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)
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)
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DOI：
10.1038/s41408-020-0311-8
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发表时间：
2020-05-11
影响因子：
12.8
通讯作者：
Barlogie, Bart
中科院分区：
文献类型：
--
作者：
Durie, Brian G. M.;Hoering, Antje;Barlogie, Bart
SWOG S 0777是一项随机III期试验，比较了硼替佐米、来那度胺和地塞米松（VRd）与来那度胺和地塞米松（Rd）。该更新分析包括460例可评价生存终点的患者：225例合格且可分析的患者随机分配至Rd组，235例随机分配至VRd组。所有患者的6个月诱导期为6个28天周期的Rd和8个21天周期的VRd，随后为Rd维持。中位随访时间为84个月。VRd的中位PFS为41个月，Rd为29个月：分层风险比（96% Wald置信区间）为0.742（0.594，0.928），单侧分层对数秩P值0.003。仍未达到VRd的中位OS，Rd的中位OS为69个月：分层风险比（96% Wald置信区间）为0.709（0.543，0.926），分层双侧P值为0.0114。与根据年龄调整的Rd相比，VRd改善了PFS和OS（P值：0.013 [PFS]; 0.033 [OS]）。Rd维持的中位持续时间为17.1个月。在来那度胺地塞米松的诱导治疗中添加硼替佐米可导致PFS统计学显著性和临床意义的改善以及更好的OS。无论年龄如何，VRd仍然代表适当的标准治疗。
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.