Aims and background: The aim of this paper is to confirm the efficacy to reduce incidence of relapses, to increase rates of conservative radical surgery and eventually survival of concomitant neo-adjuvant chemo-radiotherapy.
Methods: From January 1992 to October 1999, 140 stage II (50.7%) and III (49.3%) patients with adenocarcinoma of the rectum were treated with concomitant chemoradiotherapy followed by radical surgery. Treatment consisted of 25 fractions of 180 cGy (5 days per week), for a total dose of 45 Gy on the whole pelvis. Chemotherapy consisted of 5-FU (350 mg/m2) and leucovorin (10 mg/m2) in bolus for 5 days on days 1-5 and 29-33 of radiation. After an interval of 4-6 weeks, all patients were submitted to surgery.
Results: The median follow-up was 48 months (median, 1-97). At 5 years the overall survival was 71.3% and relapse-free survival was 79.4%. The rate of local control was 90%. Twenty-two (15.7%) patients developed distant metastases. All patients underwent surgery: 26 (18.6%) local excision, 79 (56.4%) anterior resection, 33 (23.6%) abdomino-perineal resection, and 2 (1.4%) Hartmann resection. Consequently, 107 cases (75.4%) underwent conservative surgery. At the time of surgery, 34 patients had negative specimens (24.3%), 45 were in stage I (32.2%), 31 in stage II (22.1%), 32 in stage III (21.4%). The incidence of any grade 3 acute toxicity (WHO) was 5% diarrhea, 20% tenesmus and 11.4% myelosuppression.
Conclusions: The results of this study confirm good tolerance, minor surgery-related complications and efficacy of this regimen on local and distant disease control, with a high percentage of sphincter-saving surgery.