title: Erlotinib and radiation therapy for elderly patients with esophageal cancer - clinical and correlative results from a prospective multicenter phase 2 trial.
abstract: OBJECTIVE
  Elderly patients with esophageal cancer who are not candidates for chemoradiation may benefit from targeted agents; hence erlotinib combined with radiotherapy was evaluated in this trial.
  
  
  METHODS
  Patients >65 years with carcinoma of the thoracic esophagus or gastroesophageal junction who were not eligible for platinum-based treatment received erlotinib daily for 1 year starting on day 1 of radiotherapy [50.4 Gy days 1-28 (Mon-Fri) at 1.8 Gy per fraction]. Response was assessed by endoscopy and computed tomography. The primary endpoint was overall survival (OS), and secondary endpoints were complete response, progression-free survival (PFS) and toxicity.
  
  
  RESULTS
  The ECOG performance status in the 17 study patients was 0,1 and 2 in 2, 12 and 3 patients, respectively; 1, 5, 7 and 4 patients were in stage I, II, III and IV, respectively; adenocarcinoma was noted in 16 patients and squamous cell carcinoma in 1; there were 3 current, 12 past and 2 never smokers. Median OS was 7.3 months (95% confidence interval, CI: 3.8-22.3) with 14 deaths. There were 2 mucosal complete responses, 1 residual carcinoma in situ and 3 partial endoscopic responses in 9 patients who had endoscopy after radiotherapy. Estimated PFS was 4.5 months (95% CI: 2.4-7.3). Progression was distant (n = 3), locoregional (n = 6), unknown (n = 5) and too early (n = 3). Estimated 1-year survival was 29% (95% CI: 11-51%), 5 patients lived >12 months. Treatment-related toxicities of grade 3-4 occurred in 5 patients. Patients with epidermal growth factor receptor amplification and never smokers had the longest OS (22.3 and 16.6 months, respectively).
  
  
  CONCLUSIONS
  Erlotinib with radiotherapy is tolerable and warrants further biomarker-driven evaluation in this population.
authors.affiliation: Roswell Park Cancer Institute, Buffalo, NY 14263, USA. Renuka.Iyer@roswellpark.org
authors.forename: Renuka
authors.initials: R
authors.lastname: Iyer
authors.forename: Ravi
authors.initials: R
authors.lastname: Chhatrala
authors.forename: Tracey
authors.initials: T
authors.lastname: Shefter
authors.forename: Gary
authors.initials: G
authors.lastname: Yang
authors.forename: Usha
authors.initials: U
authors.lastname: Malhotra
authors.forename: Wei
authors.initials: W
authors.lastname: Tan
authors.forename: Charles
authors.initials: C
authors.lastname: Levea
authors.forename: Melissa
authors.initials: M
authors.lastname: Robins
authors.forename: Nikhil
authors.initials: N
authors.lastname: Khushalani
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D059248:Chemoradiotherapy / Q000379:methods; D017024:Chemotherapy, Adjuvant / Q000379:methods; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000378:metabolism; D000069347:Erlotinib Hydrochloride; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D004943:Esophagogastric Junction / Q000187:drug effects / Q000473:pathology / Q000528:radiation effects; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011799:Quinazolines / Q000627:therapeutic use*; D013897:Thoracic Duct / Q000187:drug effects / Q000473:pathology / Q000528:radiation effects
chemical_list: D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors