University of Colorado Cancer Center, Denver, Colorado.
Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
Cancer. 2018 Jun 1;124(11):2407-2414. doi: 10.1002/cncr.31313. Epub 2018 Mar 26.
This is the first report of long-term (>10 years) safety, tolerability, and survival data on patients with non-small cell lung cancer (NSCLC) who received treatment with gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.
Patients with advanced NSCLC (N = 191) who entered the IRESSA Clinical Access Program (ICAP) (June 2011 to January 2013) and had previously obtained a clinical benefit from gefitinib therapy (including patients who had received gefitinib since 2001) were analyzed for adverse events (AEs). A subset of patients (n = 79) underwent retrospective chart review to capture demographic, safety, and survival data.
Seventy-five of 191 patients (39%) remained on long-term gefitinib therapy as of September 2016. Overall, serious AEs (SAEs) were reported in 64 patients (34%), the majority of which were attributed to underlying disease or comorbidities; only 3 patients (1.6%) had SAEs that were considered as possibly gefitinib-related. In the retrospective chart review cohort, 70% of patients were women; 58% were former smokers, and 30% were never-smokers; 56% were diagnosed with adenocarcinoma, and 13% were diagnosed with squamous carcinoma. Although EGFR mutational status was tested in only 17 patients (22%), it was assumed that most tumors were EGFR-mutation-positive. The median duration of gefitinib therapy was 11.1 years (7.8 years before and 3.5 years during ICAP), with 10-year and 15-year survival rates of 86% and 59%, respectively, from the initiation of therapy.
A subset of long-term NSCLC survivors who were receiving gefitinib had an excellent long-term safety profile. Although it is assumed that most of these patients' tumors harbor EGFR mutations, molecular studies of available tumor specimens are planned to uncover the features that predict long-term survival. Cancer 2018;124:2407-14. © 2018 American Cancer Society.
这是关于接受表皮生长因子受体（EGFR）酪氨酸激酶抑制剂吉非替尼治疗的非小细胞肺癌（NSCLC）患者的长期（>10 年）安全性、耐受性和生存数据的首次报告。
分析了 191 名进入 IRESSA 临床准入计划（ICAP）（2011 年 6 月至 2013 年 1 月）的晚期 NSCLC 患者的不良事件（AE），这些患者先前从吉非替尼治疗中获得了临床获益（包括自 2001 年以来接受过吉非替尼治疗的患者）。对一小部分患者（n=79）进行了回顾性病历审查，以获取人口统计学、安全性和生存数据。
截至 2016 年 9 月，191 例患者中有 75 例（39%）仍在接受长期吉非替尼治疗。总体而言，64 例患者（34%）报告了严重不良事件（SAE），其中大多数归因于基础疾病或合并症；只有 3 例（1.6%）患者的 SAE 被认为可能与吉非替尼有关。在回顾性病历审查队列中，70%的患者为女性；58%为曾经吸烟者，30%为从不吸烟者；56%的患者被诊断为腺癌，13%的患者被诊断为鳞状细胞癌。尽管只有 17 例患者（22%）进行了 EGFR 突变检测，但假设大多数肿瘤为 EGFR 突变阳性。吉非替尼治疗的中位持续时间为 11.1 年（ICAP 前 7.8 年和后 3.5 年），从治疗开始后的 10 年和 15 年生存率分别为 86%和 59%。
接受吉非替尼治疗的一组长期 NSCLC 幸存者具有极佳的长期安全性。尽管假设这些患者的大多数肿瘤都存在 EGFR 突变，但计划对现有肿瘤标本进行分子研究，以揭示预测长期生存的特征。癌症 2018；124:2407-14. © 2018 美国癌症协会。
