Phase II study of capecitabine (Xeloda) and concomitant boost radiotherapy in patients with locally advanced rectal cancer.

摘要: Purpose: The aim of this study was to determine the efficacy capecitabine (Xeloda (registered) ), an oral fluoropyrimidine, as a radiosensitizer in neoadjuvant treatment locally advanced rectal cancer (LARC). Methods and Materials: We conducted phase II (825 mg/m{sup 2} orally, twice daily continuous) with radiotherapy (52.5 Gy/30 fractions primary tumor perirectal nodes) 54 patients LARC (node-negative {>=}T3 or any node-positive tumor) staged by endoscopic ultrasound (EUS). endpoint pathologic response rate; secondary endpoints included toxicity profiles survival parameters. Results: Of (median age, 56.7 years; range, 21.3-78.7 male:female ratio, 1.7; Eastern Cooperative Oncology Group performance status 0-1: 100%), 51 (94%) had T3N0 T3N1 disease EUS. Surgery not performed 3 patients; 2 these metastatic disease, third patient refused after complete clinical response. evaluable for response, 9 (18%) achieved 12 (24%) microscopic residual (<10% viable cells). In addition, 26 all (51%) T-downstaging, 15 29 (52%) N-downstaging. Grade 3/4 toxicities were radiationmore » dermatitis (9%) diarrhea (2%). Sphincter preservation rate {<=}5 cm from anal verge 67% (18/27). Conclusion: This regimen plus is well tolerated more convenient than protracted venous infusion 5-FU. comparable our previous experience using 5-FU LARC.« less