一项随机、多中心、开放性标签研究，旨在比较阿法替尼单药治疗与 HAD-B1 联合治疗对 EGFR 突变的局部晚期或转移性非小细胞肺癌患者的安全性和疗效。
A Randomized, Multi-Center, Open Label Study to Compare the Safety and Efficacy between Afatinib Monotherapy and Combination Therapy with HAD-B1 for the Locally Advanced or Metastatic NSCLC Patients with EGFR Mutations.
机构信息
East West Cancer Center, Daejeon Korean Medicine Hospital, Daejeon University, Daejeon 35235, Republic of Korea.
Integrative Medicine Service, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
出版信息
Integr Cancer Ther. 2024 Jan-Dec;23:15347354241268231. doi: 10.1177/15347354241268231.
BACKGROUND
Lung cancer, especially non-small cell lung cancer (NSCLC), poses a significant health challenge globally due to its high mortality. Afatinib, a second-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), has shown superior efficacy over traditional chemotherapy in NSCLC treatment. However, issues like secondary resistance and adverse effects call for alternative therapies. HAD-B1, comprising 4 herbal medicines, has shown promise in lung cancer treatment in both preclinical and clinical settings. This study assesses the combination of HAD-B1 and Afatinib in advanced NSCLC patients to potentially improve outcomes by addressing the limitations of current EGFR-TKI therapies.
METHOD
A randomized, open-label trial evaluated the efficacy and safety of HAD-B1 with Afatinib in 90 EGFR-mutation-positive NSCLC patients. Participants were divided into treatment and control groups, receiving Afatinib with or without HAD-B1. The study focused on the initial dose maintenance rate and disease control rate (DCR) of Afatinib, alongside secondary outcomes like survival rates and quality of life, under continuous safety monitoring.
RESULTS
Among the 90 participants, no significant difference was found in initial dose maintenance (60.98% in the treatment group vs 52.50% in the control, = .4414) or DCR (80.49% vs 90.00%, = .2283). Secondary outcomes like PFS, TTP, and OS showed no notable differences. However, physical functioning significantly improved in the treatment group ( = .0475, PPS group). The control group experienced higher rates of adverse events of special interest and adverse drug reactions ( = .01), suggesting HAD-B1 with Afatinib might enhance physical function without increasing adverse effects.
CONCLUSION
Combining HAD-B1 with Afatinib potentially improves quality of life and reduces adverse events in advanced NSCLC patients. Further research is necessary to confirm the long-term benefits of this combination therapy, aiming to advance NSCLC treatment outcomes.
TRIAL REGISTRATION
Clinical Research Information Service (CRIS) of the Republic of Korea, https://cris.nih.go.kr/ (ID: KCT0005414).
背景
肺癌，特别是非小细胞肺癌（NSCLC），因其高死亡率而在全球范围内构成重大健康挑战。阿法替尼，一种第二代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），在 NSCLC 治疗中已显示出优于传统化疗的疗效。然而，继发性耐药和不良反应等问题需要替代疗法。HAD-B1 由 4 种草药组成，在临床前和临床环境中均显示出治疗肺癌的潜力。本研究评估了 HAD-B1 与阿法替尼联合治疗晚期 NSCLC 患者的疗效和安全性，以期通过解决当前 EGFR-TKI 治疗的局限性来改善治疗结果。
方法
一项随机、开放标签试验评估了 90 名 EGFR 突变阳性 NSCLC 患者中 HAD-B1 联合阿法替尼的疗效和安全性。参与者分为治疗组和对照组，分别接受阿法替尼联合或不联合 HAD-B1 治疗。该研究重点关注阿法替尼的初始剂量维持率和疾病控制率（DCR），以及次要终点如生存率和生活质量，同时进行持续的安全性监测。
结果
在 90 名参与者中，治疗组的初始剂量维持率（60.98%）与对照组（52.50%）无显著差异（ = .4414），DCR（80.49% vs 90.00%）也无显著差异（ = .2283）。次要终点如 PFS、TTP 和 OS 无显著差异。然而，治疗组的生理功能显著改善（ = .0475，PPS 组）。对照组出现更多的特殊关注不良事件和药物不良反应（ = .01），提示 HAD-B1 联合阿法替尼可能在不增加不良反应的情况下提高生活质量。
结论
HAD-B1 联合阿法替尼可能改善晚期 NSCLC 患者的生活质量并减少不良反应。需要进一步研究以确认这种联合治疗的长期益处，旨在改善 NSCLC 的治疗结果。
试验注册
韩国临床研究信息服务（CRIS），https://cris.nih.go.kr/（ID：KCT0005414）。
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