title: A multicenter phase II randomized trial of docetaxel/gemcitabine versus docetaxel/capecitabine as first-line treatment for advanced breast cancer: a Gruppo Oncologico Italia Meridionale study.
abstract: OBJECTIVE
  To evaluate two docetaxel-based regimens as first-line treatment in advanced breast cancer patients.
  
  
  METHODS
  Patients were randomly assigned to docetaxel/gemcitabine (arm A: docetaxel 75 mg/m(2) on day 1, gemcitabine 1,000 mg/m(2) on days 1 and 8) or docetaxel/capecitabine (arm B: docetaxel 75 mg/m(2) on day 1, capecitabine 1,250 mg/m(2) twice daily on days 1-14); both chemotherapy regimens were repeated every 21 days. The primary objective of the study was to evaluate the response rate.
  
  
  RESULTS
  Seventy-two patients were enrolled (36 each in arms A and B). Responses according to intention-to-treat analysis were as follows: arm A, 41.7% [95% confidence interval (CI) 25.6-57.8]; arm B, 38.9% (95% CI 23-54.8). Median progression-free survival was 10.9 months (95% CI 8.1-13.7) in arm A and 10 months (95% CI 8.8-11.2) in arm B. Overall survival was 26 months (95% CI 22.0-30.0) in arm A and 28 months (95% CI 23.4-32.6) in arm B. Both treatments were well tolerated; myelosuppression was the dose-limiting toxicity, with grade 3-4 neutropenia in 13.8 and 19.4% of the patients in arms A and B, respectively. No relevant differences in other toxicities were observed in the two arms, except for diarrhea (13.9%) and hand-foot syndrome (11.1%), which occurred only in arm B.
  
  
  CONCLUSIONS
  Both regimens were active and well tolerated in advanced breast cancer.
authors.affiliation: Division of Medical Oncology B, Regina Elena National Cancer Institute, Rome, Italy. pvici@ifo.it
authors.forename: P
authors.initials: P
authors.lastname: Vici
authors.forename: F
authors.initials: F
authors.lastname: Giotta
authors.forename: L
authors.initials: L
authors.lastname: Di Lauro
authors.forename: D
authors.initials: D
authors.lastname: Sergi
authors.forename: E
authors.initials: E
authors.lastname: Vizza
authors.forename: L
authors.initials: L
authors.lastname: Mariani
authors.forename: A
authors.initials: A
authors.lastname: Latorre
authors.forename: L
authors.initials: L
authors.lastname: Pizzuti
authors.forename: C
authors.initials: C
authors.lastname: D'Amico
authors.forename: D
authors.initials: D
authors.lastname: Giannarelli
authors.forename: G
authors.initials: G
authors.lastname: Colucci
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D000069287:Capecitabine; D016001:Confidence Intervals; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis / Q000379:methods; D008875:Middle Aged; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine