Weekly paclitaxel as first-line chemotherapy in elderly advanced breast cancer patients: A phase II study of the Gruppo Italiano di Oncologia Geriatrica (GIOGer)

Lucia Del Mastro, F. Perrone, L. Repetto, L. Manzione, V. Zagonel, L. Fratino, D. Marenco, M. Venturini, E. Maggi, C. Bighin, T. Catzeddu, A. Venturino, R. Rosso

Research output: Contribution to journalArticle

Abstract

Background: First-line chemotherapy regimens suitable for elderly advanced breast cancer patients are still not defined. Patients and methods: Women with stage III or IV breast cancer aged ≥70 years were enrolled in a phase II study aimed to evaluate both activity and toxicity of weekly paclitaxel. Among 46 planned patients, at least 18 responses and not more than seven unacceptable toxic events are required for a favourable conclusion. Paclitaxel 80mg/m2 was administered weekly for 3 weeks every 28 days. Results: Unacceptable toxicity occurred in seven out of 46 patients evaluated for toxicity [15.2%; exact 95% confidence interval (CI) 7.6% to 28.2%] and was represented by one case of febrile neutropenia, one case of severe allergic reaction and five cases of cardiac toxicity. Among 41 patients evaluated for response, a complete response occurred in two (4.9%) patients and a partial response in 20 (48.8%), with an overall response rate of 53.7% (exact 95% CI 38.7% to 67.9%). The median progression-free survival was 9.7 months (95% CI 8.5-18.7) and median survival was 35.8 months (95% CI 19-not defined). Conclusions: Weekly paclitaxel is highly active in elderly advanced breast cancer patients. Data on cardiovascular complications, however, indicate the need for a careful monitoring of cardiac function before and during chemotherapy.

Original languageEnglish
Pages (from-to)253-258
Number of pages6
JournalAnnals of Oncology
Volume16
Issue number2
DOIs
Publication statusPublished - Feb 2005

Keywords

  • Breast cancer
  • Cardiotoxicity
  • Chemotherapy
  • Elderly
  • Phase II study
  • Weekly paclitaxel

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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