Neoadjuvant treatment for locally advanced rectal adenocarcinoma with concomitant radiotherapy and oral capecitabine.

PURPOSE: Concomitant chemoradiotherapy prior to surgery of locally advanced rectal carcinoma (clinical T3- 4, and/or N+) might improve the therapeutic results. We report on our clinical experience with 34 patients receiving concurrent preoperative radiotherapy and capecitabine. PATIENTS AND METHODS: Between September 2001 and March 2003, 34 patients with a median age of 62 years (range 18-75 years) were treated for adenocarcinoma of the rectum. Capecitabine was administered orally at a dose of 825 mg/m(2) twice-daily concomitantly every day during pelvic irradiation. The planned total dose of radiotherapy was 50.4 Gy, given with daily fractions of 1.8Gy, 5 days a week, over a period of about 5.5 weeks. Large pelvic dose (PTV-1) was 45.0 Gy/25 fractions in 5 weeks. Higher dose up to 50.4 Gy in further 3 fractions was given using boost fields (PTV-2). Radiotherapy was performed with high-energy photon beam (18 MV) linear accelerator using 3-dimensional (3D) treatment planning for 3 or 4 fields technique. RESULTS: Toxicity was low: grade (G) 3 local dermatitis in 2 (6%), G3 diarrhea in 3 (9%) and G3 leucopenia in 1 (3%) patients. However, 2(6%) patients required drug dose reduction by 80%. Sphincter-sparing surgery was possible in 25 (76.5%) patients while 9 (26%) patients had radical surgery with removal of all macroscopic disease. Tumor mass downstaging by TNM criteria has been achieved in all of the treated patients. Pathological (p) complete response (CR) was verified in 7 (21%) patients and minimal microscopic residual cancer was found in 6 (17%) patients, for a total of 13 (38%) patients with substantial disease remission. CONCLUSION: Preoperative concomitant radiotherapy and oral capecitabine chemotherapy for locally advanced rectal adenocarcinoma appears to be an effective and safe therapeutic choice, improving the chance for rectal-sparing surgery. The follow-up time is rather short to evaluate time to progression and survival.