临床显示肝内胆管癌介入治疗有效率低

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本帖最后由 bluest 于 2012-8-17 21:40 编辑

Introduction: No established therapy exists for unresectable intrahepatic cholangiocarcinoma (ICC). We conducted a phase I/II study to ascertain the recommended dose (RD) of hepatic arterial infusion chemotherapy using gemcitabine (GEM) for ICC and to assess the efficacy and safety of this treatment.

Methods: Eligibility criteria included unresectable ICC, no priory therapy with GEM, acceptable arterial perfusion to the entire liver through an implantable port system, ECOG PS<2 and normal organ and bone marrow function. GEM was administered through the hepatic artery via the port system as a 30-minute infusion on days 1, 8 and 15 every 4 weeks for 5 cycles. In the phase I portion, dosage for levels 1, 2 and 3 was set at 600, 800, and 1,000 mg/m2, respectively, and was increased in 3-6 patients at a time. Maximum tolerated dose (MTD) was defined as a dosage resulting in dose-limiting toxicity in 2 of 3 patients or 3 of 6 patients, and RD was estimated during the first cycle. In the phase II portion, more RD patients were added to assess tumor response and toxicity using RECIST and NCI-CTC (ver. 2.0), respectively.

Results: During the phase I portion, 16 patients were registered. MTD was not reached. Assuming RD at 1,000 mg/m2, the phase II portion enrolled a total of 13 patients. In all cycles, the following Grade 3 or more toxicities were observed: neutropenia 20%, increased GGT 8%, increased AST 4%, increased ALT 4%, increased bilirubin 4%, nausea 4% and fatigue 4%. One patient showed Grade 4 increased bilirubin in 2 cycles, and this patient revealed complication of portal tumor thrombus. The tumor response rate was 7.7% (CR 0, PR 1, SD 8, PD 4).

Conclusion: While the toxicity of hepatic arterial infusion chemotherapy with 1,000 mg/m2 GEM for ICC was tolerable, expected efficacy could not be obtained, thus suggesting only minimal activity.

http://www.asco.org/ASCOv2/Meeti ... mp;abstractID=10298

临床采用肝动脉灌注化疗治疗肝内胆管癌，药物吉西他滨，有效率只有7.7%。