| Title: |
Adjuvant Chemotherapy with Traditional Chinese Herbal Granules Versus Placebo in Resected Non-Small Cell Lung Cancer: Updated Survival Analysis of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial |
| Authors: |
Wang, Yichao; Jiao, Lijing; Chen, Zhiwei; Xu, Jianfang; Che, Jiaming; Huang, Hai; Zhang, Lei; Shen, Xiaoyong; Yang, Yi; Zhao, Tiancheng; Zhang, Jie; Zhou, Di; Wang, Qin; Yao, Jialin; Yang, Wenxiao; Sun, Chenbing; Li, Jiaqi; Bi, Ling; Ding, Rongzhen; Goodfellow, Ian; Gong, Yabin; Xu, Ling |
| Contributors: |
Shanghai University of Traditional Chinese Medicine; Science and Technology Commission of Shanghai Municipality; National Natural Science Foundation of China; National Science and Technology Major Project |
| Source: |
Integrative Cancer Therapies ; volume 25 ; ISSN 1534-7354 1552-695X |
| Publisher Information: |
SAGE Publications |
| Publication Year: |
2026 |
| Description: |
Background: The NALLC trial (NCT01441752) demonstrated that postoperative adjuvant chemotherapy combined with traditional Chinese medicine (TCM) improved the quality of life (QoL) and survival in resected stage Ib-IIIa non-small-cell lung cancer (NSCLC) patients. This report updates disease-free survival (DFS) and other key outcomes. Methods: Between December 2012 and August 2015, 334 patients were randomized to receive either adjuvant chemotherapy plus traditional Chinese herbal granules (n = 167) or adjuvant chemotherapy plus placebo (n = 167) across 7 centers. Patients continued herbal granules or placebo daily until chemotherapy completion. DFS updates data was conducted in the intention-to-treat (ITT) population. Results: The median follow-up was 116.87 months. Median DFS was 71.83 months for the TCM group versus 43.60 months for the control (HR: .86; 95% CI: .64-1.15; P = .31). Two-year and 5-year DFS rates were 73.60% and 50.16% for TCM, compared to 67.45% and 44.08% for the control ( P = .23). Median overall survival (mOS) was not reached in either group, with 75% OS at 63.40 months for TCM and 53.67 months for the control. Five-year OS rates were 76.15% for TCM and 69.81% for the control ( P = .23). Subgroup analysis showed stage Ib patients benefited from TCM in both DFS (HR: .51; P = .02) and OS (HR: .34; P = .01). Conclusions: Adjuvant chemotherapy combined with TCM showed a potential trend toward improved DFS in early-stage NSCLC patients. Trial registration: This trial was registered with Clinical.Trials.gov (Number: NCT01441752, July 14, 2011). |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1177/15347354251409081 |
| Availability: |
https://doi.org/10.1177/15347354251409081; https://journals.sagepub.com/doi/pdf/10.1177/15347354251409081; https://journals.sagepub.com/doi/full-xml/10.1177/15347354251409081 |
| Rights: |
https://creativecommons.org/licenses/by-nc/4.0/ ; https://journals.sagepub.com/page/policies/text-and-data-mining-license |
| Accession Number: |
edsbas.6F2BCE8A |
| Database: |
BASE |