摘要：

Preoperative radiotherapy with continuous infusional 5-fluorouracil (CI-5FU) improves sphincter preservation and produces pathological complete remissions (pCR) in 10–30% of patients (pts) with LARC. Capecitabine (Xeloda), an oral fluoropyrimidine, is preferentially converted to 5-FU by high intra-tumor thymidine phosphorylase that can be further activated by radiotherapy. The primary endpoint of this phase II study is to evaluate the rate of pathological response with secondary endpoints on survival, recurrence, quality of life, and tumor markers. Capecitabine (825 mg/m2 PO bid/7days during XRT was administered with concomitant boost XRT (52.5 Gy/30 fractions to the primaryperirectal nodes, and 45Gy to the pelvis) in 54 pts with LARC (T3N0 or any TN1 staged by EUS). Eligible patients recieved capecitabine 1250 mg/m2 PO bid day 1–14 every 21 for four cycles as adjuvant treatment after surgery. Pts characteristics included median age: 56 (36–78), male:female ratio: 1.7; ECOG performance status 0–1 100%; 42 pts (92%) had T3N0 or T3N1 disease. The pathological response of the 44 patients who underwent resection to date includes 7 pts (16%) who achieved pCR and 28 pts (64%) had a partial response resulting in a 79% overall response rate. Stable disease was evident in 5 pts (11%) and 2 pts (5%) had progressive disease. Two pts (5%) who achieve complete clinical remissions refused surgery. Most toxicities were Grade 1/2: hand foot syndrome (27%), diarrhea (25%), fatigue (21%), leukopenia (15%), anemia (15%), and proctitis (10%). Gr 3 toxicities were limited: diarrhea (10%) and radiation dermatitis (6%), bilirubinemia (4%) and hand and foot syndrome (2%). Gr 4 diarrhea occurred only in one pt. Concomitant boost radiotherapy plus capecitabine

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