Outcomes with two different schedules of bortezomib, melphalan, and prednisone (VMP) for previously untreated multiple myeloma: matched pair analysis using long-term follow-up data from the phase 3 VISTA and PETHEMA/GEM05 trials
Outcomes with two different schedules of bortezomib, melphalan, and prednisone (VMP) for previously untreated multiple myeloma: matched pair analysis using long-term follow-up data from the phase 3 VISTA and PETHEMA/GEM05 trials
复制标题
DOI：
10.1007/s00277-016-2835-3
复制
发表时间：
2016-12-01
影响因子：
3.5
通讯作者：
San Miguel, Jesus
中科院分区：
文献类型：
--
作者：
Mateos, Maria-Victoria;Oriol, Albert;San Miguel, Jesus
硼替佐米-美法仑-泼尼松（VMP）是既往未经治疗、不适合移植的多发性骨髓瘤（MM）的标准治疗。在这里，我们比较了VISTA试验（9个周期的VMP方案，包括4个周期的每周两次硼替佐米）和PETHEMA/GEM 05试验（强度较低的6个周期的VMP方案，其中1个周期为每周两次，5个周期为每周一次硼替佐米，然后是基于硼替佐米的维持治疗）中VMP方案之间的结局。本回顾性分析共纳入了113对按倾向评分匹配的患者对（使用逻辑回归估计，并纳入8个暴露/结局相关参数）。PETHEMA/GEM 05中的中位累积硼替佐米剂量高于VISTA（49.6 vs 37.0 mg/m2）;中位剂量强度较低（2.0 vs 5.1 mg/m2/月）。在中位随访77.2个月和26.0个月后，PETHEMA/GEM 05的中位无进展生存期（PFS）和至进展时间（TTP）显著长于VISTA（PFS，30.5 vs 20.0个月，p = 0.0265; TTP，33.8 vs 24.2个月，p = 0.0049）。中位总生存期（OS）相似（61.3 vs 61.0个月，p = 0.6528;中位随访期，77.6 vs 60.1个月）。PETHEMA/GEM 05的诱导后完全缓解率低于VISTA（19 vs 31%; p = 0.03318）;研究期间（包括维持治疗）的完全缓解率相似（30 vs 31%; p = 0.89437）。该分析表明，与VISTA VMP方案相比，强度较低的PETHEMA/GEM 05 VMP方案加维持治疗可能改善PFS和TTP，但不改善OS。NCT 00111319，NCT 00443235。
Bortezomib-melphalan-prednisone (VMP) is a standard-of-care for previously untreated, transplant-ineligible multiple myeloma (MM). Here, we compared outcomes between VMP regimens in the VISTA trial (9-cycle VMP schedule, including 4 cycles of twice weekly bortezomib) and the PETHEMA/GEM05 trial (less intensive 6-cycle VMP schedule with 1 cycle of twice weekly and 5 cycles of weekly bortezomib, then bortezomib-based maintenance). A total of 113 patient pairs matched by propensity score (estimated using logistic regression and incorporating eight exposure/outcome-related parameters) were included in this retrospective analysis. Median cumulative bortezomib dose was higher in PETHEMA/GEM05 than VISTA (49.6 vs 37.0 mg/m(2)); median dose intensity was lower (2.0 vs 5.1 mg/m(2)/month). Median progression-free survival (PFS) and time-to-progression (TTP) were significantly longer in PETHEMA/GEM05 than VISTA (PFS, 30.5 vs 20.0 months, p = 0.0265; TTP, 33.8 vs 24.2 months, p = 0.0049) after a median follow-up of 77.2 and 26.0 months, respectively. Median overall survival (OS) was similar (61.3 vs 61.0 months, p = 0.6528; median follow-up, 77.6 vs 60.1 months). Post-induction complete response rate was lower in PETHEMA/GEM05 than VISTA (19 vs 31 %; p = 0.03318); on-study (including maintenance) rate was similar (30 vs 31 %; p = 0.89437). This analysis suggests that the less-intensive PETHEMA/GEM05 VMP regimen plus maintenance may improve PFS and TTP, but not OS, compared with the VISTA VMP regimen.NCT00111319, NCT00443235.