[ASCO2015]硼替佐米巩固疗法vs观察法治疗新诊断MM的疗效

2015年ASCO年会将于5月29日--6月2日在美国芝加哥召开，6月2日将公布MMY3012和MMY3013联合研究结果，这两项研究比较了硼替佐米巩固疗法和观察法治疗新诊断多发性骨髓瘤的疗效。详情如下。

【背景】

ASCT之后的巩固疗法包括可改善多发性骨髓瘤（MM）患者预后的新药。研究者报道了两项大型随机III期研究的联合结果，研究调查了硼替佐米巩固疗法或观察法治疗新诊断多发性骨髓瘤（NDMM）患者的疗效。

【方法】

MMY3012（NCT00416 273; 222 名患者，年龄≤60岁）和MMY3013（NCT00416 208; 158名患者，年龄61?75岁）研究纳入NDMM患者接受诱导疗法，随后接受ASCT。ASCT 60-120天之后，患者按1:1随机分配接受硼替佐米巩固疗法（1.6 mg/m2，第1, 8, 15, 22天，35天为一疗程，共4个疗程）或观察法。

主要终点是从诱导开始的无进展生存期（PFS）；次要终点包括缓解率，总生存期（OS）和安全性。

【结果】

研究纳入371名患者，中位年龄59岁（35-76岁）；62%的患者为男性，14%/84%为Durie-Salmon II/III期。278名评估细胞遗传学的患者中有37%被分类为高危。

50%的患者接受先前硼替佐米疗法；最常见的诱导疗法为VCD（40%）。其它疗法包括地塞米松/去甲氧基柔红霉素（14%），地塞米松（13%）和VAD（9%）。中位随访42个月，预后如下表。

【结论】

接受硼替佐米巩固疗法的患者缓解≥VGPR的比例高于观察组。PFS显著改善~6个月，但是OS无改善，可能与使用有效挽救疗法相关。从硼替佐米巩固疗法中获益的患者亚组似乎是< VGPR和高危疾病的患者。硼替佐米给药方案通常耐受性良好。

英文摘要：

Results from two phase III studies of bortezomib (BTZ) consolidation vs observation (OBS) post-transplantin patients (pts) with newly diagnosed multiple myeloma (NDMM).（AbstractNo: 8511）

Session Type：Oral Abstract Session

Background: Following ASCT, consolidation therapy including novel agents can improve outcomes in pts with MM. Here we report the combined outcomes of two large randomized phase III studies investigating BTZ consolidation or OBS in pts with NDMM.

Methods: MMY3012 (NCT00416273; 222 pts aged ≤ 60yrs) and MMY3013 (NCT00416208; 158 pts aged 61?75 yrs) recruited adults with NDMM who underwent induction therapy followed by ASCT. Pts were randomized 1:1 to receive BTZ consolidation (1.6 mg/m2 days 1, 8, 15, 22; 4 x 35-day cycles) or OBS, 60?120days after ASCT. Primary endpoint was progression-free survival (PFS) fromstart of induction; secondary endpoints included response rate, overall survival(OS), and safety.

Results: In 371 pts, median age was 59 yrs (35?76); 62% were male, 14%/84% were Durie-Salmon stage II / III. 37% of the 278 pts assessed for cytogenetics were classified as high-risk. 50% of pts had received prior BTZ; the most common induction regimen was VCD (40%). Others included dexamethasone/idarubicin (14%), dexamethasone (13%), and VAD (9%). Outcomes are shown in the table (median follow-up 42 mos).

Conclusions: A higher proportion of pts had a response of ≥ VGPR after BTZ consolidation than OBS. PFS was significantly improved by ~6 mos, but there was no improvement in OS, likely related to the use of effective salvage options. Subgroups that seemed tobenefit from BTZ consolidation were pts with < VGPR and those with high-risk cytogenetics. The BTZ dosing regimen was generally well-tolerated.

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