Barlogie Bart, Anaissie Elias, Haessler Jeffrey, van Rhee Fritz, Pineda-Roman Mauricio, Hollmig Klaus, Alsayed Yazan, Epstein Joshua, Shaughnessy John D, Crowley John
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, USA.
Cancer. 2008 Jul 15;113(2):355-9. doi: 10.1002/cncr.23546.
Complete response (CR) has been considered a necessary although not sufficient early clinical endpoint for extended survival in multiple myeloma.
By using Total Therapy 2 (TT2) clinical outcome data in 668 patients, whether sustained CR (SUS-CR) was potentially a superior surrogate for survival than attaining CR status per se was evaluated.
Compared with not achieving CR (NON-CR) and especially achieving and subsequently losing CR status (LOS-CR) within a 3-year landmark from treatment initiation, SUS-CR was associated with highly superior postlandmark survival (P < .0001). These results were validated in 231 untreated patients enrolled in the predecessor trial, TT1 (hazard ratio [HR] = 0.54, P = .013) and in 1103 previously treated patients on other transplant protocols (HR = 0.49; P < .001).
In all 3 trial settings the survival benefit of SUS-CR was independent of metaphase abnormalities as a dominant adverse parameter. Given its bleak prognosis despite high CR rates, SUS-CR should be evaluated as a primary trial endpoint in high-risk myeloma.
完全缓解（CR）一直被认为是多发性骨髓瘤延长生存期的必要早期临床终点，尽管并非充分条件。
利用668例患者的全疗法2（TT2）临床结局数据，评估持续完全缓解（SUS-CR）是否可能是比单纯达到CR状态更好的生存替代指标。
与未达到CR（NON-CR），特别是在治疗开始后的3年标志性时间内达到CR状态随后又失去CR状态（LOS-CR）相比，SUS-CR与标志性时间后的生存期显著更长相关（P <.0001）。这些结果在前身试验TT1纳入的231例未治疗患者（风险比[HR]=0.54，P = 0.013）和1103例接受其他移植方案治疗的既往治疗患者中得到验证（HR = 0.49；P <.001）。
在所有3种试验环境中，SUS-CR的生存获益与作为主要不良参数的中期异常无关。鉴于尽管CR率很高但其预后不佳，SUS-CR应作为高危骨髓瘤的主要试验终点进行评估。
