Phase II study of bi-weekly irinotecan for patients with previously treated HER2-negative metastatic breast cancer: KMBOG0610B |
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Authors: | Hidetoshi Hayashi Junji Tsurutani Taro Satoh Norikazu Masuda Wataru Okamoto Ryotaro Morinaga Masaaki Terashima Masaki Miyazaki Isamu Okamoto Yukihiro Nishida Shusei Tominaga Yukihiko Tokunaga Masahide Yamaguchi Junichi Sakamoto Takahiro Nakayama Kazuhiko Nakagawa |
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Affiliation: | 1. Department of Medical Oncology, Kinki University Faculty of Medicine, 377-2 Ohno-higashi, Osaka-Sayama, Osaka, 589-8511, Japan 2. Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, Osaka, Osaka, 540-0006, Japan 3. Department of Breast Surgery, Higashiosaka City General Hospital, 3-4-5 Nishi-Iwata, Higashiosaka, Osaka, 578-8588, Japan 4. Department of Surgery, Osaka Kita Posts and Telecommunications Hospital, 1-1-6 Nakazaki, Kita-ku, Osaka, Osaka, 530-8798, Japan 5. Department of Surgery, Matsushita Memorial Hospital, 5-55 Sotojima-cho, Moriguchi, Osaka, 570-8540, Japan 6. Young Leaders Program of Health Care Administration, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan 7. Department of Breast and Endocrine Surgery, Graduate School of Medicine, Osaka University, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan
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Abstract: | Background A trial was conducted to evaluate the feasibility, efficacy, and safety of biweekly administration of irinotecan, a novel topoisomerase I inhibitor, for patients with metastatic breast cancer (MBC) previously treated with either anthracycline-based or taxane-based chemotherapy. Methods Eligible patients were HER2-negative, had a performance status of 0 to 2, and had been treated previously with either anthracyclines or taxanes for MBC. Patients received irinotecan intravenously at 150 mg/m2 on days 1 and 15 every 4 weeks. The primary end-point was feasibility, and the treatment was considered feasible if a patient was able to receive three administrations of irinotecan within the first 8 weeks, as pre-specified in the protocol. Results Eighteen patients (median age 60 years) were enrolled. Fifteen patients received irinotecan more than 3 times within the first 8 weeks, with resulting feasibility of 83.3%. The median number of treatment cycles was 2 (range 1–16) during this period, and the relative dose intensity was 91.2%. Partial response was observed for one patient, so overall response rate was 5.6%. Nine patients (50.0%) had stable disease, and overall disease control was 50.0%. Median progression-free survival and overall survival periods were 3.2 and 9.6 months, respectively. The only grade 3/4 hematological toxicity was neutropenia (22.2%). Grade 3/4 non-hematological toxicities were anorexia (11.2%), diarrhea (11.2%), and fatigue (5.6%). No treatment-related death occurred. Conclusions This study demonstrated that biweekly administration of 150 mg/m2 irinotecan was feasible for patients with MBC treated previously with anthracyclines or taxanes. |
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