Astragalus polysaccharides combined with radiochemotherapy for cervical cancer: a systematic review and meta-analysis...

Cervical cancer ranks among the most common malignant tumors affecting women globally. Currently, radiotherapy and chemotherapy are commonly used treatments for cervical cancer, yet they are often accompanied by severe toxic side effects. Therefore, enhancing the efficacy of radiotherapy and chemotherapy while mitigating their adverse reactions has become a critical challenge in contemporary cervical cancer treatment. Exploring or developing novel combination therapy regimens has also emerged as a significant research direction. Astragalus Polysaccharides, a natural extract derived from the traditional Chinese medicinal herb Astragalus membranaceus (Huang Qi), is currently widely used in China as an adjunctive therapy for various cancers.

This systematic review aims to determine the clinical efficacy and safety of Astragalus Polysaccharide Injection (APS) combined with chemoradiotherapy for cervical cancer based on existing data.

Systematic searches were conducted in PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Scientific Journal Database (VIP), SinoMed, and China Clinical Trials Registry Platform. The search period spanned from the inception of each database to August 1, 2025. The ROB2 tool was used to evaluate the quality of included RCTs. Meta-analysis was performed using Review Manager software, and sensitivity analysis was conducted with Stata 18 software. Evidence quality was assessed using the GRADE system. Additionally, TSA was employed to calculate the final required sample size for this meta-analysis and to validate the reliability of conclusions. The protocol for this systematic review was registered and published in PROSPERO (CRD420251139830).

This study included 9 RCTs involving 776 patients. Meta-analysis results showed that compared with chemoradiotherapy alone, APS combined with chemoradiotherapy improved the objective response rate (ORR, RR = 1.43, 95% CI: 1.24-1.64) and disease control rate (DCR, RR = 1.16, 95% CI: 1.08-1.24), and Karnofsky Performance Status (KPS) score (MD = 6.64, 95% CI: 4.12-9.16). It also modulates immune function: CD3⁺ T lymphocyte ratio (MD = 14.51, 95% CI: 1.64-27.39), CD4⁺ T lymphocyte ratio (MD = 4.87, 95% CI: 1.79-7.96), and CD4⁺/CD8⁺ ratio (MD = 0.25, 95% CI: 0.17-0.33). Furthermore, APS combined with chemoradiotherapy further reduced tumor marker levels, including: CEA (MD = -1.24, 95% CI: -1.58 to -0.89), SCC (MD = -1.18, 95% CI: -1.51 to -0.84), and CA125 (MD = -9.12, 95% CI: -18.22 to -0.01). Subgroup analyses of ORR and DCR suggest that APS can enhance the clinical efficacy of radiotherapy and chemotherapy for cervical cancer, respectively. TSA indicated that the results for ORR, DCR, and ADRs were certain, with other trials unlikely to alter the findings.

APS combined with chemoradiotherapy improves response rates, enhances immune function, and reduces treatment-related toxicity in cervical cancer; however, confirmation through larger, high-quality multicenter RCTs is warranted.

https://www.crd.york.ac.uk/PROSPERO/recorddashboard, identifier CRD420251139830.