title: High complete pathological response in locally advanced breast cancer using paclitaxel and cisplatin.
abstract: BACKGROUND
  In an earlier study, we have demonstrated a high response rate in metastatic breast cancer using paclitaxel (P) and cisplatin (C). A phase II study using the same regimen (PC) has been conducted in locally advanced breast cancer (LABC).
  
  
  METHODS
  A total of 72 consecutive patients with non-inflammatory LABC (T2 > or = 4 cm, T3 or T4, N0-N2, M0). Patients were scheduled to receive 3-4 cycles of the neoadjuvant PC (paclitaxel 135 mg/m2 and cisplatin 75 mg/m2 on day 1) every 21 days. Patients were then subjected to surgery and subsequently received 6 cycles of FAC (5-fluorouracil 500 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2) or 4 cycles of AC (doxorubicin 60 mg/m2, and cyclophosphamide 600 mg/m2). Patients then received radiation therapy, and those with hormone receptor positive tumors were given adjuvant tamoxifen intended for 5 years.
  
  
  RESULTS
  The median age was 39 years (range, 24-78). Clinically, 7%, 58%, and 35% of patients had T2 > or = 4 cm, T3, and T4, respectively. Disease stage at diagnosis was IIB (33%), IIIA (27%), and IIIB (40%). Complete and partial clinical response to PC was demonstrated in 13 (18%), and 52 (72%) patients, respectively. Of those patients with evaluable pathologic response (68 patients), complete pathologic response (pCR) was achieved in 15 (22%) patients. At a median follow-up of 22 (+/- 3.5) months, 58 (81%) were alive with no recurrence, nine (12%) were alive with evidence of disease, and five (7%) were dead. None of the patients achieving pCR has developed any relapse. The median overall survival has not been reached for all 72 patients with a projected 3-year survival (+/- SE) of 90% (+/- 4%). The median progression-free survival (PFS) was 42.1 (+/- 4.8) months with a projected PFS of 74% +/- 7% at 3-years (for 68 patients).
  
  
  CONCLUSIONS
  PC regimen in LABC produced a high pCR. The contribution of the other added modalities to survival could not be assessed.
authors.affiliation: Department of Oncology, King Faisal Specialist Hospital & Research Center, Riyadh, Kingdom of Saudi Arabia. ezzat@kfshrc.edu.sa
authors.forename: A A
authors.initials: AA
authors.lastname: Ezzat
authors.forename: E M
authors.initials: EM
authors.lastname: Ibrahim
authors.forename: D S
authors.initials: DS
authors.lastname: Ajarim
authors.forename: M M
authors.initials: MM
authors.lastname: Rahal
authors.forename: M A
authors.initials: MA
authors.lastname: Raja
authors.forename: R K
authors.initials: RK
authors.lastname: Stuart
authors.forename: A M
authors.initials: AM
authors.lastname: Tulbah
authors.forename: A
authors.initials: A
authors.lastname: Kandil
authors.forename: O A
authors.initials: OA
authors.lastname: Al-Malik
authors.forename: S M
authors.initials: SM
authors.lastname: Bazarbashi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D017239:Paclitaxel / Q000008:administration & dosage; D011446:Prospective Studies; D012529:Saudi Arabia / Q000453:epidemiology; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D002945:Cisplatin