第一个和第三代EGFR-TKI用于治疗晚期非小细胞肺癌的比较:现实研究
Maitri Shah1, Kashvi Shah1, Hetvi Dave1
1Pharm.D section, L. M. College of Pharmacy, Ahmedabad, India.
概括
在印度,奥西米尔提尼布在EGFR突变的转移性非小细胞肺癌 (NSCLC) 方面没有表现出高于格菲提尼布/埃洛提尼布的优势. 虽然它更安全,但其较高的成本并不能由临床有效性来证明是合理的.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床研究 临床研究
背景情况:
- 肺癌是全球主要的死亡原因之一.
- 表皮生长因子受体 (EGFR) 突变的转移性非小细胞肺癌 (NSCLC) 在印度很普遍.
- 第一个和第二代EGFR-tyrosine kinase抑制剂 (TKIs),如gefitinib/erlotinib和第三代TKIs,如osimertinib用于治疗.
研究的目的:
- 为了比较奥西默蒂尼布与格菲蒂尼布/埃洛蒂尼布的临床有效性和安全性,印度患者患有EGFR突变转移性转移性NSCLC.
- 评估客观反应率 (ORR),疾病控制率 (DCR),无进展生存率 (PFS) 和不良事件 (AE).
主要方法:
- 西印度的回顾性观察队列研究.
- 包括EGFR突变转移性转移性NSCLC的患者.
- 使用ORR,DCR,PFS和AE发生率评估治疗反应.
主要成果:
- 在ORR (11.11%与25.64%) 或DCR (69.44%与82.05%) 之间没有统计学上显著的差异, osimertinib和gefitinib/erlotinib.
- 奥西默蒂尼布的PFS中位数为8.43个月,而格菲蒂尼布/埃洛蒂尼布的PFS中位数为10.68个月.
- 奥西默提尼布显示不良事件发生率较低 (1.94对2.49).
结论:
- 在这个患者队列中,osmertinib在临床上并不优于gefitinib/erlotinib.
- 奥西默提尼布显示出更好的安全性概况.
- 与gefitinib/erlotinib相比, osimertinib 的更高的成本并不能由其临床有效性来证明是合理的.
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