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Preoperative multimodality therapy improves disease-free survival in patients with carcinoma of the rectum: NSABP R-03
Journal of Clinical Oncology, 09/28/09

Roh MS et al. – Preoperative chemoradiotherapy, compared with postoperative chemoradiotherapy, significantly improved DFS and shows a trend toward improved OS.

Methods

Patients with clinical T3 or T4 or node-positive rectal cancer randomly assigned to preoperative or postoperative chemoradiotherapy
Chemotherapy consisted of fluorouracil and leucovorin with 45 Gy in 25 fractions with 5.40-Gy boost within original margins of treatment
In preop group, surgery was performed within 8 weeks after completion of radiotherapy
In postop group, chemotherapy began after recovery from surgery but no later than 4 weeks postop
Primary end points were DFS and OS

Results

From August 1993 to June 1999, 267 patients randomly assigned to NSABP R-03
Intended sample size 900 patients
Excluding 11 ineligible and two eligible patients without follow-up data, analysis used data on 123 patients randomly assigned to preop and 131 to postop chemoradiotherapy
Surviving patients observed for median of 8.4 years
5-year DFS for preop was 64.7% v 53.4% for postop
Complete pathologic response achieved in 15% of preop patients
No preop patient with complete pathologic response has had recurrence

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