Outcome of locally advanced rectal cancer patients treated with radical surgery followed by concurrent capecitabine and radiotherapy

Objective: To evaluate the toxicities and long-term survival of a pilot study of radical surgery followed by concurrent capecitabine and radiotherapy for stage II/III rectal cancer patients. Methods: From March 1, 2005 to December 31, 2007, 131 pathologically proved stage II and III rectal cancer patients received radical surgery followed by chemoradiotherapy and adjuvant chemotherapy. Capecitabine was delivered daily in twice, for 2 weeks followed by a 2nd cycle after a rest of 7 days during radiotherapy, with the dosage of 1600 mg/m2/d. Three-dimensional conformal radiotherapy was encouraged to the dose of 50 Gy in 25 fractions, and Oxaliplatin/5-fluorouracil or leucovorin based adjuvant chemotherapy was recommended. Results: Grade 3 + 4 toxicities during concurrent chemoradiotherapy were observed in 28.2% of patients. The follow-up rate was 93.9%. The 3-year overall survival (OS), locoregional-free survival and distant metastasis-free survival rates were 85.1%, 96.7% and 79.5%, respectively. Among the 31 patients with relapse, 5 had loco-regional recurrence and 28 had distant metastasis. Univariate analysis indicated that patients with low and moderate-low differentiated adenocarcinoma, no adjuvant chemotherapy, stage IIIC disease or positive lymph node ratio (LNR) more than 30% had lower OS (χ2 =15.49, 15.85, 8.80 and 9.76, P = 0.000, 0.000, 0.011 and 0.002). Patients with N2 disease had more loco-regional recurrence. Patients with stage IIIC, without adjuvant chemotherapy, or LNR more than 30% were at higher risk of distant metastasis (χ2 =6.51, 11.57 and 9.70, P =0.034, 0.001 and 0.002). However, patients who didn't receive adjuvant chemotherapy were likely to have low differentiated adenocarcinoma and T4 stage disease (χ2 =7.20, 6.48, P =0.027, 0.039). Conclusions: After radical surgery and concurrent capecitabine and radiotherapy for stage II/III rectal cancer patients, loco-regional recurrence rate is pretty low. Distant metastasis is the main treatment failure. (authors)