Cancer management and research · 2026
Safety and Clinical Outcomes of Kanglaite Injection in Combination with Toripalimab and Chemotherapy for Advanced Non-Small Cell Lung Cancer: A Real-World Retrospective Analysis.
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Zhang Riwen, Feng Zicong, Pan Xiaozhou, Lin Qiyou, Huang Chuanju, Wei Xuejian
Аннотация
INTRODUCTION: For advanced non-small cell lung cancer (NSCLC) without oncogenic drivers, PD-1 inhibitors combined with chemotherapy represent a standard first-line regimen. However, treatment-related adverse events (TRAEs) and suboptimal tumor control remain challenges. Kanglaite injection (KLTI), derived from Coix lacryma-jobi oil, exhibits immunomodulatory and antitumor properties; however, its role as an adjunct to immunochemotherapy in advanced NSCLC remains unclear.
METHODS: This retrospective single-arm study analyzed clinical data from 53 patients (aged ≥18 years) with pathologically confirmed, EGFR/ALK wild-type, PD-L1 TPS >1% advanced NSCLC treated with KLTI combined with toripalimab and chemotherapy at Guangdong Provincial People's Hospital Nanhai Hospital (February 2022 to June 2024). Efficacy was evaluated according to RECIST version 1.1. Serum VEGF, CYFRA21-1, and neutrophil-to-lymphocyte ratio (NLR) were measured before and after treatment. TRAEs were graded using CTCAE version 5.0.
RESULTS: After four treatment cycles, the objective response rate (ORR) was 58.5% and the disease control rate (DCR) was 98.4%. With a median follow-up of 12 months, the 1-year overall survival (OS) rate was 75.9% and the 1-year progression-free survival (PFS) rate was 63.8%. The most common grade 1-2 TRAEs included elevated liver enzymes (56.6%), anemia (52.8%), and neutropenia (24.5%), while grade ≥3 TRAEs were mainly elevated liver enzymes (11.3%). Post-treatment serum VEGF and CYFRA21-1 levels were significantly reduced (p=0.0057 and p=0.0011, respectively). A lower post-/pre-treatment VEGF ratio was associated with a higher tumor regression rate (r=-0.3511, p=0.010).
CONCLUSION: The combination of KLTI with toripalimab and chemotherapy demonstrated a manageable safety profile and preliminary antitumor activity in patients with advanced NSCLC. Dynamic changes in serum VEGF levels were associated with treatment response; however, these findings should be interpreted with caution due to the retrospective design and absence of a control group. Further well-designed prospective controlled studies are warranted to validate these observations.
METHODS: This retrospective single-arm study analyzed clinical data from 53 patients (aged ≥18 years) with pathologically confirmed, EGFR/ALK wild-type, PD-L1 TPS >1% advanced NSCLC treated with KLTI combined with toripalimab and chemotherapy at Guangdong Provincial People's Hospital Nanhai Hospital (February 2022 to June 2024). Efficacy was evaluated according to RECIST version 1.1. Serum VEGF, CYFRA21-1, and neutrophil-to-lymphocyte ratio (NLR) were measured before and after treatment. TRAEs were graded using CTCAE version 5.0.
RESULTS: After four treatment cycles, the objective response rate (ORR) was 58.5% and the disease control rate (DCR) was 98.4%. With a median follow-up of 12 months, the 1-year overall survival (OS) rate was 75.9% and the 1-year progression-free survival (PFS) rate was 63.8%. The most common grade 1-2 TRAEs included elevated liver enzymes (56.6%), anemia (52.8%), and neutropenia (24.5%), while grade ≥3 TRAEs were mainly elevated liver enzymes (11.3%). Post-treatment serum VEGF and CYFRA21-1 levels were significantly reduced (p=0.0057 and p=0.0011, respectively). A lower post-/pre-treatment VEGF ratio was associated with a higher tumor regression rate (r=-0.3511, p=0.010).
CONCLUSION: The combination of KLTI with toripalimab and chemotherapy demonstrated a manageable safety profile and preliminary antitumor activity in patients with advanced NSCLC. Dynamic changes in serum VEGF levels were associated with treatment response; however, these findings should be interpreted with caution due to the retrospective design and absence of a control group. Further well-designed prospective controlled studies are warranted to validate these observations.