School of Traditional Chinese Medicine University, Chongqing, China (mainland).
Department of Traditional Chinese Medicine, Chongqing Cancer Hospital, Chongqing University Cancer Hospital, Chongqing, China (mainland).
Med Sci Monit. 2019 Nov 9;25:8430-8437. doi: 10.12659/MSM.917251.
BACKGROUND Lung cancer is the most common cause of cancer-associated deaths worldwide. This study aimed to investigate the efficacy and safety of Traditional Chinese Medicine combining EGFR-TKIs in treatment of NSCLC patients harboring EGFR mutations. MATERIAL AND METHODS This study involved 153 advanced-stage NSCLC patients harboring EGFR mutations. Patients were divided into a Control group (administered EGFR-TKI, n=61) and an Experimental group (administered Traditional Chinese Medicine combining EGFR and TKI, n=92). Progression-free survival (PFS) was evaluated for exon 19 deletion and/or 21 deletion patients. Disease control rate (DCR) was assessed to observe therapeutic effects. Adverse effects, including rashes, diarrhea, ALT/AST increase, dental ulcers, and onychia lateralis, were also evaluated. RESULTS TCM combining EGFR-TKI (90.11%) demonstrated no DCR improvement compared to single EGFR-TKI (83.33%) (p>0.05). Median PFS (mPFS) of TCM combining EGFR-TKI (13 months) was significantly longer compared to that in the single EGFR-TKI group (8.8 months) (p=0.001). For 19DEL mutant NSCLC, the mPFS (11 months) in TCM combining EGFR-TKI was significantly longer compared to single EGFR-TKI (8.5 months) (p=0.007). The mPFS of L858 mutant NSCLC patients in EGFR-TKI combining CTM (14 months) was significantly longer compared to single EGFR-TKI (9.5 months) (p=0.015). TCM combining EGFR-TKI was more inclined to prolong mPFS of NSCLC with exon 21 deletion. TCM combining EGFR-TKI illustrated no additional adverse effects in NSCLC patients (p=0.956). CONCLUSIONS Application of Traditional Chinese Medicine prolonged progression-free survival and enhanced therapeutic effect in NSCLC patients harboring EGFR mutations receiving EGFR-TKI treatment. Meanwhile, adjunctive Chinese medicine combining EGFR-TKI in NSCLC with EGFR mutations caused no adverse effects.
肺癌是全球癌症相关死亡的最常见原因。本研究旨在探讨中药联合 EGFR-TKI 治疗 EGFR 突变的 NSCLC 患者的疗效和安全性。
本研究纳入了 153 例晚期 EGFR 突变的 NSCLC 患者。患者分为对照组（给予 EGFR-TKI，n=61）和实验组（给予中药联合 EGFR-TKI，n=92）。对 exon19 缺失和/或 21 缺失的患者进行无进展生存期（PFS）评估。评估疾病控制率（DCR）以观察治疗效果。还评估了不良反应，包括皮疹、腹泻、ALT/AST 升高、口腔溃疡和甲床侧突。
与单独使用 EGFR-TKI 相比，中药联合 EGFR-TKI（90.11%）的 DCR 无改善（p>0.05）。中药联合 EGFR-TKI 组的中位 PFS（mPFS）（13 个月）明显长于单独 EGFR-TKI 组（8.8 个月）（p=0.001）。对于 19DEL 突变的 NSCLC，中药联合 EGFR-TKI 的 mPFS（11 个月）明显长于单独 EGFR-TKI（8.5 个月）（p=0.007）。EGFR-TKI 联合 CTM 治疗 L858 突变 NSCLC 患者的 mPFS（14 个月）明显长于单独 EGFR-TKI（9.5 个月）（p=0.015）。中药联合 EGFR-TKI 更倾向于延长 EGFR-TKI 治疗的 EGFR 突变 NSCLC 的 mPFS。中药联合 EGFR-TKI 治疗 NSCLC 患者无不良反应增加（p=0.956）。
应用中药可延长 EGFR 突变 NSCLC 患者的无进展生存期，增强 EGFR-TKI 治疗的疗效。同时，中药联合 EGFR-TKI 治疗 EGFR 突变的 NSCLC 不会引起不良反应。
