Barlogie Bart, Shaughnessy John D
Myeloma Institute for Research and Therapy, USA.
Int J Hematol. 2002 Aug;76 Suppl 1:337-9. doi: 10.1007/BF03165280.
Long-term follow-up on Total Therapy I revealed, with a median follow-up of about 10 years, median durations of event-free survival (EFS) and overall survival (OS) of 37 and 80 mos in the 88% of patients lacking cytogenetic abnormalities (CA) of chromosome 13 compared to only 28 and 34 mos in those with CA 13. Total Therapy II (TT II) was developed to test whether more intensive remission induction and post-tandem transplant consolidation chemotherapy prior to interferon maintenance could further improve clinical outcome. All patients were also randomized to +/- thalidomide at a starting dose of 400 mg. Results obtained in the first 231 patients enrolled in TT II are presented for the two study arms combined (data for effect of thalidomide still blinded). Three-year projection of EFS and OS are 71% and 77%. On an intent-to-treat basis, 66% achieved complete remission (CR) or near-CR. Major independent adverse features associated with shortened survival included CA and chromosome 13 deletion using interphase FISH. CA identified 29 among 102 patients with FISH 13 deletion who had a very grave prognosis (3 yr EFS, 32%; OS 49%) compared to all remaining patients who enjoyed 3 yr EFS of 79% and OS of 83%. Thus, both cytogenetics and FISH are recommended in the initial evaluation of patients with MM.
对全程疗法I的长期随访显示，中位随访时间约为10年，在88%缺乏13号染色体细胞遗传学异常（CA）的患者中，无事件生存期（EFS）和总生存期（OS）的中位持续时间分别为37个月和80个月，相比之下，有13号染色体CA的患者中这两个数值仅为28个月和34个月。全程疗法II（TT II）旨在测试在干扰素维持治疗之前，更强化的缓解诱导和串联移植后巩固化疗是否能进一步改善临床结果。所有患者还被随机分为起始剂量400mg沙利度胺的加用或不用组。本文展示了纳入TT II的前231例患者在两个研究组合并后的结果（沙利度胺效果的数据仍处于盲态）。EFS和OS的三年预测值分别为71%和77%。在意向性治疗基础上，66%的患者实现了完全缓解（CR）或接近CR。与生存期缩短相关的主要独立不良特征包括使用间期荧光原位杂交（FISH）检测到的CA和13号染色体缺失。在102例FISH检测到13号染色体缺失的患者中，有29例被鉴定为CA，其预后极差（3年EFS为32%；OS为49%），相比之下，其余所有患者的3年EFS为79%，OS为83%。因此，在多发性骨髓瘤患者的初始评估中，推荐同时进行细胞遗传学和FISH检测。
