Phase II study of bi-weekly irinotecan for patients with previously treated HER2-negative metastatic breast cancer: KMBOG0610B

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

Research output: Contribution to journalArticlepeer-review

13 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)131-136
Number of pages6
JournalBreast Cancer
Issue number2
Publication statusPublished - Apr 2013
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Pharmacology (medical)


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