Thorac Cancer:EGFR阳性老年NSCLC患者吉非替尼进展后单药联合继续吉非替尼可改善患者PFS

2022-05-23 yd2015 网络

EGFR阳性老年NSCLC患者吉非替尼进展后单药联合继续吉非替尼可改善患者PFS,但是也增加了不良反应。

近期,Thoracic Cancer杂志上发表了一项II期随机临床研究成果(JMTO LC12-01),主要是评估EGFR阳性老年NSCLC患者吉非替尼治疗进展后,使用多西他赛(Doc)或培美曲塞(Pem)单药化疗联合或不联合吉非替尼(G)的疗效。

纳入患者随机分配至每21天接受Pem 500mg /m2或Doc 60mg /m2的化疗,接受250 mg G (G+ Doc/Pem组)或不接受G (Doc/Pem组),直到疾病进一步恶化或出现不可接受的毒性。

该试验因累积缓慢而提前终止。最终纳入22例患者进行分析,两组各有11例患者。中位随访时间为8.8个月。Doc/Pem组的中位PFS和OS分别为1.6个月(95% CI: 1.2-4.1)和8.6个月(95% CI: 4.6-16.3), G + Doc/Pem组的中位PFS和OS分别为5.6个月(95% CI: 4.2-9.1)和14.1个月(95% CI: 5.-未达到)。PFS差异有统计学意义(HR = 0.40, 95% CI: 0.16 0.99, p = 0.0391),但OS差异无统计学意义(HR = 0.49, 95% CI: 0.17 1.39, p = 0.169)。

Doc/Pem组的RR和DCR分别为0% (95% CI: 0.0-28.5)和27.3% (95% CI: 6.0-61.0), G +- Doc/Pem组的RR和DCR分别为18.2% (95% CI: 2.3-51.8)和54.5% (95% CI: 23.4-83.3)。两组间RR (p = 0.476)和DCR (p = 0.387)差异无统计学意义。

≥3级不良事件在G + Doc/Pem组更为常见(45.5% vs. 90.9%,p = 0.032)。

综上,研究表明,EGFR阳性老年NSCLC患者吉非替尼进展后单药联合继续吉非替尼可改善患者PFS,但是也增加了不良反应。

原始出处:

Asami K, Ando M,Nishimura T, Yokoi T, Tamura A, Minato K, et al. A randomized phase II study of docetaxel or pemetrexed with or without the continuation of gefitinib after disease progression in elderly patients with non-small cell lung cancer harboring EGFR mutations (JMTO LC12-01). Thorac Cancer. 2022. https://doi.org/10.1111/1759-7714.14465

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    2023-03-16 jklm09
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    2022-08-19 yyj062
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    2022-05-22 jeanqiuqiu
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    2022-05-22 liuyiping

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