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Phase II study of paclitaxel (BMS-181339) intravenously infused over 3 hours for advanced or metastatic breast cancer in Japan

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Abstract

A Phase II study of paclitaxel in patients with primary advanced or metastatic breast cancer was conducted by a cooperative study group consisting of 16 institutions in Japan. Paclitaxel at a dose of 210 mg/m2 was intravenously infused over 3 hours, along with premedication to prevent hypersensitivity reactions. The course was repeated at 21-day intervals. Of 62 eligible patients, 60 were evaluable for toxicity and 59 were evaluable for efficacy. Forty-five patients were previously treated with anthracyclines. Twenty-one of 59 patients (35.6%) had a major objective response including 2 CRs and 19 PRs (95% confidence interval, 23.6–49.1%). A response rate of 35.5% (CR1, PR10) was observed in 31 patients refractory to the anthracyclines containing prior metastatic chemotherapy. Median (range) time was 41 (6–100) days to onset of and median duration of response was 125 (36–305) days. Toxicities included leukopenia (grade 3, 4: 67%), anemia (grade 1–3: 80%), thrombocytopenia (grade 1: 8%), alopecia (grade 3: 43%), peripheral neuropathy (grade 1–3: 93%), arthralgia (59%), myalgia (46%), nausea and vomiting (40%), fever (33%), allergic reaction (grade 3: 2%) and hypotension (grade 3: 5%). All toxicities were tolerable and manageable. Paclitaxel intravenously infused over 3 hours demonstrated a significant antitumor activity for metastatic breast cancer. Furthermore, paclitaxel exhibited non-cross resistance to anthracycline. Paclitaxel administered as a convenient 3-hour infusion is effective for patients with metastatic breast cancer and has an acceptable toxicity profile.

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Authors and Affiliations

  1. Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Japan

    Yoshinori Ito & Noboru Horikoshi

  2. Department of Internal Medicine, National Cancer Center Hospital, Japan

    Toru Watanabe

  3. Division of Oncology and Hematology, Department of Medicine, National Cancer Center Hospital East, Japan

    Yasutsuna Sasaki

  4. Department of Surgery, Tokyo Metropolitan Komagome Hospital, Japan

    Takeshi Tominaga

  5. Department of Radiology, Tokyo Women's Medical College, Japan

    Tomohiko Okawa

  6. Department of Endocrinology, Saitama Cancer Center, Japan

    Toshio Tabei

  7. 3rd Department of Internal Medicine, The Jikei University School of Medicine, Japan

    Yasunobu Kuraishi

  8. Department of Internal Medicine, Miyazaki Prefectural Hospital, Japan

    Kazuo Tamura

  9. 2nd Department of Surgery, Fukushima Medical College, Japan

    Rikiya Abe

  10. Department of Gastrointestinal Surgery, School of Medicine, Keio University, Japan

    Masaki Kitajima

  11. Department of Surgery I, St. Marianna, University School of Medicine, Japan

    Susumu Yamaguchi

  12. Japan

    Tetsuro Kobayashi

  13. Department of Surgery, The Center for Adult Disease, Osaka

    Hiroki Koyama

  14. 1st Department of Surgery, Okayama University School of Medicine, Japan

    Kunzo Orita

  15. Department of Surgery, National Shikoku Cancer Center, Japan

    Shigemitsu Takashima

  16. Department of Breast Surgery, National Kyushu Cancer Center, Japan

    Yasuo Nomura

  17. Aichi Cancer Center, Japan

    Makoto Ogawa (Chairman)

Authors
  1. Yoshinori Ito
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  2. Noboru Horikoshi
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  3. Toru Watanabe
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  4. Yasutsuna Sasaki
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  5. Takeshi Tominaga
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  6. Tomohiko Okawa
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  7. Toshio Tabei
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  8. Yasunobu Kuraishi
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  9. Kazuo Tamura
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  10. Rikiya Abe
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  11. Masaki Kitajima
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  12. Susumu Yamaguchi
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  13. Tetsuro Kobayashi
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  14. Hiroki Koyama
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  15. Kunzo Orita
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  16. Shigemitsu Takashima
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  17. Yasuo Nomura
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  18. Makoto Ogawa
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Ito, Y., Horikoshi, N., Watanabe, T. et al. Phase II study of paclitaxel (BMS-181339) intravenously infused over 3 hours for advanced or metastatic breast cancer in Japan. Invest New Drugs 16, 183–190 (1998). https://doi.org/10.1023/A:1006036923200

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  • DOI: https://doi.org/10.1023/A:1006036923200

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