Morrison Vicki A, Jung Sin-Ho, Johnson Jeffrey, LaCasce Ann, Blum Kristie A, Bartlett Nancy L, Pitcher Brandelyn N, Cheson Bruce D
University of Minnesota and VAMC , Minneapolis, MN , USA.
Leuk Lymphoma. 2015 Apr;56(4):958-64. doi: 10.3109/10428194.2014.938333. Epub 2014 Aug 13.
Cancer and Leukemia Group B designed a phase II trial of lenalidomide + bortezomib for relapsed/refractory mantle cell lymphoma (MCL). Induction therapy was lenalidomide (days 1-14) plus bortezomib (days 1/4/8/11), every 21 days for eight cycles. Complete/partial responders (CR, PR) received maintenance lenalidomide (days 1-14) and bortezomib (days 1/8), every 21 days. Primary endpoint was overall response rate; secondary endpoints were CR rate, progression-free (PFS), event-free (EFS) and overall survival (OS). Fifty-three eligible patients, median age 67 years, were accrued. Median number of cycles received was 4 (range, 1-82). Median followup was 46 (range, 12-67) months. Best response was CR 15%, PR 25%. 5/8 CR, and 4/13 PR patients received maintenance. Six CR and one PR patient remain in remission (median, 3.2 years). Thirty-three (62%) patients have died. One-year PFS, EFS and OS are 40%, 25% and 68%, respectively. This combination will not be pursued further.
癌症与白血病B组设计了一项来那度胺+硼替佐米用于复发/难治性套细胞淋巴瘤（MCL）的II期试验。诱导治疗为来那度胺（第1 - 14天）加硼替佐米（第1/4/8/11天），每21天为一个周期，共八个周期。完全/部分缓解者（CR，PR）接受维持治疗，来那度胺（第1 - 14天）和硼替佐米（第1/8天），每21天一次。主要终点为总缓解率；次要终点为CR率、无进展生存期（PFS）、无事件生存期（EFS）和总生存期（OS）。共纳入53例符合条件的患者，中位年龄67岁。接受的周期数中位数为4（范围1 - 82）。中位随访时间为46（范围12 - 67）个月。最佳缓解为CR 15%，PR 25%。5/8例CR患者和4/13例PR患者接受了维持治疗。6例CR患者和1例PR患者仍处于缓解状态（中位时间3.2年）。33例（62%）患者死亡。1年的PFS、EFS和OS分别为40%、25%和68%。此联合方案将不再进一步研究。
