Phase I Study of Hepatic Arterial Infusion of Oxaliplatin in Advanced Hepatocellular Cancer A Brown University Oncology Group Study
Phase I Study of Hepatic Arterial Infusion of Oxaliplatin in Advanced Hepatocellular Cancer A Brown University Oncology Group Study
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DOI：
10.1097/coc.0b013e31819d8668
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发表时间：
2010-02-10
影响因子：
2.6
通讯作者：
Kennedy, Teresa
中科院分区：
文献类型：
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作者：
Rathore, Ritesh;Safran, Howard;Kennedy, Teresa
目的：我们进行了一项 I 期研究，以评估晚期肝细胞癌 (HCC) 肝动脉输注 (HAI) 奥沙利铂的可行性并确定最大耐受剂量。患者和方法：患有不可切除或复发性 HCC 的患者接受 HAI-奥沙利铂治疗 2 小时以上，剂量递增水平为 90、110、130 和 150 mg/m(2)，每 3 周一次。继续治疗直至疾病进展或过度毒性而无法进行适当的修改。每2个周期后进行一次重新分期。结果：共有23名患者入组，其中17名患者可进行毒性评估。中位年龄为 63 岁（范围：47-84 岁），其中男性 22 例，女性 1 例。分期分布如下：11期3例，III期12例，W期8例。总共交付了 53 个周期（范围：1-3）的 HAI-奥沙利铂。传统的 3/4 级血液学和胃肠道毒性并不常见。在接受超过 2 个周期的 17 名可评估患者中，3 名患者出现部分缓解，8 名患者病情稳定。 3 名部分缓解患者和 3 名疾病稳定患者的甲胎蛋白降低了 50% 以上。 结论：HAI-奥沙利铂是一种可行的、耐受性良好的药物，并且在该晚期 HCC 队列中已得到证实。每3周一次的HAI-奥沙利铂150 mg/m(2)被确定为II期试验中进一步评估的剂量。
Purpose: We performed a phase I study to evaluate the feasibility and determine the maximally tolerated dose of hepatic arterial infusion (HAI) of oxaliplatin in advanced hepatocellular carcinoma (HCC). Patients andMethods: Patients With unresectable or recurrent HCC received HAI-oxaliplatin over 2 hours at dose escalation levels of 90, 110, 130, and 150 mg/m(2) given every 3 weeks. The therapy was Continued until disease progression or excessive toxicity not amenable to appropriate modifications. Restaging was performed after every 2 cycles.Results: A total of 23 patients were enrolled, with 17 patients evaluable for toxicity assessment. The median age was 63 years (range: 47-84 years), with 22 men and 1 woman. Stage distribution was as follows: stage 11, 3 patient,stage III 12 patients: and stage W, 8 patients. A total of 53 cycles (range: 1-3) of HAI-oxaliplatin were delivered. The conventional grade 3/4 hematologic and gastrointestinal toxicities were infrequent. Among 17 evaluable patients receiving >2 cycles, 3 patients had partial responses and 8 had stable disease. A greater than 50% reduction in alphafetoprotein was seen in the 3 patients with partial responses and 3 patients with stable disease.Conclusions: HAI-oxaliplatin is a feasible, well tolerated, and demonstrated activity in this advanced HCC cohort. HAI-oxaliplatin 150 mg/m(2) every 3 weeks was determined is the dose for further evaluation in phase II trials.