title: Phase II trial of erlotinib plus capecitabine as first-line treatment for metastatic pancreatic cancer (XELTA study).
abstract: OBJECTIVE
  To evaluate the efficacy and safety of erlotinib plus capecitabine for metastatic pancreatic cancer.
  
  
  METHODS
  This was a multicenter, uncontrolled, phase II trial. Patients with untreated metastatic pancreatic cancer received oral capecitabine at 1,000 mg/m(2) twice daily on days 1-14, of a 21-day treatment cycle; and oral erlotinib at 150 mg daily.
  
  
  RESULTS
  Thirty-two patients were enrolled. The overall response rate (ORR) was 6%, with a median time to treatment failure of 2.1 months. The median follow-up was 7.6 months. The median progression-free survival was 2.1 months and median overall survival was 4.3 months. The one-year survival rate was 22%. Major grade 1 and 2 non-hematological toxicities were skin rash (34%), asthenia (31%) and diarrhea (31%). Grade 3 hematological toxicity was <13%. No grade 4 toxicities were detected. None of the patients died due to treatment toxicity.
  
  
  CONCLUSIONS
  The combination of capecitabine with erlotinib is an active regimen with a favorable safety profile for patients with metastatic pancreatic cancer.
authors: Servicio de Oncología Médica, Complejo Hospitalario Universitario de Santiago de Compostela, Travesía de Choupana s/n. 15706 Santiago de Compostela, Spain. Rafael.Lopez.Lopez@sergas.es
authors: Rafael
authors: R
authors: López
authors: Carlos Méndez
authors: CM
authors: Méndez
authors: Mónica Jorge
authors: MJ
authors: Fernández
authors: Carlos Romero
authors: CR
authors: Reinoso
authors: Guillermo Quintero
authors: GQ
authors: Aldana
authors: Mercedes Salgado
authors: MS
authors: Fernández
authors: Juan
authors: J
authors: DE LA Cámara Gómez
authors: Margarita Reboredo
authors: MR
authors: López
authors: Manuel Ramos
authors: MR
authors: Vázquez
authors: Sonia Candamio
authors: SC
authors: Folgar
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D002277:Carcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000069347:Erlotinib Hydrochloride; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D011799:Quinazolines; D003841:Deoxycytidine; D000069287:Capecitabine; D000069347:Erlotinib Hydrochloride; D005472:Fluorouracil