Preventive Effect and Safety Evaluation of Xiaozhen Formula （消疹方） on Skin Toxicity Induced by Epidermal Growth Factor Receptor Inhibitors in the Treatment of Non-small Cell Lung Cancer：A Multicenter，Randomized，Double-Blind，Placebo-Controlled Trial
10.13288/j.11-2166/r.2026.18.013
- VernacularTitle:消疹方对非小细胞肺癌患者应用表皮生长因子受体抑制剂所致皮肤毒性的预防效果及安全性评价——多中心、随机、双盲、安慰剂对照试验
- Author:
Ling LUO
1
;
Xintian WANG
1
;
Cheng CHENG
1
;
Zitong HAN
1
;
Chunru WANG
1
;
Guoli WEI
2
;
Jianyue LI
1
;
Li WANG
3
;
Jirong WANG
4
;
Peng SHU
5
;
Liang LI
6
;
Fenglin LIU
7
;
Ran SONG
7
;
Jing BAI
8
;
Haiyan XING
1
Author Information
1. Affiliated Hospital of Integrated Traditional Chinese and Western Medicine，Nanjing University of Chinese Medicine，Nanjing，210028
2. Lishui District Hospital of Traditional Chinese Medicine，Nanjing
3. Jiangsu Cancer Hospital，Jiangsu Province
4. The Second Affiliated Hospital of Nanjing Medical University
5. Jiangsu Province Hospital of Chinese Medicine
6. Zhenjiang Hospital of Traditional Chinese Medicine
7. Xuzhou Hospital of Traditional Chinese Medicine
8. Jintan First People's Hospital，Changzhou City
- Publication Type:Journal Article
- Keywords:
non-small cell lung cancer;
skin toxicity;
rash;
epidermal growth factor receptor inhibitors;
Xiaozhen Formula （消疹方）;
quality of life;
randomized controlled trial
- From:
Journal of Traditional Chinese Medicine
2026;67(18):1987-1994
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the clinical efficacy and safety of Xiaozhen Formula （消疹方） in preventing skin toxicity induced by epidermal growth factor receptor inhibitors （EGFRIs） in patients with EGFR-mutant non-small cell lung cancer （NSCLC）. MethodsA randomized， double-blind， placebo-controlled， multicenter clinical study was conducted. A total of 120 patients with EGFR-mutant NSCLC from seven centers were enrolled and randomly assigned to a treatment group （60 cases） or a control group （60 cases）. On the basis of EGFRI-targeted therapy， patients in the treatment group received Xiaozhen Formula granules， whereas those in the control group received Xiaozhen Formula placebo granules， both at 10 g twice daily for 4 consecutive weeks. The primary outcomes were the grading of skin toxicity evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events （NCI-CTCAE） version 5.0 and the incidence of rash. Secondary outcomes included the time to onset and time to resolution of the highest-grade rash， the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 （EORTC QLQ-C30） scores， the Hospital Anxiety and Depression Scale （HADS） scores， and disease control rate， together with safety assessments. ResultsBased on the full analysis set （FAS）， the incidence of skin toxicity in the treatment group was 18.33% （11/60）， significantly lower than 45.00% （27/60） in the control group （P＜0.01）， with the highest severity of skin toxicity in both groups was grade 2. Among patients who developed rash， the resolution rate in the treatment group was 90.91% （10/11）， higher than that 33.33% （9/27） in the control group. The median time to resolution was 15 days （95%CI： 8-17 days） in the treatment group and it was not reached in the control group； the distribution of time to resolution differed significantly between groups （P＜0.001）. After treatment， the treatment group had higher EORTC QLQ-C30 functional scale and global health status/quality-of-life scores， and lower symptom scale， single-item scores， as well as HADS-A， and HADS-D scores than the control group （P＜0.05）. In the FAS analysis， the disease control rate （DCR） was 85.0% （51/60） in the treatment group， lower than 100.0% （60/60） in the control group （P=0.003）， whereas no significant between-group difference was observed in the per-protocol set （PPS） analysis （P=0.464）. The incidence of adverse events did not differ significantly between the two groups （P＞0.05）， and no definite safety signals related to the investigational drug were observed. ConclusionXiaozhen Formula can reduce the incidence of EGFRI-induced skin toxicity， and improve the outcome of rash regression， the patients' quality of life and psychological status in EGFR-mutant NSCLC patients.
