伽玛刀联合吉西他滨治疗局部晚期胰腺癌的Ⅰ期临床观察

 目的 探索吉西他滨联合伽玛刀治疗局部晚期胰腺癌的最适剂量。方法 采用“3+3”试验设计模式，患者接受伽玛刀和吉西他滨治疗，伽玛刀治疗计划52 Gy/13F，吉西他滨初始剂量700 mg/m²，每周1次，连续3周，剂量按照100 mg/m²依次递增，直至出现剂量限制性毒性反应。结果 入组9例患者，700 mg/m²和800 mg/m²组完成治疗计划，当吉西他滨的剂量递增至900 mg/m²时出现剂量限制性的血液学毒性反应，试验中止。结论 伽玛刀联合吉西他滨治疗局部晚期胰腺癌，吉西他滨的推荐剂量为800 mg/m²，每周1次，连续3周。

A phase I study of gemcitabine combined with gamma knife therapy for locally advanced pancreatic cancer

Objective To estimate the optimal dose of gemcitabine administered concurrently with gamma knife therapy in patients with locally advanced pancreatic cancer. Method “3+3” model was measured in the study. Eligible patients had histologically confirmed pancreatic adenocarcinoma deemed locally unresectable. Patients received gamma knife therapy (52 Gy/13F) with concurrent infused weekly gemcitabine(dose escalated from 700 mg/m² to 900 mg/m² weekly) until dose-restricted toxicity. Results 9 patients were enrolled. Patients enrolled in gemcitabine 700 mg/m² and 800 mg/m² completed the plan.III-IV degree hematology toxicity was seen in patients when gemcitabine dose escalated to 900 mg/m². Conclutions The combination of gemcitabine and gamma knife therapy is well tolerated. The optimal dose of gemcitabine is 800 mg/m² weekly.