abstract

Purpose Carboplatin/paclitaxel is the standard first-line chemotherapy for patients with advanced ovarian cancer. Multicentre Italian Trials in Ovarian Cancer-2 (MITO-2), an academic multicenter phase III trial, tested whether carboplatin/pegylated liposomal doxorubicin (PLD) was more effective than standard chemotherapy. Patients and Methods Chemotherapy-naive patients with stage IC to IV ovarian cancer (age ≤ 75 years; Eastern Cooperative Oncology Group performance status ≤ 2) were randomly assigned to carboplatin area under the curve (AUC) 5 plus paclitaxel 175 mg/m2 or to carboplatin AUC 5 plus PLD 30 mg/m2, every 3 weeks for six cycles. Primary end point was progression-free survival (PFS). With 632 events in 820 enrolled patients, the study would have 80% power to detect a 0.80 hazard ratio (HR) of PFS. Results Eight hundred twenty patients were randomly assigned. Disease stages III and IV were prevalent. Occurrence of PFS events substantially slowed before obtaining the planned number. Therefore, in concert with the Independent Data Monitoring Committee, final analysis was performed with 556 events, after a median follow-up of 40 months. Median PFS times were 19.0 and 16.8 months with carboplatin/PLD and carboplatin/paclitaxel, respectively (HR, 0.95; 95% CI, 0.81 to 1.13; P = .58). Median overall survival times were 61.6 and 53.2 months with carboplatin/PLD and carboplatin/paclitaxel, respectively (HR, 0.89; 95% CI, 0.72 to 1.12; P = .32). Carboplatin/PLD produced a similar response rate but different toxicity (less neurotoxicity and alopecia but more hematologic adverse effects). There was no relevant difference in global quality of life after three and six cycles. Conclusion Carboplatin/PLD was not superior to carboplatin/paclitaxel, which remains the standard first-line chemotherapy for advanced ovarian cancer. However, given the observed CIs and the different toxicity, carboplatin/PLD could be considered an alternative to standard therapy. © 2011 by American Society of Clinical Oncology.
Lingua originaleEnglish
pagine (da-a)3628-3635
Numero di pagine8
RivistaJournal of Clinical Oncology
Volume29
Stato di pubblicazionePublished - 2011

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All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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Valerio, M. R., Gebbia, V., Musso, P., Ferro, A., Scaltriti, L., Brandes, A., Di Maio, M., Gebbia, V., Frigerio, L., Scollo, P., Ravaioli, A., Lombardi, A. V., Tamberi, S., Del Medico, P., Legge, F., Salutari, V., Febbraro, A., Aitini, E., Pisano, C., ... Natale, D. (2011). Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: The MITO-2 randomized phase III trial. Journal of Clinical Oncology, 29, 3628-3635.