Some cytogenetic abnormalities (CAs) are associated with poorer prognosis in multiple myeloma (MM); proteasome inhibitors appear to benefit patients with high-risk CAs. We evaluated 2247 MM patients from the TOURMALINE-MM1/-MM2/-MM3/-MM4 trials to assess the PFS benefit of ixazomib plus lenalidomide-dexamethasone (Rd) vs placebo-Rd (TOURMALINE-MM1/-MM2) or ixazomib vs placebo (TOURMALINE-MM3/-MM4) in specific high-risk CAs. After a pooled median follow-up of 25.6 months, the hazard ratio (HR) for PFS with ixazomib- vs placebo-based therapy for high-risk patients was 0.74 (95% confidence interval [CI]: 0.59–0.93; median PFS [mPFS] 17.8 vs 13.2 months), and 0.70 (95% CI: 0.62–0.80; mPFS 26.3 vs 17.6 months) for complementary standard-risk patients. The HR for expanded high-risk patients was 0.75 (95% CI: 0.64–0.87; mPFS 18.1 vs 14.1 months), and 0.71 (95% CI: 0.59–0.85; mPFS 36.1 vs 21.4 months) for complementary standard-risk patients. The HR for PFS with ixazomib- vs placebo-based therapy was 0.68 in patients with t(4;14) (95% CI: 0.48–0.96; mPFS 22.4 vs 13.2 months), and 0.77 for patients with amp1q21 (95% CI: 0.63–0.93; mPFS 18.8 vs 14.5 months). A PFS benefit was demonstrated with ixazomib- vs placebo-based therapy regardless of cytogenetic status, with greatest benefit observed in patients with t(4;14) and amp1q21.
某些细胞遗传学异常（CAs）与多发性骨髓瘤（MM）的不良预后相关；蛋白酶体抑制剂似乎对高危CAs患者有益。我们评估了来自TOURMALINE-MM1/-MM2/-MM3/-MM4试验的2247例MM患者，以评估伊沙佐米联合来那度胺-地塞米松（Rd）对比安慰剂-Rd（TOURMALINE-MM1/-MM2）或伊沙佐米对比安慰剂（TOURMALINE-MM3/-MM4）在特定高危CAs中对无进展生存期（PFS）的益处。经过中位25.6个月的汇总随访后，高危患者接受基于伊沙佐米的治疗对比基于安慰剂的治疗的PFS风险比（HR）为0.74（95%置信区间[CI]：0.59–0.93；中位PFS为17.8个月对比13.2个月），而互补性标危患者为0.70（95% CI：0.62–0.80；中位PFS为26.3个月对比17.6个月）。扩展高危患者的HR为0.75（95% CI：0.64–0.87；中位PFS为18.1个月对比14.1个月），而互补性标危患者为0.71（95% CI：0.59–0.85；中位PFS为36.1个月对比21.4个月）。对于携带t(4;14)的患者，基于伊沙佐米的治疗对比基于安慰剂的治疗的PFS HR为0.68（95% CI：0.48–0.96；中位PFS为22.4个月对比13.2个月）；对于amp1q21患者为0.77（95% CI：0.63–0.93；中位PFS为18.8个月对比14.5个月）。无论细胞遗传学状态如何，基于伊沙佐米的治疗均显示出PFS获益，其中在携带t(4;14)和amp1q21的患者中观察到最大获益。
肿瘤(癌症)患者之家