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.
Original language | English |
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Pages (from-to) | 49-54 |
Number of pages | 6 |
Journal | Oncology |
Volume | 76 |
Issue number | 1 |
DOIs | |
Publication status | Published - Dec 2008 |
Keywords
- Anthracyclines
- Carboplatin
- Ovarian cancer
- Paclitaxel
- Pegylated liposomal doxorubicin
ASJC Scopus subject areas
- Cancer Research
- Oncology