title: A Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation for Patients With Non-Small-Cell Lung Cancer.
abstract: BACKGROUND
  The downstream signaling pathways of the epidermal growth factor receptor might influence radiation resistance. Data from preclinical work support the hypothesis that erlotinib concurrent with radiation therapy (RT) might increase cancer cell killing. The present trial was designed to examine the efficacy and toxicity of combined erlotinib and palliative chest thoracic RT in non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Patients with newly diagnosed stage III-IV (American Joint Committee on Cancer, version 6) or recurrent NSCLC received 3 weeks of erlotinib at a dose of 150 mg daily, starting 1 week before palliative thoracic RT to 30 Gy in 10 fractions within 2 weeks. The primary outcome was a change in the quality of life, as measured by the Lung Cancer Symptom Scale (LCSS) question on the "symptoms of lung cancer" from baseline to 4 weeks after treatment.
  
  
  RESULTS
  A total of 40 patients were recruited from 2 institutions. Of the 40 patients, 22 (55%) were men, with an average age of 71 years, and 60% had stage IV disease. A total of 26 patients (65%) completed the full course of erlotinib, and 35 (88%) completed the planned RT. Twenty-five patients (62.5%) reported LCSS scores at 4 weeks after treatment, with an average change (improvement) of -12.5 U (95% confidence interval, -23.0 to -1.9; 2P = .023). This was less than the a priori hypothesis of a change of -17.5 U. The median overall and progression-free survival was 5.2 and 3.2 months, respectively.
  
  
  CONCLUSIONS
  The present single-arm, phase II trial did not demonstrate additional symptomatic benefit from concurrent erlotinib therapy with standard palliative thoracic RT for patients with locally advanced or metastatic NSCLC.
authors.affiliation: Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Juravinski Cancer Centre, Hamilton Health Sciences, Hamilton, Ontario, Canada. Electronic address: swaminath@hhsc.ca.
authors.forename: Anand
authors.initials: A
authors.lastname: Swaminath
authors.affiliation: Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Juravinski Cancer Centre, Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: James R
authors.initials: JR
authors.lastname: Wright
authors.affiliation: Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Juravinski Cancer Centre, Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Theodoros K
authors.initials: TK
authors.lastname: Tsakiridis
authors.affiliation: Odette Cancer Centre and University of Toronto, Toronto, Ontario, Canada.
authors.forename: Yee C
authors.initials: YC
authors.lastname: Ung
authors.affiliation: Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Ontario Clinical Oncology Group, Juravinski Hospital, Hamilton, Ontario, Canada.
authors.forename: Gregory R
authors.initials: GR
authors.lastname: Pond
authors.affiliation: Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Juravinski Cancer Centre, Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Ranjan
authors.initials: R
authors.lastname: Sur
authors.affiliation: Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Juravinski Cancer Centre, Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Corbett
authors.affiliation: Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Juravinski Cancer Centre, Hamilton Health Sciences, Hamilton, Ontario, Canada.
authors.forename: Gordon
authors.initials: G
authors.lastname: Okawara
authors.affiliation: Department of Oncology, McMaster University, Hamilton, Ontario, Canada; Juravinski Cancer Centre, Hamilton Health Sciences, Hamilton, Ontario, Canada; Ontario Clinical Oncology Group, Juravinski Hospital, Hamilton, Ontario, Canada.
authors.forename: Mark N
authors.initials: MN
authors.lastname: Levine
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy; D066246:ErbB Receptors / Q000037:antagonists & inhibitors; D000069347:Erlotinib Hydrochloride / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D010166:Palliative Care; D011788:Quality of Life; D012008:Recurrence; D016019:Survival Analysis; D013909:Thorax / Q000528:radiation effects*; D016896:Treatment Outcome
chemical_list: D000069347:Erlotinib Hydrochloride; C512478:EGFR protein, human; D066246:ErbB Receptors
keywords: Clinical trial; Combined-modality therapy; Palliative radiation; Quality of life; Radiation sensitizer