A randomized multicentre study of chemoradiotherapy in patients with locally advanced (inoperable) rectal cancer / 中华放射肿瘤学杂志

ABSTRACT

Objective To evaluate the feasibility and efficacy of chemoradiotherapy for locally advanced (inoperable) rectal cancer. Methods Seventy-six patients with locally advanced (T_4) or recurrent rectal cancer were randomized into two groups of concurrent chemoradiotherapy with either oxaliplatin plus 5-FU (oxaliplatin 130 mg/m~2, day 1,5-FU 350 mg/m~2, day 1 -5 ,LV 200 mg/m~2, day 1 -5, 4 weeks per cycle) or capecitabine (1650 mg/m~2, day 1 -14, 3 weeks per cycle) alone. All patients received pelvic three-dimensional conforrnal radiotherapy (3 DCRT) of 46 -50 Gy in 23 -25 fractions, with a boost of 14 -18 Gy in 7 -9 fractions. Results The median follow-up time was 19 months. The overall response rate was 64% in the oxaliplatin/5-FU group comparing with 58% in the capecitabine group (χ~2 = 0. 08 ,P =0. 772), with the median survival time of 22 months and 18 months (u = 17.71, P = 0. 077), respectively. The overall survival in the two groups was 68% and 63% at 1 year, and 21% and 19% at 2 years, respectively (χ~2 = 0. 97, P = 0. 326). There were no treatment-related deaths or grade 4 toxicities. Neutrocytopenia (39. 5% vs 77.7%, z = -3.97,P =0. 0001), diarrhea (47.4% vs 88.9%, z = -4. 78, P = 0. 0001), nausea and vomiting (68.4% vs 97.2%, z = -3. 17, P = 0. 0001), and neurotoxicity (5.3% vs 66.7%, z= -6.56, P= 0.0001) were more common in the oxaliplatin/5-FU group. Conclusions Concurrent chemoradiotherapy is well-tolerated and effective in patients with locally advanced (inoperable) rectal cancer.