title: Final results of a safety and efficacy trial of preoperative sequential chemoradiation therapy for the nonsurgical treatment of early breast cancer: Japan Clinical Oncology Group Study JCOG0306.
abstract: OBJECTIVE
  To explore the possibility of nonsurgical treatment of primary breast cancers by a sequential treatment of chemotherapy and radiotherapy.
  
  
  METHODS
  We conducted a safety and efficacy trial of chemotherapy and radiation therapy sequentially as primary therapy in patients with stage I-IIIA breast cancer. All patients underwent mastectomy or lumpectomy 12-16 weeks after the completion of radiation therapy to maximize the effect of radiation therapy. The primary endpoint was the pathological complete response (pCR) rate.
  
  
  RESULTS
  Between June 2004 and April 2005, one hundred eight patients were enrolled. Thirty six percent of the entire population achieved a pCR, which could not reject the null hypothesis. The pCR rate was 57% in patients with hormone receptor (HR)-negative/HER-2-positive tumors and 52% in patients with triple-negative tumors. While 7% of the HR-negative/HER2-positive patients recurred, a higher incidence of recurrence (24%) was observed in triple-negative tumors in a follow-up of 4.5 years. The rate of breast-conserving surgery was 88.9% (96/108).
  
  
  CONCLUSIONS
  The pCR rate was not high enough, even though preoperative sequential chemoradiation therapy did not increase the risk of operative complications and could achieve a high rate of breast-conserving surgery.
authors.affiliation: National Cancer Center Hospital East, Chiba, Japan.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Mukai
authors.forename: Toru
authors.initials: T
authors.lastname: Watanabe
authors.forename: Michihide
authors.initials: M
authors.lastname: Mitsumori
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Tsuda
authors.forename: Seigo
authors.initials: S
authors.lastname: Nakamura
authors.forename: Norikazu
authors.initials: N
authors.lastname: Masuda
authors.forename: Naohito
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Taro
authors.initials: T
authors.lastname: Shibata
authors.forename: Akihiro
authors.initials: A
authors.lastname: Sato
authors.forename: Hiroji
authors.initials: H
authors.lastname: Iwata
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Aogi
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000737:chemistry / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects; D005260:Female; D006801:Humans; D008408:Mastectomy; D008875:Middle Aged; D009367:Neoplasm Staging; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human