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NSABP R-03 trial: Preoperative chemoradiotherapy improved survival outcomes in rectal cancer
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Neoadjuvant chemoradiotherapy improved DFS and demonstrated a trend toward improved OS in patients with rectal carcinoma when compared with adjuvant chemoradiotherapy, according to the results of the National Surgical Adjuvant Breast and Bowel Project R-03 trial.
Participants included patients with T3 or T4 or node-positive rectal cancer. Researchers assigned 123 patients to preoperative treatment and 131 patients to postoperative treatment. Patients who survived were observed for a median of 8.4 years.
DFS was better in preoperative therapy patients (64.7%) than in postoperative therapy patients (53.4%), with a HR of 0.629 (95% CI, 0.439-0.902). Five-year OS was also higher among patients assigned to preoperative chemoradiotherapy (74.5%) vs. those assigned to postoperative chemoradiotherapy (65.6%); the HR was 0.693 (95% CI, 0.468-1.026).
Preoperative patients had a lower five-year incidence of recurrence (23.9%) compared with postoperative patients (27.5%; HR=0.564; 95% CI, 0.360-0.885). Fifteen percent of patients who achieved complete pathologic response had no recurrences.
Both groups had similar postoperative complication rates, and nearly all patients enrolled in the study experienced some toxicity.
The findings of this trial are contrary to other phase-3 trials with different treatment regimens, according to researchers.
“Clearly, there is a need for better patient selection, improved imaging and the testing of novel chemoradiotherapy programs,” Bruce D. Minsky, MD, professor of radiation and cellular oncology at the University of Chicago Medical Center, said in an accompanying editorial. “However, preoperative chemoradiotherapy remains the treatment of choice for cT3 and node-positive rectal cancer.”
Roh MS. J Clin Oncol. 2009;doi:10.1200/JCO.2009.22.0467.