Lung and Esophageal Cancer Clinic, Chonnam National University Hwasun Hospital, Jeonnam 519-809, South Korea.
Lung Cancer. 2012 Jul;77(1):121-7. doi: 10.1016/j.lungcan.2012.01.012. Epub 2012 Feb 12.
Most patients with non-small-cell lung cancer (NSCLC) who initially respond to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) eventually experience progression of disease. Based on previous trials which showed second response after switching to another EGFR-TKI, we hypothesized that the reintroduction of gefitinib would lead to disease control rate (DCR) in more than 30% of patients. This was a single-arm, open-label, prospective, phase II trial of gefitinib for the treatment of advanced or metastatic NSCLC. Eligible patients had previously responded to, or had experienced disease stabilization with, initial gefitinib treatment for at least 3 months. Prior to retreatment, progressive disease (PD) should be observed, with at least one cytotoxic treatment following initial gefitinib failure. Twenty-three patients were recruited and defined as the intention to treat (ITT) group. Most of the enrolled patients were female (86.9%), never-smokers (91.3%), and adenocarcinoma patients (95.7%). Responses to initial gefitinib were partial response (PR) in 10 cases (43.5%) and stable disease (SD) in 13 cases (56.5%). PR and DCR were observed in 21.7% (5 patients) and 65.2% (15 patients) in the ITT group. Among 14 DNA samples, 13 cases had either exon 19 deletion or L858R point mutation, whereas one patient evidenced the wild-type EGFR gene. Re-initiation of EGFR-TKI can be considered as an option after failure of chemotherapy for those patients who previously controlled to EGFR-TKI treatment.
大多数初始对表皮生长因子受体酪氨酸激酶抑制剂 (EGFR-TKI) 有反应的非小细胞肺癌 (NSCLC) 患者最终会出现疾病进展。基于先前的试验表明，在切换到另一种 EGFR-TKI 后会有第二次反应，我们假设重新引入吉非替尼将使超过 30%的患者获得疾病控制率 (DCR)。这是一项单臂、开放标签、前瞻性、II 期吉非替尼治疗晚期或转移性 NSCLC 的试验。符合条件的患者之前曾对初始吉非替尼治疗有反应，或至少有 3 个月的初始吉非替尼治疗稳定。在重新治疗之前，应观察到疾病进展 (PD)，在初始吉非替尼失败后至少进行一次细胞毒性治疗。共招募了 23 名患者，并将其定义为意向治疗 (ITT) 组。入组的大多数患者为女性 (86.9%)、从不吸烟 (91.3%) 和腺癌患者 (95.7%)。初始吉非替尼的反应为部分缓解 (PR) 10 例 (43.5%)，稳定疾病 (SD) 13 例 (56.5%)。在 ITT 组中，观察到 21.7% (5 例)的 PR 和 65.2% (15 例)的 DCR。在 14 个 DNA 样本中，有 13 例存在外显子 19 缺失或 L858R 点突变，而 1 例患者存在野生型 EGFR 基因。对于那些先前对 EGFR-TKI 治疗有控制作用的患者，在化疗失败后，重新开始 EGFR-TKI 治疗可以被认为是一种选择。
