An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy
An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy
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DOI：
10.1093/annonc/mdm399
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发表时间：
2008-01-01
影响因子：
50.5
通讯作者：
Peeters, M.
中科院分区：
文献类型：
--
作者：
Van Cutsem, E.;Siena, S.;Peeters, M.
背景资料：一项3期研究表明，帕尼单抗，人类单克隆抗表皮生长因子受体抗体，显着延长无进展生存与最佳支持治疗（BSC）在化疗难治性转移性结直肠cancer.Patients和方法：这开放标签的扩展研究评价帕尼单抗单药治疗BSC患者的放射学记录的疾病进展的3期研究。患者接受帕尼单抗6 mg/kg，每2周一次。主要终点是安全性，疗效也evaluated.Results：176例患者被随机分配到BSC臂的3期研究中接受>= 1帕尼单抗剂量在这个扩展研究。帕尼单抗耐受性良好。最常见的治疗相关不良事件是皮肤毒性反应。3例（2%）患者发生4级治疗相关不良事件。未发生输注反应。1例（0.6%）患者完全缓解; 19例（11%）患者部分缓解; 58例（33%）患者病情稳定。中位无进展生存期为9.4（95%置信区间（Cl）：8.0-13.4）周。中位总生存时间为6.3（95% CI：5.1-6.8）个月。抗帕尼单抗抗体中检测到3（4.2%）的71例基线后samples.Conclusions：这些结果是从3期研究和支持帕尼单抗单药治疗化疗难治性结直肠癌。
Background: A phase 3 study demonstrated that panitumumab, a human monoclonal anti-epidermal growth factor receptor antibody, significantly prolonged progression-free survival versus best supportive care (BSC) in patients with chemorefractory metastatic colorectal cancer.Patients and methods: This open-label extension study evaluated panitumumab monotherapy in BSC patients with radiographically documented disease progression in the phase 3 study. Patients received panitumurnab 6 mg/kg every 2 weeks. The primary end point was safety; efficacy was also evaluated.Results: One hundred and seventy-six patients were randomly assigned to the BSC arm of the phase 3 study received >= 1 panitumumab dose in this extension study. Panitumumab was well tolerated. The most frequent treatment-related adverse events were skin toxic effects. Three (2%) patients had a grade 4 treatment-related adverse event. There were no infusion reactions. One (0.6%) patient had a complete response; 19 (11%) patients had a partial response; and 58 (33%) patients had stable disease. Median progression-free survival time was 9.4 [95% confidence interval (Cl): 8.0-13.4) weeks. Median overall survival time was 6.3 (95% Cl: 5.1-6.8) months. Anti-panitumumab antibodies were detected in 3 (4.2%) of 71 patients with a post-baseline sample.Conclusions: These findings are comparable to those from the phase 3 study and support panitumumab monotherapy for chemorefractory colorectal cancer.