Jianpi Rougan Method in Support of Lenvatinib Therapy: A Real-World Study on Maintaining Relative Dose Intensity and Mitigating Toxicity–Driven Discontinuation in Intermediate-to-Advanced HCC

Tianbin Zhang,1 Peng Kuang2 1Department of Oncology, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310005, People’s Republic of China; 2Department of Traditional Chinese Medicine, Ji’an Central People’s Hospital, Ji’an, Jiangxi, 343000, People’s Republic of ChinaCorrespondence: Peng Kuang, Department of Traditional Chinese Medicine, Ji’an Central People’s Hospital, No. 106 Jinggangshan Avenue, Ji’an, Jiangxi, 343000, People’s Republic of China, Email [email protected]: To investigate the effects of Jianpi Rougan method on lenvatinib (LEN) relative dose intensity (RDI), toxicity-related treatment discontinuation, and treatment tolerability in intermediate-to-advanced hepatocellular carcinoma (HCC).Methods: A real-world, retrospective study was conducted on 152 intermediate-to-advanced HCC patients receiving LEN. Patients were grouped based on concurrent use of Jianpi Rougan decoction (combined, n = 73) or not (monotherapy, n = 79). Primary endpoints were RDI at weeks 8, 12, and overall, and the proportion of RDI ≥ 80%. Secondary endpoints included toxicity-related discontinuation, adverse events, and short-term efficacy (objective response rate, ORR; disease control rate, DCR). Propensity score matching (PSM, 1:1) was employed to balance baseline confounders.Results: After PSM (65 pairs, n = 130), baseline characteristics were balanced. The combined group showed significantly higher RDI at week 12 (P = 0.001) and overall (P = 0.003), increased proportion of RDI ≥ 80% (P = 0.029), fewer dose reductions (P = 0.022) and interruptions (P = 0.045), reduced toxicity-related permanent discontinuation (P = 0.021), decreased overall discontinuation (P = 0.034), and longer treatment duration (P = 0.042). Decreased appetite was less frequent in the combined group (P = 0.036), with trends towards less diarrhea and transaminase elevation. ORR and DCR were higher in the combined group, but the differences were not statistically significant (P > 0.05).Conclusion: Jianpi Rougan method combined with LEN was associated with improved RDI, lower rates of toxicity-related treatment discontinuation, and enhanced treatment persistence in real-world practice, supporting its role as a feasible integrative strategy to maintain targeted therapy intensity.Keywords: intermediate-to-advanced hepatocellular carcinoma, lenvatinib, relative dose intensity, Jianpi Rougan method, integrative Chinese and western medicine, real-world study, treatment tolerability, toxicity-related discontinuation