Preoperative radiotherapy with @entity416 and XXXX in locally advanced rectal carcinoma.

@entity1 @entity137 @entity416 @entity5 @entity1138 @entity294 @entity1398 @entity20787 @entity3028
PURPOSE: To evaluate the efficacy and safety of preoperative radiotherapy with @entity416 and @entity1138 in @entity1 with locally advanced @entity5 . METHODS: A prospective, open-label, non-randomized, phase II study was performed on 49 @entity1 with locally advanced @entity5 . Preoperative radiotherapy was conducted on linear accelerators (15 or 18  MV) with a @entity5 dose of 45  Gy in 25 fractions over 5  weeks, combined with @entity1138 7  mg/m(2) on days 1 and 29 and oral @entity416 825  mg/m(2) twice daily on days 1-35. Surgery was performed 5-6  weeks after the end of chemoradiation. The primary study endpoint was histopathological complete regression rate (pCR; Dworak grade 4). RESULTS: Disease stage at diagnosis was T3 in 34 @entity1 (69%) and T4 in 15 @entity1 (31%). Positive lymph nodes were diagnosed in 28 @entity1 (57%). @entity137 (all grades) was documented in 35 @entity1 (71%). Grade 3 @entity137 were @entity20787 (25%), @entity294 (2%), @entity1398 (2%), and @entity3028 (2%). No @entity1 experienced grade 4 @entity137 . A pCR was seen in 8 (16%, 95% CI 9-29%) @entity1 , a major response was noted in 24 (49%) @entity1 and a minor response in 14 (29%) @entity1 . R0 resection was performed in 46 @entity1 (93.9%) and R1 in 3 @entity1 (6.1%). @entity5 downstaging was documented in 26 @entity1 (53%). One-year disease-free survival was 93.3% and 1-year survival was 97.7%. CONCLUSION: Preoperative chemoradiation with @entity416 and @entity1138 appeared to be effective with low @entity137 in @entity1 with locally advanced @entity5 .
