Clinical efficacy of domestic decitabine monotherapy in elder patients with myelodysplastic syndrome
-
摘要: 目的:探讨国产地西他滨单药治疗老年骨髓增生异常综合征(MDS)的临床疗效和安全性。方法:评价我院2013-07-2015-06使用国产地西他滨(25 mg×5 d)治疗15例中危或不能耐受联合化疗的高危老年初治MDS患者的疗效和不良反应。结果:15例MDS患者中位年龄70岁,中危Ⅰ9例,中危Ⅱ及高危6例。至少经过3个疗程的治疗,6例获得完全缓解,2例获得部分缓解,2例脱离成分血输注,1例疾病稳定,4例未缓解,总反应率达66.7%。在6例细胞遗传学异常的患者中,5例获得完全细胞遗传学缓解,1例获得部分细胞遗传学缓解。Ⅲ~Ⅳ级血液学毒性发生率为73.3%,Ⅲ~Ⅳ级感染发生率为53.3%,无一例发生Ⅲ~Ⅳ级出血、严重恶心呕吐和肝功能损害。中位随访时间12(2~24)个月,随访期间1例死亡。结论:国产地西他滨治疗中危或不能耐受联合化疗的高危MDS可取得良好的疗效。Abstract: Objective:To explore the clinical efficacy and safety of domestic decitabine monotherapy in elder patients with myelodysplastic syndrome (MDS).Method:From July 2013 to June 2015,we collected the clinical data of 15 cases of intermediate-risk or combined chemotherapy non-tolerable high-risk elder patients with MDS.The patients received domestic decitabine (25 mg intravenously once daily for 5 days),and the efficacy and safety were evaluated.Result:Among the enrolled 15 patients,median age was 70 years,including 9 intermediate-riskⅠ patients and 6 intermediate-riskⅡ and high-risk patients.All patients at least underwent 3 courses of chemotherapy.Six cases achieved complete remission,2 cases achieved partial remission,2 cases was out of component blood transfusion,1 case got stable disease,4 cases was non-remission.The overall response rate was 66.7%.Of the 6 cases in whom cytogenetic evaluation could be performed,5 cases achieved completely cytogenetic remission,1 case achieved partial cytogenetic remission.Grade Ⅲ to Ⅳ hematologic toxicity rate was 73.3%,and grade Ⅲ to Ⅳ infection rate was 53.3%.There was none with grade Ⅲ to Ⅳ bleeding,severe nausea and vomiting,liver injury.The median follow-up time was 12 (2 to 24) months,1 patient died during the follow-up period.Conclusion:Domestic decitabine monotherapy shows a promising clinical efficacy and tolerance in intermediate-risk or combined chemotherapy non-tolerable high-risk elder patients with MDS.
-
Key words:
- domestic decitabine /
- elderly patients /
- myelodysplastic syndrome
-
[1] Platzbecker U,Santini V,Mufti GJ,et al.Update on developments in the diagnosis and prognostic evaluation of patients with myelodysplastic syndromes (MDS):consensus statements and report from an expert workshop[J].Leuk Res,2012,36:264-270.
[2] Figueroa ME,Skrabanek L,Li Y,et al.MDS and secondary AML display unique patterns and abundance of aberrant DNA methylation[J].Blood,2009,114:3448-3458.
[3] Steensma DP,Baer MR,Slack JL,et al.Multicenter study of decitabine administered daily for 5 days every 4 weeks to adults with myelodysplastic syndromes:the alternative dosing for outpatient treatment (ADOPT) trial[J].J Clin Oncol,2009,27:3842-3848.
[4] Swerdlow SH,Campo E,Harris NL,et al.WHO classification of tumours of haematopoietic and lymphoid tissues[M].Lyon:IARC,2008:109-133.
[5] Cheson BD,Greenberg PL,Bennett JM,et al.Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia[J].Blood,2006,108:419-425.
[6] 孙燕,周际昌.临床肿瘤内科手册[M].4版.北京:人民卫生出版社,2003:102-103.
[7] Borthakur G,Ahdab SE,Ravandi F,et al.Activity of decitabine in patients with myelodysplastic syndrome previously treated with azacitidine[J].Leuk Lymphoma,2008,49:690-695.
[8] Kantarjian H,Issa JP,Rosenfeld CS,et al.Decitabine improves patient outcomes in myelodysplastic syndromes:results of a phase III randomized study[J].Cancer,2006,106:1794-1803.
[9] Lübbert M,Suciu S,Baila L,et al.Low-dose decitabine versus best supportive care in elderly patients with intermediate- or high-risk myelodysplastic syndrome (MDS) ineligible for intensive chemotherapy:final results of the randomized phase III study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study Group[J].J Clin Oncol,2011,29:1987-1996.
[10] Kantarjian H,Oki Y,Garcia-Manero G,et al.Results of a randomized study of 3 schedules of low-dose decitabine in higher risk myelodysplastic syndrome and chronic myelomonocytic leukemia[J].Blood,2007,109:52-57.
[11] Lee JH,Jang JH,Park J,et al.A prospective multicenter observational study of decitabine treatment in Korean patients with myelodysplastic syndrome[J].Haematologica,2011,96:1441-1447.
[12] 朱雨,洪明,许乾,等.地西他滨联合粒细胞集落刺激因子预激治疗骨髓增生异常综合征[J].临床血液学杂志,2014,27(9):766-769.
[13] 高苏,仇惠英,金正明,等.地西他滨单药及联合半程和全程CAG方案治疗骨髓增生异常综合征和急性髓系白血病疗效观察[J].中华血液学杂志,2014,35(11):961-965.
计量
- 文章访问数: 213
- PDF下载数: 102
- 施引文献: 0