Objective  To evaluate the economic differences between albumin paclitaxel monotherapy and its combination with atezolizumab in the treatment of programmed cell death ligand 1 (PD-L1)-positive advanced triple-negative breast cancer (TNBC) from the perspective of Chinese healthcare system.

Methods  A partitioned survival model was constructed based on data from the IMpassion130 Phase III clinical trial, simulating a 5-year treatment cycle. The package survHE of R programming language was used to fit Kaplan-Meier survival curves (the combination group: log-Normal distribution; the monotherapy group: log-Logistic distribution). Cost parameters were derived from actual procurement prices in Chinese medical institutions, and utility values were sourced from international literature. Using 3 times the per capita gross domestic product (GDP) [¥257,097/quality-adjusted life year (QALY)] as the willingness-to-pay (WTP) threshold, cost-effectiveness was assessed via the incremental cost-utility ratio (ICUR). The robustness of the results was verified by univariate analysis and probabilistic sensitivity analysis.

Results  The combination therapy added 2.36 quality-adjusted life months (QALM) compared to monotherapy, but the monthly ICUR reached ¥92,273.95/QALM (annualized: ¥1,107,287/QALY), significantly exceeding the WTP threshold. Univariate analysis identified the utility value in the disease progression phase as the most influential factor (contribution: 38.7%). Probabilistic sensitivity analysis showed a 100% probability of the combination regimen being cost-effective.

Conclusion  For PD-L1-positive advanced TNBC patients, albumin paclitaxel monotherapy demonstrates significant cost-effectiveness advantages, while the combination regimen is economically unfavorable under the current healthcare payment system in China. Clinically, monotherapy should be prioritized, or stringent patient selection criteria should be applied for combination therapy in potential high-benefit populations.

1.GBD 2017 DALYs and HALE Collaborators. Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2017: a systematic analysis for the global burden of disease study 2017[J]. Lancet, 2018, 392(10159): 1859-1922. DOI: 10.1016/s0140-6736(18)32335-3.

2.Garrido-Castro AC, Lin NU, Polyak K. Insights into molecular classifications of triple-negative breast cancer: improving patient selection for treatment[J]. Cancer Discov, 2019, 9(2): 176-198. DOI: 10.1158/2159-8290.Cd-18-1177.

3.Yin L, Duan JJ, Bian XW, et al. Triple-negative breast cancer molecular subtyping and treatment progress[J]. Breast Cancer Res, 2020, 22(1): 61. DOI: 10.1186/s13058-020-01296-5.

4.廖登辉, 王婷, 甘霖, 等. COL1A1、KPNA2在三阴性乳腺癌组织中的表达及与远期预后的关系[J]. 西部医学, 2024, 36(5): 713-718. [Liao DH, Wang T, Gan L, et al. Expression of COL1A1 and KPNA2 in triple-negative breast cancer tissues and their correlation with long-term prognosis[J]. Medical Journal of West China, 2024, 36(5): 713-718.] DOI: 10.3969/j.issn.1672-3511.2024.05.016.

5.Miquel-Cases A, Retèl VP, Lederer B, et al. Exploratory cost-effectiveness analysis of response-guided neoadjuvant chemotherapy for hormone positive breast cancer patients[J]. PLoS One, 2016, 11(4): e0154386. DOI: 10.1371/journal.pone.0154386.

6.Bianchini G, De Angelis C, Licata L, et al. Treatment landscape of triple-negative breast cancer-expanded options, evolving needs[J]. Nat Rev Clin Oncol, 2022, 19(2): 91-113. DOI: 10.1038/s41571-021-00565-2.

7.Keenan TE, Tolaney SM. Role of immunotherapy in triple-negative breast cancer[J]. J Natl Compr Canc Netw, 2020, 18(4): 479-489. DOI: 10.6004/jnccn.2020.7554.

8.Won KA, Spruck C. Triple-negative breast cancer therapy: current and future perspectives (Review)[J]. Int J Oncol, 2020, 57(6): 1245-1261. DOI: 10.3892/ijo.2020.5135.

9.刘丽, 苏明珠, 张锦欣, 等. 中国恶性肿瘤患者经济毒性发生率的Meta分析: 基于患者报告经济毒性综合评分量表 [J]. 中国循证医学杂志, 2023, 23(11): 1269-1274. [Liu  L, Su MZ, Zhang JX, et al. The prevalence of financial toxicity based on comprehensive scores for financial toxicity in Chinese cancer patients: a Meta-analysis[J]. Chinese Journal of Evidence-Based Medicine, 2023, 23(11): 1269-1274.] DOI: 10.7507/1672-2531.202306083.

10.Schmid P, Adams S, Rugo HS, et al. Atezolizumab and nab-paclitaxel in advanced triple-negative breast cancer[J]. N Engl J Med, 2018, 379(22): 2108-2121. DOI: 10.1056/NEJMoa1809615.

11.曾小慧, 彭六保, 谭重庆, 等. 药物经济学评价中的分区生存模型[J]. 中国新药与临床杂志, 2020, 39(8): 504-507. [Zeng XH, Peng LB, Tan CQ, et al. Partitioned survival model in pharmacoeconomics[J]. Chinese Journal of New Drugs and Clinical Remedies, 2020, 39(8): 504-507.] DOI: 10.14109/j.cnki.xyylc.2020.08.12.

12.孟蕊, 芮明军, 王欣恬, 等. 不同决策分析模型在抗肿瘤药物经济学评价中的应用——以加拿大CADTH为例[J]. 中国药房, 2021, 32(14): 1752-1757. [Meng R, Rui MJ, Wang XT, et al. Application of different decision analysis models in the economic evaluation of antitumor drugs: taking CADTH in canada as an example[J]. China Pharmacy, 2021, 32(14): 1752-1757.] DOI: 10.6039/j.issn.1001-0408.2021.14.15.

13.苏展, 车金辉, 裴锐锋. 替雷利珠单抗较索拉非尼作为晚期不可切除肝细胞癌一线治疗的成本-效用分析[J]. 中国药师, 2024, 27(1): 109-116. [Su Z, Che JH, Pei RF. Cost-utility analysis of tislelizumab versus sorafenib as first-line therapy for advanced unresectable hepatocellular carcinoma[J]. China Pharmacist, 2024, 27(1): 109-116.] DOI: 10.12173/j.issn.1008-049X.202312216.

14.王子怡, 卢存存, 刘文迪, 等. 应用复杂系统模型进行公共卫生干预措施经济学评价指南的解读[J]. 中国循证医学杂志, 2023, 23(12): 1365-1372. [Wang ZY, Lu CC, Liu WD, et al. Interpretation of guidelines for economic evaluation of public health interventions using complex system models[J]. Chinese Journal of Evidence-Based Medicine, 2023, 23(12): 1365-1372.] DOI: 10.7507/1672-2531.202305113.

15.刘月姣. 《中国居民营养与慢性病状况报告（2020年）》发布[J]. 中国食物与营养, 2020, 26(12): 封2. [Liu YJ. Report on the nutrition and chronic disease status of chinese residents (2020)[J]. Food and Nutrition in China, 2020, 26(12): Cover2.] DOI: 10.3969/j.issn.1006-9577.2020.12.001.

16.祝颖星, 邹悦, 冯萧萧, 等. 阿柏西普治疗糖尿病性黄斑水肿的研究进展[J]. 国际眼科纵览, 2023, 47(1): 74-78. [Zhu YX, Zou Y, Feng XX, et al. Research advances in aflibercept for diabetic macular edema[J]. International Review of Ophthalmology, 2023, 47(1): 74-78.] DOI: 10.3760/cma.j.issn.1673-5803.2023.01.014.

17.Wu B, Ma F. Cost-effectiveness of adding atezolizumab to first-line chemotherapy in patients with advanced triple-negative breast cancer[J]. Ther Adv Med Oncol, 2020, 12: 1758835920916000. DOI: 10.1177/1758835920916000.

18.Hurvitz S, Guerin A, Brammer M, et al. Investigation of adverse-event-related costs for patients with metastatic breast cancer in a real-world setting[J]. Oncologist, 2014, 19(9): 901-908. DOI: 10.1634/theoncologist.2014-0059.

19.Zhang B, Long EF. Cost-effectiveness analysis of palbociclib or ribociclib in the treatment of advanced hormone receptor-positive, HER2-negative breast cancer[J]. Breast Cancer Res Treat, 2019, 175(3): 775-779. DOI: 10.1007/s10549-019-05190-3.

20.Durkee BY, Qian Y, Pollom EL, et al. Cost-effectiveness of pertuzumab in human epidermal growth factor receptor 2-positive metastatic breast cancer[J]. J Clin Oncol, 2016, 34(9): 902-909. DOI: 10.1200/jco.2015.62.9105.

21.Miles D, Gligorov J, André F, et al. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer[J]. Ann Oncol, 2021, 32(8): 994-1004. DOI: 10.1016/j.annonc.2021.05.801.

22.杨丹, 王金秀, 毛大华. 免疫治疗及抗体偶联药物治疗三阴性乳腺癌的临床研究进展[J]. 中国药师, 2024, 27(5): 901-908. [Yang D, Wang JX, Mao DH. Clinical research advances in immunotherapy and antibody-drug conjugates for triple-negative breast cancer[J]. China Pharmacist, 2024, 27(5): 901-908. DOI: 10.12173/j.issn.1008-049X.202402077.

23.国家肿瘤质控中心乳腺癌专家委员会, 中国抗癌协会乳腺癌专业委员会, 中国抗癌协会肿瘤药物临床研究专业委员会. 中国晚期乳腺癌规范诊疗指南（2022版）[J]. 中华肿瘤杂志, 2022, 44(12): 1262-1287. [National Cancer Quality Control Center Breast Cancer Expert Committee, Chinese Anti-Cancer Association Breast Cancer Professional Committee, Chinese Anti-Cancer Association Cancer Drug Clinical Research Professional Committee. Chinese guidelines for standardized diagnosis and treatment of advanced breast cancer (2022 edition)[J]. Chinese Journal of Oncology, 2022, 44(12): 1262-1287.] DOI: 10.3760/cma.j.cn112152-20221007-00680.