HER-2阳性乳腺癌患者2种新辅助化疗方案的药物经济学评价
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摘要
目的对乳腺癌新辅助化疗方案多柔比星联合环磷酰胺序贯紫衫醇和曲妥珠单抗(AC-TH方案)及多西他赛联合卡铂和曲妥珠单抗(TCH方案)进行药物经济学分析,为该病治疗的选择提供决策依据。方法建立Markov模型,对接受AC-TH与TCH新辅助化疗方案的患者进行模拟,综合应用临床试验研究结果、其他公开发表的文献和两大型综合性医院的病例资料,评价2种化疗方案的成本效果比,并进行敏感度分析。结果成本效果分析显示,TCH组治疗乳腺癌的5年健康结果值为3.6质量调整生命年(quality-adjusted life years,QALYs),比AC-TH组多0.2QALYs;AC-TH组的成本为207 987元,比TCH组多45 940元,增量成本-效果比为?229 700元/QALY。结论从中国医疗卫生体系角度出发,5年内新辅助化疗方案TCH比AC-TH对Her-2阳性乳腺癌患者更具成本效果比。
OBJECTIVE To analyze the cost-effectiveness of doxorubicin/cyclophosphamide/paclitaxel/trastuzumab(AC-TH) and docetaxel/carboplatin/trastuzumab(TCH). METHODS A Markov model was built to simulate the process of breast cancer events and death occurred in both AC-TH and TCH armed patients and to choose a suitable chemotherapy method.Data were collected from the clinical trials, some publicized literatures and patients' diaries of a large Chinese comprehensive hospital. The cost-effectiveness analysis of two regimens and sensitivity analysis were performed using a Markov model.RESULTS The 5 years' results showed that patients receiving TCH gained 3.6(quality-adjusted life years, QALYs) which were 0.2 QALYs more than patients receiving AC-TH. The ICER value was ?229700 Yuan/QALY. The costs of patients receiving AC-TH were 207 987 Yuan which were 45 940 Yuan more than that of TCH. CONCLUSION Compared with AC-TH regimen,TCH can be viewed as cost-effective for breast cancer patients in 5 years horizon from a Chinese health system perspective.
OBJECTIVE To analyze the cost-effectiveness of doxorubicin/cyclophosphamide/paclitaxel/trastuzumab(AC-TH) and docetaxel/carboplatin/trastuzumab(TCH). METHODS A Markov model was built to simulate the process of breast cancer events and death occurred in both AC-TH and TCH armed patients and to choose a suitable chemotherapy method.Data were collected from the clinical trials, some publicized literatures and patients' diaries of a large Chinese comprehensive hospital. The cost-effectiveness analysis of two regimens and sensitivity analysis were performed using a Markov model.RESULTS The 5 years' results showed that patients receiving TCH gained 3.6(quality-adjusted life years, QALYs) which were 0.2 QALYs more than patients receiving AC-TH. The ICER value was ?229700 Yuan/QALY. The costs of patients receiving AC-TH were 207 987 Yuan which were 45 940 Yuan more than that of TCH. CONCLUSION Compared with AC-TH regimen,TCH can be viewed as cost-effective for breast cancer patients in 5 years horizon from a Chinese health system perspective.
引文
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[27]曹燕.决策分析模型在药物经济学中的应用[J].中国药房,2007,18(8):561-564
[28]万小敏.乳腺癌化疗多柔吡星/环磷酞胺(AC)和多西他赛/环磷酰胺(TC)的成本-效果研究[D].中南大学,2009.
[29]罗霞,彭六保,万小敏,等.乳腺癌辅助化学治疗方案AC与FAC的成本效果分析[J].中国新药与临床杂志,2010,29(3):232-236
[30]LEUNG W,KVIZHINADZE G,NAIR N,et al.Adjuvant trastuzumab in HER2-positive early breast cancer by age and hormone receptor status:a cost-utility analysis[J].PLoS Med,2016,13(8):e1002067.Doi:10.1371/journal.pmed.1002067.eCollection 2016 Aug.
[31]ALVARADO M D,MOHAN A J,ESSERMAN L J,et al.Cost-effectiveness analysis of intraoperative radiation therapy for early-stage breast cancer[J].Ann Surg Oncol 2013,20(9):2873-2880.
[32]JITAWATANARAT P,O’CONNOR T L,KOSSOFF E B.Safety and tolerability of docetaxel,cyclophosphamide,and trastuzumab compared to standard trastuzumab-based chemotherapy regimens for early-stage human epidermal growth factor receptor 2-positive breast cancer[J].J Breast Cancer,2014,17(4):356-362.
[2]郑莹,吴春晓,张敏璐.乳腺癌在中国的流行状况和疾病特征[J].中国癌症杂志,2013,23(8):561-569.
[3]EISENHAUER E A,THERASSE P,BOGAERTS J.New response evaluation criteria in solid tumours:revised RECISTguideline(version 1.1)[J].Gan to Kagaku Ryoho Cancer&Chemotherapy,2009,36(13):2495-2501.
[4]BECK J R,KASSIRER J P,PAUKER S G.A convenient approximation of life expectancy(the“DEALE”)-I.Validation of the method[J].Am J Med,1982,73(6):883-888.
[5]BECK J R,PAUKER S G,GOTTLIEB J E,et al.Aconvenient approximation of life expectancy(the“DEALE”)-II.Use in medical decision-making[J].Am J Med,1982,73(6):889-897.
[6]ROMOND E H,PEREZ E A,BRYANT J,et al Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer[J].N Engl J Med,2005,353(16):1673-1684.
[7]UNTCH M,FASCHING P A,KONECNY G E,et al.Pathologic complete response after neoadjuvant chemotherapy plus trastuzumab predicts favorable survival in human epidermal growth factor receptor 2-overexpressing breast cancer:results from the TECHNO trial of the AGO and GBGstudy groups[J].J Clin Oncol,2011(29):3351-3357.
[8]JITAWATANARAT P,O'CONNOR T L,KOSSOFF E B,et al.Safety and tolerability of docetaxel,cyclophosphamide,and trastuzumab compared to standard trastuzumab-based chemotherapy regimens for early-stage human epidermal growth factor receptor 2-positive breast cancer[J].J Breast Cancer,2014(17):356-362.
[9]PATRICIA A.GANZ EHR,REENA S.Cecchini(2017)long-term follow-up of cardiac function and quality of life for patients in NSABP protocol B-31/NRG oncology:a randomized trial comparing the safety and efficacy of doxorubicin and cyclophosphamide(AC)followed by paclitaxel with AC followed by paclitaxel and trastuzumab in patients with node-positive breast cancer with tumors overexpressing human epidermal growth factor receptor 2[J].J Clin Oncol,2017(35):3942-3948.
[10]DANG C,LIN N,MOY B,et al.(2010)Dose-dense doxorubicin and cyclophosphamide followed by weekly paclitaxel with trastuzumab and lapatinib in HER2/neu-overexpressed/amplified breast cancer is not feasible because of excessive diarrhea[J].J Clin Oncol,2010(28):2982-2988.
[11]BAYRAKTAR S,GONZALEZ-ANGULO A M,LEI X,et al.Efficacy of neoadjuvant therapy with trastuzumab concurrent with anthracycline-and nonanthracycline-based regimens for HER2-positive breast cancer[J].Cancer,2012(118):2385-2393.
[12]CHEN W,HE J,SONG S,et al.Efficacy of TCH/TECneoadjuvant chemotherapy for the treatment of HER-2-overexpressing breast cancer[J].Oncol Lett,2015(9):1922-1926.
[13]KOLBERG H C,AKPOLAT-BASCI L,STEPHANOU M,et al.Neoadjuvant chemotherapy with docetaxel,carboplatin and weekly trastuzumab is active in HER2-positive early breast cancer:results after a median follow-up of over 4 years[J].Breast Care(Basel),2016(11):323-327.
[14]ECHAVARRIA I,GRANJA M,BUENO C,et al.Multicenter analysis of neoadjuvant docetaxel,carboplatin,and trastuzumab in HER2-positive breast cancer[J].Breast Cancer Res Treat,2017(162):181-189.
[15]TIWARI A,GOGIA A,DEO S,et al.Retrospective study of efficacy and safety of neoadjuvant docetaxel,carboplatin,and trastuzumab in HER2-positive locally advanced and oligometastatic breast cancer:An Indian experience[J].Indian J Cancer,2017(54):343-346.
[16]ASUKAI Y,VALLADARES A,CAMPS C.Costeffectiveness analysis of pemetrexed versus docetaxel in the second-line treatment of non-small cell lung cancer in Spain:results for the non-squamous histology population[J].BMCCancer,2010,10(1):26-40.
[17]DIANA B.PETITTI D.Meta-Analysis,decision analysis,and cost-effectiveness analysis.second edition[J].New York:Oxford Uniersity Press,2000.
[18]WARD S,SIMPSON E,DAVIS S.Taxanes for the adjuvant treatment of early breast cancer:systematic review and economic evaluation[J].Health Technol Assess,2007,11(40):1-144.
[19]TROTTI A,COLEVAS A D,SETSER A.CTCAE v3.0:development of a comprehensive grading system for the adverse effects of cancer treatment[J].Semin Radiat Oncology,2016,13(3):176-181.
[20]《中国药物经济学评价指南》课题组.中国药物经济学评价指南(2011版)[J].中国药物经济学,2011(3):8-11,13-50.
[21]XIAO Y,CUI Y H,LI S F.Application of cost-effectiveness analysis to the evaluation of three mammary gland cancer chemotherapeutic programs for mammary gland carcinoma[J].Chin J Mod Appl Pharm(中国现代应用药学),2005,22(9):892-894.
[22]XU S M,LYU S H,WANG Y L,et al.Analysis of pharmacoeconomic of three therapeutic schemes for mammary cancer[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(2):271-274.
[23]GAO L,ZHAO Z Y,ZHENG X H,et al.Cost-effectiveness analysis of capecitabine plus docetaxel versus epirubicin plus docetaxel for advanced or metastatic breast cancer[J].Chin JMod Appl Pharm(中国现代应用药学),2015,32(4):493-497.
[24]YOUNIS T,RAYSON D,SELLON M,et al.Adjuant chemotherapy for breast cancer:a cost-utility analysis of FEC-D vs FEC100[J].Breast Cancer Res Treat,2008,111(2):261.
[25]WOLOWACZ S E,CAMERON D A,TATE H C,et al.Docetaxel in combination with doxorubicin and cyclophosphamide as adjuvant treatment for early node-positive Breast Cancer:A cost-effectiveness and cost-utility analysis[J].J Clin Oncol,2008,26(6):925-933.
[26]LEE S G,JEE Y G,CHUNG H C,et al.Cost-effectiveness analysis of adjuvant the therapy for node positive breast cancer in Korea:docetaxel,doxorubicin and cyclophosphamide(TAC)versus fluorounracil,doxorubicin and cyclophosphamide(FAC)[J].Breast Cancer Res Treat,2009,114(3):589-595.
[27]曹燕.决策分析模型在药物经济学中的应用[J].中国药房,2007,18(8):561-564
[28]万小敏.乳腺癌化疗多柔吡星/环磷酞胺(AC)和多西他赛/环磷酰胺(TC)的成本-效果研究[D].中南大学,2009.
[29]罗霞,彭六保,万小敏,等.乳腺癌辅助化学治疗方案AC与FAC的成本效果分析[J].中国新药与临床杂志,2010,29(3):232-236
[30]LEUNG W,KVIZHINADZE G,NAIR N,et al.Adjuvant trastuzumab in HER2-positive early breast cancer by age and hormone receptor status:a cost-utility analysis[J].PLoS Med,2016,13(8):e1002067.Doi:10.1371/journal.pmed.1002067.eCollection 2016 Aug.
[31]ALVARADO M D,MOHAN A J,ESSERMAN L J,et al.Cost-effectiveness analysis of intraoperative radiation therapy for early-stage breast cancer[J].Ann Surg Oncol 2013,20(9):2873-2880.
[32]JITAWATANARAT P,O’CONNOR T L,KOSSOFF E B.Safety and tolerability of docetaxel,cyclophosphamide,and trastuzumab compared to standard trastuzumab-based chemotherapy regimens for early-stage human epidermal growth factor receptor 2-positive breast cancer[J].J Breast Cancer,2014,17(4):356-362.