Phase II Study of Capecitabine, Oxaliplatin, and Cetuximab for Advanced Hepatocellular Carcinoma.
Phase II Study of Capecitabine, Oxaliplatin, and Cetuximab for Advanced Hepatocellular Carcinoma.
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发表时间：
2011-05
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通讯作者：
H. Sanoff;S. Bernard;R. Goldberg;M. Morse;Reynaldo A. Garcia;L. Woods;D. Moore;B. O'Neil
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作者：
H. Sanoff;S. Bernard;R. Goldberg;M. Morse;Reynaldo A. Garcia;L. Woods;D. Moore;B. O'Neil
背景肝细胞癌（HCC）经常对化疗耐药。然而，表皮生长因子受体（EGFR）抑制剂在HCC中表现出活性，并克服了其他环境中的化疗耐药性。我们研究了抗EGFR抗体西妥昔单抗联合卡培他滨和奥沙利铂治疗晚期HCC的疗效。方法：未经化疗的晚期/不可切除的HCC和任何Childs-Pugh级慢性肝病患者（前提是AFP胆红素降低50%）。中位至进展时间为4.5个月（95% CI，3.2-6.4），总生存期为4.4个月（95% CI，2.4-7.3）。最常见的毒性包括腹泻（13例患者，45%）、疲劳（12例患者，41%）和低镁血症（12例患者，41%）。疲乏（6例患者）和腹泻（5例患者）是最常见的3-4级毒性。3例患者在治疗的前30天内死亡（1例毒性，2例肝功能衰竭，推测与疾病进展相关）。结论：卡培他滨/奥沙利铂/西妥昔单抗联合治疗在该人群中是耐受的，尽管腹泻明显。联合治疗的缓解率适中，但AFP缓解率和放射学稳定性疾病的发生率较高。疾病进展时间和总生存期短于索拉非尼治疗的预期。
BACKGROUND Hepatocellular carcinoma (HCC) is frequently resistant to chemotherapy. However, epidermal growth factor receptor (EGFR) inhibition has demonstrated activity in HCC and overcomes chemotherapy resistance in other settings. We studied the efficacy of combining the anti-EGFR antibody cetuximab with capecitabine and oxaliplatin in advanced HCC. METHODS Patients who had chemotherapy-naive advanced/unresectable HCC and any Childs-Pugh-class chronic liver disease (provided bilirubin was 50% reduction in AFP. Median time to progression was 4.5 months (95% CI, 3.2-6.4), and overall survival was 4.4 months (95% CI, 2.4-7.3). Most common toxicities included diarrhea (13 patients, 45%), fatigue (12 patients, 41%), and hypomagnesemia (12 patients, 41%). Fatigue (6 patients) and diarrhea (5 patients) were the most common grade 3-4 toxicities. Three patients died within the first 30 days of treatment (one of toxicity, two of liver failure presumed to be related to disease progression). CONCLUSIONS The capecitabine/oxaliplatin/cetuximab combination was tolerable, though diarrhea was pronounced, in this population. The combination was associated with a modest response rate, but a high rate of AFP response and radiographic stable disease. Time to progression and overall survival were shorter than would be expected for treatment with sorafenib.