Phase II trial of systemic continuous fluorouracil and subcutaneous recombinant interferon Alfa-2b for treatment of hepatocellular carcinoma
Phase II trial of systemic continuous fluorouracil and subcutaneous recombinant interferon Alfa-2b for treatment of hepatocellular carcinoma
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DOI：
10.1200/jco.2003.10.103
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发表时间：
2003-02-01
影响因子：
45.3
通讯作者：
Ellis, LM
中科院分区：
文献类型：
--
作者：
Patt, YZ;Hassan, MM;Ellis, LM
目的：由于肝硬化在美国的肝细胞癌（HCC）中极为常见，并且它排除了几种化疗药物的使用，因此氟尿嘧啶（FU）和重组干扰素α-2b的II期试验患者和方法：43例HCC患者（34例）和纤维板层HCC患者（34例），（FLHCC; 9例）接受连续静脉（IV）FU（200 mg/m2/d × 21，每28天一次）和皮下（SC）rIFN α 2b（4百万U/m2）每周三次治疗。在所有43例患者中确定生存，并在28 HCC和8 FLHCC patients.Results的反应可以进行评估：患者的中位年龄分别为63.5和19岁之间的HCC和FLHCC患者，分别。71%的HCC患者存在肝硬化，但FLHCC患者中无肝硬化。可评估缓解的36例患者中有9例（25%; 28例HCC患者中有4例[14%]; 8例FLHCC患者中有5例[62.5%]）达到完全缓解（CR; 1例FLHCC患者，无HCC患者）或部分缓解（PR; 8例患者[4例HCC患者和4例FLHCC患者]）。4名HCC患者接受了切除术，2名患者的组织学CR; 1名伴FOR的HCC患者接受了原位肝移植。1例FLHCC患者也接受了无明确边缘的切除术。总体中位生存期为19.5个月（95%置信区间[CI]，11.2至27.8个月）; HCC患者的中位生存期为15.5个月（95% CI，8.5至22.5个月），FLHCC患者的中位生存期为23.1个月（95% CI，10.3至35.9个月）。总体3级或4级毒性包括口腔炎（32.6%），疲劳（4.7%）和血液学毒性（9.3%）。结论：连续IV FU和每周三次SC rIFN α 2b是一种有效的治疗方法，特别是对于FLHCC，并可能在这种疾病中具有新辅助作用。该方案在HCC中具有活性，并且甚至可以被肝硬化患者耐受。(C)2003年，美国临床肿瘤学会。
Purpose: Because cirrhosis is extremely common in hepatocellular carcinoma (HCC) in the United States, and it precludes the use of several chemotherapy agents, this phase II trial of fluorouracil (FU) and recombinant interferon alfa-2b (rIFNalpha2b) in HCC was launched with the assumption that it could be tolerated by cirrhotics.Patients and Methods: Forty-three patients with HCC (34), and fibrolamellar HCC (FLHCC; nine) were treated with continuous intravenous (IV) FU (200 mg/m(2)/d x 21 every 28 days) and subcutaneous (SC) rIFNalpha2b (4 million U/m(2)) three times weekly. Survival was determined in all 43 patients, and response could be assessed in 28 HCC and 8 FLHCC patients.Results: The median ages of the patients were 63.5 and 19 years among HCC and FLHCC patients, respectively. Liver cirrhosis was present among 71% of HCC patients but among none of the FLHCC patients. Nine of 36 (25%; four of 28 [14%] HCC patients; five of eight [62.5%] FLHCC patients) patients in which a response could be assessed had a complete response (CR; one patient with FLHCC and no patients with HCC) or partial response (PR; eight patients [four HCC and four FLHCC patients]). Four HCC patients underwent resection, and two had a histologic CR; one HCC patient with a FOR underwent orthotopic liver transplantation. One FLHCC patient also underwent resection without clear margins. Overall median survival was 19.5 months (95% confidence interval [CI], 11.2 to 27.8 months); median survival was 15.5 months (95% Cl, 8.5 to 22.5 months) among HCC patients, and that of FLHCC patients was 23.1 months (95% Cl, 10.3 to 35.9 months). Overall grade 3 or 4 toxicity included stomatitis (32.6%), fatigue (4.7%), and hematologic toxicity (9.3%).Conclusion: Continuous IV FU and thrice-weekly SC rIFNalpha2b are an effective treatment, especially for FLHCC, and may have a neoadjuvant role in this disease. This regimen has activity in HCC and can be tolerated even by cirrhotic patients. (C) 2003 by American Society of Clinical Oncology.