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Gefitinib Versus Gefitinib Plus Pemetrexed and Carboplatin Chemotherapy in EGFR Mutated Lung Cancer Noronha V, Patil VM, Joshi A, et al. Gefitinib Versus Gefitinib Plus Pemetrexed and Carboplatin Chemotherapy in EGFR-Mutated Lung Cancer. Journal of Clinical Oncology;0:JCO.19.01154. Kumar Prabhash, MBBS, MD, DM, Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Parel, Mumbai, Maharashtra, India; Twitter: @TataMemorial; e-mail:kumarprabhashtmh@gmail.com
Standard first-line therapy for EGFR-mutant advanced non–small-cell lung cancer (NSCLC) is an epidermal growth factor receptor (EGFR)–directed oral tyrosine kinase inhibitor. Adding pemetrexed and carboplatin chemotherapy to an oral tyrosine kinase inhibitor may improve outcomes.EGFR突变型晚期非小细胞肺癌（NSCLC）的标准一线治疗是表皮生长因子受体（EGFR）引导的口服酪氨酸激酶抑制剂。将培美曲塞和卡铂化疗加入口服酪氨酸激酶抑制剂可能会改善预后。PATIENTS AND METHODS 患者与方法 This was a phase III randomized trial in patients with advanced NSCLC harboring an EGFR-sensitizing mutation and a performance status of 0 to 2 who were planned to receive first-line palliative therapy. Random assignment was 1:1 to gefitinib 250 mg orally per day (Gef) or gefitinib 250 mg orally per day plus pemetrexed 500 mg/m2 and carboplatin area under curve 5 intravenously every 3 weeks for four cycles, followed by maintenance pemetrexed (gefitinib plus chemotherapy [Gef+C]). The primary end point was progression-free survival (PFS); secondary end points included overall survival (OS), response rate, and toxicity. 这是一项对晚期非小细胞肺癌患者进行的III期随机试验，患者有EGFR敏感突变，表现状态为0-2，计划接受一线姑息治疗。随机分配为每天口服250毫克吉非替尼（Gef）或每天口服250毫克吉非替尼加500毫克/m2培美曲塞和曲线5下的卡铂面积，每3周静脉注射4个周期，随后进行培美曲塞维持治疗（吉非替尼加化疗[Gef+C]）。主要终点是无进展生存期（PFS）；次要终点包括总生存期（OS）、反应率和毒性。Between 2016 and 2018, 350 patients were randomly assigned to Gef (n = 176) and Gef+C (n = 174). Twenty-one percent of patients had a performance status of 2, and 18% of patients had brain metastases. Median follow-up time was 17 months (range, 7 to 30 months). Radiologic response rates were 75% and 63% in the Gef+C and Gef arms, respectively (P = .01). Estimated median PFS was significantly longer with Gef+C than Gef (16 months [95% CI, 13.5 to 18.5 months] v 8 months [95% CI, 7.0 to 9.0 months], respectively; hazard ratio for disease progression or death, 0.51 [95% CI, 0.39 to 0.66]; P , .001). Estimated median OS was significantly longer with Gef+C than Gef (not reached v 17 months [95% CI, 13.5 to 20.5 months]; hazard ratio for death, 0.45 [95% CI, 0.31 to 0.65]; P,.001). Clinically relevant grade 3 or greater toxicities occurred in 51% and 25% of patients in the Gef+C and Gef arms, respectively (P , .001).在2016年至2018年间，350名患者被随机分配到Gef（n = 176）和Gef + C（n = 174）两组。21％的患者的表现状态为2，18％的患者有脑转移。中位随访时间为17个月（7-30个月）。Gef + C组和Gef组的放射学反应率分别为75％和63％（P = .01）。GEF+C组的预估中位PFS明显长于Gef组（16个月[95% CI，13.5-18.5个月] vs 8个月[95% CI，7.0-9.0个月]；疾病进展或死亡的危险比为0.51[95% CI，0.39-0.66]；P.001）。Gef + C组的预估中位OS明显长于Gef组（未达到V 17个月[95％ CI，13.5-20.5个月]；死亡风险比为0.45 [95％ CI，0.31-0.65]; P，.001）。Gef+C组和Gef组分别有51%和25%的患者出现临床相关3级或更高的毒性（p.001）。Adding pemetrexed and carboplatin chemotherapy to gefitinib significantly prolonged PFS and OS but increased toxicity in patients with NSCLC. 对于NSCLC患者，在吉非替尼中加入培美曲塞和卡铂化疗可显著延长非小细胞肺癌患者的PFS和OS，但同时也增加了毒性。陪您一起学习SCI医学论文 每天5分钟，让自己的英语牛逼起来 特殊福利让您惊喜连连
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