© 2005 European Society for Medical Oncology
Original article |
Clinical and pharmacokinetic phase II study of pegylated liposomal doxorubicin and vinorelbine in heavily pretreated recurrent ovarian carcinoma
1 Department of Obstetrics and Gynecology, Gynecologic Oncology Unit, and 5 Department of Science and Drug Technology, University of Turin, Turin; 2 Department of Oncology, San Giovanni Antica Sede Hospital, Turin; 3 Division of Obstetrics and Gynecology, Gynecologic Oncology Unit, Mauriziano Hospital, University of Turin, Turin; 4 Department of Medical Oncology, COES, San Giovanni Battista Hospital, Turin, Italy
* Correspondence to: Dr D. Katsaros, Department of Obstetrics and Gynecology, Gynecologic Oncology Unit, University of Turin, Via Ventimiglia 3, 10126 Turin, Italy. Tel: +39-011-3134459; Fax: +39-011-3134859; Email: dhocc{at}libero.it
Background: This multicenter phase II study evaluated feasibility, clinical efficacy, toxicity and pharmacokinetics of the combination of pegylated liposomal doxorubicin (PLD) and vinorelbine (VNR) in patients with platinum–paclitaxel pretreated recurrent ovarian cancer.
Patients and methods: All patients received prior treatment with platinum and paclitaxel. Thirty-two heavily pretreated (median number of chemotherapy regimens two, range one to six) ovarian cancer patients received treatment with PLD 30 mg/m2 and VNR 30 mg/m2 every three weeks for six cycles. Ten patients entered the pharmacokinetic study, five receiving the PLD–VNR and five the VNR–PLD sequence.
Results: In 30 patients evaluated for response and toxicity, the overall response rate was 37% and 10% of patients achieved stable disease. Median time to progression and overall survival were 5.5 months (range 1–10) and 9 months (range 2–16), respectively. Toxicity was generally mild and reversible. VNR AUCtot and plasma levels were considerably higher in the PLD–VNR sequence.
Conclusions: The PLD–VNR regimen exhibits significant activity in heavily pretreated patients, is well tolerated and is associated with encouraging survival. Preliminary pharmacokinetic results suggest the PLD–VNR sequence for further clinical applications. This regimen should be considered as a treatment option in patients with chemotherapy-resistant ovarian cancer.
Key words: ovarian cancer, pegylated liposomal doxorubicin, pharmacokinetics, relapse, survival, vinorelbine
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