title: A phase II study of the combination of gemcitabine plus carboplatin as the neoadjuvant treatment in locally advanced breast cancer.
abstract: OBJECTIVE
  Although anthracycline-based regimen is standard neoadjuvant chemotherapy (NAC) for locally advanced breast cancer (LABC), there is some concern over its toxicities such as alopecia and cardiotoxicity. Gemcitabine is another active agent in metastatic breast cancer after failure to anthracycline with less toxicity. The objective of the present study is to evaluate the efficacy and safety of the combination of gemcitabine and carboplatin as NAC in LABC.
  
  
  METHODS
  Patients with histologically confirmed LABC (T3, T4 or N2 and M0) were included. Patients were scheduled to receive 3 cycles of neoadjuvant GC (gemcitabine 1,000 mg/m2 D1, D8 and carboplatin AUC x 5 D1) every 21 days. Patients with clinical response underwent surgery and additional 3 cycles of adjuvant GC. Primary endpoint was clinical response rate whereas secondary endpoints included pathological response, DFS, OS and toxicity.
  
  
  RESULTS
  Between 2004 and 2007, 40 LABC patients were enrolled. Of 40 patients, 35 were evaluable for efficacy and 40 for toxicity. Twenty-three out of 35 patients (65%) obtained cPR. Among 22 patients who had clinical response and who underwent surgery, overall pathological response rate was 51.5% with 1-pCR (2.9%) and 17-pPR (48.5%). All 7 triple-negative patients had pathological response (1-pCR, 6-pPR). At median follow-up of 59 months, median DFS and OS were not reached. Five-year OS and DFS were 67% and 62%, respectively Major adverse effect was myelosuppression without fatal complications.
  
  
  CONCLUSIONS
  The combination GC was feasible and well-tolerated for LABC in neoadjuvant setting. Triple-negative subgroup seems to have high response to GC.
authors.affiliation: Division of Medical Oncology, Department of Medicine, Faculty ofMedicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Suthinee
authors.initials: S
authors.lastname: Ithimakin
authors.forename: Adune
authors.initials: A
authors.lastname: Ratanawichitrasin
authors.forename: Vutisiri
authors.initials: V
authors.lastname: Veerasarn
authors.forename: Charuwan
authors.initials: C
authors.lastname: Akewanlop
authors.forename: Nopadol
authors.initials: N
authors.lastname: Soparattanapaisarn
authors.forename: Supakorn
authors.initials: S
authors.lastname: Rojananin
authors.forename: Pornchai
authors.initials: P
authors.lastname: O-Charoenrat
authors.forename: Poramaporn
authors.initials: P
authors.lastname: Prasarttong-Osoth
authors.forename: Vichien
authors.initials: V
authors.lastname: Srimuninnimit
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016190:Carboplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D016190:Carboplatin; D000093542:Gemcitabine