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.

IF 2.9 3区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Cancer Therapies Pub Date : 2024-01-01 DOI:10.1177/15347354241268231

Eunbin Kwag, Soo-Dam Kim, Seong-Hoon Shin, Chulho Oak, So-Jung Park, Jun-Yong Choi, Seong Hoon Yoon, In-Cheol Kang, Mi-Kyung Jeong, Hyun Woo Lee, Sun-Hwi Bang, Ji Woong Son, Sanghun Lee, Seung Joon Kim, Hwa-Seung Yoo

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引用次数: 0

Abstract

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, 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.

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).

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一项随机、多中心、开放标签研究，比较阿法替尼单药治疗与HAD-B1联合治疗对表皮生长因子受体突变的局部晚期或转移性NSCLC患者的安全性和有效性。

背景：肺癌，尤其是非小细胞肺癌（NSCLC），因其死亡率高而对全球健康构成重大挑战。阿法替尼是第二代表皮生长因子受体-酪氨酸激酶抑制剂（EGFR-TKI），在NSCLC治疗中显示出优于传统化疗的疗效。然而，继发性耐药性和不良反应等问题呼唤着替代疗法的出现。由 4 种中药组成的 HAD-B1 在临床前和临床环境中均显示出治疗肺癌的前景。本研究评估了HAD-B1和阿法替尼在晚期NSCLC患者中的联合应用，以解决目前EGFR-TKI疗法的局限性，从而改善治疗效果：一项随机、开放标签试验评估了HAD-B1联合阿法替尼治疗90例表皮生长因子受体突变阳性NSCLC患者的疗效和安全性。参与者被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。研究重点是阿法替尼的初始剂量维持率和疾病控制率（DCR），以及生存率和生活质量等次要结果，并对其进行持续的安全性监测：在90名参与者中，初始剂量维持率（治疗组为60.98%，对照组为52.50%，P = .4414）和疾病控制率（80.49%，对照组为90.00%，P = .2283）无明显差异。PFS、TTP和OS等次要结果无明显差异。不过，治疗组的身体功能明显改善（P = .0475，PPS 组）。对照组发生特别关注的不良事件和药物不良反应的比例更高（P = .01），这表明HAD-B1与阿法替尼联合治疗可能会在不增加不良反应的情况下增强患者的身体功能：结论：HAD-B1与阿法替尼联用可改善晚期NSCLC患者的生活质量，减少不良反应。有必要开展进一步研究，以确认这种联合疗法的长期疗效，从而提高NSCLC的治疗效果：大韩民国临床研究信息服务处（CRIS），https://cris.nih.go.kr/（ID：KCT0005414）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Integrative Cancer Therapies 医学-全科医学与补充医学

CiteScore

4.80

自引率

3.40%

发文量

审稿时长

>12 weeks

期刊介绍： ICT is the first journal to spearhead and focus on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative medicine and traditional medicine therapies, and their responsible integration with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments. Contributors are leading oncologists, researchers, nurses, and health-care professionals.