Objective: To determine whether preoperative administration of combination chemotherapy and external beam irradiation ("chemoradiation") for patients with stage II or stage III rectal carcinoma had an impact on perioperative morbidity on oncologic outcome, as compared with patients not receiving preoperative chemoradiation.
Design: A group of patients with stage II or stage III rectal carcinoma receiving preoperative chemoradiation were followed up prospectively and compared in a nonrandomized fashion with an inception cohort group of similar patients.
Setting: Northwestern Memorial Hospital, Chicago, Ill, a tertiary care academic medical center.
Patients: Thirty patients with rectal carcinoma undergoing preoperative chemoradiation were compared with 56 patients not undergoing preoperative chemoradiation, and also with a subset group of 24 patients who received standard postoperative adjuvant chemoradiation.
Intervention: External beam radiation, 45 to 50 Gy, was delivered concurrently with fluorouracil and mitomycin 4 to 8 weeks prior to surgical resection.
Main outcome measures: Patients were followed up at regular intervals for either tumor recurrence or death. In addition, the group receiving preoperative chemoradiation was evaluated for major preoperative morbidity.
Results: All patients agreeing to preoperative chemoradiation completed therapy. Perioperative major morbidity in this group (13%) was comparable to previously published results. Of the 56 patients with stage II or stage III rectal carcinoma not receiving preoperative chemoradiation, only 24 (43%) completed standard postoperative adjuvant chemoradiation. Patients receiving preoperative chemoradiation (n = 30), patients not receiving preoperative chemoradiation (n = 56), and the subset of the group not receiving preoperative chemoradiation who completed standard postoperative chemoradiation (n = 24) were followed up for a mean of 39 months, 31 months, and 32 months, respectively. Five-year actuarial local control rates were 96%, 83%, and 88%, respectively. Disease-free-survival rates were 80%, 57%, and 47%, respectively. Overall survival rates were 85%, 48%, and 78%, respectively.
Conclusions: Preoperative chemoradiation in the treatment of stage II or stage III rectal carcinoma is well tolerated and not associated with an increase in subsequent perioperative major morbidity. In addition, local control, disease-free survival, and overall survival compare favorably with a nonrandomized inception cohort group of patients receiving standard postoperative adjuvant chemoradiation.