Hulin Cyrille, de la Rubia Javier, Dimopoulos Meletios A, Terpos Evangelos, Katodritou Eirini, Hungria Vania, De Samblanx Hadewijch, Stoppa Anne-Marie, Aagesen Jesper, Sargin Deniz, Sioni Anastasia, Belch Andrew, Diels Joris, Olie Robert A, Robinson Don, Potamianou Anna, van de Velde Helgi, Delforge Michel
Service d'Hématologie Hôpital Haut-Lévêque CHU Bordeaux France.
Department of Hematology, Hospital Dr Peset Universidad Católica de Valencia Valencia Spain.
Health Sci Rep. 2018 Dec 7;2(1):e104. doi: 10.1002/hsr2.104. eCollection 2019 Jan.
Studies have shown that bortezomib retreatment is effective in relapsed/refractory multiple myeloma (MM). The observational, prospective electronic VELCADE OBservational Study (eVOBS) study assessed bortezomib-based therapies for patients with MM in everyday practice. Here, we report on those patients receiving retreatment with bortezomib.
Consenting adults scheduled to receive bortezomib for MM were enrolled at 162 sites across Europe, Canada, Brazil, Russia, and Turkey between 2006 and 2010. Retrospective data on prior therapies and prospective observational data after bortezomib initiation were captured electronically at baseline, after every bortezomib cycle, and every 12 weeks after discontinuation or progression. Investigator-assessed responses and adverse events (AEs) were evaluated.
Ninety-six of 873 patients enrolled to eVOBS received bortezomib as first retreatment for progressive disease during the prospective observation period. Median age was 62 years, 53% were male, and median number of prior therapies at retreatment was 4. Overall, 41% of patients initiated bortezomib retreatment in combination with dexamethasone, 16% in combination with lenalidomide, and 21% received monotherapy. Rate of partial response or better (≥PR) was 75% at initial bortezomib therapy, including 44% complete response (CR)/near CR (nCR); at retreatment, ≥PR rate was 46%, including 15% CR/nCR. Median progression-free survival was 11.4 months (95% confidence interval [CI]: 9.1-12.7) from start of initial bortezomib treatment and 6.4 months (95% CI: 4.4-7.2) from start of retreatment. Median overall survival from start of retreatment was 17.6 months (95% CI: 14.4-23.5). Of the 96 patients retreated with bortezomib, 77% reported an AE. Peripheral neuropathy during bortezomib retreatment occurred in 49% of patients, including 10% grade 3/4.
These data suggest that retreatment with bortezomib is a feasible option for patients with relapsed/refractory MM.
研究表明，硼替佐米再次治疗对复发/难治性多发性骨髓瘤（MM）有效。观察性、前瞻性电子万珂观察研究（eVOBS）评估了在日常临床实践中对MM患者采用以硼替佐米为基础的治疗方法。在此，我们报告那些接受硼替佐米再次治疗的患者情况。
2006年至2010年间，计划接受硼替佐米治疗MM的成年受试者在欧洲、加拿大、巴西、俄罗斯和土耳其的162个地点入组。关于既往治疗的回顾性数据以及硼替佐米开始治疗后的前瞻性观察数据在基线时、每个硼替佐米治疗周期后以及停药或病情进展后每12周以电子方式收集。评估研究者评定的缓解情况和不良事件（AE）。
eVOBS研究入组的873例患者中，96例在前瞻性观察期接受硼替佐米作为疾病进展后的首次再次治疗。中位年龄为62岁，53%为男性，再次治疗时既往治疗的中位次数为4次。总体而言，41%的患者开始硼替佐米再次治疗时联合地塞米松，16%联合来那度胺，21%接受单药治疗。初始硼替佐米治疗时部分缓解或更好（≥PR）的比例为75%，包括44%的完全缓解（CR）/接近完全缓解（nCR）；再次治疗时，≥PR比例为46%，包括15%的CR/nCR。从初始硼替佐米治疗开始计算，中位无进展生存期为11.4个月（95%置信区间[CI]：9.1 - 12.7），从再次治疗开始计算为6.4个月（95% CI：4.4 - 7.2）。从再次治疗开始计算的中位总生存期为17.6个月（95% CI：14.4 - 23.5）。在96例接受硼替佐米再次治疗的患者中，77%报告了AE。硼替佐米再次治疗期间49%的患者发生周围神经病变，包括10%的3/4级。
这些数据表明，硼替佐米再次治疗对于复发/难治性MM患者是一种可行的选择。
