Two-year incidence of malignancy in sirolimus-treated renal transplant recipients: results from five multicenter studies
Two-year incidence of malignancy in sirolimus-treated renal transplant recipients: results from five multicenter studies
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DOI：
10.1111/j.1399-0012.2004.00188.x
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发表时间：
2004-08-01
影响因子：
2.1
通讯作者：
Friend, P
中科院分区：
文献类型：
--
作者：
Mathew, T;Kreis, H;Friend, P
我们研究了接受西罗莫司（SRL）持续联合环孢素（CsA）、SRL作为基础治疗或早期停用CsA后SRL维持治疗的肾移植患者移植后2年的恶性肿瘤发生率。共有1295例患者参加了两项双盲研究，比较了SRL与硫唑嘌呤（AZA）或安慰剂在CsA连续给药方案中的作用。在另外两项试验（n = 161）中，将SRL作为基础治疗与CsA进行了比较。在第五项试验中，患者在3个月时被随机分配继续接受CsA + SRL治疗（n = 215）或停用CsA，继续接受浓度控制剂量的SRL治疗（n = 215）。移植后2年，与接受安慰剂的患者相比，接受SRL持续联合CsA的患者皮肤癌的发病率显著降低。接受SRL作为基础治疗的患者没有发生恶性肿瘤，而接受CsA的患者发生率为5%。与继续接受CsA + SRL治疗的患者相比，接受浓度控制SRL治疗并消除CsA的患者的恶性肿瘤发生率显著降低。根据现有数据，早期停用CsA后接受基于SRL的治疗而不使用CsA或SRL维持治疗的患者在肾移植后前2年的恶性肿瘤发生率较低。SRL免疫治疗可能有益于保护肾移植患者免受皮肤癌的侵袭，即使与CsA联合使用。
We examined the rates of malignancy at 2 yr after transplantation in renal allograft patients receiving sirolimus (SRL) in continuous combination with cyclosporine (CsA), SRL as base therapy or SRL maintenance therapy after early withdrawal of CsA. A total of 1295 patients were enrolled in two double-blind studies comparing SRL with azathioprine (AZA) or placebo administered in continuous regimens with CsA. In two other trials (n = 161), SRL given as base therapy was compared with CsA. In the fifth trial, patients were randomly assigned at 3 months to either remain on CsA + SRL therapy (n = 215) or to have CsA eliminated with SRL being continued in concentration-controlled doses (n = 215). At 2 yr after transplantation, patients receiving SRL in continuous combination with CsA had a significantly lower incidence of skin cancer compared with patients receiving placebo. Patients receiving SRL as base therapy had no malignancies compared with a 5% incidence in those receiving CsA. The incidence of malignancy was significantly lower in patients receiving concentration-controlled SRL with elimination of CsA compared with those who remained on CsA + SRL. Based on the currently available data, patients receiving SRL-based therapy without CsA or SRL maintenance therapy after early CsA withdrawal have lower rates of malignancy in the first 2 yr after renal transplantation. SRL immunotherapy may be beneficial in protecting renal transplant patients from skin cancer even when given in combination with CsA.