title: Phase II open-label study of erlotinib in combination with gemcitabine in unresectable and/or metastatic adenocarcinoma of the pancreas: relationship between skin rash and survival (Pantar study).
abstract: BACKGROUND
  Skin rash is an adverse event which might be associated with longer survival in patients treated with epidermal growth factor receptor tyrosine kinase inhibitors. The aim of this nonrandomised phase II clinical trial is to prospectively evaluate the relationship between skin rash and overall survival (OS) in advanced/metastatic pancreatic cancer treated with erlotinib plus gemcitabine.
  
  
  METHODS
  Patients were given gemcitabine (1000 mg/m2/week, 3 weeks every 4 weeks) plus erlotinib (100 mg/day orally continuously) until disease progression/unacceptable toxicity. The primary end point was OS.
  
  
  RESULTS
  A total of 153 eligible patients were enrolled (grade≥2 rash, 25%; grade<2 rash, 75%). OS was longer in patients with grade≥2 rash versus grade<2 (11 versus 5 months; P<0.001). Progression-free survival was longer in patients with grade≥2 rash versus grade<2 (6 versus 3 months; P<0.001) and shorter in those without rash versus grade 1 (2 versus 4 months; P=0.005) or grade≥2 (2 versus 6 months; P<0.001). Patients with grade≥2 rash showed higher rates of overall response (21% versus 7%; P<0.05) and disease control (84% versus 43%; P<0.05) versus grade<2.
  
  
  CONCLUSIONS
  This study prospectively confirms the relationship between rash and longer OS in unresectable locally advanced/metastatic pancreatic cancer treated with erlotinib plus gemcitabine.
authors.affiliation: Department of Oncology, Hospital Universitario Reina Sofía, Córdoba, Spain. earandaa@seom.org
authors.forename: E
authors.initials: E
authors.lastname: Aranda
authors.forename: J L
authors.initials: JL
authors.lastname: Manzano
authors.forename: F
authors.initials: F
authors.lastname: Rivera
authors.forename: M
authors.initials: M
authors.lastname: Galán
authors.forename: M
authors.initials: M
authors.lastname: Valladares-Ayerbes
authors.forename: C
authors.initials: C
authors.lastname: Pericay
authors.forename: M J
authors.initials: MJ
authors.lastname: Safont
authors.forename: M J
authors.initials: MJ
authors.lastname: Mendez
authors.forename: A
authors.initials: A
authors.lastname: Irigoyen
authors.forename: A
authors.initials: A
authors.lastname: Arrivi
authors.forename: J
authors.initials: J
authors.lastname: Sastre
authors.forename: E
authors.initials: E
authors.lastname: Díaz-Rubio
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000069347:Erlotinib Hydrochloride; D005076:Exanthema / Q000139:chemically induced*; D005260:Female; 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; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D011799:Quinazolines; D003841:Deoxycytidine; D000069347:Erlotinib Hydrochloride; D000093542:Gemcitabine