Department of Oncology, Lund University, Lund 22185, Sweden.
Radiother Oncol. 2010 Jun;95(3):292-7. doi: 10.1016/j.radonc.2010.04.004. Epub 2010 May 5.
In this multicentre phase I-II trial we evaluated the feasibility and efficacy of capecitabine and oxaliplatin followed by the combination of these two drugs with radiotherapy in patients with locally advanced pancreatic or biliary tract cancer.
Thirty-nine patients with inextirpable adenocarcinoma of the pancreas, gallbladder or extrahepatic bile ducts were included. Two cycles of XELOX (capecitabine 1000 mg/m(2) bid d1-14+oxaliplatin 130 mg/m(2) d1, q3w) were followed by XELOX-RT (radiotherapy (50.4 Gy), combined with capecitabine 750-675 mg/m(2) bid every radiotherapy day and oxaliplatin 40-30 mg/m(2) once weekly). Primary end-points were tolerance (phase I) and objective response (phase II).
The maximum tolerated doses of oxaliplatin and capecitabine to combine with irradiation were 30 mg/m(2) and 675 mg/m(2), respectively. Twenty-one percent (95% CI: 9-38%) of evaluable patients achieved partial response. Five patients went through surgery (three R0 resections). Two-year survival was 28%, and estimated local tumour control rate at 2 years was 72%. The most common grade 3-4 toxicity was nausea and vomiting.
XELOX-RT (30 mg/m(2) oxaliplatin/675 mg/m(2) capecitabine in combination with 50.4Gy/28 fractions) was well tolerated and effective for locally advanced pancreatic and biliary tract cancer.
在这项多中心 I- II 期试验中，我们评估了卡培他滨和奥沙利铂联合放化疗治疗局部晚期胰或胆管癌患者的可行性和疗效。
共纳入 39 例不可切除的胰腺、胆囊或肝外胆管腺癌患者。给予两周期的 XELOX（卡培他滨 1000mg/m²bid d1-14+奥沙利铂 130mg/m²d1，q3w），随后行 XELOX-RT（放疗（50.4Gy），同时给予卡培他滨 750-675mg/m²bid 每天放疗日和奥沙利铂 40-30mg/m²每周一次）。主要终点为耐受性（I 期）和客观反应（II 期）。
联合放疗时奥沙利铂和卡培他滨的最大耐受剂量分别为 30mg/m²和 675mg/m²。可评价患者中 21%（95%CI：9-38%）达到部分缓解。5 例患者接受手术（3 例 RO 切除）。2 年生存率为 28%，2 年时估计局部肿瘤控制率为 72%。最常见的 3-4 级毒性为恶心和呕吐。
XELOX-RT（联合放疗 30mg/m²奥沙利铂/675mg/m²卡培他滨和 50.4Gy/28 次）对局部晚期胰或胆管癌具有良好的耐受性和疗效。
