title: Phase II study of bi-weekly irinotecan for patients with previously treated HER2-negative metastatic breast cancer: KMBOG0610B.
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/m(2) 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/m(2) irinotecan was feasible for patients with MBC treated previously with anthracyclines or taxanes.
authors: Department of Medical Oncology, Kinki University Faculty of Medicine, 377-2 Ohno-higashi, Osaka-Sayama, Osaka, 589-8511, Japan.
authors: Hidetoshi
authors: H
authors: Hayashi
authors: Junji
authors: J
authors: Tsurutani
authors: Taro
authors: T
authors: Satoh
authors: Norikazu
authors: N
authors: Masuda
authors: Wataru
authors: W
authors: Okamoto
authors: Ryotaro
authors: R
authors: Morinaga
authors: Masaaki
authors: M
authors: Terashima
authors: Masaki
authors: M
authors: Miyazaki
authors: Isamu
authors: I
authors: Okamoto
authors: Yukihiro
authors: Y
authors: Nishida
authors: Shusei
authors: S
authors: Tominaga
authors: Yukihiko
authors: Y
authors: Tokunaga
authors: Masahide
authors: M
authors: Yamaguchi
authors: Junichi
authors: J
authors: Sakamoto
authors: Takahiro
authors: T
authors: Nakayama
authors: Kazuhiko
authors: K
authors: Nakagawa
mesh_terms: D000328:Adult; D000368:Aged; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D002166:Camptothecin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019008:Drug Resistance, Neoplasm / Q000187:drug effects; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D000077146:Irinotecan; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000556:secondary; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D016879:Salvage Therapy; D059003:Topoisomerase Inhibitors / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D002166:Camptothecin; D000077146:Irinotecan; D018719:Erb-b2 Receptor Tyrosine Kinases; D059003:Topoisomerase Inhibitors