Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: An eastern cooperative oncology group study
Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: An eastern cooperative oncology group study
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DOI：
10.1200/jco.2005.02.4646
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发表时间：
2005-12-01
影响因子：
45.3
通讯作者：
Forastiere, AA
中科院分区：
文献类型：
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作者：
Burtness, B;Goldwasser, MA;Forastiere, AA
目的头颈部复发/转移性鳞状细胞癌的治疗导致中位无进展生存期（PFS）为2个月。这些癌症富含表皮生长因子受体（EGFR）。我们希望确定是否添加西妥昔单抗，抑制EGFR的激活，将改善PFS.Patients和方法复发/转移性鳞状细胞癌的头部和颈部患者被随机分配到接受顺铂每4周，每周：西妥昔单抗（A组）或安慰剂（3组）。通过免疫组织化学测定肿瘤组织的EGFR表达。主要终点是PFS。次要终点的兴趣是反应率，毒性，总生存率，EGFR与临床终点的相关性。B组的中位PFS为2.7个月，A组为4.2个月。A组进展至B组的风险比为0.78（95%CI，0.54至1.12）。B组的中位总生存期为8.0个月，A组为9.2个月（P = 0.21）。西妥昔单抗治疗患者皮肤毒性的生存风险比为0.42（95% CI，0.21 - 0.86）。A组的客观缓解率为10%，B组为26%（P = 0.03）。增强反应是更大的EGFR染色存在于小于80%的cells.Conclusion除了西妥昔单抗顺铂显着提高反应率的患者。对于皮疹的发展有生存优势。在本研究中，西妥昔单抗的加入并未显著改善无进展生存期和总生存期。
Purpose Therapy of recurrent/metastatic squamous cell carcinoma of the head and neck results in median progression-free survival (PFS) of 2 months. These cancers are rich in epidermal growth factor receptor (EGFR). We wished to determine whether the addition of cetuximab, which inhibits activation of EGFR, would improve PFS.Patients and Methods Patients with recurrent/metastatic squamous cell carcinoma of the head and neck were randomly assigned to receive cisplatin every 4 weeks, with weekly: cetuximab (arm A) or placebo (arm 3). Tumor tissue was assayed for EGFR expression by immunohistochemistry. The primary end point was PFS. Secondary end points of interest were response rate, toxicity, overall survival, and correlation of EGFR with clinical end points.Results There were 117 analyzable patients enrolled. Median PFS was 2.7 months for arm B and 4.2 months for arm A. The hazard ratio for progression of arm A to arm B was 0.78 (95% CI, 0.54 to 1.12). Median overall survival was 8.0 months for arm B and 9.2 months for arm A (P = .21). The hazard ratio for survival by skin toxicity in cetuximab-treated patients was 0.42 (95% CI, 0.21 to 0.86). Objective response rate was 10% for arm A and 26% for arm B (P =.03). Enhancement of response was greater for patients with EGFR staining present in less than 80% of cells.Conclusion Addition of cetuximab to cisplatin significantly improves response rate. There was a survival advantage for the development of rash. Progression-free and overall survival were not significantly improved by the addition of cetuximab in this study.