Journal Article

Carboplatin and Pegylated Liposomal Doxorubicin for Advanced Ovarian Cancer: Preliminary Activity Results of the MITO-2 Phase III Trial

Cognetti, F., Scollo, P., Signoriello, G., Pignata, S., Pisano, C., Vernaglia Lombardi, A., Morabito, A., Scambia, G., Gebbia, V., Perrone, F., Sorio, R., Savarese, A., Lorusso, D., Breda, E.

2009

Overview

Background: Based on the efficacy of pegylated liposomal doxorubicin (PLD) in relapsed ovarian cancer, we are conducting a phase III study comparing carboplatin plus either paclitaxel or PLD as first-line therapy in advanced ovarian cancer. Because of limited phase I and II data on PLD plus carboplatin in this setting, we conducted an interim activity analysis. Patients and Methods: Patients with stage 1c-IV epithelial ovarian cancer were randomized to carboplatin AUC 5 plus either paclitaxel 175 mg/m 2 or PLD 30 mg/m 2 every 3 weeks for 6 cycles. The interim activity analysis was planned according to a single-stage phase II design with an auspicated 50% response rate; 50 patients eligible for response assessment were required. Response was defined according to RECIST (Response Evaluation Criteria in Solid Tumors). Results: A complete response was achieved in 14 patients (28%) and a partial response in 20 (40%), which produced an overall response rate of 68%. The activity exceeded the minimum required for study continuation. Stable disease was reported in an additional 10 patients (20%). Conclusions: The adopted schedule of PLD plus carboplatin demonstrates activity as a first-line treatment for advanced ovarian cancer.

• Publisher: Karger,S. Karger AG
• Subject: Adult / Aged / Antibiotics, Antineoplastic - therapeutic use / Antineoplastic Agents - therapeutic use / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Area Under Curve / Biological and medical sciences / Carboplatin - administration & dosage / Carboplatin - therapeutic use / Clinical Study / Comparative studies / Doxorubicin - administration & dosage / Doxorubicin - analogs & derivatives / Doxorubicin - therapeutic use / Drug therapy / Female / Female genital diseases / Gynecology. Andrology. Obstetrics / Humans / Medical sciences / Middle Aged / Neoplasm Staging / Neoplasms, Glandular and Epithelial - drug therapy / Neoplasms, Glandular and Epithelial - mortality / Neoplasms, Glandular and Epithelial - pathology / Oncology / Ovarian cancer / Ovarian Neoplasms - drug therapy / Ovarian Neoplasms - mortality / Ovarian Neoplasms - pathology / Paclitaxel - administration & dosage / Paclitaxel - therapeutic use / Polyethylene Glycols - administration & dosage / Polyethylene Glycols - therapeutic use / Survival Analysis / Treatment Outcome / Tumors