■肺癌,尤其是非小细胞肺癌(NSCLC),由于其高死亡率,在全球范围内构成了重大的健康挑战。阿法替尼,第二代表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI),在NSCLC治疗中显示出比传统化疗更好的疗效。然而,诸如继发性抵抗和不良反应等问题需要替代疗法。HAD-B1,包括4种草药,在临床前和临床环境中的肺癌治疗中都显示出了希望。这项研究评估了HAD-B1和阿法替尼在晚期NSCLC患者中的组合,以通过解决当前EGFR-TKI疗法的局限性来潜在改善预后。
■随机,开放标签试验评估了HAD-B1联合阿法替尼在90例EGFR突变阳性NSCLC患者中的疗效和安全性.参与者分为治疗组和对照组,接受阿法替尼伴或不伴HAD-B1。该研究集中于阿法替尼的初始剂量维持率和疾病控制率(DCR),除了生存率和生活质量等次要结果,在持续的安全监控下。
■在90名参与者中,在初始剂量维持方面没有发现显着差异(治疗组为60.98%,对照组为52.50%,P=.4414)或DCR(80.49%vs90.00%,P=.2283)。次要结果如PFS,TTP,和OS没有显着差异。然而,治疗组的身体功能显着改善(P=.0475,PPS组)。对照组的特殊不良事件和药物不良反应发生率较高(P=0.01),提示HAD-B1联合阿法替尼可能增强身体功能而不增加不良反应.
■联合使用HAD-B1和阿法替尼可能改善晚期NSCLC患者的生活质量并减少不良事件。需要进一步的研究来确认这种联合疗法的长期益处,旨在提高NSCLC治疗结果。
■大韩民国临床研究信息服务(CRIS),https://cris.nih.走吧。kr/(ID:KCT0005414)。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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, P = .4414) or DCR (80.49% vs 90.00%, P = .2283). Secondary outcomes like PFS, TTP, and OS showed no notable differences. However, physical functioning significantly improved in the treatment group (P = .0475, PPS group). The control group experienced higher rates of adverse events of special interest and adverse drug reactions (P = .01), suggesting HAD-B1 with Afatinib might enhance physical function without increasing adverse effects.
UNASSIGNED: 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.
UNASSIGNED: Clinical Research Information Service (CRIS) of the Republic of Korea, https://cris.nih.go.kr/ (ID: KCT0005414).