Locally advanced rectal cancer: Resection and intraoperative radiotherapy using the flab method combined with preoperative or postoperative radiochemotherapy

PURPOSE: Surgery often fails to achieve local control in advanced rectal cancer. Additional measures are necessary to prevent local recurrence. The aim of this study was to evaluate intraoperative radiation therapy (IORT) (flab technique) combined with preoperative or postoperative radiochemotherapy. PATIENTS/METHODS: IORT is performed using a flexible flab containing hollow plastic tubes that are connected to a multichannel afterloading device with a 370 Gbq-192-Ir source. Patients receive an intraoperative dose of 15 Gy. Target volumes were measured in a cadaver experiment. From 1989 to 1993, 38 patients were included in this study. Nineteen patients were staged as T3 tumors by preoperative endosonography (Group I) and 19 as T4 tumors (Group II). Patients in Group I underwent resection (abdominoperineal resection (APR), 16; anterior resection, 3) and IORT, followed by postoperative radiochemotherapy (50 Gy/5-fluorouracil), whereas patients in Group II received preoperative radiochemotherapy (40 Gy/5-fluorouracil) followed by resection (APR, 18; anterior resection, 1) and IORT. Mean follow-up was 25.5 months. RESULTS: Operative radicality in Group I was R0 (13), R1 (3), and R2 (3), and in Group II it was $0 (14), R1 (3), R2 (2). R2 resections were attributable to preoperative undetected distant metastases. Perioperative mortality was 9 percent in Group I and 10.5 percent (n = 2) in Group II. Postoperative morbidity was 53 percent (n = 10) in Group I and 84 percent (n = 16) in Group II with delayed sacral wound healing being the predominant problem. Stenosis of the ureter occurred in two patients (Group II). Late or persistent therapy-related complications were seen in two patients in Group I and in six patients in Group II. Local recurrence developed in three patients in Group I (15.8 percent) and in two patients in Group II (10.5 percent). Survival data do not reach statistical significance between the two groups because of small numbers but show a favorable trend for the preoperative radiochemotherapy group. When compared with a matched historical control group of patients receiving resection only, adjuvant/neoadjuvant radiotherapy with resection/IORT improves survival significantly. CONCLUSION: the flab method is a simple but especially practical technique for IORT in the pelvis. Adjuvant/neoadjuvant therapy combined with resection/IORT is associated with high morbidity but acceptable mortality. Preliminary survival data are encouraging and call for a controlled prospective randomized trial.