非鳞NCLC:培美曲塞+吉非替尼(gefitinib)PFS优于吉非替尼(gefitinib)单药

  • A+
所属分类:医疗资讯
摘要

Randomized Phase II Trial of Gefitinib With and Without Pemetrexed as First-Line

本文标签:易瑞沙是第几代靶向药

Randomized Phase II Trial of Gefitinib With and Without Pemetrexed as First-Line Therapy in Patients With Advanced Nonsquamous Non-S ll-Cell Lung Cancer With Activating Epider l Growth Factor Receptor Mutations.吉非替尼(gefitinib)加和不加培美曲塞一线治疗具有活化表皮生长因子受体突变的晚期非鳞非小细胞肺癌患者的随机Ⅱ期试验。山东省肿瘤医院呼吸内科张品良

Abstract摘要

PURPOSE:目的:

To determine whether the addition of pemetrexed to gefitinib (P+G) provides clinical benefit, compared with gefitinib monotherapy, in patients with advanced nonsquamous (NS) non-s ll-cell lung cancer (NSCLC) and activating epider l growth factor receptor (EGFR) mutations.确定在具有活化表皮生长因子受体(EGFR)突变的晚期非鳞(NS)非小细胞肺癌(NSCLC)患者中,与吉非替尼(gefitinib)单药治疗相比,添加培美曲塞至吉非替尼(gefitinib)(P+G)是否可提供临床收益。

PATIENTS AND METHODS:患者和方法:

Chemotherapy-naïve for advanced NSCLC patients from China, Japan, Korea, and Taiwan (35 sites) with advanced, EGFR-mutant, NS NSCLC were randomly assigned (2:1; computer-generated, interactive voice response) to open-label pemetrexed (500 mg/m(2) on day 1 of every 21-day cycle) plus gefitinib (250 mg/d [n = 129]) or gefitinib alone (n = 66). The pri ry end point was progression-free-survival (PFS); secondary end points were time to progressive disease, overall survival, tumor response rates, duration of response, and safety. All end points were assessed in the intent-to-treat and safety population (P+G, n = 126; gefitinib alone, n = 65).来自中国、日本、韩国和台湾(35个中心)的具有EGFR突变、未曾化疗的晚期非鳞非小细胞肺癌患者随机分为(2∶1;计算机生成、交互式语音应答)开放标签的培美曲塞(500mg/㎡,d1,每21天为1周期)加吉非替尼(gefitinib)(每天250mg[n=129])或单纯吉非替尼(gefitinib)(n=66)。主要终点是无进展生存期(PFS);次要终点是至疾病进展时间、总生存期、肿瘤应答率、医治效果持续时间和安全特性。在意向治疗和安全特性人群中评估所有终点(P+G,n=126;单纯吉非替尼(gefitinib),n=65)。

RESULTS:结果:

PFS was significantly longer with P+G (median, 15.8 months; 95% CI, 12.6 to 18.3 months) than with gefitinib (median, 10.9 months; 95% CI, 9.7 to 13.8 months; adjusted hazard ratio [HR], 0.68; 95% CI, 0.48 to 0.96; one-sided P = .014; two-sided P = .029). Results of EGFR exon 19 deletion and EGFR exon 21 L858R point mutation subgroup yses were consistent with the intent-to-treat result. P+G, compared with gefitinib alone, resulted in significantly longer time to progressive disease (median, 16.2 v 10.9 months, respectively; HR, 0.66; 95% CI, 0.47 to 0.93) and numerically longer duration of response (median, 15.4 v 11.3 months, respectively; HR, 0.74; 95% CI, 0.50 to 1.08). Tumor response rates did not differ. Overall survival data are im ture. Drug-related grade 3 or 4 adverse events were more common with P+G, but toxicities were nageable.无进展生存期P+G(中位数15.8个月;95%CI,12.6-18.3个月)显著长于吉非替尼(gefitinib)(中位数10.9个月;95%CI,9.7-13.8个月;调整 比[HR],0.68;95%CI,0.48-0.96;单侧P=0.014;双侧P=0.029)。EGFR外显子19缺失与EGFR外显子21 L858R点突变亚组分析的结果与意向治疗结果相一致。与单独吉非替尼(gefitinib)相比,至疾病进展时间P+G显著更长(中位数分别为,16.2个月对10.9个月;HR,0.66;95%CI,0.47-0.93),且医治效果持续时间更长(中位数分别为,15.4个月对11.3个月;HR,0.74;95% CI,0.50-1.08)。肿瘤缓解率没有差异。总生存期数据还不成熟。药物相关的3或4级 P+G更常见,但毒性是可控的。

CONCLUSION:结论:

P+G improved PFS compared with gefitinib alone in East Asian patients with advanced NS NSCLC and activating EGFR mutations. This combination y offer EGFR mutation-positive patients new treatment options and improved clinical outcomes compared with the current standard of care. 在具有活化EGFR突变的晚期非鳞非小细胞肺癌东亚患者中,与单独使用吉非替尼(gefitinib)相比,P+G延长无进展生存期。该组合可能提供给EGFR突变阳性患者新的治疗选择,而且与目前的标准治疗相比改善临床结局。

J Clin Oncol. 2016 Sep 20;34(27):3258-66. doi: 10.1200/JCO.2016.66.9218.

药道网—药到病除,助力生命。汇聚全球药品资讯:易瑞沙 肚胀

  • 微信咨询
  • 这是我的微信扫一扫
  • weinxin
  • WhatsApp 沟通
  • 手机扫一扫二维码
  • weinxin

发表评论

:?: :razz: :sad: :evil: :!: :smile: :oops: :grin: :eek: :shock: :???: :cool: :lol: :mad: :twisted: :roll: :wink: :idea: :arrow: :neutral: :cry: :mrgreen: