Originally published as JCO Early Release 10.1200/JCO.2009.22.0467 on September 21 2009

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

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 Oncology Program, San Juan, PR; Helen F. Graham Cancer Center, Newark, DE.

Corresponding author: Mark S. Roh, MD, M. D. Anderson Cancer Center Orlando, 1400 South Orange Blvd, Orlando, FL 32806; e-mail: mark.roh{at}orlandohealth.com.

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.

See accompanying editorial on page 5115

Supported by Public Health Service Grants No. U10-CA-37377, U10-CA-69974, U10-CA-12027, U10-CA-69651, and U24-CA-114732 from the National Cancer Institute, Department of Health and Human Services.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: PDQ: NSABP-R-03.

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