Beck Juliane, Schwarzer Andreas, Gläser Dietrich, Mügge Lars-Olof, Uhlig Jens, Heyn Simone, Kragl Brigitte, Mohren Martin, Hoffmann Franz Albert, Lange Thoralf, Schliwa Thomas, Zehrfeld Thomas, Becker Cornelia, Kreibich Ute, Winkelmann Cornelia, Edelmann Thomas, Andrea Marc, Bill Marius, Jentzsch Madlen, Schwind Sebastian, Niederwieser Dietger, Pönisch Wolfram
Department of Haematology and Oncology, University of Leipzig, Johannisallee 32A, 04103, Leipzig, Germany.
Haematology Practice, Strümpelstrasse 41, Leipzig, Germany.
J Cancer Res Clin Oncol. 2017 Dec;143(12):2545-2553. doi: 10.1007/s00432-017-2504-5. Epub 2017 Aug 21.
While lenalidomide monotherapy is established for relapsed and/or refractory multiple myeloma (MM) treatment, combination therapies including lenalidomide are still under investigation in a number of phase 2/3 studies. In the current study, a treatment regime of lenalidomide (Revlimid), bendamustine and prednisolone (RBP) was tested in patients with relapsed/refractory MM.
In the previously completed phase 1 study RBP with a dose of 75 mg/m bendamustine days 1-2, prednisolone 100 mg days 1-4 and 25 mg lenalidomide days 1-21 was well tolerated.
Between July 2011 and September 2013, 25 patients were included in this analysis. The median number of previous treatments was 1 (range 1-2). Twenty-two patients (88%) responded after at least two cycles of RBP (one sCR, five nCR, eight VGPR and eight PR). The median time to first haematological response was 28 days, and median time to best response was 56 days. Due to increased haematological toxicity a dose reduction in most patients required in subsequent cycles of therapy. The median progression-free and overall survival was 22 and 38 months, respectively. In conclusion RBP is a highly effective therapy for patients with relapsed/refractory MM. In contrast to our phase 1 study, dose reduction was necessary in many patients because of haematological toxicity.
虽然来那度胺单药疗法已被确立用于复发和/或难治性多发性骨髓瘤（MM）的治疗，但包括来那度胺在内的联合疗法仍在多项2/3期研究中进行调查。在本研究中，对复发/难治性MM患者测试了来那度胺（瑞复美）、苯达莫司汀和泼尼松龙（RBP）的治疗方案。
在先前完成的1期研究中，RBP方案（第1 - 2天给予75mg/m²苯达莫司汀、第1 - 4天给予100mg泼尼松龙、第1 - 21天给予25mg来那度胺）耐受性良好。
在2011年7月至2013年9月期间，25例患者纳入本分析。既往治疗的中位数为1次（范围1 - 2次）。22例患者（88%）在至少两个周期的RBP治疗后有反应（1例严格完全缓解、5例完全缓解、8例非常好的部分缓解和8例部分缓解）。首次血液学反应的中位时间为28天，最佳反应的中位时间为56天。由于血液学毒性增加，在后续治疗周期中大多数患者需要降低剂量。无进展生存期和总生存期的中位数分别为22个月和38个月。总之，RBP是复发/难治性MM患者的一种高效疗法。与我们的1期研究不同，由于血液学毒性，许多患者有必要降低剂量。
