Effects of Bojungikki-Tang on immune response and clinical outcomes in NSCLC patients receiving immune checkpoint inhibitors: a randomized pilot study

作者：Mi Mi Ko, Se Won Na, Jin-Mu Yi, Ho G. Jang, Chang‐Min Choi, Seung Hyeun Lee, Sung Yong Lee, Sung Yong Lee, Sung Yong Lee, Mi-Kyung Jeong · 发表于：BMC Cancer · 年份：2025 · DOI：10.1186/s12885-025-14629-4 · 被引用次数：4 · 研究领域：Pharmacological Effects of Natural Compounds、Complementary and Alternative Medicine Studies、Traditional Chinese Medicine Studies

BACKGROUND: Cancer immunotherapy with immune checkpoint inhibitors (ICIs) is a pivotal treatment for cancers, including non-small cell lung cancer (NSCLC). ICIs are often associated with adverse events (AEs), including immune-related AEs (irAEs). Bojungikki-tang (BJIKT), a traditional herbal medicine, has immunomodulatory properties and may alleviate fatigue and inflammation in patients with advanced cancer.In this multicenter, randomized, placebo-controlled pilot trial, we evaluated the safety and potential effects of BJIKT on fatigue, muscle loss, and immune response in patients with advanced NSCLC undergoing atezolizumab monotherapy. METHODS: Twenty-eight patients were randomized to either the BJIKT (n = 14) or placebo (n = 14) groups. Primary outcomes included AEs and irAEs, while secondary outcomes assessed fatigue and muscle loss. Exploratory immune profiling was performed on peripheral blood mononuclear cells and plasma samples from a subset of patients (BJIKT n = 12, placebo n = 7). RESULTS: AEs occurred in 53.57% of participants, with 64.29% in the BJIKT group (23 events, including one severe irAE) and 42.86% in the placebo group (12 events). Most AEs were mild or moderate and resolved by the study's completion. The objective response rate was 16.67% in the BJIKT group and 8.33% in the placebo group, while the disease control rate was 41.67% and 25.0%, respectively; however, these differences were not statistically significant. BJIKT showed non-significant trends tow...