Real-world treatment pattern and clinical outcomes in Chinese NSCLC patients with KRAS G12C mutation.
7 affiliations
- 1Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 20030, China.
- 2Laboratory of Translational Medicine, National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
- 3Department of Phase I Clinical Trial Ward, Zhejiang Cancer Hospital, Hangzhou, 310022, China.
- 4Department of Respiratory Oncology, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, 450008, China.
- 5Department of Medical Affairs, Novartis Pharmaceuticals, Beijing, 1001102, China.
- 6Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 20030, China. [email protected].
- 7Department of Medical Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 20030, China. [email protected].
Abstract
Background
To establish a historical benchmark by describing the treatment patterns and clinical outcomes of Chinese patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) in the real world, prior to the widespread availability of KRAS G12C inhibitors.Methods
This retrospective cohort study utilized electronic medical records from four tertiary hospitals in China (January 2015 to March 2023).Inclusion criteria
age ≥ 18 years, histologically confirmed locally advanced/metastatic NSCLC, KRAS G12C mutation, receipt of ≥1st line treatment, and ≥ 6 months of follow-up. The primary endpoint was the proportion of different regimens used per line of therapy. Secondary endpoints included real-world overall response rate (rwORR), progression-free survival (rwPFS). Multivariable COX regression and treatment era analyses (<2020 vs. ≥ 2020) were additionally conducted.Results
Among 244 included patients (93.85% male, 74.57% were smokers), first-line treatment comprised chemotherapy-based (38.70%), immune-based (10.87%), chemo-immunotherapy (50.00%). The first-line rwORR was 19.1% (chemotherapy), 20% (immune-based), and 26.96% (chemo-immunotherapy), respectively. Median rwPFS was 8.25, 21.00, 16.00 months, respectively. In multivariable Cox analysis, compared to chemotherapy, chemo-immunotherapy (HR 0.39, 95% CI 0.24-0.63, p < 0.001) and immune-based therapy (HR 0.34, 95% CI 0.15-0.80, p = 0.014) showed independent rwPFS benefit. However, the immune-based group was highly enriched for PD-L1 ≥ 50% (52.00% vs. 26.96% in the overall first-line cohort). STK11 mutation was a strong independent predictor of poor rwPFS (HR 5.53, 95% CI 2.77-11.05, p < 0.001). Treatment patterns shifted significantly, with first-line chemo-immunotherapy increasing from 24.64% (< 2020) to 60.87% (≥ 2020).Conclusions
This real-world study provides a comprehensive characterization of the clinical management and outcomes of KRAS G12C-mutated NSCLC in China in the pre-KRAS G12C inhibitor treatment era. First-line chemo-immunotherapy provides independent survival benefit over chemotherapy, with immune monotherapy reserved for carefully selected PD-L1 high cases. STK11 co-mutation predicts extremely poor outcomes (median PFS 3.75 months), representing an unmet clinical need. This study provides an essential historical reference for quantifying their real-world clinical impact.
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BibTeX
@article{shen2026realworld,
title = {{Real-world treatment pattern and clinical outcomes in Chinese NSCLC patients with KRAS G12C mutation.}},
author = {Lan Shen and Yibo Gao and Zhengbo Song and Qiming Wang and Qiaoxia Zhou and Yan Lei and Shun Lu and Ziming Li},
journal = {BMC cancer},
year = {2026},
month = jul,
doi = {10.1186/s12885-026-16643-6},
url = {https://europepmc.org/article/MED/42958117},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Real-world treatment pattern and clinical outcomes in Chinese NSCLC patients with KRAS G12C mutation.
AU - Lan Shen
AU - Yibo Gao
AU - Zhengbo Song
AU - Qiming Wang
AU - Qiaoxia Zhou
AU - Yan Lei
AU - Shun Lu
AU - Ziming Li
PY - 2026
DA - 2026/07/01
JO - BMC cancer
DO - 10.1186/s12885-026-16643-6
UR - https://europepmc.org/article/MED/42958117
AB - Background To establish a historical benchmark by describing the treatment patterns and clinical outcomes of Chinese patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) in the real world, prior to the widespread availability of KRAS G12C inhibitors.Methods This retrospective cohort study utilized electronic medical records from four tertiary hospitals in China (January 2015 to March 2023).Inclusion criteria age ≥ 18 years, histologically confirmed locally advanced/metastatic NSCLC, KRAS G12C mutation, receipt of ≥1st line treatment, and ≥ 6 months of follow-up. The primary endpoint was the proportion of different regimens used per line of therapy. Secondary endpoints included real-world overall response rate (rwORR), progression-free survival (rwPFS). Multivariable COX regression and treatment era analyses (<2020 vs. ≥ 2020) were additionally conducted.Results Among 244 included patients (93.85% male, 74.57% were smokers), first-line treatment comprised chemotherapy-based (38.70%), immune-based (10.87%), chemo-immunotherapy (50.00%). The first-line rwORR was 19.1% (chemotherapy), 20% (immune-based), and 26.96% (chemo-immunotherapy), respectively. Median rwPFS was 8.25, 21.00, 16.00 months, respectively. In multivariable Cox analysis, compared to chemotherapy, chemo-immunotherapy (HR 0.39, 95% CI 0.24-0.63, p < 0.001) and immune-based therapy (HR 0.34, 95% CI 0.15-0.80, p = 0.014) showed independent rwPFS benefit. However, the immune-based group was highly enriched for PD-L1 ≥ 50% (52.00% vs. 26.96% in the overall first-line cohort). STK11 mutation was a strong independent predictor of poor rwPFS (HR 5.53, 95% CI 2.77-11.05, p < 0.001). Treatment patterns shifted significantly, with first-line chemo-immunotherapy increasing from 24.64% (< 2020) to 60.87% (≥ 2020).Conclusions This real-world study provides a comprehensive characterization of the clinical management and outcomes of KRAS G12C-mutated NSCLC in China in the pre-KRAS G12C inhibitor treatment era. First-line chemo-immunotherapy provides independent survival benefit over chemotherapy, with immune monotherapy reserved for carefully selected PD-L1 high cases. STK11 co-mutation predicts extremely poor outcomes (median PFS 3.75 months), representing an unmet clinical need. This study provides an essential historical reference for quantifying their real-world clinical impact.
SN - 1471-2407
ER -