Efficacy and safety of adjuvant EGFR-TKIs for resected non-small cell lung cancer: a systematic review and meta-analysis based on randomized control trials.
Efficacy and safety of adjuvant EGFR-TKIs for resected non-small cell lung cancer: a systematic review and meta-analysis based on randomized control trials.
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DOI：
10.1186/s12885-022-09444-0
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发表时间：
2022-03-26
期刊：
影响因子：
3.8
通讯作者：
Cao B
中科院分区：
文献类型：
--
作者：
Zhao P;Zhen H;Zhao H;Zhao L;Cao B
数十年来，基于顺铂的术后辅助化疗一直是完全切除的高危IB至IIIA期非小细胞肺癌（NSCLC）患者的标准治疗。然而，在临床实践中，生存获益远不能令人满意。因此，基于更新的文献和研究，进行了这项荟萃分析，以比较表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）辅助治疗在切除的NSCLC患者中的疗效和安全性。使用PubMed、Embase和科克伦图书馆数据库中的关键词，基于随机对照试验（RCT）进行了系统性文献检索。所有文章均比较了EGFR-TKI与安慰剂或化疗作为早期切除NSCLC辅助治疗的效果。进行荟萃分析，以生成无病生存期（DFS）、总生存期（OS）的合并风险比（HR）和95%置信区间（CI），以及疾病复发和不良事件（AE）的风险比（RR）和95% CI。使用Stata统计软件（版本14.0）合成数据。共纳入9项RCT，包括3098例患者。在切除的携带表皮生长因子受体（EGFR）突变的NSCLC患者中，辅助EGFR-TKI可显著延长DFS（HR 0.46，95% CI 0.29-0.72），但对OS无影响（HR 0.87，95% CI 0.69-1.11）。亚组分析表明，在大多数亚组中，辅助EGFR-TKI在DFS方面具有上级优势，包括不同的吸烟状态、EGFR突变类型、性别、年龄、东部肿瘤协作组体力状态和腺癌。奥希替尼导致脑复发率低于第一代EGFR-TKI（RR 0.12，95% CI 0.04-0.34 vs. RR 1.07，95% CI 0.64-1.78）。AE通常可管理且可耐受。EGFR-TKI辅助治疗后，包括腹泻（RR 5. 68，95% CI 2. 94 - 10. 98）和皮疹（RR 27. 74，95% CI 11. 43 - 67. 30）在内的高级别（≥ 3）AE的发生率增加。在完全切除的早期EGFR突变阳性NSCLC患者中，辅助EGFR-TKI治疗可显著延长DFS，但对OS无影响。辅助EGFR-TKI可能是切除的早期EGFR突变NSCLC患者的重要治疗选择。在线版本包含补充材料，可通过10.1186/s12885-022-09444-0获得。
Postoperative adjuvant cisplatin-based chemotherapy had been the standard care in patients with completely resected high-risk stage IB to IIIA non-small cell lung cancer (NSCLC) for decades. However, the survival benefits were far from satisfactory in clinical practice. Thus, this meta-analysis was performed to compare the efficacy and safety of adjuvant epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) in patients with resected NSCLC based on updated literature and research. A systematic literature search based on random control trials (RCTs) was conducted with keywords on PubMed, Embase and the Cochrane library databases. All articles compared EGFR-TKIs to placebo or chemotherapy as adjuvant therapies for early-stage resected NSCLC. A meta-analysis was performed to generate combined hazard ratio (HR) with 95% confidence intervals (CI) for disease-free survival (DFS), overall survival (OS), and risk ratio (RR) with 95% CI for disease recurrence and adverse events (AEs). The Stata statistical software (version 14.0) was used to synthesis the data. A total of 9 RCTs comprising 3098 patients were included. Adjuvant EGFR-TKIs could significantly prolong DFS in patient with resected NSCLC harboring epidermal growth factor receptor (EGFR) mutations (HR 0.46, 95% CI 0.29–0.72), but had no impact on OS (HR 0.87, 95% CI 0.69–1.11). The subgroup analyses indicated that adjuvant EGFR-TKIs were superior in regard to DFS in most subgroups, including varied smoking status, EGFR mutations type, gender, age, Eastern Cooperative Oncology Group performance status and adenocarcinoma. Osimertinib resulted in decreased brain recurrence than first generation of EGFR-TKIs (RR 0.12, 95% CI 0.04–0.34 vs. RR 1.07, 95% CI 0.64–1.78, respectively). The AEs were generally manageable and tolerable. The incidence of high-grade (≥ 3) AEs including diarrhea (RR 5.68, 95% CI 2.94–10.98) and rash (RR 27.74, 95% CI 11.43–67.30) increased after adjuvant EGFR-TKIs treatment. Adjuvant EGFR-TKIs therapy could significantly prolong DFS in patients with completely resected early-stage EGFR mutation-positive NSCLC, but had no impact on OS. Adjuvant EGFR-TKIs could be an important treatment option in patients with resected early-stage EGFR-mutant NSCLC. The online version contains supplementary material available at 10.1186/s12885-022-09444-0.
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