贝伐珠单抗联合化疗与单纯化疗治疗转移性结直肠癌的疗效比较：一项 III 期随机对照临床研究
Belatacept-based regimens versus a cyclosporine A-based regimen in kidney transplant recipients: 2-year results from the BENEFIT and BENEFIT-EXT studies.
机构信息
Emory Transplant Center and Department of Surgery, Emory University, Atlanta, GA, USA.
出版信息
Transplantation. 2010 Dec 27;90(12):1528-35. doi: 10.1097/TP.0b013e3181ff87cd.
BACKGROUND
At 1 year, belatacept was associated with similar patient/graft survival, better renal function, and an improved cardiovascular/metabolic risk profile versus cyclosporine A (CsA) in the Belatacept Evaluation of Nephroprotection and Efficacy as Firstline Immunosuppression Trial (BENEFIT) and Belatacept Evaluation of Nephroprotection and Efficacy as Firstline Immunosuppression Trial-EXTended criteria donors (BENEFIT-EXT) studies. Acute rejection was more frequent with belatacept in BENEFIT. Posttransplant lymphoproliferative disorder (PTLD)--specifically central nervous system PTLD--was observed more frequently in belatacept-treated patients. This analysis assesses outcomes from BENEFIT and BENEFIT-EXT after 2 years of treatment.
METHODS
Patients received a more intensive (MI) or a less intensive (LI) regimen of belatacept or a CsA-based regimen.
RESULTS
Four hundred ninety-three of 666 patients (74%) in BENEFIT and 347 of 543 (64%) in BENEFIT-EXT completed 2 years of treatment. The proportion of patients who survived with a functioning graft was similar across groups (BENEFIT: 94% MI, 95% LI, and 91% CsA; BENEFIT-EXT: 83% MI, 84% LI, and 83% CsA). Belatacept's renal benefits were sustained, as evidenced by a 16 to 17 mL/min (BENEFIT) and an 8 to 10 mL/min (BENEFIT-EXT) higher calculated glomerular filtration rate in the belatacept groups versus CsA. There were few new acute rejection episodes in either study between years 1 and 2. Because PTLD risk was highest in Epstein-Barr virus (EBV) (-) patients, an efficacy analysis of EBV (+) patients was performed and was consistent with the overall population results. There were two previously reported cases of PTLD in each study between years 1 and 2 in the belatacept groups. The overall balance of safety and efficacy favored the LI over the MI regimen.
CONCLUSIONS
At 2 years, belatacept-based regimens sustained better renal function, similar patient/graft survival, and an improved cardiovascular/metabolic risk profile versus CsA; outcomes that were maintained in EBV (+) patients. No new safety signals emerged.
背景
在为期 1 年的随访中，与环孢素 A（CsA）相比，贝那普利塞（belatacept）可使患者/移植物存活率相似，肾功能改善，心血管/代谢风险谱改善，这在贝那普利塞评估肾保护和一线免疫抑制作用试验（BENEFIT）和贝那普利塞评估肾保护和一线免疫抑制作用试验-扩展标准供体（BENEFIT-EXT）研究中得到了证实。在 BENEFIT 研究中，贝那普利塞治疗组急性排斥反应更为频繁。在接受贝那普利塞治疗的患者中，更频繁地观察到移植后淋巴组织增生性疾病（PTLD），特别是中枢神经系统 PTLD。本分析评估了 BENEFIT 和 BENEFIT-EXT 治疗 2 年后的结果。
方法
患者接受更密集（MI）或较不密集（LI）的贝那普利塞或基于 CsA 的方案治疗。
结果
在 BENEFIT 中，666 例患者中有 493 例（74%），在 BENEFIT-EXT 中，543 例患者中有 347 例（64%）完成了 2 年的治疗。各组患者有功能移植物存活率相似（BENEFIT：MI 组 94%，LI 组 95%，CsA 组 91%；BENEFIT-EXT：MI 组 83%，LI 组 84%，CsA 组 83%）。贝那普利塞的肾脏益处得到了维持，BENEFIT 研究中贝那普利塞组的肾小球滤过率估算值比 CsA 组高 16-17ml/min，BENEFIT-EXT 研究中高 8-10ml/min。在这两项研究中，1 年到 2 年之间，新的急性排斥反应事件很少。因为 EBV（-）患者的 PTLD 风险最高，所以对 EBV（+）患者进行了疗效分析，结果与总体人群结果一致。在贝那普利塞组，每个研究中在 1 年到 2 年期间都有两例先前报道的 PTLD 病例。安全性和疗效的总体平衡倾向于 LI 方案而非 MI 方案。
结论
在 2 年的随访中，与 CsA 相比，贝那普利塞方案维持了更好的肾功能，患者/移植物存活率相似，改善了心血管/代谢风险谱；在 EBV（+）患者中也观察到了同样的结果。没有出现新的安全信号。
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