title: A phase 2 study of the combination of gemcitabine and cisplatin in patients with locally advanced or metastatic breast cancer previously treated with anthracyclines with/without taxanes.
abstract: OBJECTIVE
  Many patients with relapsed metastatic breast cancer are pre-treated with taxanes and anthracyclines, which are usually given in the neoadjuvant/adjuvant setting or as first-line treatment for metastatic disease. The primary objective of this study was to determine the overall response rate for combination treatment with gemcitabine and cisplatin in patients with locally advanced or metastatic breast cancer who had relapsed after receiving one adjuvant/neoadjuvant or first-line metastatic chemotherapy regimen containing an anthracycline with/without a taxane. Secondary endpoints included duration of response, time to progression, one-year survival probability, and toxicity.
  
  
  METHODS
  A single-arm, open-label, phase 2 study conducted at 17 investigative sites in Egypt.
  
  
  METHODS
  treatment consisted of gemcitabine (1250 mg/m2) on Days 1 and 8 and cisplatin (70 mg/m2) on Day 1 of each 21-day cycle. Treatment continued until disease progression or a maximum of 6 cycles.
  
  
  RESULTS
  Of 144 patients all were evaluable for safety and 132 patients were evaluable for efficacy. The overall response rate was 33.3% and 45.5% of the patients with stable disease as their best response. The median time-to-progression was 5.1 months and the one-year survival probability was 73%. The most common grade 3/4 adverse events were nausea/vomiting (20.1%), neutropenia (19.4%), anemia (13.9%), asthenia (11.1%), diarrhea (9.7%), stomatitis (7.6%), leucopenia (7.6%), and thrombocytopenia (6.2%). twelve (8.3%) patients had serious adverse events.
  
  
  CONCLUSIONS
  The results of this study indicate that gemcitabine and cisplatin were active and generally well tolerated in pretreated patients with locally advanced or metastatic breast cancer.
authors.affiliation: Cancer Centre, Alexandria University, Alexandria. mmeshref@hotmail.com
authors.forename: H
authors.initials: H
authors.lastname: Kohail
authors.forename: S
authors.initials: S
authors.lastname: Shehata
authors.forename: O
authors.initials: O
authors.lastname: Mansour
authors.forename: Y
authors.initials: Y
authors.lastname: Gouda
authors.forename: R
authors.initials: R
authors.lastname: Gaafar
authors.forename: T A
authors.initials: TA
authors.lastname: Hamid
authors.forename: S
authors.initials: S
authors.lastname: El Nowieam
authors.forename: A
authors.initials: A
authors.lastname: Al Khodary
authors.forename: H
authors.initials: H
authors.lastname: El Zawahry
authors.forename: A A
authors.initials: AA
authors.lastname: Wareth
authors.forename: I A
authors.initials: IA
authors.lastname: Halim
authors.forename: F A
authors.initials: FA
authors.lastname: Taleb
authors.forename: E
authors.initials: E
authors.lastname: Hamada
authors.forename: M
authors.initials: M
authors.lastname: Barsoum
authors.forename: M
authors.initials: M
authors.lastname: Abdullah
authors.forename: M
authors.initials: M
authors.lastname: Meshref
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D016879:Salvage Therapy; D000093542:Gemcitabine
chemical_list: D018943:Anthracyclines; D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine