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Phase II study of the combination of pegylated liposomal doxorubicin and topotecan in platinum-resistant ovarian cancer
  1. M. Verhaar-Langereis*,
  2. A. Karakus*,
  3. M. Van Eijkeren,
  4. E. Voest* and
  5. E. Witteveen*
  1. *Section of Medical Oncology, UMC Utrecht, Utrecht, The Netherlands
  2. Section of Gynecology, UMC Utrecht, Utrecht, The Netherlands
  1. Address correspondence and reprint requests to: Els Witteveen, MD, PhD, University Medical Centre Utrecht, Heidelberglaan 100, 3508 GA Utrecht, The Netherlands. Email: p.o.witteveen{at}umcutrecht.nl

Abstract

The combination of liposomal doxorubicin and topotecan was evaluated in a phase II study in patients with platinum-resistant ovarian cancer. Twenty-seven patients received liposomal doxorubicin (30 mg/m2) infused at day 1, followed by topotecan (1 mg/m2) infusion daily for 5 days. Cycles were repeated every 21 days. This combination regimen showed an overall response rate of 28%. Median time to progression was 30 weeks, with a median overall survival of 40 weeks. Grade 3/4 neutropenia was shown in 70% of patients and grade 3/4 thrombopenia in 41% of patients. Neutropenic fever was reported in 11% of patients. After reviewing the first 12 patients, the internal review board decided to administer topotecan at a dose of 0.75 mg/m2 and liposomal doxorubicin at 40 mg/m2 for the remainder of the study. However, this adjustment did not lead to reduction in bone marrow toxicity nor to an improvement in dose intensity. Palmar–plantar erythrodysesthesia and mucositis were more reported in the second cohort but usually mild. The combination of liposomal doxorubicin and topotecan demonstrates favorable response data in platinum-resistant ovarian cancer. However, substantial bone marrow toxicity limits further clinical use.

  • liposomal doxorubicin
  • ovarian cancer
  • platinum-resistant ovarian cancer
  • topotecan

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