Effects of BojungikkiTang on immune response and clinical outcomes in NSCLC patients receiving immune checkpoint inhibitors a randomized pilot study

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Britany: Welcome back to PACULit. Today, we’re discussing a pilot study on Bojungikki-Tang (BJIKT) and its effects on immune response and clinical outcomes in advanced non-small cell lung cancer (NSCLC) patients receiving immune checkpoint inhibitors (ICIs). Seth, this is timely given the challenges with variable responses and immune-related adverse events (irAEs) in NSCLC treatment.

Seth: Absolutely, Britany. NSCLC remains a leading cause of cancer mortality. While ICIs like atezolizumab have revolutionized treatment, their efficacy is inconsistent, and irAEs can limit therapy. Adjunct therapies that enhance efficacy and modulate toxicity are compelling.

Britany: BJIKT, a traditional East Asian herbal formula, has immunomodulatory and anti-fatigue properties. Preclinical studies suggest it boosts T-cell infiltration and reduces immune exhaustion, potentially synergizing with ICIs. But clinical data combining BJIKT with ICIs in NSCLC has been sparse.

Seth: This pilot study by Ko et al. addressed that gap, evaluating safety, immune effects, and preliminary clinical outcomes of BJIKT plus atezolizumab in advanced NSCLC. It was a multicenter, randomized, double-blind, placebo-controlled trial with 28 patients.

Britany: Inclusion criteria included histologically confirmed advanced NSCLC, planned atezolizumab monotherapy, adequate organ function, and suitable ECOG status. They excluded prior ICI treatment or concurrent immunomodulatory agents or herbal supplements to avoid confounding.

Seth: Excluding prior ICI exposure ensured a homogeneous population to assess BJIKT’s adjunctive effects. The intervention group received BJIKT plus atezolizumab; controls got placebo plus atezolizumab. Treatment and follow-up were typical for pilot studies—enough to assess safety and early outcomes.

Britany: The primary endpoint was incidence and severity of adverse events, especially irAEs. Secondary endpoints included patient-reported fatigue and muscle loss assessments. Exploratory immune profiling of peripheral blood mononuclear cells and plasma was performed to understand immunological changes.

Seth: Safety data showed adverse events in 64.29% of BJIKT patients versus 42.86% in placebo. Most were mild to moderate and resolved by study end. One severe irAE occurred in the BJIKT group, but overall safety was acceptable.

Britany: This suggests BJIKT might slightly increase AEs, but these are manageable. Clinicians should monitor but not be deterred from considering BJIKT adjunctive therapy.

Seth: Regarding efficacy, non-significant trends favored BJIKT. Objective response rate was 16.67% versus 8.33%, and disease control rate 41.67% versus 25.0% in placebo.

Britany: Though not statistically significant, likely due to small sample size, these trends hint at potential clinical benefit. BJIKT also showed trends toward reducing fatigue and muscle symptoms, common and debilitating in NSCLC.

Seth: Fatigue and muscle loss impact quality of life and treatment adherence. If BJIKT mitigates these, it could improve outcomes beyond tumor response.

Britany: The exploratory immune profiling is intriguing. BJIKT was associated with activation of CD4+ T cells, increased CD3+CD4+ cells, enhanced T cell function, and reduced immune exhaustion markers. Notably, PD-1+ CD8+ T cells decreased and natural killer (NK) cell counts increased.

Seth: This suggests BJIKT enhances adaptive and innate immunity, potentially improving antitumor effects. Reduced PD-1+ exhausted CD8+ T cells may mean better cytotoxic activity; increased NK cells enhance innate surveillance.

Britany: This aligns with preclinical data showing BJIKT plus anti-PD-L1 antibodies increases tumor-infiltrating CD3+ and CD8+ T cells, augmenting antitumor effects. BJIKT may also modulate the tumor microenvironment to reduce irAEs by balancing immune activation.

Seth: Clinically important—BJIKT may enhance immune activation without significantly worsening irAEs, offering a therapeutic window to improve efficacy safely. Still, the slight increase in AEs means careful monitoring is essential.

Britany: From a pharmacologic perspective, potential drug-herb interactions should be considered. BJIKT contains multiple herbs that might affect cytochrome P450 enzymes or immune pathways, altering ICI metabolism or immune modulation.

Seth: Although no significant interactions were reported here, clinicians should be cautious, especially with polypharmacy. Coordination with oncology teams and thorough medication reconciliation are vital before starting BJIKT.

Britany: Special populations also warrant attention. Patients with autoimmune conditions or organ dysfunction might respond differently. The study excluded prior immunomodulatory therapies, but real-world patients often have complex histories.

Seth: Future larger trials should include or stratify these populations to assess safety and efficacy comprehensively. Standardizing BJIKT formulations is also important for reproducibility and safety.

Britany: Larger trials are underway, including a multicenter randomized controlled trial evaluating BJIKT with pembrolizumab in stage IV NSCLC, focusing on progression-free survival.

Seth: That’s promising. Mechanistic studies support BJIKT’s immunomodulatory role. Transcriptomic analyses show upregulation of interferon-gamma and TNF-alpha pathways, enhancing immune cell interactions. Animal models show reduced T-cell exhaustion and improved anti-PD-1 efficacy.

Britany: These insights strengthen the biological rationale for BJIKT as an adjunct. Scoping reviews also highlight consistent improvements in fatigue and quality of life across cancers, reinforcing symptomatic benefits.

Seth: Another angle is BJIKT’s potential to mitigate cancer therapy-related muscle atrophy. Preclinical studies with related herbal formulas show accelerated recovery from chemotherapy-induced muscle loss, aligning with fatigue and muscle symptom trends here.

Britany: That could be a game-changer for supportive oncology care. Improving muscle mass and reducing fatigue enhances functional status and treatment tolerance, indirectly impacting survival.

Seth: Limitations include small sample size and pilot design, limiting generalizability and statistical power. Exploratory immune outcomes are hypothesis-generating and need validation.

Britany: The short follow-up also limits long-term efficacy and safety assessment. Larger, powered trials with longer follow-up are needed to confirm these findings and clarify BJIKT’s role.

Seth: Clinicians should stay informed about BJIKT’s evolving evidence. It may become a valuable adjunct but should be used cautiously within multidisciplinary care until more robust data emerge.

Britany: Patient education is key, especially about herbal supplement use and potential interactions. Open communication ensures safe integration of complementary therapies.

Seth: To summarize, this pilot suggests BJIKT adjunctive to atezolizumab may enhance immune responses and show trends toward improved clinical outcomes in advanced NSCLC. Safety appears acceptable, with mostly mild to moderate AEs.

Britany: BJIKT’s immunomodulatory effects—increased CD4+ T cell activation and NK cell counts—provide a compelling biological basis for synergy with ICIs. Symptom improvements in fatigue and muscle loss support its supportive care role.

Seth: While promising, these findings are preliminary. Larger randomized trials underway will be critical to establish BJIKT’s efficacy, safety, and place in therapy.

Britany: Thanks for the discussion, Seth. For listeners, watch for emerging data on BJIKT and complementary therapies in oncology. Integrative approaches may soon enhance treatment of challenging cancers like NSCLC.

Seth: Absolutely, Britany. It’s an exciting time in cancer immunotherapy, and adjuncts like BJIKT could optimize outcomes and quality of life.

Britany: That wraps up today’s PACULit update. Thanks for tuning in, and we’ll catch you next time with more clinical literature insights.