盐酸多柔比星脂质体注射液用于多种肿瘤治疗的卫生技术评估
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摘要
目的:评估盐酸多柔比星脂质体注射液(pegylated liposomal doxorubicin,PLD)用于多种肿瘤治疗的有效性、安全性和经济性,为医保决策和临床用药提供证据支持。方法:按照纳入排除标准,系统检索已发表的卫生技术评估(HTA)报告、系统评价/Meta分析、随机对照试验(RCTs)、药物经济学分析,并评价研究质量。对RCTs进行荟萃分析,对其他研究结果进行定性分析。结果:共纳入7项系统评价/Meta分析、23项RCT研究和6项经济学研究。PLD在肿瘤治疗中应用广泛:对于艾滋病相关的卡波氏肉瘤(AIDS-KS)、乳腺癌、多发性骨髓瘤、软组织及骨肉瘤、急性淋巴细胞白血病及非鼻咽头颈部肿瘤患者,PLD对总生存期(OS)的延长与对照药物相比无统计学差异,但可显著延长晚期胃癌患者的无进展生存期(PFS)与OS。PLD耐受性良好,大多数毒性反应的发生与对照组无统计学差异。与蒽环类药物、紫杉醇等其他化疗药物相比,PLD可显著降低心脏毒性、血液学毒性、脱发、乏力等不良事件的发生率,但会增加手足综合征的发生率。国外经济学评价结果显示,在AIDS-KS患者中,PLD的经济性优于柔红霉素脂质体,劣于紫杉醇。结论:PLD治疗AIDS-KS具有良好的有效性、安全性,在乳腺癌、胃癌治疗中可能有效,在国内的经济性仍需进一步研究证实。
Objective: To support decision-making in insurance coverage and clinical practice by evaluating the efficacy,safety and economic efficiency of pegylated liposomal doxorubicin( PLD) for cancer therapy. Methods:Published HTA reports,systematic reviews/Meta-analyses,RCTs and pharmacoeconomic studies were retrieved according to defined inclusion criteria,of which quality was assessed. Included RCTs were pooled through metaanalysis,while other studies were analyzed qualitatively. Results: 7 systematic review/meta-analyses,23 RCTs and 6 economic evaluations were included. PLD was widely used and evaluated in a variety of malignant tumors.The OS was not significantly different between PLD group and the control group in breast cancer,AIDS-KS,multiple myeloma,soft tissue sarcoma,acute lymphoblastic leukemia and non-nasopharyngeal head and neck cancer.However,the improvement by PLD in PFS and OS was significant in gastric cancer. In these malignant tumors,the occurrence of most adverse events was similar,while PLD was associated with significantly less cardiac toxicity,hematological toxicity,alopecia and fatigue,and more hand-foot syndrome. Foreign economic evaluation results show that PLD is more economical than liposomal daunorubicin in the treatment of AIDS-KS,while less than paclitaxel.Conclusion: PLD has favorable profiles in the efficacy,safety in the treatment of AIDS-KS,and it might be effective in gastric cancer and breast cancer. Its economy in China still needs more studies in the future to confirm.
Objective: To support decision-making in insurance coverage and clinical practice by evaluating the efficacy,safety and economic efficiency of pegylated liposomal doxorubicin( PLD) for cancer therapy. Methods:Published HTA reports,systematic reviews/Meta-analyses,RCTs and pharmacoeconomic studies were retrieved according to defined inclusion criteria,of which quality was assessed. Included RCTs were pooled through metaanalysis,while other studies were analyzed qualitatively. Results: 7 systematic review/meta-analyses,23 RCTs and 6 economic evaluations were included. PLD was widely used and evaluated in a variety of malignant tumors.The OS was not significantly different between PLD group and the control group in breast cancer,AIDS-KS,multiple myeloma,soft tissue sarcoma,acute lymphoblastic leukemia and non-nasopharyngeal head and neck cancer.However,the improvement by PLD in PFS and OS was significant in gastric cancer. In these malignant tumors,the occurrence of most adverse events was similar,while PLD was associated with significantly less cardiac toxicity,hematological toxicity,alopecia and fatigue,and more hand-foot syndrome. Foreign economic evaluation results show that PLD is more economical than liposomal daunorubicin in the treatment of AIDS-KS,while less than paclitaxel.Conclusion: PLD has favorable profiles in the efficacy,safety in the treatment of AIDS-KS,and it might be effective in gastric cancer and breast cancer. Its economy in China still needs more studies in the future to confirm.
引文
[1]LAWRIE TA,BRYANT A,CAMERON A,et al.Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer[J].Cochrane Db Syst Rev,2013(7):D6910.
[2]曾晓芳,蔡鸿福,杨菁,等.基于药动学及代谢物组学研究多柔比星在大鼠体内的心脏毒性[J].中国现代应用药学,2019,36(6):666-674.
[3]GABIZON AA,PATIL Y,LA-BECK NM.New insights and evolving role of pegylated liposomal doxorubicin in cancer therapy.Drug Resist Update[J].Drug Resist Updat,2016(29):90-106.
[4]GABIZON AA,LYASS O,BERRY GJ,et al.Cardiac safety of pegylated liposomal doxorubicin(Doxil/Caelyx)demonstrated by endomyocardial biopsy in patients with advanced malignancies[J].Cancer Invest,2004,22(5):663-669.
[5]LYSENG-WILLIAMSON KA,DUGGAN ST,KEATING GM.Pegylated liposomal doxorubicin:a guide to its use in various malignancies[J].Bio Drugs,2013,27(5):533-540.
[6]ANSARI L,SHIEHZADEH F,TAHERZADEH Z,et al.The most prevalent side effects of pegylated liposomal doxorubicin monotherapy in women with metastatic breast cancer:a systematic review of clinical trials[J].Cancer Gene Ther,2017,24(5):189-193.
[7]HUANG M,CHEN ZL,FU J,et al.Pegylated or non-pegylated liposomal doxorubicin in the management of advanced breast cancer:a meta-analysis[J].Int J Clin Exp Med,2016,9(2):525-534.
[8]LIN J,CHEN J,ZENG Z,et al.Efficacy and safety of pegylated liposomal doxorubicin for multiple myeloma:a systematic review and meta-analysis of randomized controlled trials[J].Int J Clin Exp Med,2017,10(6):8956-8968.
[9]LIU R,ZHOU J,YANG S,et al.Efficacy and safety of pegylated liposomal doxorubicin-based chemotherapy of AIDS-related Kaposi's sarcoma:a meta-analysis[J].2018,25(6):e719-e721.
[10]MANN K,RANA C,WADHWA A.Preserved antitumor activity and reduced cardiotoxicity of first-line pegylated liposomal doxorubicin compared with conventional doxorubicin in patients with metastatic breast cancer[J].2010,13(7):A251.
[11]RAFIYATH SM,RASUL M,LEE B,et al.Comparison of safety and toxicity of liposomal doxorubicin vs.conventional anthracyclines:a meta-analysis[J].Exp Hematol Oncol,2012,23(1):10.
[12]WILSON FR,VARU A,MITRA D,et al.Systematic review and network meta-analysis comparing palbociclib with chemotherapy agents for the treatment of postmenopausal women with HR-positive and HER2-negative advanced/metastatic breast cancer[J].Breast Cancer Res,2017,166(1):167-177.
[13]COOLEY T,HENRY D,TONDA M,et al.A randomized,double-blind study of pegylated liposomal doxorubicin for the treatment of AIDS-related Kaposi's sarcoma[J].Oncologist,2007,12(1):114-123.
[14]DIMOPOULOS MA,POULI A,ZERVAS K,et al.Prospective randomized comparison of vincristine,doxorubicin and dexamethasone(VAD)administered as intravenous bolus injection and VAD with liposomal doxurubicin as first-line treatment in multiple myeloma[J].Ann Oncol,2003,14(7):1039-1044.
[15]HUNAULT-BERGER M,LEGUAY T,THOMAS X,et al.Arandomized study of pegylated liposomal doxorubicin versus continuous-infusion doxorubicin in elderly patients with acute lymphoblastic leukemia:The GRAALL-SA1 study[J].Haematologica,2011,96(2):245-252.
[16]JUDSON I,RADFORD JA,HARRIS M,et al.Randomised phase II trial of pegylated liposomal doxorubicin(DOXIL/CAELYX)versus doxorubicin in the treatment of advanced or metastatic soft tissue sarcoma:A study by the EORTC Soft Tissue and Bone Sarcoma Group[J].Eur J Cancer,2001,37(7):870-877.
[17]NORTHFELT DW,DEZUBE BJ,THOMMES JA,et al.Pegylated-liposomal doxorubicin versus doxorubicin,bleomycin,and vincristine in the treatment of AIDS-related Kaposi's sarcoma:results of a randomized phase III clinical trial[J].J Clin Oncol,1998,16(7):2445-2451.
[18]O'BRIEN MER,WIGLER N,INBAR M,et al.Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl(CAELYXTM/Doxil)versus conventional doxorubicin for first-line treatment of metastatic breast cancer[J].Ann Oncol,2004,15(3):440-449.
[19]OSOBA D,NORTHFELT DW,BUDD DW,et al.Effect of treatment on health-related quality of life in acquired immunodeficiency syndrome(AIDS)-related Kaposi's sarcoma:a randomized trial of pegylated-liposomal doxorubicin versus doxorubicin,bleomycin,and vincristine[J].Cancer Invest,2001,19(6):573-580.
[20]RAYSON D,SUTER TM,JACKISCH C,et al.Cardiac safety of adjuvant pegylated liposomal doxorubicin with concurrent trastuzumab:a randomized phase II trial[J].Ann Oncol,2012,23(7):1780-1788.
[21]RIFKIN RM,GREGORY SA,MOHRBACHER A,et al.Pegylated liposomal doxorubicin,vincristine,and dexamethasone provide significant reduction in toxicity compared with doxorubicin,vincristine,and dexamethasone in patients with newly diagnosed multiple myeloma:a Phase III multicenter randomized trial[J].Cancer,2006,106(4):848-858.
[22]VICI P,COLUCCI G,GIOTTA F,et al.A multicenter prospective phase II randomized trial of epirubicin/vinorelbine versus pegylated liposomal doxorubicin/vinorelbine as first-line treatment in advanced breast cancer.A GOIM study[J].J Exp Clin Cancer Res,2011(12):30-39.
[23]王琼,王南瑶,曾洁,等.多柔比星脂质体对比表柔比星联合奥沙利铂、亚叶酸钙和氟尿嘧啶治疗晚期胃癌的临床观察[J].临床肿瘤学杂志,2011,16(6):542-545.
[24]ALBA E,RUIZ-BORREGO M,MARGELI M,et al.Maintenance treatment with pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer:GEICAM 2001-01 study[J].Breast Cancer Res Treat,2010,122(1):169-176.
[25]CASCINU S,GALIZIA E,LABIANCA R,et al.Pegylated liposomal doxorubicin,5-fluorouracil and cisplatin versus mitomycinC,5-fluorouracil and cisplatin for advanced gastric cancer:a randomized phase II trial[J].Cancer Chemother Pharmacol,2011,68(1):37-43.
[26]CIANFROCCA M,LEE S,Von ROENN J,et al.Randomized trial of paclitaxel versus pegylated liposomal doxorubicin for advanced human immunodeficiency virus-associated Kaposi sarcoma:evidence of symptom palliation from chemotherapy[J].Cancer,2010,116(16):3969-3977.
[27]FOUNTZILAS G,PAPAKOSTAS P,DAFNI U,et al.Paclitaxel and gemcitabine vs.paclitaxel and pegylated liposomal doxorubicin in advanced non-nasopharyngeal head and neck cancer.An efficacy and cost analysis randomized study conducted by the Hellenic Cooperative Oncology Group[J].Ann Oncol,2006,17(10):1560-1567.
[28]KELLER AM,MENNEL RG,GEORGOULIAS VA,et al.Randomized phase III trial of pegylated liposomal doxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer[J].J Clin Oncol,2004,22(19):3893-3901.
[29]MARTN-CARBONERO L,BARRIOS A,SABALLS P,et al.Pegylated liposomal doxorubicin plus highly active antiretroviral therapy versus highly active antiretroviral therapy alone in HIVpatients with Kaposi's sarcoma[J].AIDS,2004,18(12):1737-1740.
[30]HARBECK N,SAUPE S,JGER E,et al.A randomized phase III study evaluating pegylated liposomal doxorubicin versus capecitabine as first-line therapy for metastatic breast cancer:results of the PELICAN study[J].Breast Cancer Res Theat,2017,161(1):63-72.
[31]ORLOWSKI RZ,NAGLER A,SONNEVELD P,et al.Final overall survival results of a randomized trial comparing bortezomib plus pegylated liposomal doxorubicin with bortezomib alone in patients with relapsed or refractory multiple myeloma[J].Cancer,2016(13):2050-2056.
[32]SMORENBURG CH,DE GROOT SM,VAN LEEUWEN-STOKAE,et al.A randomized phase III study comparing pegylated liposomal doxorubicin with capecitabine as first-line chemotherapy in elderly patients with metastatic breast cancer:results of the O-MEGA study of the Dutch Breast Cancer Research Group BOOG[J].Ann Oncol,2014,25(3):599-605.
[33]SPARANO JA,MAKHSON AN,SEMIGLAZOV VF,et al.Pegylated liposomal doxorubicin plus docetaxel significantly improves time to progression without additive cardiotoxicity compared with docetaxel monotherapy in patients with advanced breast cancer previously treated with neoadjuvant-adjuvant anthracycline therapy:results from a randomized phase III study[J].JClin Oncol,2009,27(27):4522-4529.
[34]STEWART S,JABLONOWSKI H,GOEBEL FD,et al.Randomized comparative trial of pegylated liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma.International Pegylated Liposomal Doxorubicin Study Group[J].J Clin Oncol,1998,16(2):683-691.
[35]YARDLEY DA,BURRIS III HA,SPIGEL DR,et al.A phase II randomized crossover study of liposomal doxorubicin versus weekly docetaxel in the first-line treatment of women with metastatic breast cancer[J].Clin Breast Cancer,2009,9(4):247-252.
[36]BENNETT CL,GOLUB RM,STINSON TJ,et al.Cost-effectiveness analysis comparing liposomal anthracyclines in the treatment of AIDS-related Kaposi's sarcoma[J].J Acquir Immune Defic Syndr Hum Retrovirol,1998,18(5):460-465.
[37]HJORTSBERG C,PERSSON U,LIDBRINK E,et al.Cost-effectiveness analysis of pegylated-liposomal doxorubicin and liposomal daunorubicin treatments in patients with Kaposi's sarcoma[J].Acta Oncol,1999,38(8):1063-1067.
[38]RAIMUNDO K,BISKUPIAK J,GOODMAN M,et al.Cost effectiveness of liposomal doxorubicin vs.paclitaxel for the treatment of advanced AIDS-Kaposi's sarcoma[J].J Med Econ,2013,16(5):606-613.
[39]VANNI T,FONSECA BA,POLANCZYK CA.Cost-effectiveness analysis comparing chemotherapy regimens in the treatment of AIDS-related Kaposi's sarcoma in Brazil[J].HIV Clin Trials,2006,7(4):194-202.
[40]PORTER CA,RIFKIN RM.Clinical benefits and economic analysis of pegylated liposomal doxorubicin/vincristine/dexamethasone versus doxorubicin/vincristine/dexamethasone in patients with newly diagnosed multiple myeloma[J].Clin Lymphoma Myeloma,2007,7(Suppl 4):S150-S155.
[41]ROBINSON P,VON DER MAASE H,BHALLA S,et al.Costutility analysis of the GC versus MVAC regimens for the treatment of locally advanced or metastatic bladder cancer[J].Expert Rev Pharmacoecon Outcomes Res,2004,4(1):27-38.
[2]曾晓芳,蔡鸿福,杨菁,等.基于药动学及代谢物组学研究多柔比星在大鼠体内的心脏毒性[J].中国现代应用药学,2019,36(6):666-674.
[3]GABIZON AA,PATIL Y,LA-BECK NM.New insights and evolving role of pegylated liposomal doxorubicin in cancer therapy.Drug Resist Update[J].Drug Resist Updat,2016(29):90-106.
[4]GABIZON AA,LYASS O,BERRY GJ,et al.Cardiac safety of pegylated liposomal doxorubicin(Doxil/Caelyx)demonstrated by endomyocardial biopsy in patients with advanced malignancies[J].Cancer Invest,2004,22(5):663-669.
[5]LYSENG-WILLIAMSON KA,DUGGAN ST,KEATING GM.Pegylated liposomal doxorubicin:a guide to its use in various malignancies[J].Bio Drugs,2013,27(5):533-540.
[6]ANSARI L,SHIEHZADEH F,TAHERZADEH Z,et al.The most prevalent side effects of pegylated liposomal doxorubicin monotherapy in women with metastatic breast cancer:a systematic review of clinical trials[J].Cancer Gene Ther,2017,24(5):189-193.
[7]HUANG M,CHEN ZL,FU J,et al.Pegylated or non-pegylated liposomal doxorubicin in the management of advanced breast cancer:a meta-analysis[J].Int J Clin Exp Med,2016,9(2):525-534.
[8]LIN J,CHEN J,ZENG Z,et al.Efficacy and safety of pegylated liposomal doxorubicin for multiple myeloma:a systematic review and meta-analysis of randomized controlled trials[J].Int J Clin Exp Med,2017,10(6):8956-8968.
[9]LIU R,ZHOU J,YANG S,et al.Efficacy and safety of pegylated liposomal doxorubicin-based chemotherapy of AIDS-related Kaposi's sarcoma:a meta-analysis[J].2018,25(6):e719-e721.
[10]MANN K,RANA C,WADHWA A.Preserved antitumor activity and reduced cardiotoxicity of first-line pegylated liposomal doxorubicin compared with conventional doxorubicin in patients with metastatic breast cancer[J].2010,13(7):A251.
[11]RAFIYATH SM,RASUL M,LEE B,et al.Comparison of safety and toxicity of liposomal doxorubicin vs.conventional anthracyclines:a meta-analysis[J].Exp Hematol Oncol,2012,23(1):10.
[12]WILSON FR,VARU A,MITRA D,et al.Systematic review and network meta-analysis comparing palbociclib with chemotherapy agents for the treatment of postmenopausal women with HR-positive and HER2-negative advanced/metastatic breast cancer[J].Breast Cancer Res,2017,166(1):167-177.
[13]COOLEY T,HENRY D,TONDA M,et al.A randomized,double-blind study of pegylated liposomal doxorubicin for the treatment of AIDS-related Kaposi's sarcoma[J].Oncologist,2007,12(1):114-123.
[14]DIMOPOULOS MA,POULI A,ZERVAS K,et al.Prospective randomized comparison of vincristine,doxorubicin and dexamethasone(VAD)administered as intravenous bolus injection and VAD with liposomal doxurubicin as first-line treatment in multiple myeloma[J].Ann Oncol,2003,14(7):1039-1044.
[15]HUNAULT-BERGER M,LEGUAY T,THOMAS X,et al.Arandomized study of pegylated liposomal doxorubicin versus continuous-infusion doxorubicin in elderly patients with acute lymphoblastic leukemia:The GRAALL-SA1 study[J].Haematologica,2011,96(2):245-252.
[16]JUDSON I,RADFORD JA,HARRIS M,et al.Randomised phase II trial of pegylated liposomal doxorubicin(DOXIL/CAELYX)versus doxorubicin in the treatment of advanced or metastatic soft tissue sarcoma:A study by the EORTC Soft Tissue and Bone Sarcoma Group[J].Eur J Cancer,2001,37(7):870-877.
[17]NORTHFELT DW,DEZUBE BJ,THOMMES JA,et al.Pegylated-liposomal doxorubicin versus doxorubicin,bleomycin,and vincristine in the treatment of AIDS-related Kaposi's sarcoma:results of a randomized phase III clinical trial[J].J Clin Oncol,1998,16(7):2445-2451.
[18]O'BRIEN MER,WIGLER N,INBAR M,et al.Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl(CAELYXTM/Doxil)versus conventional doxorubicin for first-line treatment of metastatic breast cancer[J].Ann Oncol,2004,15(3):440-449.
[19]OSOBA D,NORTHFELT DW,BUDD DW,et al.Effect of treatment on health-related quality of life in acquired immunodeficiency syndrome(AIDS)-related Kaposi's sarcoma:a randomized trial of pegylated-liposomal doxorubicin versus doxorubicin,bleomycin,and vincristine[J].Cancer Invest,2001,19(6):573-580.
[20]RAYSON D,SUTER TM,JACKISCH C,et al.Cardiac safety of adjuvant pegylated liposomal doxorubicin with concurrent trastuzumab:a randomized phase II trial[J].Ann Oncol,2012,23(7):1780-1788.
[21]RIFKIN RM,GREGORY SA,MOHRBACHER A,et al.Pegylated liposomal doxorubicin,vincristine,and dexamethasone provide significant reduction in toxicity compared with doxorubicin,vincristine,and dexamethasone in patients with newly diagnosed multiple myeloma:a Phase III multicenter randomized trial[J].Cancer,2006,106(4):848-858.
[22]VICI P,COLUCCI G,GIOTTA F,et al.A multicenter prospective phase II randomized trial of epirubicin/vinorelbine versus pegylated liposomal doxorubicin/vinorelbine as first-line treatment in advanced breast cancer.A GOIM study[J].J Exp Clin Cancer Res,2011(12):30-39.
[23]王琼,王南瑶,曾洁,等.多柔比星脂质体对比表柔比星联合奥沙利铂、亚叶酸钙和氟尿嘧啶治疗晚期胃癌的临床观察[J].临床肿瘤学杂志,2011,16(6):542-545.
[24]ALBA E,RUIZ-BORREGO M,MARGELI M,et al.Maintenance treatment with pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer:GEICAM 2001-01 study[J].Breast Cancer Res Treat,2010,122(1):169-176.
[25]CASCINU S,GALIZIA E,LABIANCA R,et al.Pegylated liposomal doxorubicin,5-fluorouracil and cisplatin versus mitomycinC,5-fluorouracil and cisplatin for advanced gastric cancer:a randomized phase II trial[J].Cancer Chemother Pharmacol,2011,68(1):37-43.
[26]CIANFROCCA M,LEE S,Von ROENN J,et al.Randomized trial of paclitaxel versus pegylated liposomal doxorubicin for advanced human immunodeficiency virus-associated Kaposi sarcoma:evidence of symptom palliation from chemotherapy[J].Cancer,2010,116(16):3969-3977.
[27]FOUNTZILAS G,PAPAKOSTAS P,DAFNI U,et al.Paclitaxel and gemcitabine vs.paclitaxel and pegylated liposomal doxorubicin in advanced non-nasopharyngeal head and neck cancer.An efficacy and cost analysis randomized study conducted by the Hellenic Cooperative Oncology Group[J].Ann Oncol,2006,17(10):1560-1567.
[28]KELLER AM,MENNEL RG,GEORGOULIAS VA,et al.Randomized phase III trial of pegylated liposomal doxorubicin versus vinorelbine or mitomycin C plus vinblastine in women with taxane-refractory advanced breast cancer[J].J Clin Oncol,2004,22(19):3893-3901.
[29]MARTN-CARBONERO L,BARRIOS A,SABALLS P,et al.Pegylated liposomal doxorubicin plus highly active antiretroviral therapy versus highly active antiretroviral therapy alone in HIVpatients with Kaposi's sarcoma[J].AIDS,2004,18(12):1737-1740.
[30]HARBECK N,SAUPE S,JGER E,et al.A randomized phase III study evaluating pegylated liposomal doxorubicin versus capecitabine as first-line therapy for metastatic breast cancer:results of the PELICAN study[J].Breast Cancer Res Theat,2017,161(1):63-72.
[31]ORLOWSKI RZ,NAGLER A,SONNEVELD P,et al.Final overall survival results of a randomized trial comparing bortezomib plus pegylated liposomal doxorubicin with bortezomib alone in patients with relapsed or refractory multiple myeloma[J].Cancer,2016(13):2050-2056.
[32]SMORENBURG CH,DE GROOT SM,VAN LEEUWEN-STOKAE,et al.A randomized phase III study comparing pegylated liposomal doxorubicin with capecitabine as first-line chemotherapy in elderly patients with metastatic breast cancer:results of the O-MEGA study of the Dutch Breast Cancer Research Group BOOG[J].Ann Oncol,2014,25(3):599-605.
[33]SPARANO JA,MAKHSON AN,SEMIGLAZOV VF,et al.Pegylated liposomal doxorubicin plus docetaxel significantly improves time to progression without additive cardiotoxicity compared with docetaxel monotherapy in patients with advanced breast cancer previously treated with neoadjuvant-adjuvant anthracycline therapy:results from a randomized phase III study[J].JClin Oncol,2009,27(27):4522-4529.
[34]STEWART S,JABLONOWSKI H,GOEBEL FD,et al.Randomized comparative trial of pegylated liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma.International Pegylated Liposomal Doxorubicin Study Group[J].J Clin Oncol,1998,16(2):683-691.
[35]YARDLEY DA,BURRIS III HA,SPIGEL DR,et al.A phase II randomized crossover study of liposomal doxorubicin versus weekly docetaxel in the first-line treatment of women with metastatic breast cancer[J].Clin Breast Cancer,2009,9(4):247-252.
[36]BENNETT CL,GOLUB RM,STINSON TJ,et al.Cost-effectiveness analysis comparing liposomal anthracyclines in the treatment of AIDS-related Kaposi's sarcoma[J].J Acquir Immune Defic Syndr Hum Retrovirol,1998,18(5):460-465.
[37]HJORTSBERG C,PERSSON U,LIDBRINK E,et al.Cost-effectiveness analysis of pegylated-liposomal doxorubicin and liposomal daunorubicin treatments in patients with Kaposi's sarcoma[J].Acta Oncol,1999,38(8):1063-1067.
[38]RAIMUNDO K,BISKUPIAK J,GOODMAN M,et al.Cost effectiveness of liposomal doxorubicin vs.paclitaxel for the treatment of advanced AIDS-Kaposi's sarcoma[J].J Med Econ,2013,16(5):606-613.
[39]VANNI T,FONSECA BA,POLANCZYK CA.Cost-effectiveness analysis comparing chemotherapy regimens in the treatment of AIDS-related Kaposi's sarcoma in Brazil[J].HIV Clin Trials,2006,7(4):194-202.
[40]PORTER CA,RIFKIN RM.Clinical benefits and economic analysis of pegylated liposomal doxorubicin/vincristine/dexamethasone versus doxorubicin/vincristine/dexamethasone in patients with newly diagnosed multiple myeloma[J].Clin Lymphoma Myeloma,2007,7(Suppl 4):S150-S155.
[41]ROBINSON P,VON DER MAASE H,BHALLA S,et al.Costutility analysis of the GC versus MVAC regimens for the treatment of locally advanced or metastatic bladder cancer[J].Expert Rev Pharmacoecon Outcomes Res,2004,4(1):27-38.