Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.
Center for Clinical Trials, National Cancer Center Korea, Goyang, Republic of Korea.
Clin Lung Cancer. 2020 Nov;21(6):e572-e582. doi: 10.1016/j.cllc.2020.05.003. Epub 2020 May 12.
We aimed to evaluate whether intercalated combination of EGFR tyrosine kinase inhibitor gefitinib and chemotherapy improves survival outcomes in never-smokers with advanced lung adenocarcinoma.
Never-smokers with chemo-naive stage IIIB/IV lung adenocarcinoma were randomly assigned to receive either gefitinib or placebo on days 5 to 18 of a 3-weekly cycle of pemetrexed and cisplatin. Chemotherapy was given up to 9 cycles, after which gefitinib or placebo was given daily. Patients in the placebo arm who had progression were crossed over to receive gefitinib.
Between June 2012 and December 2014, 76 patients with median age of 58.0 years were randomized, 39 on gefitinib and 37 on the placebo arm. EGFR mutation was positive in 34 (44.7%) patients. Baseline characteristics were well balanced between the 2 arms. The gefitinib arm had a better response rate (79.5% vs. 51.4%, P = .010) and median progression-free survival (PFS) (12.4 vs. 6.7 months, hazard ratio [HR] 0.49, P = .005) than the placebo arm; however, there was no statistically significant difference in median overall survival between the 2 arms (31.8 vs. 22.9 months, HR 0.78, P = .412). The PFS benefit of intercalated use of gefitinib over placebo was more apparent for patients with EGFR-mutant tumors (13.3 vs. 7.8 months, P = .025) than those with EGFR-wild-type tumors (8.2 vs. 6.6 months, P = .063). Overall, there was no difference in the frequency of severe adverse effect between the 2 arms.
Intercalated combination of gefitinib with pemetrexed and cisplatin was well tolerated and improved PFS in never-smoker patients with lung adenocarcinoma.
我们旨在评估表皮生长因子受体酪氨酸激酶抑制剂吉非替尼与化疗联合应用是否能改善从不吸烟的晚期肺腺癌患者的生存结局。
从未吸烟的、初治的Ⅲ B/Ⅳ期肺腺癌患者被随机分配，在培美曲塞和顺铂每 3 周周期的第 5 天至第 18 天接受吉非替尼或安慰剂治疗。化疗最多进行 9 个周期，之后给予吉非替尼或安慰剂每日治疗。安慰剂组中出现进展的患者交叉接受吉非替尼治疗。
2012 年 6 月至 2014 年 12 月，共纳入 76 例中位年龄为 58.0 岁的患者，其中 39 例接受吉非替尼治疗，37 例接受安慰剂治疗。34 例（44.7%）患者的表皮生长因子受体突变呈阳性。两组患者的基线特征均衡。吉非替尼组的客观缓解率（79.5%比 51.4%，P =.010）和中位无进展生存期（PFS）（12.4 个月比 6.7 个月，风险比[HR]0.49，P =.005）均优于安慰剂组；然而，两组患者的中位总生存期无统计学差异（31.8 个月比 22.9 个月，HR 0.78，P =.412）。与安慰剂相比，吉非替尼与培美曲塞和顺铂联合应用的 PFS 获益在表皮生长因子受体突变型肿瘤患者中更为明显（13.3 个月比 7.8 个月，P =.025），而在表皮生长因子受体野生型肿瘤患者中则不明显（8.2 个月比 6.6 个月，P =.063）。总体而言，两组患者严重不良事件的发生频率无差异。
吉非替尼与培美曲塞和顺铂联合应用在从不吸烟的肺腺癌患者中耐受性良好，可改善患者的 PFS。
