Jianpi Rougan Method in Support of Lenvatinib Therapy: A Real-World Study on Maintaining Relative Dose Intensity and...

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).

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.

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).

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.