Paclitaxel plus ifosfamide in advanced ovarian cancer. A multicenter phase II study

L. Miglietta, D. Amoroso, M. Bruzzone, C. Granetto, E. Catsafados, S. Mammoliti, D. Guarneri, F. Pedullà, G. Foglia, N. Ragni, M. C. Martini, F. Brema, G. Addamo, L. Moraglio, G. Pastorino, F. Boccardo

Research output: Contribution to journalArticlepeer-review

Abstract

Background: While ovarian cancer is one of the most sensitive cancers to cytotoxic drugs, with objective response rates of 60-80% routinely being reported in previously untreated patients, the majority of individuals with advanced disease ultimately relapse. Paclitaxel, a new and novel antimicrotubule agent, has shown activity as a salvage therapy in epithelial ovarian cancer. More importantly, in a prior study, it has been shown to be active in tumors that have displayed resistance to platinum compounds, with a reported response rate of 20%. Ifosfamide has shown activity in the treatment of patients who previously demonstrated clinical resistance to a platinum-cyclophosphamide combination. Recently, a synergistic activity of Taxol combined with ifosfamide has been reported in ovarian cell lines. Based on these data, a phase I/II study of a combination treatment with paclitaxel and ifosfamide was performed. Patients and methods: Thirty-one patients with recurrent ovarian cancer or ovarian cancer refractory to cisplatin (CDDP)-containing regimens were treated with paclitaxel at a dose of 135 mg/m 2 on day 1; ifosfamide was administered at 1 g/m 2 on days 2 and 3 for the first cycle and 1.5 and 2 g/m 2 with the same schedule in cycles 2 and 3, respectively. In the absence of toxicity, the dose of ifosfamide was maintained at 2 g/m 2 for the last three cycles. Cytotoxic therapy was repeated every 3 weeks. Results: A 30% overall objective response rate was achieved in the 30 patients assessable for response. Among 21 platinum-resistant patients, 4 partial responses (19%) were observed, while in the 9 platinum-sensitive patients 2 complete responses and 3 partial responses (55%) were observed. Myelosuppression was the predominant toxicity. Leukopenia (WHO grade 3-4) occurred in 10% of patients who received ifosfamide at a dose of 1 g/m 2 and in 18% of patients treated with ifosfamide at 1.5 g/m 2. Conclusion: Our results confirmed a low activity of paclitaxel in platinum-resistant patients. The results of this combination treatment with paclitaxel-ifosfamide in our platinum-sensitive patients support further investigations in a randomized study of the combination regimen against paclitaxel alone or retreatment with organoplatinum compounds.

Original languageEnglish
Pages (from-to)102-107
Number of pages6
JournalOncology
Volume54
Issue number2
Publication statusPublished - Mar 1997

Keywords

  • Advanced ovarian cancer
  • Ifosfamide
  • Paclitaxel

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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