title: Comparative effectiveness of sphincter-sparing surgery versus abdominoperineal resection in rectal cancer: patient-reported outcomes in National Surgical Adjuvant Breast and Bowel Project randomized trial R-04.
abstract: OBJECTIVE
  National Surgical Adjuvant Breast and Bowel Project (NSABP) R-04 was a randomized controlled trial of neoadjuvant chemoradiotherapy in patients with resectable stage II-III rectal cancer. We hypothesized that patients who underwent abdominoperineal resection (APR) would have a poorer quality of life than those who underwent sphincter-sparing surgery (SSS).
  
  
  METHODS
  To obtain patient-reported outcomes (PROs) we administered two symptom scales at baseline and 1 year postoperatively: the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) and the European Organization for the Research and Treatment of Cancer module for patients with Colorectal Cancer Quality of Life Questionnaire (EORTC QLQ-CR38). Scoring was stratified by nonrandomly assigned definitive surgery (APR vs SSS). Analyses controlled for baseline scores and stratification factors: age, sex, stage, intended surgery, and randomly assigned chemoradiotherapy.
  
  
  RESULTS
  Of 1,608 randomly assigned patients, 987 had data for planned analyses; 62% underwent SSS; 38% underwent APR. FACT-C total and subscale scores were not statistically different by surgery at 1 year. For the EORTC QLQ-CR38 functional scales, APR patients reported worse body image (70.3 vs 77.0, P = 0.0005) at 1 year than did SSS patients. Males undergoing APR reported worse sexual enjoyment (43.7 vs 54.7, P = 0.02) at 1 year than did those undergoing SSS. For the EORTC QLQ-CR38 symptom scale scores, APR patients reported worse micturition symptoms than the SSS group at 1 year (26.9 vs 21.5, P = 0.03). SSS patients reported worse gastrointestinal tract symptoms than did the APR patients (18.9 vs 15.2, P < 0.0001), as well as weight loss (10.1 vs 6.0, P = 0.002).
  
  
  CONCLUSIONS
  Symptoms and functional problems were detected at 1 year by EORTC QLQ-CR38, reflecting different symptom profiles in patients who underwent APR than those who underwent SSS. Information from these PROs may be useful in counseling patients anticipating surgery for rectal cancer.
authors.affiliation: *National Surgical Adjuvant Breast and Bowel Project (NSABP) Operations and Biostatistical Centers, Pittsburgh, PA †David Geffen School of Medicine at UCLA, VA Greater Los Angeles Healthcare System, Los Angeles, CA ‡UCLA Schools of Medicine & Public Health and Jonsson Comprehensive Cancer Center, University of California, Los Angeles, CA §University of Pittsburgh Graduate School of Public Health Department of Biostatistics, Pittsburgh, PA ∥UCLA, Los Angeles, CA ¶Kaiser Permanente Oncology Clinical Trials, Northern California, Vallejo, CA **Southeast Cancer Control Consortium CCOP, Goldsboro, NC ††University of Pittsburgh Medical Center, Pittsburgh, PA ‡‡Missouri Valley Cancer Consortium CCOP, Omaha, NE §§Beaumont Hospital System, Royal Oak, MI ∥∥Florida Cancer Specialists, Sarasota, FL ¶¶Montana Cancer Consortium, Billings, MT ***Helen F. Graham Cancer Center, Newark, DE †††Glendale Memorial Hospital and Health Center, Glendale, CA ‡‡‡Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA.
authors.forename: Marcia M
authors.initials: MM
authors.lastname: Russell
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Ganz
authors.forename: Samia
authors.initials: S
authors.lastname: Lopa
authors.forename: Greg
authors.initials: G
authors.lastname: Yothers
authors.forename: Clifford Y
authors.initials: CY
authors.lastname: Ko
authors.forename: Amit
authors.initials: A
authors.lastname: Arora
authors.forename: James N
authors.initials: JN
authors.lastname: Atkins
authors.forename: Nathan
authors.initials: N
authors.lastname: Bahary
authors.forename: Gamini S
authors.initials: GS
authors.lastname: Soori
authors.forename: John M
authors.initials: JM
authors.lastname: Robertson
authors.forename: Janice
authors.initials: J
authors.lastname: Eakle
authors.forename: Benjamin T
authors.initials: BT
authors.lastname: Marchello
authors.forename: Timothy F
authors.initials: TF
authors.lastname: Wozniak
authors.forename: Robert W
authors.initials: RW
authors.lastname: Beart
authors.forename: Norman
authors.initials: N
authors.lastname: Wolmark
mesh_terms: D000005:Abdomen / Q000601:surgery; D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery*; D001003:Anal Canal / Q000601:surgery; D001828:Body Image; D005260:Female; D005767:Gastrointestinal Diseases / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010502:Perineum / Q000601:surgery; D011183:Postoperative Complications; D011446:Prospective Studies; D011788:Quality of Life; D012004:Rectal Neoplasms / Q000473:pathology / Q000601:surgery*; D012735:Sexual Dysfunction, Physiological / Q000209:etiology; D016896:Treatment Outcome; D014555:Urination Disorders / Q000209:etiology