Cedars Sinai Cancer Center, Los Angeles, CA, USA.
SWOG Statistical Center, Seattle, WA, USA.
Blood Cancer J. 2020 May 11;10(5):53. doi: 10.1038/s41408-020-0311-8.
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.
SWOG S0777 是一项随机 III 期临床试验，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）。此次更新分析纳入了 460 例可评估生存终点的患者：225 例符合条件且可分析的患者被随机分配至 Rd 组，235 例被分配至 VRd 组。所有患者均接受 6 个月的诱导治疗，即 Rd 治疗 6 个 28 天周期和 VRd 治疗 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 的中位 PFS 为 41 个月，Rd 的中位 PFS 为 29 个月：分层风险比（96% Wald 置信区间）为 0.742（0.594，0.928），单侧分层对数秩检验 P 值为 0.003。VRd 的中位 OS 仍未达到，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。在调整年龄因素后，VRd 与 Rd 相比，PFS（P 值：0.013）和 OS（P 值：0.033）均有改善。Rd 维持治疗的中位持续时间为 17.1 个月。硼替佐米联合来那度胺和地塞米松用于诱导治疗可显著改善 PFS，并带来更好的 OS。无论年龄大小，VRd 均代表一种适当的治疗标准。
