Non‑pegylated liposomal doxorubicin for patients with recurrent ovarian cancer: A multicentric phase II trial

Brucker,Janina; Mayer,Christine; Gebauer,Gerhard; Mallmann,Peter; Belau,Antje Kristina; Schneeweiss,Andreas; Sohn,Christof; Eichbaum,Michael

doi:10.3892/ol.2016.4740

Non‑pegylated liposomal doxorubicin for patients with recurrent ovarian cancer: A multicentric phase II trial

Authors:
- Janina Brucker
- Christine Mayer
- Gerhard Gebauer
- Peter Mallmann
- Antje Kristina Belau
- Andreas Schneeweiss
- Christof Sohn
- Michael Eichbaum
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Affiliations: Department of Gynecology and Obstetrics, University of Heidelberg Medical School, D‑69120 Heidelberg, Germany, Department of Gynecology and Gynecological Oncology, Marien Hospital Hamburg, D‑22087 Hamburg, Germany, Department of Gynecology and Obstetrics, University of Cologne Medical School, D‑50931 Köln, Germany, Department of Gynecology and Obstetrics, University of Greifswald Medical School, D‑17475 Greifswald, Germany, National Center for Tumor Diseases, University Hospital Heidelberg, D‑69120 Heidelberg, Germany, Department of Gynecology, St. Marien Hospital Frankfurt, D‑60318 Frankfurt, Germany
Published online on: June 16, 2016 https://doi.org/10.3892/ol.2016.4740
Pages: 1211-1215

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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/m2 d1q22 and 60 mg/m2 d1q22 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/m2 d1q22. The findings suggest that non‑pegylated liposomal doxorubicin administered in a schedule of 60 mg/m2 d1q22 is well‑manageable and is associated with tolerable non‑hematological toxicities (predominantly nausea).

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