Efficacy of Prophylactic Traditional Chinese Medicine on Skin Toxicity of Afatinib in EGFR Mutation-Positive Advanced Lung Adenocarcinoma: A Single-Center, Prospective, Double-Blinded, Randomized-Controlled Pilot Trial

Abstract

Objectives: To evaluate the efficacy of prophylactic traditional Chinese medicine (TCM) on skin toxicities in patients with advanced lung adenocarcinoma treated with first-line epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) in a randomized-controlled trial (RCT). Materials and methods: This pilot study was a prospective, single-center, double-blinded RCT. The study enrolled patients with a new diagnosis of locally advanced and metastatic lung adenocarcinoma harboring EGFR mutations who were treated with first-line afatinib from July 1, 2016 to December 31, 2017. Thirty patients who met the inclusion and exclusion criteria were assigned to the TCM and placebo groups with simple randomization. TCM and placebo were initiated at the same time as afatinib and were administered for 3 months. The survival of each subject was followed until 3 years. Results: There were 36 patients with newly diagnosed lung adenocarcinoma during the study period. After the exclusion of 6 patients, the remaining 30 patients were assigned to the TCM (n = 14) and placebo (n = 16) groups comprising the intention-to-treat population. The time to first skin toxicity was 22.3 days in the TCM group and 17.6 days in the placebo group (P = .510) in the per-protocol population. The analysis of the present pilot study results determined that the difference in time to first skin toxicity between the 2 groups would reach statistical significance with a sample size of 237 based on a power of 0.8. There were significant differences in certain subscales of quality of life between the TCM and placebo groups; however, there was no significant difference in progression-free survival or overall survival between the 2 groups. Conclusions: Integrative TCM may prolong the time to first skin toxicity in patients with advanced lung adenocarcinoma treated with first-line afatinib. Prophylactic TCM could delay skin toxicity of any grade and reduce the incidence of grade 3 skin toxicity. Future large-scale RCTs are warranted to validate these findings. Trial Registration: ClinicalTrials.gov, NCT05204758. Registered on 24 Jan 2022.

In lung adenocarcinoma, low expression of the cell surface extracellular nucleotidase CD39 is related to immune infiltration and a poor prognosis

“…Immune checkpoint therapies using anti-programmed death 1 (PD-1) and anti-programmed death ligand-1 (PD-L1) have transformed the management of lung adenocarcinoma and other metastatic malignancies (24).…”

“…Immune checkpoint therapies using anti-programmed death 1 (PD-1) and anti-programmed death ligand-1 (PD-L1) have transformed the management of lung adenocarcinoma and other metastatic malignancies ( 24 ). Even though immune checkpoint inhibitors can greatly improve the prognosis for lung adenocarcinoma patients, a substantial proportion of patients are resistant to them or they prove ineffective.…”

Traditional Chinese medicines for non-small cell lung cancer: Therapies and mechanisms

“…The result showed that the combined therapy had a certain effect to prolong mPFS (12.3 vs 8.9 months, P < 0.05) and mOS (28.2 vs 24.2 months, P < 0.05), especially for the patients with exon 21 deletion mutation (L858R) ( Wang et al, 2021 ). At the same time, TCM could delay EGFR-tyrosine kinase inhibitors (EGFR-TKIs) related skin toxicity of any grade and reduce the incidence of grade 3 skin toxicity ( Li et al, 2022 ).…”

Investigating the effects and mechanisms of Erchen Decoction in the treatment of colorectal cancer by network pharmacology and experimental validation

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