Division of Hematology and Oncology, Moores Cancer Center, University of California-San Diego, La Jolla, California.
Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Cancer. 2018 May 15;124(10):2169-2173. doi: 10.1002/cncr.31346. Epub 2018 Mar 26.
Cutaneous squamous cell carcinoma (CSCC) is a very common malignancy in which most patients present with localized disease. Recurrent and metastatic disease is rare, and there is no standard therapy. These tumors frequently overexpress the epidermal growth factor receptor (EGFR). We conducted a phase 2 trial to determine the response rate to therapy with erlotinib, an EGFR tyrosine kinase inhibitor, in patients with locoregionally recurrent or metastatic CSCC that was not amenable to curative treatment (NCT01198028).
Eligible patients had CSCC not amenable to curative intent therapy. Patients who had previously received anti-EGFR targeted therapy were excluded. All patients received oral therapy with erlotinib 150 mg daily. Response was assessed every 8 weeks, and treatment continued until progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint was overall response rate according to RECIST 1.1 criteria.
A total of 39 patients received treatment during the trial; 29 of these patients were evaluable for response. The overall response rate was 10% (3/29); all responses were partial responses. The disease control rate (partial response + stable disease) was 72% (21/29). The median progression-free survival was 4.7 months (95% confidence interval, 3.5-6.2 months); the median overall survival was 13 months (95% confidence interval, 8.4-20.5 months). No unexpected toxicities were seen.
Erlotinib therapy was feasible for most patients with incurable CSCC and was associated with expected toxicities. However, only a modest response rate of 10% was observed. Further study of EGFR tyrosine kinase inhibitors in this patient population is not warranted. Cancer 2018;124:2169-73. © 2018 American Cancer Society.
皮肤鳞状细胞癌（CSCC）是一种非常常见的恶性肿瘤，大多数患者表现为局限性疾病。复发性和转移性疾病很少见，也没有标准的治疗方法。这些肿瘤常常过度表达表皮生长因子受体（EGFR）。我们进行了一项 2 期临床试验，以确定表皮生长因子受体酪氨酸激酶抑制剂厄洛替尼治疗不能治愈的局部复发性或转移性 CSCC 患者的反应率，这些患者不适宜进行治愈性治疗（NCT01198028）。
符合条件的患者患有不能进行治愈性治疗的 CSCC。先前接受过抗 EGFR 靶向治疗的患者被排除在外。所有患者均接受厄洛替尼 150mg 每日口服治疗。每 8 周评估一次反应，直至疾病进展、无法耐受毒性或患者撤回同意。主要终点是根据 RECIST 1.1 标准的总缓解率。
共有 39 名患者在试验期间接受了治疗；其中 29 名患者可评估反应。总缓解率为 10%（29/29）；所有反应均为部分缓解。疾病控制率（部分缓解+稳定疾病）为 72%（21/29）。中位无进展生存期为 4.7 个月（95%置信区间，3.5-6.2 个月）；中位总生存期为 13 个月（95%置信区间，8.4-20.5 个月）。未观察到意外毒性。
厄洛替尼治疗对大多数不能治愈的 CSCC 患者是可行的，且与预期毒性相关。然而，仅观察到 10%的适度缓解率。进一步在该患者人群中研究 EGFR 酪氨酸激酶抑制剂是没有必要的。癌症 2018;124:2169-73。©2018 美国癌症协会。
