title: Non-pegylated liposomal doxorubicin for patients with recurrent ovarian cancer: A multicentric phase II trial.
abstract: Patients with non-platinum-sensitive recurrent ovarian cancer have a poor prognosis. Non-pegylated liposomal doxorubicin (Myocet®) is a promising drug that may be able to improve treatment for such patients. In the current study, patients with recurrent ovarian cancer relapsing within 12 months after primary treatment received non-pegylated liposomal doxorubicin at 75 mg/m2d1q22 and 60 mg/m2d1q22 after study dose modification, respectively. There were 29 patients enrolled in the trial, and 124 cycles of non-pegylated liposomal doxorubicin were administered in total. All 29 patients were evaluable for toxicity. The clinical benefit rate (defined as the proportion of patients with either complete remission or partial remission, or with stable disease for >6 months) was 50%. The predominant non-hematological toxicity was nausea and vomiting (18 patients, grade I/II), whilst no palmar plantar erythrodysesthesia was observed. In 3 patients, a grade III hematological toxicity occurred, and the treatment schedule was consequently modified to 60 mg/m2d1q22. The findings suggest that non-pegylated liposomal doxorubicin administered in a schedule of 60 mg/m2d1q22 is well-manageable and is associated with tolerable non-hematological toxicities (predominantly nausea).
authors.affiliation: Department of Gynecology and Obstetrics, University of Heidelberg Medical School, D-69120 Heidelberg, Germany.
authors.forename: Janina
authors.initials: J
authors.lastname: Brucker
authors.affiliation: Department of Gynecology and Obstetrics, University of Heidelberg Medical School, D-69120 Heidelberg, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Mayer
authors.affiliation: Department of Gynecology and Gynecological Oncology, Marien Hospital Hamburg, D-22087 Hamburg, Germany.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Gebauer
authors.affiliation: Department of Gynecology and Obstetrics, University of Cologne Medical School, D-50931 Köln, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Mallmann
authors.affiliation: Department of Gynecology and Obstetrics, University of Greifswald Medical School, D-17475 Greifswald, Germany.
authors.forename: Antje Kristina
authors.initials: AK
authors.lastname: Belau
authors.affiliation: National Center for Tumor Diseases, University Hospital Heidelberg, D-69120 Heidelberg, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schneeweiss
authors.affiliation: Department of Gynecology and Obstetrics, University of Heidelberg Medical School, D-69120 Heidelberg, Germany.
authors.forename: Christof
authors.initials: C
authors.lastname: Sohn
authors.affiliation: Department of Gynecology, St. Marien Hospital Frankfurt, D-60318 Frankfurt, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Eichbaum
keywords: epithelial ovarian cancer; non-pegylated liposomal doxorubicin; platinum-resistant recurrence