title: Analysis of longitudinal quality-of-life data in high-risk operable patients with lung cancer: results from the ACOSOG Z4032 (Alliance) multicenter randomized trial.
abstract: BACKGROUND
  Prior studies have suggested that low baseline quality-of-life (QOL) scores predict worse survival in patients undergoing lung cancer surgery. However, these studies involved average-risk patients undergoing lobectomy. We report QOL results from a multicenter trial, American College of Surgeons Oncology Group Z4032, which randomized high-risk operable patients to sublobar resection (SR), or SR with brachytherapy, and included longitudinal QOL assessments.
  
  
  METHODS
  Global QOL, using the 36-item Short-Form Health Survey (SF36), and the dyspnea score from the University of California, San Diego Shortness of Breath Questionnaire (SOBQ) scale, was measured at baseline, 3, 12, and 24 months. SF36 physical component summary (PCS) and mental component summary (MCS) scores were standardized and adjusted for age and gender normals, with scores <50 indicating below-average health status. SOBQ scores were transformed to a 0-100 (poor-excellent) scale. Aims were to: (1) determine the impact of baseline scores on recurrence-free survival, overall survival, and 30-day adverse events (AEs); and (2) identify subgroups (surgical approach, resection type. tumor location, tumor size, respiratory function) with a ≥ 10-point decline or improvement in QOL after SR.
  
  
  RESULTS
  Two hundred twelve eligible patients were included. There were no significant differences in baseline QOL scores between arms. Median baseline PCS, MCS, and SOBQ scores were 42.7, 51.1, and 70.8, respectively. There were no differences in grade-3+ AEs, overall survival, or recurrence-free survival in patients with baseline scores ≤ median versus > median values, except for a significantly worse overall survival for patients with baseline SOBQ scores ≤ median value. There were no significant differences between the study arms in percentage change of QOL scores from baseline to 3, 12, or 24 months. Further comparison combining the 2 arms demonstrated a higher percentage of patients with a ≥ 10-point decline in SOBQ scores with segmentectomy compared with wedge resection (40.5% vs 21.9%, P = .03) at 12 months, with thoracotomy versus video-assisted thoracic surgery (VATS) (38.8% vs 20.4%, P = .03) at 12 months, and T1b versus T1a tumors (46.9% vs 23.5%, P = .020) at 24 months. A ≥ 10-point improvement in PCS score was seen at 3 months with VATS versus thoracotomy (16.5% vs 3.6%, P = .02).
  
  
  CONCLUSIONS
  In high-risk operable patients, poor baseline QOL scores were not predictive for worse overall or recurrence-free survival, or for higher risk for AEs following SR. VATS was associated with improvement in physical function at 3 months, and improved dyspnea scores at 12 months, lending support for the preferential use of VATS when SR is undertaken.
authors.affiliation: Boston Medical Center, Boston, Mass. Electronic address: Hiran.Fernando@bmc.org.
authors.forename: Hiran C
authors.initials: HC
authors.lastname: Fernando
authors.affiliation: University of Pittsburgh, Pittsburgh, Pa.
authors.forename: Rodney J
authors.initials: RJ
authors.lastname: Landreneau
authors.affiliation: Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minn.
authors.forename: Sumithra J
authors.initials: SJ
authors.lastname: Mandrekar
authors.affiliation: Mayo Clinic, Rochester, Minn.
authors.forename: Francis C
authors.initials: FC
authors.lastname: Nichols
authors.affiliation: Rhode Island Hospital, Providence, RI.
authors.forename: Thomas A
authors.initials: TA
authors.lastname: DiPetrillo
authors.affiliation: Washington University of St Louis, St Louis, Mo.
authors.forename: Bryan F
authors.initials: BF
authors.lastname: Meyers
authors.affiliation: University of Pittsburgh, Pittsburgh, Pa.
authors.forename: Dwight E
authors.initials: DE
authors.lastname: Heron
authors.affiliation: Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minn.
authors.forename: Shauna L
authors.initials: SL
authors.lastname: Hillman
authors.affiliation: University of Virginia, Charlottesville, Va.
authors.forename: David R
authors.initials: DR
authors.lastname: Jones
authors.affiliation: University of Cincinnati, Cincinnati, Ohio.
authors.forename: Sandra L
authors.initials: SL
authors.lastname: Starnes
authors.affiliation: Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minn.
authors.forename: Angelina D
authors.initials: AD
authors.lastname: Tan
authors.affiliation: University of Pittsburgh, Pittsburgh, Pa.
authors.forename: Benedict D T
authors.initials: BD
authors.lastname: Daly
authors.affiliation: Vanderbilt University Medical Center, Nashville, Tenn.
authors.forename: Joe B
authors.initials: JB
authors.lastname: Putnam
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006304:Health Status; D006801:Humans; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000523:psychology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011013:Pneumonectomy / Q000009:adverse effects / Q000401:mortality / Q000523:psychology*; D011446:Prospective Studies; D011788:Quality of Life; D018714:Radiotherapy, Adjuvant; D018570:Risk Assessment; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
keywords: lung cancer; quality of life; surgery