Preoperative Multimodality Therapy Improves Disease-Free Survival in Patients With Carcinoma of the Rectum: NSABP R-03

Author:

Roh Mark S.1,Colangelo Linda H.1,O'Connell Michael J.1,Yothers Greg1,Deutsch Melvin1,Allegra Carmen J.1,Kahlenberg Morton S.1,Baez-Diaz Luis1,Ursiny Carol S.1,Petrelli Nicholas J.1,Wolmark Norman1

Affiliation:

1. From the National Surgical Adjuvant Breast and Bowel Project (NSABP) Operations Center; Allegheny General Hospital; NSABP Biostatistical Center at the University of Pittsburgh, Graduate School of Public Health, Department of Biostatistics; University of Pittsburgh Medical Center, Presbyterian Hospital, Pittsburgh, PA; University of Florida, Division of Hematology and Oncology, Gainesville, FL; University of Texas Health Science Center at San Antonio, San Antonio, TX; Minority-Based Community Clinical...

Abstract

Purpose Although chemoradiotherapy plus resection is considered standard treatment for operable rectal carcinoma, the optimal time to administer this therapy is not clear. The NSABP R-03 (National Surgical Adjuvant Breast and Bowel Project R-03) trial compared neoadjuvant versus adjuvant chemoradiotherapy in the treatment of locally advanced rectal carcinoma. Patients and Methods Patients with clinical T3 or T4 or node-positive rectal cancer were randomly assigned to preoperative or postoperative chemoradiotherapy. Chemotherapy consisted of fluorouracil and leucovorin with 45 Gy in 25 fractions with a 5.40-Gy boost within the original margins of treatment. In the preoperative group, surgery was performed within 8 weeks after completion of radiotherapy. In the postoperative group, chemotherapy began after recovery from surgery but no later than 4 weeks after surgery. The primary end points were disease-free survival (DFS) and overall survival (OS). Results From August 1993 to June 1999, 267 patients were randomly assigned to NSABP R-03. The intended sample size was 900 patients. Excluding 11 ineligible and two eligible patients without follow-up data, the analysis used data on 123 patients randomly assigned to preoperative and 131 to postoperative chemoradiotherapy. Surviving patients were observed for a median of 8.4 years. The 5-year DFS for preoperative patients was 64.7% v 53.4% for postoperative patients (P = .011). The 5-year OS for preoperative patients was 74.5% v 65.6% for postoperative patients (P = .065). A complete pathologic response was achieved in 15% of preoperative patients. No preoperative patient with a complete pathologic response has had a recurrence. Conclusion Preoperative chemoradiotherapy, compared with postoperative chemoradiotherapy, significantly improved DFS and showed a trend toward improved OS.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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