Phytomedicine Plus · Published 2026-07-22 · DOI 10.1016/j.phyplu.2026.101028
Huiru Guo, Hegen Li, Jan P.A. Baak
Background: Internationally standardised Chinese medicine pattern classification is essential for interoperable integrative oncology research. The WHO ICD-11 Traditional Medicine Module provides a harmonised framework. However, the reproducibility and prognostic value of ICD-11-aligned Chinese medicine (CM) pattern classification in stage IV lung adenocarcinoma (LUAD-IV) remain uncertain across evolving systemic therapy eras. Methods: Two prospective real-world cohorts of newly diagnosed LUAD-IV patients from different therapeutic eras were analysed (2009–2018, n = 412; 2020–2024, n = 133).Eligible patients had ECOG performance status 0–1, complete survival follow-up data, and received systemic anticancer therapy plus Chinese herbal medicine from baseline.Baseline patterns were assigned using the China Association of Chinese Medicine (CACM) criteria and mapped to ICD-11 Traditional Medicine codes. Interobserver agreement was assessed in 50 randomly selected cases (Cohen's κ). Overall survival was analysed using Kaplan–Meier methods and multivariable Cox regression with time-dependent treatment covariates to address measured confounding and immortal-time bias. Results: Predominant baseline patterns were Lung–Spleen Qi deficiency (48% vs 37%), Qi–Yin deficiency (46% vs 26%), and Lung–Kidney deficiency (4%vs 32%) in the earlier and contemporary cohorts, respectively. Interobserver agreement was substantial (κ = 0.64 and κ = 0.68). Median overall survival increased from 24 to 48 months. Age ≥68 years, absence of EGFR-TKI or anti-VEGF therapy, and stage IVB disease independently predicted poorer survival, whereas baseline Chinese medicine patterns did not. Conclusions: ICD-11-aligned CACM pattern classification is reproducible across therapeutic eras but does not independently predict survival in LUAD-IV, supporting its use for standardised reporting and treatment individualisation rather than prognostic stratification.
Abstract from DOAJ. Public domain (CC0 1.0).
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Guo, H., Li, H., Baak, J. (2026). ICD-11–aligned Chinese medicine pattern classification in stage IV lung adenocarcinoma: reproducibility and prognostic assessment in two prospective real-world cohorts. Phytomedicine Plus. https://doi.org/10.1016/j.phyplu.2026.101028