Annals of Oncology Advance Access originally published online on November 9, 2005
Annals of Oncology 2006 17(1):93-96; doi:10.1093/annonc/mdj032
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© 2005 European Society for Medical Oncology
Pegylated liposomal doxorubicin and carboplatin in advanced gynecologic tumors: a prospective phase I/II study of the Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR)
1 HSK, Dr Horst Schmidt Klinik, Department of Gynecology & Gynecologic Oncology, Wiesbaden; 2 University of Muenchen-Grosshadern, Department of Gynecology & Obstetrics, Muenchen; 3 Evangelisches Krankenhaus Duesseldorf, Department of Gynecology & Obstetrics, Duesseldorf; 4 University of Schleswig-Holstein, Campus Kiel, Department of Gynecology & Obstetrics, Kiel; 5 Technical University Muenchen, Department of Gynecologiy & Obstetrics, Muenchen; 6 University of Dresden, Department of Gynecology & Obstetrics, Dresden; 7 University of Muenster, Department of Gynecology & Obstetrics, Muenster; 8 St-Vincentius-Hospital, Department of Gynecology & Obstetrics, Karlsruhe; 9 University of Essen, Department of Gynecologic & Obstetrics, Essen; 10 AGO-OVAR, Central Study Office, Wiesbaden, Germany
* Correspondence to: Professor Dr A. du Bois, HSK, Dr Horst Schmidt Klinik, Department of Gynecology & Gynecologic Oncology, Ludwig-Erhard-Str. 100, D-65199 Wiesbaden, Germany. Tel: +49-611-433203; Fax: +49-611-433205; E-mail: dubois.hsk-wiesbaden{at}uumail.de
Background: Single-agent platinum and single-agent pegylated liposomal doxorubicin (PLD) are both effective in the treatment of gynecologic malignancies. Based on evidence that combination platinum-containing regimens offer superior efficacy versus single-agent regimens, we conducted this study to determine the maximum tolerated dose (MTD) of PLD in combination with carboplatin.
Patients and methods: In this phase I/II dose-finding study, six courses of PLD (20, 30, 40 or 50 mg/m2) and carboplatin (AUC 6) were administered every 28 days to women with advanced gynecologic malignancies. Three to six patients were treated at each dose level; an additional 12 patients were treated at the MTD.
Results: PLD 40 mg/m2 was identified as the MTD when administered with carboplatin. Five of 18 patients experienced a dose-limiting toxicity at the MTD; two patients had grade 3/4 neutropenia, and one each had grade 3 emesis and grade 3 thrombocytopenia and thrombosis. No patient developed cardiotoxicity. In 11 patients evaluable for response, there were two complete responses, two partial responses and four patients with stable disease.
Conclusions: The MTD for PLD when administered in combination with carboplatin is 40 mg/m2. This regimen is well tolerated and offers promising activity in women with advanced gynecologic malignancies.
Key words: carboplatin, gynecologic neoplasm, pegylated liposomal doxorubicin
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