Final analysis of the RESONATE-2 study: up to 10 years of follow-up of first-line ibrutinib treatment for CLL/SLL.

Patients aged ≥65 years with previously untreated CLL/SLL without del(17p) were randomly assigned to receive either single-agent ibrutinib (420 mg/d; n = 136) or chlorambucil (0.5-0.8 mg/kg; ≤12 cycles; n = 133).

年龄≥65岁的先前未经治疗的CLL/SLL患者，且没有del(17p)的患者，被随机分配接受单药伊布替尼（420 mg/d; n = 136）或苯丁酸氮芥（0.5-0.8 mg/kg; ≤12周期; n = 133）。

With a median follow-up of 9.6 years in the ibrutinib arm, the median progression-free survival(PFS) was 8.9 years (95% confidence interval[CI], 7.0 to not estimable [NE]) vs 1.3 years (95% CI, 0.9-1.6) for the chlorambucil arm.

在伊布替尼组中位随访9.6年的情况下，中位无进展生存期（PFS）为8.9年（95%置信区间[CI]，7.0至不可估计[NE]），而苯丁酸氮芥组为1.3年（95% CI，0.9-1.6）。

Among patients with unmutated immunoglobulin heavy chain variable (uIGHV), del (11q), mutated TP53, or complex karyotype, the median PFS was 8.4 years (95% CI, 6.8 to NE) with ibrutinib and 0.7 years (95% CI, 0.4-1.2) with chlorambucil.

在未突变免疫球蛋白重链可变区（uIGHV）、del (11q)、突变TP53或复杂核型的患者中，伊布替尼的中位PFS为8.4年（95% CI，6.8至NE），而苯丁酸氮芥为0.7年（95% CI，0.4-1.2）。

Median overall survival(OS) with ibrutinib was not reached.

使用伊布替尼的中位总生存期尚未达到。

The most common adverse events (AEs) of any grade included diarrhea (52%), fatigue (41%), cough (39%), nausea (32%), arthralgia (31%), peripheral edema (31%), and hypertension (30%).

任何级别的不良事件（AEs）中最常见的是腹泻（52％）、疲劳（41％）、咳嗽（39％）、恶心（32％）、关节痛（31％）、周围水肿（31％）和高血压（30％）。

During the entire study period, 34 of 136 patients (25%) had an ibrutinib dose reduction due to AEs; these AEs improved in 30 of 34 patients (88%).

在整个研究期间，136名患者中有34名（25%）因不良事件（AEs）减少了伊布替尼的剂量；在34名患者中，有30名（88%）的不良事件得到了改善。

At study completion, 27% of patients remained on first-line ibrutinib treatment.

研究结束时，有27%的患者仍在接受一线伊布替尼治疗。

This landmark RESONATE-2 study defines median PFS and demonstrates continued OS benefit of first-line ibrutinib treatment for patients with CLL/SLL, including those with high-risk genomic features.

这项具有里程碑意义的RESONATE-2研究定义了无进展生存期（PFS）的中位数，并展示了对于慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）患者，包括那些具有高风险基因组特征的患者，一线使用伊布替尼治疗的持续总生存（OS）获益。

Sustained efficacy and tolerability of ibrutinib reemphasize the favorable benefit-risk profile.

伊布替尼的持续疗效和耐受性再次强调了其有利的效益-风险比。

This trial was registered at www.ClinicalTrials.gov as NCT01722487/NCT01724346.

该试验已在www.ClinicalTrials.gov注册，注册号为NCT01722487/NCT01724346。