Comprehensive Cancer Center, Division of Clinical Oncology, Shinshu University School of Medicine, Shinshu University Hospital, 3-1-1, Asahi Matsumoto, Matsumoto 390-8621, Japan.
Cancer Chemother Pharmacol. 2012 May;69(5):1241-6. doi: 10.1007/s00280-012-1831-0. Epub 2012 Jan 26.
There is as yet no optimal treatment regimen for patients with epidermal growth factor receptor (EGFR) gene wild-type non-small-cell lung cancer (NSCLC) that has progressed despite cytotoxic chemotherapy. This trial was performed to evaluate the efficacy and toxicity of erlotinib, a tyrosine kinase inhibitor of EGFR, in Japanese patients with EGFR wild-type tumors.
Patients with stage III/IV or postoperative recurrence of NSCLC whose tumors have wild-type EGFR were eligible. Erlotinib (150 mg/day) was administered until disease progression or unacceptable toxicity occurred. The primary end point was disease control rate (DCR).
Thirty-one patients (23 men and 8 women; median age, 71 years; range, 31-89) were enrolled between January 2008 and June 2011. Twenty-one had adenocarcinoma, nine had squamous cell carcinoma, and one had large cell carcinoma. Ten, nine, eight, and four patients showed performance status 0, 1, 2, and 3, respectively. Erlotinib was administered following the median 3.1 regimens of cytotoxic chemotherapies. One patient achieved complete response, four showed partial response, and eight had stable disease. Thus, response rate was 17.2%, and DCR was 44.8%. Skin rash was the most common side effect (80.6%). Two patients developed interstitial lung disease. Nevertheless, all of these events were reversible, and there were no treatment-related deaths. The median progression-free survival and survival times were 2.1 and 7.7 months, respectively.
Erlotinib might be an alternative option for patients resistant to cytotoxic chemotherapy even in those with EGFR wild-type NSCLC.
对于表皮生长因子受体（EGFR）基因野生型非小细胞肺癌（NSCLC）患者，尽管进行了细胞毒性化疗，但仍没有最佳的治疗方案。本试验旨在评估 EGFR 酪氨酸激酶抑制剂厄洛替尼在 EGFR 野生型肿瘤的日本患者中的疗效和毒性。
符合条件的患者为 III/IV 期或 NSCLC 术后复发且肿瘤 EGFR 为野生型的患者。厄洛替尼（150mg/天）给药，直至疾病进展或出现不可接受的毒性。主要终点为疾病控制率（DCR）。
2008 年 1 月至 2011 年 6 月期间共纳入 31 例患者（23 例男性，8 例女性；中位年龄 71 岁；范围 31-89 岁）。21 例为腺癌，9 例为鳞癌，1 例为大细胞癌。10、9、8 和 4 例患者的表现状态分别为 0、1、2 和 3。在接受厄洛替尼治疗前，患者接受中位数为 3.1 个周期的细胞毒性化疗。1 例患者完全缓解，4 例部分缓解，8 例病情稳定。因此，缓解率为 17.2%，DCR 为 44.8%。皮疹是最常见的副作用（80.6%）。有 2 例患者发生间质性肺病。然而，所有这些事件都是可逆的，没有与治疗相关的死亡。中位无进展生存期和总生存期分别为 2.1 个月和 7.7 个月。
即使在 EGFR 野生型 NSCLC 患者中，厄洛替尼也可能是对细胞毒性化疗耐药患者的一种替代选择。
