MANNHEIM, GERMANY- Complete or nearly complete responses occurred in 41% of patients in a phase II trial of capecitabine(Drug information on capecitabine) (Xeloda) and irinotecan(Drug information on irinotecan) (Camptosar) for neoadjuvant treatment of patients with locally advanced rectal cancer (abstract 3589). "The efficacy is promising," the investigators concluded, and the regimen "is feasible and more convenient than infusional 5-FU-based chemoradiation." A total of 36 patients were recruited to receive weekly neoadjuvant irinotecan (50 mg/m2) 1 hour before radiotherapy and capecitabine (1,000 mg/m2 on days 1 to 38) with a concurrent radiotherapy dose of 50.4 Gy (45 + 5.4 Gy). Dose reductions and/or postponement of chemotherapy were required in 13 patients. Surgery was scheduled 4 to 6 weeks after completion of chemoradiotherapy. Trial participants had clinical stage T3/4 Nx or N+ rectal cancer. The median age was 62 years, and the male:female ratio was 27:9. The Eastern Cooperative Oncology Group (ECOG) performance status was 0 in 15 patients, 1 in 18 patients, and 2 in 3 patients. The median distance of the tumor from the anal verge was 5 cm. Three patients had local recurrences. Anemia Tops Toxicity List According to updated data reported by Frank Willeke, MD, of the Mannheim University Clinic in Germany, 34 patients had resection of the primary tumor and 41% had complete or nearly complete tumor remission. One patient refused surgery, and one patient was diagnosed with metastases before surgery could be performed. The most common toxicities were anemia, diarrhea, and leukopenia. The only grade 4 toxicities reported were two cases of leukopenia (see Table 1 on previous page). Postoperative complications included bowel atonia and bladder dysfunction. Five patients needed surgical revision, and three patients had fistulas. One patient died postoperatively due to septic complications concerning a perirectal abscess.