title: Second-line chemotherapy with capecitabine (Xeloda) and docetaxel (Taxotere) in previously treated, unresectable adenocarcinoma of pancreas: the final results of a phase II trial.
abstract: OBJECTIVE
  To investigate the efficacy and toxicity of the docetaxel and capecitabine combination in patients with previously treated, unresectable adenocarcinoma of the pancreas.
  
  
  METHODS
  Patients with pancreatic adenocarcinoma, pre-treated with gemcitabine-based chemotherapy, were treated with capecitabine (800 mg/m(2) orally, twice a day for 14 days) and docetaxel (75 mg/m(2) i.v, on day 1), every 3 weeks. The primary end-point was overall response rate (RR).
  
  
  RESULTS
  Thirty-one patients were enrolled in the study; 93.6% of them had a performance status (PS) of 0-1 and 96.8% had stage IV disease. Patients received a median of 4 cycles/patient, and the main reason for treatment discontinuation was disease progression. Partial response was observed in three (9.7%) patients, stable disease in seven (22.6%) (disease control rate: 32.3%, 95% CI: 15.80-48.71%) and disease progression in 21 (67.6%). The median progression-free survival (PFS) was 2.4 months (95% CI: 1.6-3.13) and the median overall survival (OS) was 6.3 months (95% CI: 3.38-9.23); the estimated 1-year survival rate was 14.7%. Grade III/IV neutropenia occurred in 10 (32.2%) patients and febrile neutropenia in one patient. Other severe non-hematologic toxicities were mild and manageable. After 2 chemotherapy cycles, pain control occurred in 20% of patients and stabilization of body weight in 40%.
  
  
  CONCLUSIONS
  The combination of docetaxel/capecitabine may confer good disease control associated with improvement of quality of life as second-line chemotherapy in patients with metastatic pancreatic cancer.
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lombardou str., 11470 Athens, Greece.
authors.forename: Ourania
authors.initials: O
authors.lastname: Katopodis
authors.forename: Aris
authors.initials: A
authors.lastname: Polyzos
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Kentepozidis
authors.forename: Stylianos
authors.initials: S
authors.lastname: Giassas
authors.forename: Maria
authors.initials: M
authors.lastname: Rovithi
authors.forename: Vasiliki
authors.initials: V
authors.lastname: Bozionelou
authors.forename: Kostas
authors.initials: K
authors.lastname: Kalbakis
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.forename: Dimitris
authors.initials: D
authors.lastname: Mavroudis
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D005472:Fluorouracil