A phase II study of cetuximab, capecitabine and radiotherapy in neoadjuvant treatment of patients with locally advanced resectable rectal cancer

摘要: Abstract Background Neoadjuvant chemoradiotherapy (CRT) reduces local tumor recurrence in locally advanced rectal cancer (LARC). This phase II study assessed neoadjuvant cetuximab with capecitabine-based CRT LARC. Methods Patients stage II/III LARC received capecitabine 1250 mg/m 2 twice daily for weeks followed by intravenous 400 at week 3, then weekly 250 plus including 825 (including weekends during radiotherapy) radiotherapy of 45 Gy (25 × 1.8 Gy), 5 days a weeks. Total mesorectal excision was scheduled 4–6 following completion CRT. The primary endpoint pathological complete response (pCR). Results Thirty-seven patients were eligible safety and efficacy. TMN staging baseline was: T4N2, 11%; T3N2, 40%; T2N2, 3%; T3N1, 35%; T2N1, 3% T3N0 8%. most common adverse events included, grade 1/2 acneiform skin rash (86%), 3 radiodermatitis, (16%), diarrhea (11%) hypersensitivity (5%). pCR achieved (8%). Overall-, T- N-downstaging rates 73%, 57% 81% respectively. sphincter preservation rate 76%, 53% 17 whose tumors located within cm from the anal verge. Non-fatal perioperative complications occurred 13 (35%) delayed wound healing occurring 6 (16%). One death recorded due to sepsis colonic necrosis. Conclusion is tolerable resectable Whilst similar recent reports, high downstaging achieved.