Morgan Gareth, Palumbo Antonio, Dhanasiri Sujith, Lee Dawn, Weisel Katja, Facon Thierry, Delforge Michel, Oriol Albert, Zaki Mohamed, Yu Xin, Sternas Lars, Jacques Christian, Akehurst Ron, Offner Fritz, Dimopoulos Meletios A
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Br J Haematol. 2015 Mar;168(6):820-3. doi: 10.1111/bjh.13227. Epub 2014 Nov 18.
In the phase III MM-003 trial, pomalidomide plus low-dose dexamethasone (POM+LoDEX) improved overall survival (OS) versus high-dose dexamethasone (HiDEX) in 455 patients with relapsed and refractory multiple myeloma (RRMM) after treatment with bortezomib and lenalidomide. Here, a two-stage Weibull method was used to adjust for the crossover of patients in the HiDEX arm to pomalidomide-based therapy. The adjusted difference in median OS between patients in the POM+LoDEX and HiDEX arms was 7·0 months (12·7 vs. 5·7 months, respectively). These findings provide important evidence for understanding the clinical efficacy of pomalidomide on OS benefits seen in RRMM patients.
在III期MM - 003试验中，对于455例接受硼替佐米和来那度胺治疗后复发难治性多发性骨髓瘤（RRMM）患者，泊马度胺联合低剂量地塞米松（POM + LoDEX）较之于高剂量地塞米松（HiDEX）改善了总生存期（OS）。在此，采用两阶段威布尔方法对HiDEX组中交叉接受基于泊马度胺治疗的患者进行校正。POM + LoDEX组和HiDEX组患者的校正后中位OS差异为7.0个月（分别为12.7个月和5.7个月）。这些发现为理解泊马度胺对RRMM患者OS获益的临床疗效提供了重要证据。
