title: Clinically meaningful differences in patient-reported outcomes with amifostine in combination with chemoradiation for locally advanced non-small-cell lung cancer: an analysis of RTOG 9801.
abstract: OBJECTIVE
  The purpose of this study is to analyze changes in quality of life (QOL) and symptoms from pretreatment to 6 weeks posttreatment in a Phase III randomized study (Radiation Therapy Oncology Group 9801) of amifostine (AM) vs. no AM in patients with Stages II-III non-small-cell lung cancer receiving paclitaxel and carboplatin as induction and then concurrently with hyperfractionated radiation therapy (RT).
  
  
  METHODS
  One hundred thirty-eight patients with baseline and 6-week posttreatment QOL data were analyzed. There were no significant differences in baseline demographics between those who did and did not have QOL data. The QOL and symptoms were assessed by using the European Organization for Research and Treatment of Cancer (EORTC) Global QOL and Pain subscales and the EORTC-Lung Cancer-13 symptom tool. Clinically relevant changes in QOL were characterized by 10-point differences in individual scores pre/post treatment. A daily diary of patient-rated difficulty swallowing and a weekly physician-rated dysphagia log (using National Cancer Institute Common Toxicity Criteria) were completed during treatment. Weight loss was monitored. Differences in outcomes were examined according to smoking status, alcohol use, and sex.
  
  
  RESULTS
  Patients receiving AM reported significantly greater pain reduction after chemoradiation (34% vs. no AM, 21%), less difficulty swallowing during chemoradiation, and less weight loss than patients not receiving AM. However, physician-rated assessments of dysphagia were not significantly different by treatment arm. There were no other significant changes in QOL or symptoms according to treatment arm, smoking status, alcohol use, or sex.
  
  
  CONCLUSIONS
  Patient evaluations of difficulty swallowing and pain suggest benefits from AM use that are distinct from clinician-rated assessments.
authors.affiliation: University of California, Los Angeles, CA, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Sarna
authors.forename: Suzanne
authors.initials: S
authors.lastname: Swann
authors.forename: Corey
authors.initials: C
authors.lastname: Langer
authors.forename: Maria
authors.initials: M
authors.lastname: Werner-Wasik
authors.forename: Nicos
authors.initials: N
authors.lastname: Nicolaou
authors.forename: Ritsuko
authors.initials: R
authors.lastname: Komaki
authors.forename: Mitchell
authors.initials: M
authors.lastname: Machtay
authors.forename: Roger
authors.initials: R
authors.lastname: Byhardt
authors.forename: Todd
authors.initials: T
authors.lastname: Wasserman
authors.forename: Benjamin
authors.initials: B
authors.lastname: Movsas
mesh_terms: D004999:Amifostine / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology / Q000523:psychology / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D003679:Deglutition / Q000502:physiology; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology / Q000523:psychology / Q000532:radiotherapy*; D008297:Male; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011788:Quality of Life; D011837:Radiation-Protective Agents / Q000627:therapeutic use; D012725:Sexual Behavior; D012959:Socioeconomic Factors; D016896:Treatment Outcome; D015431:Weight Loss
chemical_list: D011837:Radiation-Protective Agents; D016190:Carboplatin; D004999:Amifostine; D017239:Paclitaxel