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Japanese Journal of Clinical Oncology Advance Access originally published online on June 1, 2005
Japanese Journal of Clinical Oncology 2005 35(6):310-315; doi:10.1093/jjco/hyi090
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© 2005 Foundation for Promotion of Cancer Research

Late Phase II Clinical Study of Vinorelbine Monotherapy in Advanced or Recurrent Breast Cancer Previously Treated with Anthracyclines and Taxanes

Masakazu Toi1, Toshiaki Saeki2,3, Kenjiro Aogi2, Muneaki Sano4, Kiyohiko Hatake5, Taro Asaga6, Yutaka Tokuda7, Shoshu Mitsuyama8, Morihiko Kimura9, Tadashi Kobayashi10, Motoshi Tamura11, Toshio Tabei12, Eisei Shin13,14, Reiki Nishimura15, Shinji Ohno16 and Shigemitsu Takashima2

1 Department of Clinical Trials and Research, Tokyo Metropolitan Komagome Hospital, Tokyo, 2 Department of Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, 3 Department of Breast Oncology, Saitama Medical School Hospital, Iruma, Saitama, 4 Department of Surgery, Niigata Cancer Center Hospital, Niigata, 5 Division of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, 6 Department of Breast and Thyroid Surgery, Kanagawa Cancer Center Hospital, Yokohama, 7 Department of Surgery, Tokai University School of Medicine, Kanagawa, 8 Department of Surgery, Kitakyushu Municipal Medical Center, Kitakyushu, Fukuoka, 9 Department of Surgery, Gunma Cancer Center, Ota, Gunma, 10 Department of Clinical Oncology, Jikei University School of Medicine, Tokyo, 11 Department of Breast Surgery, National Hospital Organization Hokkaido Cancer Center, Sapporo, 12 Department of Endocrinology, Saitama Cancer Center, Kitaadachi, Saitama, 13 Department of Surgery, National Osaka Hospital, Osaka, 14 Clinical Science Department, AstraZeneca K.K., Osaka, 15 Department of Surgery, Kumamoto City Hospital, Kumamoto and 16 Department of Breast Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan

For reprints and all correspondence: Masakazu Toi, Department of Clinical Trials and Research, Tokyo Metropolitan Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, 113-8687 Japan. E-mail: maktoi77{at}wa2.so-net.ne.jp

Received February 10, 2005; accepted April 27, 2005

Background: At present, it is one of the most important issues for the treatment of breast cancer to develop the standard therapy for patients previously treated with anthracyclines and taxanes. With the objective of determining the usefulness of vinorelbine monotherapy in patients with advanced or recurrent breast cancer after standard therapy, we evaluated the efficacy and safety of vinorelbine in patients previously treated with anthracyclines and taxanes.

Methods: Vinorelbine was administered at a dose level of 25 mg/m2 intravenously on days 1 and 8 of a 3 week cycle. Patients were given three or more cycles in the absence of tumor progression. A maximum of nine cycles were administered.

Results: The response rate in 50 evaluable patients was 20.0% (10 out of 50; 95% confidence interval, 10.0–33.7%). Responders plus those who had minor response (MR) or no change (NC) accounted for 58.0% [10 partial responses (PRs) + one MR + 18 NCs out of 50]. The Kaplan–Meier estimate (50% point) of time to progression (TTP) was 115.0 days. The response rate in the visceral organs was 17.3% (nine PRs out of 52). The major toxicity was myelosuppression, which was reversible and did not require discontinuation of treatment.

Conclusion: The results of this study show that vinorelbine monotherapy is useful in patients with advanced or recurrent breast cancer previously exposed to both anthracyclines and taxanes.

Key Words: breast cancer • vinorelbine • chemotherapy • phase II clinical trials


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