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Caspofungin first-line therapy for invasive aspergillosis in allogeneic hematopoietic stem cell transplant patients: an European Organisation for Research and Treatment of Cancer study.
卡泊芬净作为一线药物治疗异基因干细胞移植患者的侵袭性曲霉病:一项来自欧洲癌症研究治疗组织的研究报告

出处: Bone Marrow Transplant   2010   Jul   45 (7) :1227-33

作者:Herbrecht R;Maertens J;Baila L;Aoun M;Heinz W;Martino R;Schwartz S;Ullmann AJ;Meert L;Paesmans M;Marchetti O;Akan H;Ameye L;Shivaprakash M;Viscoli C

PMID:20062093

Caspofungin at standard dose was evaluated as first-line monotherapy of mycologically documented probable/proven invasive aspergillosis (IA) (unmodified European Organisation for Research and Treatment of Cancer/Mycosis Study Group criteria) in allogeneic hematopoietic SCT patients. The primary efficacy end point was complete or partial response at end of caspofungin treatment. Response at week 12, survival and safety were additional end points. Enrollment was stopped prematurely because of low accrual, with 42 enrolled and 24 eligible, giving the study a power of 85%. Transplant was from unrelated donors in 16 patients; acute or chronic GVHD was present in 15. In all, 12 patients were neutropenic (<500/microl) at baseline, 10 received steroids and 16 calcineurin inhibitors or sirolimus. Median duration of caspofungin treatment was 24 days. At the end of caspofungin therapy, 10 (42%) patients had complete or partial response (95% confidence interval: 22-63%); 1 (4%) and 12 (50%) had stable and progressing disease, respectively; one was not evaluable. At week 12, eight patients (33%) had complete or partial response. Survival rates at week 6 and 12 were 79 and 50%, respectively. No patient had a drug-related serious adverse event or discontinued because of toxicity. Caspofungin first-line therapy was effective and well tolerated in allogeneic hematopoietic SCT patients with mycologically documented IA.

评估标准剂量卡泊芬净作为一线药物单药治疗拟诊/确诊侵袭性曲霉病(未修改的欧洲癌症研究治疗组织/真菌研究组标准)的接受异基因造血干细胞移植患者的疗效。主要疗效终点是卡泊芬净治疗结束时达到完全缓解或部分缓解,其它终点包括12周时的治疗反应,患者存活和安全性。因为入组的病例数增加缓慢而提前结束入组登记。共入组42例患者,其中24例符合观察条件,是预计病例数的85%。患者中16例接受的是无关供者移植;15例发生了急性或慢性移植物抗宿主病。共12例基线时有粒细胞缺乏(<500/微升),10例接受了类固醇激素治疗,16例接受了钙调磷酸酶抑制剂或西罗莫斯治疗。卡泊芬净中位治疗时间为24天。治疗结束时,10(42%)例患者达到完全或部分缓解(95% 可信区间: 22-63%);1例(4%)病情稳定;12例(50%)疾病进展;1例无法评价。12周时,8例(33%) 患者达到了完全或部分缓解。6周和12周时生存率分别为79%和50%。没有患者出现药物相关的严重副作用或因为药物毒性中断治疗。卡泊芬净一线治疗异基因造血干细胞移植患者侵袭性真菌病是有效且可耐受的。