Late phase II clinical study of RP56976 (Docetaxel) in patients with advanced/recurrent breast cancer

T. Taguchi, S. Mori, R. Abe, K. Hasegawa, Y. Morishita, T. Tabei, Y. Sasaki, M. Fujita, K. Enomoto, K. Hamano, T. Tominaga, T. Sasaki, S. Yamaguchi, K. Nishiyama, F. Iida, K. Kanda, H. Takagi, A. Masaoka, T. Takahashi

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19 Citations (Scopus)

Abstract

A late phase II clinical study of RP56976 (Docetaxel), a new semisynthetic anticancer agent, was conducted in patients with advanced/recurrent breast cancer. RP56976 (Docetaxel) was in general administered at an intravenous dose of 60 mg/m2 with dose-free intervals of 3-4 weeks. Of the 74 patients enrolled, 64 patients completed the scheduled course of treatment. Three patients showed complete response (CR), 32 patients partial response (PR), 3 patients minor response (MR), 18 patients no change (NC), and 8 patients had progressive disease (PD). The overall response rate was 54.7%. The response rate in patients who previously had received chemotherapy was 55.7%, and the response rate in patients who had resistance to anthracycline agents or who did not respond to previous treatment was 58.7%. Adverse reactions included nausea/vomiting in 38 patients (57.6%), fatigue in 46 patients (69.7%), anorexia in 46 patients (69.7%), fever in 26 patients (39.4%), and alopecia in 60 patients (90.9%), all of which were tolerable. Abnormal laboratory findings included leukopenia (Grade III or more) in 57 patients (86.4%) and neutropenia (Grade III or more) in 56 patients (86.2%). The results show that RP56976 (Docetaxel) is an excellent agent with high antitumor effect for the treatment of advanced/recurrent breast cancer.

Original languageEnglish
Pages (from-to)2625-2632
Number of pages8
JournalJapanese Journal of Cancer and Chemotherapy
Volume21
Issue number15
Publication statusPublished - 1994

Keywords

  • Docetaxel
  • RP56976
  • breast cancer
  • late phase II study

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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