文章：

随机III期SWOG S0777试验的长期随访：硼替佐米、来那度胺和地塞米松对比来那度胺和地塞米松治疗既往未治且未计划立即行自体干细胞移植（ASCT）的多发性骨髓瘤患者（Pts）

Longer term follow-up of the randomized phase III trial SWOG S0777: bortezomib, lenalidomide and dexamethasone vs. lenalidomide and dexamethasone in patients (Pts) with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT)

原文发布日期：2020-05-11

DOI: 10.1038/s41408-020-0311-8

类型: Article

开放获取: 是

英文摘要：

SWOG S0777, a randomized phase III trial, compared bortezomib, lenalidomide and dexamethasone (VRd) with lenalidomide and dexamethasone (Rd). This updated analysis includes 460 patients evaluable for survival endpoints: 225 eligible and analyzable patients were randomized to Rd and 235 to VRd. The 6-month induction was six 28-day cycles of Rd and eight 21-day cycles of VRd followed by Rd maintenance for all patients. Median follow up is 84 months. Median PFS is 41 months for VRd and 29 months for Rd: stratified hazard ratio (96% Wald Confidence Interval) was 0.742 (0.594, 0.928) and one-sided stratified log-rank P-value 0.003. Median OS for VRd is still not reached with median OS for Rd being 69 months: stratified hazard ratio (96% Wald Confidence Interval) was 0.709 (0.543, 0.926) and stratified two-sided P-value was 0.0114. Both PFS and OS were improved with VRd versus Rd adjusting for age (P-values: 0.013 [PFS]; 0.033 [OS])). Median duration of Rd maintenance was 17.1 months. The addition of bortezomib to lenalidomide dexamethasone for induction therapy results in a statistically significant and clinically meaningful improvement in PFS as well as better OS. VRd continues to represent an appropriate standard of care irrespective of age.
 

摘要翻译： 

SWOG S0777是一项随机III期临床试验，对比了硼替佐米、来那度胺和地塞米松（VRd）与来那度胺和地塞米松（Rd）的治疗方案。本次更新分析共纳入460例可评估生存终点的患者：其中225例符合条件且可分析的患者随机分配至Rd组，235例分配至VRd组。6个月诱导治疗阶段，Rd组为6个28天周期，VRd组为8个21天周期，随后所有患者均接受Rd维持治疗。中位随访时间为84个月。VRd组中位无进展生存期（PFS）为41个月，Rd组为29个月：分层风险比（95% Wald置信区间）为0.742（0.594, 0.928），单侧分层对数秩检验P值为0.003。VRd组中位总生存期（OS）尚未达到，Rd组中位OS为69个月：分层风险比（95% Wald置信区间）为0.709（0.543, 0.926），双侧分层P值为0.0114。经年龄校正后，VRd组在PFS和OS方面均优于Rd组（P值分别为0.013[PFS]和0.033[OS]）。Rd维持治疗的中位持续时间为17.1个月。在来那度胺+地塞米松诱导治疗方案中加入硼替佐米，可显著改善PFS并提高OS，兼具统计学显著性与临床意义。无论年龄如何，VRd方案始终是合适的标准治疗方案。

原文链接：

Longer term follow-up of the randomized phase III trial SWOG S0777: bortezomib, lenalidomide and dexamethasone vs. lenalidomide and dexamethasone in patients (Pts) with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT)