This FIRST trial final analysis examined survival outcomes in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM) treated with lenalidomide and low-dose dexamethasone until disease progression (Rd continuous), Rd for 72 weeks (18 cycles; Rd18), or melphalan, prednisone, and thalidomide (MPT; 72 weeks). The primary endpoint was progression-free survival (PFS; primary comparison: Rd continuous vs MPT). Overall survival (OS) was a key secondary endpoint (final analysis prespecified ≥60 months' follow-up). Patients were randomized to Rd continuous (n = 535), Rd18 (n = 541), or MPT (n = 547). At a median follow-up of 67 months, PFS was significantly longer with Rd continuous vs MPT (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.59-0.79; P < .00001) and was similarly extended vs Rd18. Median OS was 10 months longer with Rd continuous vs MPT (59.1 vs 49.1 months; HR, 0.78; 95% CI, 0.67-0.92; P = .0023), and similar with Rd18 (62.3 months). In patients achieving complete or very good partial responses, Rd continuous had an ≈30-month longer median time to next treatment vs Rd18 (69.5 vs 39.9 months). Over half of all patients who received second-line treatment were given a bortezomib-based therapy. Second-line outcomes were improved in patients receiving bortezomib after Rd continuous and Rd18 vs after MPT. No new safety concerns, including risk for secondary malignancies, were observed. Treatment with Rd continuous significantly improved survival outcomes vs MPT, supporting Rd continuous as a standard of care for patients with transplant-ineligible NDMM. This trial was registered at www.clinicaltrials.gov as #NCT00689936 and EudraCT as 2007-004823-39.

中文翻译：

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随机 3 期 FIRST 试验中生存结果的最终分析

这项 FIRST 试验最终分析检查了不适合移植的新诊断多发性骨髓瘤 (NDMM) 患者的生存结果，这些患者接受来那度胺和低剂量地塞米松治疗直至疾病进展（Rd 连续）、Rd 72 周（18 个周期；Rd18）或美法仑、泼尼松和沙利度胺（MPT；72 周）。主要终点是无进展生存期（PFS；主要比较：Rd 连续 vs MPT）。总生存期 (OS) 是一个关键的次要终点（最终分析预设≥60 个月的随访）。患者被随机分配到 Rd 连续 (n = 535)、Rd18 (n = 541) 或 MPT (n = 547)。在 67 个月的中位随访中，Rd 连续与 MPT 的 PFS 显着更长（风险比 [HR]，0.69；95% 置信区间 [CI]，0.59-0.79；P < .00001），并且与路 18. Rd 连续与 MPT 的中位 OS 长 10 个月（59.1 与 49.1 个月；HR，0.78；95% CI，0.67-0.92；P = .0023），与 Rd18 相似（62.3 个月）。在实现完全或非常好的部分反应的患者中，Rd 连续与 Rd18 相比，下一次治疗的中位时间长约 30 个月（69.5 个月对 39.9 个月）。接受二线治疗的所有患者中有一半以上接受了基于硼替佐米的治疗。接受硼替佐米治疗的患者在 Rd 连续治疗和 Rd18 治疗后与 MPT 治疗后的二线结局相比有所改善。没有观察到新的安全问题，包括继发性恶性肿瘤的风险。与 MPT 相比，Rd 连续治疗显着改善了生存结果，支持将 Rd 连续治疗作为不适合移植的 NDMM 患者的护理标准。该试验在 www.clinicaltrials 注册。