Abstract：
OBJECTIVE: To analyze the impact of prior therapies on outcomes with selinexor, bortezomib, and dexamethasone (SVd) versus bortezomib and dexamethasone (Vd) in 402 patients with relapsed/refractory multiple myeloma (RRMM) in the phase 3 BOSTON trial.
METHODS: Post hoc analysis of progression-free survival (PFS), overall survival (OS), and safety for lenalidomide-refractory, proteasome inhibitor (PI)-naïve, bortezomib-naïve, and one prior line of therapy (1LOT) patient subgroups.
RESULTS: At a median follow-up of over 28 months, clinically meaningful improvements in PFS were noted across all groups with SVd. The median SVd PFS was longer in all subgroups (lenalidomide-refractory: 10.2 vs. 7.1 months, PI-naïve: 29.5 vs. 9.7; bortezomib-naïve: 29.5 vs. 9.7; 1LOT: 21.0 vs. 10.7; p < .05). The lenalidomide-refractory subgroup had longer OS with SVd (26.7 vs. 18.6 months; HR 0.53; p = .015). In all subgroups, overall response and ≥very good partial response rates were higher with SVd. The manageable safety profile of SVd was similar to the overall patient population.
CONCLUSIONS: With over 2 years of follow-up, these clinically meaningful outcomes further support the use of SVd in patients who are lenalidomide-refractory, PI-naïve, bortezomib-naïve, or who received 1LOT (including a monoclonal antibody) and underscore the observed synergy between selinexor and bortezomib.
METHODS: Post hoc analysis of progression-free survival (PFS), overall survival (OS), and safety for lenalidomide-refractory, proteasome inhibitor (PI)-naïve, bortezomib-naïve, and one prior line of therapy (1LOT) patient subgroups.
RESULTS: At a median follow-up of over 28 months, clinically meaningful improvements in PFS were noted across all groups with SVd. The median SVd PFS was longer in all subgroups (lenalidomide-refractory: 10.2 vs. 7.1 months, PI-naïve: 29.5 vs. 9.7; bortezomib-naïve: 29.5 vs. 9.7; 1LOT: 21.0 vs. 10.7; p < .05). The lenalidomide-refractory subgroup had longer OS with SVd (26.7 vs. 18.6 months; HR 0.53; p = .015). In all subgroups, overall response and ≥very good partial response rates were higher with SVd. The manageable safety profile of SVd was similar to the overall patient population.
CONCLUSIONS: With over 2 years of follow-up, these clinically meaningful outcomes further support the use of SVd in patients who are lenalidomide-refractory, PI-naïve, bortezomib-naïve, or who received 1LOT (including a monoclonal antibody) and underscore the observed synergy between selinexor and bortezomib.
摘要：
目的：分析既往治疗对selinexor结局的影响，硼替佐米,在3期BOSTON试验的402例复发/难治性多发性骨髓瘤（RRMM）患者中，地塞米松（SVd）与硼替佐米和地塞米松（Vd）的比较。
方法：无进展生存期（PFS）的事后分析，总生存期（OS），来那度胺难治性的安全性，蛋白酶体抑制剂（PI）-幼稚，硼替佐米-天真的，和一个先前的治疗线（1LOT）患者亚组。
结果：中位随访时间超过28个月，在所有使用SVd的组中,PFS均有临床意义的改善.所有亚组的中位SVdPFS均更长（来那度胺难治性：10.2vs.7.1个月,PI天真的：29.5vs.9.7；硼替佐米天真：29.5vs.9.7；1LOT：21.0与10.7；p<.05）。来那度胺难治性亚组的SVdOS更长（26.7vs.18.6个月；HR0.53；p=.015）。在所有子组中，SVd组的总体缓解率和≥非常好的部分缓解率较高.SVd的可管理安全性与总体患者群体相似。
结论：经过2年以上的随访，这些有临床意义的结果进一步支持来那度胺难治性患者使用SVd,PI-天真的，硼替佐米-天真的，或谁接受了1LOT（包括单克隆抗体），并强调观察到的selinexor和硼替佐米之间的协同作用。
方法：无进展生存期（PFS）的事后分析，总生存期（OS），来那度胺难治性的安全性，蛋白酶体抑制剂（PI）-幼稚，硼替佐米-天真的，和一个先前的治疗线（1LOT）患者亚组。
结果：中位随访时间超过28个月，在所有使用SVd的组中,PFS均有临床意义的改善.所有亚组的中位SVdPFS均更长（来那度胺难治性：10.2vs.7.1个月,PI天真的：29.5vs.9.7；硼替佐米天真：29.5vs.9.7；1LOT：21.0与10.7；p<.05）。来那度胺难治性亚组的SVdOS更长（26.7vs.18.6个月；HR0.53；p=.015）。在所有子组中，SVd组的总体缓解率和≥非常好的部分缓解率较高.SVd的可管理安全性与总体患者群体相似。
结论：经过2年以上的随访，这些有临床意义的结果进一步支持来那度胺难治性患者使用SVd,PI-天真的，硼替佐米-天真的，或谁接受了1LOT（包括单克隆抗体），并强调观察到的selinexor和硼替佐米之间的协同作用。
