title: PROSPECT Eligibility and Clinical Outcomes: Results From the Pan-Canadian Rectal Cancer Consortium.
abstract: The PROSPECT trial (N1048) is evaluating the selective use of chemoradiation in patients with cT2N1 and cT3N0-1 rectal cancer undergoing sphincter-sparing low anterior resection. We evaluated outcomes of PROSPECT-eligible and -ineligible patients from a multi-institutional database.
  
  
  
  Data from patients with locally advanced rectal cancer who received chemoradiation and low anterior resection from 2005 to 2014 were retrospectively collected from 5 Canadian centers. Overall survival, disease-free survival (DFS), recurrence-free survival (RFS), and time to local recurrence (LR) were estimated using the Kaplan-Meier method, and a multivariate analysis was performed adjusting for prognostic factors.
  
  
  
  A total of 566 (37%) of 1531 patients met the PROSPECT eligibility criteria. Eligible patients were more likely to have better PS (P = .0003) and negative circumferential resection margin (P < .0001). PROSPECT eligibility was associated with improved DFS (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.61-0.91), overall survival (HR, 0.73; 95% CI, 0.57-0.95), and RFS (HR, 0.68; 95% CI, 0.54-0.86) in univariate analyses. In multivariate analysis, only RFS remained significantly improved for PROSPECT-eligible patients (HR, 0.75; 95% CI, 0.57-1.00, P = .0499). The 3-year DFS and freedom from LR for PROSPECT-eligible patients were 79.1% and 97.4%, respectively, compared to 71.1% and 96.8% for PROSPECT-ineligible patients.
  
  
  
  Real-world data corroborate the eligibility criteria used in the PROSPECT study; the criteria identify a subgroup of patients in whom risk of recurrence is lower and in whom selective use of chemoradiation should be actively examined.
authors.affiliation: The Ottawa Hospital Cancer Center, Ottawa, ON, Canada. Electronic address: dbosse@toh.ca.
authors.forename: Dominick
authors.initials: D
authors.lastname: Bossé
authors.affiliation: Dr H. Bliss Murphy Cancer Centre, St John's, NL, Canada.
authors.forename: Jamison
authors.initials: J
authors.lastname: Mercer
authors.affiliation: Tom Baker Cancer Centre, Calgary, AB, Canada.
authors.forename: Soundouss
authors.initials: S
authors.lastname: Raissouni
authors.affiliation: The Ottawa Hospital Cancer Center, Ottawa, ON, Canada.
authors.forename: Kristopher
authors.initials: K
authors.lastname: Dennis
authors.affiliation: The Ottawa Hospital Cancer Center, Ottawa, ON, Canada.
authors.forename: Rachel
authors.initials: R
authors.lastname: Goodwin
authors.affiliation: University of Ottawa, Ottawa, ON, Canada.
authors.forename: Di
authors.initials: D
authors.lastname: Jiang
authors.affiliation: Dr H. Bliss Murphy Cancer Centre, St John's, NL, Canada.
authors.forename: Erin
authors.initials: E
authors.lastname: Powell
authors.affiliation: Tom Baker Cancer Centre, Calgary, AB, Canada.
authors.forename: Aalok
authors.initials: A
authors.lastname: Kumar
authors.affiliation: BC Cancer Agency, Vancouver, BC, Canada.
authors.forename: Richard
authors.initials: R
authors.lastname: Lee-Ying
authors.affiliation: Cross Cancer Institute, Edmonton, AB, Canada.
authors.forename: Julie
authors.initials: J
authors.lastname: Price-Hiller
authors.affiliation: Tom Baker Cancer Centre, Calgary, AB, Canada.
authors.forename: Daniel Y C
authors.initials: DY
authors.lastname: Heng
authors.affiliation: Tom Baker Cancer Centre, Calgary, AB, Canada.
authors.forename: Patricia A
authors.initials: PA
authors.lastname: Tang
authors.affiliation: University of Calgary, Calgary, AB, Canada.
authors.forename: Anthony
authors.initials: A
authors.lastname: MacLean
authors.affiliation: BC Cancer Agency, Vancouver, BC, Canada.
authors.forename: Winson Y
authors.initials: WY
authors.lastname: Cheung
authors.affiliation: The Ottawa Hospital Cancer Center, Ottawa, ON, Canada.
authors.forename: Michael M
authors.initials: MM
authors.lastname: Vickers
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D000328:Adult; D000368:Aged; D002170:Canada; D017024:Chemotherapy, Adjuvant / Q000379:methods*; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D003131:Combined Modality Therapy; D013505:Digestive System Surgical Procedures; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D016032:Randomized Controlled Trials as Topic; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D012189:Retrospective Studies
keywords: Chemoradiation; Clinical trial; Neoadjuvant chemotherapy; Oxaliplatin; Toxicity