title: Neoadjuvant paclitaxel for operable breast cancer: multicenter phase II trial with clinical outcomes.
abstract: OBJECTIVE
  To determine the efficacy of preoperative weekly paclitaxel for patients with operable breast cancer tumors greater than 3 cm.
  
  
  METHODS
  Paclitaxel 80 mg/m2 weekly x 3 times every 4 weeks for 3 cycles was administered to 53 patients. Twenty-two patients were stage 11, 26 stage III, 5 stage IV Median age (range) was 53 (24-73) years, and 32 patients were negative for estrogen receptor. Thirteen patients showed HER2 overexpression.
  
  
  RESULTS
  Eligible cases composed of 53 patients for evaluation of response. Seven patients had a clinical complete response and 29 patients had a partial response. The overall response rate was 67.9%, including three patients with a pathological complete response. In 18 patients with HER2 overexpression, a clinical complete response was observed in 5, a partial response was observed in 9, and stable disease was found in 4. No treatment, related to grade 3 neutropenia, was given for 1 patient (2%). Other hematological and non-hematological toxicity was found in only 1 patient with fatigue.
  
  
  CONCLUSIONS
  Preoperative weekly paclitaxel induced a high clinical response rate with a high safety profile. HER2-overepressing tumors had a higher clinical response rate than non-HER2-overepxressing tumors (91% vs. 50%, respectively). Further studies are needed to determine whether an increase in the cycles of paclitaxel and/or adding anthracyclines may lead to higher pathological complete response and breast-conservation rates in the neoadjuvant setting.
authors.affiliation: Department of Surgery, General Ota Hospital, Ota, Gunma 373-8585, Japan. kimuraota@yahoo.co.jp
authors.forename: Morihiko
authors.initials: M
authors.lastname: Kimura
authors.forename: Muneaki
authors.initials: M
authors.lastname: Sano
authors.forename: Minoru
authors.initials: M
authors.lastname: Fujimori
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nakagomi
authors.forename: Takeshi
authors.initials: T
authors.lastname: Negishi
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Yanagita
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Sato
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology / Q000601:surgery; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000096:biosynthesis; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases