title: Pain and emotional well-being outcomes in Southwest Oncology Group-directed intergroup trial S0205: a phase III study comparing gemcitabine plus cetuximab versus gemcitabine as first-line therapy in patients with advanced pancreas cancer.
abstract: OBJECTIVE
  S0205 was a randomized clinical trial that compared the therapeutic impact of gemcitabine versus gemcitabine plus cetuximab. Study results for patient-reported health-related quality of life (HRQL) outcomes are reported.
  
  
  METHODS
  Patients completed the Brief Pain Inventory and a measure of emotional well-being (each measured on a 0 to 10 scale) at baseline and at weeks 5, 9, 13, and 17 postrandom assignment. Worst pain status was classified as palliated (worst pain scores < 5 maintained for 2 consecutive cycles) or not palliated (remaining patients) and tested with a chi(2) test. Change in emotional well-being and worst pain (exploratory analysis) were assessed over 17 weeks using generalized estimating equations with inverse probability of censoring weights.
  
  
  RESULTS
  Seven hundred twenty of 766 enrolled patients contributed baseline HRQL data. The two treatment arms did not differ statistically in the percentage of patients with successful worst pain palliation. Longitudinal analyses showed significantly improved emotional well-being for patients on both arms by weeks 13 and 17 (P < .01 and P < .001). An exploratory longitudinal analysis of worst pain showed significant decreases at all time points for both arms (P < .01 and P < .001). Significant treatment arm differences for either worst pain or emotional well-being were not observed at any of the assessment times.
  
  
  CONCLUSIONS
  We observed palliated pain and improved well-being for patients on this trial. However, these improvements were similar in both treatment arms, suggesting that the addition of cetuximab did not contribute to improvement in these HRQL outcomes.
authors.affiliation: Southwest Oncology Group Statistical Center, Seattle, WA 98105, USA. cmoinpou@fhcrc.org
authors.forename: Carol M
authors.initials: CM
authors.lastname: Moinpour
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Vaught
authors.forename: Bryan
authors.initials: B
authors.lastname: Goldman
authors.forename: Mary W
authors.initials: MW
authors.lastname: Redman
authors.forename: Philip A
authors.initials: PA
authors.lastname: Philip
authors.forename: Barbara
authors.initials: B
authors.lastname: Millwood
authors.forename: Scott M
authors.initials: SM
authors.lastname: Lippman
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Seay
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Flynn
authors.forename: Eileen M
authors.initials: EM
authors.lastname: O'Reilly
authors.forename: Kendrith M
authors.initials: KM
authors.lastname: Rowland
authors.forename: Ralph P
authors.initials: RP
authors.lastname: Wong
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Benedetti
authors.forename: Charles D
authors.initials: CD
authors.lastname: Blanke
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001294:Attitude to Health; D000068818:Cetuximab; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008297:Male; D008603:Mental Health; D008875:Middle Aged; D010146:Pain / Q000150:complications / Q000188:drug therapy*; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000523:psychology*; D011788:Quality of Life; D000093542:Gemcitabine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000068818:Cetuximab; D000093542:Gemcitabine