title: A phase 2 study of sequential neoadjuvant chemotherapy with gemcitabine and doxorubicin followed by gemcitabine and cisplatin in patients with large or locally advanced operable breast cancer: results from long-term follow-up.
abstract: BACKGROUND
  Neoadjuvant chemotherapy (NACT) is being increasingly used for patients with large-size operable breast cancer. This phase 2 study of sequential NACT with gemcitabine and doxorubicin (Gem + Dox) followed by gemcitabine and cisplatin (Gem + Cis) was conducted in women with large or locally advanced breast cancer. The objectives were to evaluate the pathological complete response (pCR) rate, toxicity, pathological and genetic markers predicting response, the proportion of patients undergoing breast conservation surgery, progression-free survival (PFS) and overall survival (OS) after 5 years, and time to treatment failure (TtTF). In this manuscript, we report the long-term OS, PFS, and TtTF results.
  
  
  METHODS
  Female patients aged at least 18 years with large T2 (at least 3 cm) or locally advanced (T3, T4, or N2) breast carcinoma were included. Treatment consisted of 4 cycles of Gem + Dox (gemcitabine 1,200 mg/m(2) on days 1 and 8 plus doxorubicin 60 mg/m(2) on day 1 of each 21-day cycle), followed by 4 cycles of Gem + Cis (gemcitabine 1,000 mg/m(2) on days 1 and 8 plus cisplatin 70 mg/m(2) on day 1 of each 21-day cycle), and then surgery.
  
  
  RESULTS
  Sixty-five patients were enrolled. The pCR rate was 20%. The 5-year OS probability was 71% (95% CI 56-82%), and the 4-year PFS and TtTF probabilities were 63% (95% CI 48-74%) and 45% (95% CI 32-57%), respectively.
  
  
  CONCLUSIONS
  NACT with Gem + Dox followed by Gem + Cis was efficacious in patients with operable breast cancer.
authors.affiliation: Department of Radiotherapy and Oncology, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Pramod K
authors.initials: PK
authors.lastname: Julka
authors.forename: Raju T
authors.initials: RT
authors.lastname: Chacko
authors.forename: Shona
authors.initials: S
authors.lastname: Nag
authors.forename: Rajinder
authors.initials: R
authors.lastname: Parshad
authors.forename: Aravindan
authors.initials: A
authors.lastname: Nair
authors.forename: Chaitanyanand B
authors.initials: CB
authors.lastname: Koppiker
authors.forename: Fen Chao Richard
authors.initials: FC
authors.lastname: Xue
authors.forename: Helen
authors.initials: H
authors.lastname: Barraclough
authors.forename: Navreet
authors.initials: N
authors.lastname: Dhindsa
authors.forename: Anil
authors.initials: A
authors.lastname: Seth
authors.forename: Anurita
authors.initials: A
authors.lastname: Majumdar
authors.forename: Tarun
authors.initials: T
authors.lastname: Puri
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011379:Prognosis; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D004317:Doxorubicin; D002945:Cisplatin; D000093542:Gemcitabine