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- Title
Carboplatin and Pegylated Liposomal Doxorubicin for Advanced Ovarian Cancer: Preliminary Activity Results of the MITO-2 Phase III Trial.
- Authors
Pignata, S.; Scambia, G.; Savarese, A.; Breda, E.; Sorio, R.; Pisano, C.; Lorusso, D.; Cognetti, F.; Vernaglia Lombardi, A.; Gebbia, V.; Scollo, P.; Morabito, A.; Signoriello, G.; Perrone, F.
- Abstract
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/m2 or PLD 30 mg/m2 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. Copyright © 2008 S. Karger AG, Basel
- Subjects
DOXORUBICIN; ANTHRACYCLINES; OVARIAN cancer; AMINOGLYCOSIDES; ANTINEOPLASTIC antibiotics
- Publication
Oncology, 2009, Vol 76, Issue 1, p49
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000178760