Four-Year Outcomes of First-Line Nivolumab Plus Ipilimumab for 6 Months Versus Continuation in Patients With Advanced NSCLC: Results of the Randomized IFCT-1701 "DICIPLE" Phase III Trial.

We evaluated 6-month nivolumab-ipilimumab (Nivo-Ipi) in patients with disease control (DC).

我们评估了在疾病得到控制（DC）的患者中使用6个月的纳武单抗-伊匹木单抗（Nivo-Ipi）的疗效。

Methods

This randomized, open-label, noninferiority trial enrolled treatment-naive patients with metastatic NSCLC (aged 18-75 y, Eastern Cooperative Oncology Group performance status 0-1, no actionable genomic alterations).

这项随机、开放标签、非劣效试验招募了接受治疗的转移性非小细胞肺癌患者（年龄在18-75岁之间，东部肿瘤协作组表现状态为0-1，没有可采取的基因组改变）。

After 6-month induction treatment with Nivo (3 mg/kg biweekly) plus Ipi (1 mg/kg every 6 wk), patients with DC were randomized to continue treatment or stop and resume at disease progression.

经过6个月的诱导治疗，使用Nivo（每两周3 mg/kg）加上Ipi（每6周1 mg/kg），疾病控制（DC）的患者被随机分配继续治疗或停止并在疾病进展时恢复治疗。

The primary outcome was progression-free survival(PFS).

主要结果指标为无进展生存期（PFS）。

Results

Among 265 patients enrolled, 71 were randomized to the continuation control arm (n = 36) or to the experimental arm (n = 35), with trial premature interruption because of the lack of European filing for the immunotherapy combination.

在纳入的265名患者中，有71名被随机分配到持续对照组（n = 36）或实验组（n = 35），由于免疫疗法组合缺乏欧洲上市申请，试验被迫提前中断。

Median PFS follow-up was 47.8 months (95% confidence interval[CI]: 43.1-51.0).

中位无进展生存期随访时间为47.8个月（95%置信区间[CI]: 43.1-51.0）。

In the per-protocol population, median PFS was 18.7 months (95% CI: 7.1-37.1) in the continuation arm versus not reached (NR) (95% CI: 16.1-NR) in the experimental arm.

在符合方案的人群中，继续治疗组的中位无进展生存期为18.7个月（95%置信区间[CI]: 7.1-37.1），而实验组的中位无进展生存期未达到（NR）（95%置信区间[CI]: 16.1-NR）。

Median OS was 55.5 months (95% CI: 32.4-NR) in the continuation arm versus NR in the experimental group.

在继续治疗组中，中位总生存期为55.5个月（95%置信区间：32.4-未达到），而在实验组中为未达到。

The 18-month OS was 80.6% (95% CI: 63.5-90.2) and 93.8% (95% CI: 77.3-98.4), respectively.

18个月的总生存率分别为80.6%（95%置信区间：63.5-90.2）和93.8%（95%置信区间：77.3-98.4）。

Grade 3 to 5 treatment-related adverse eventrates were higher in the continuation arm (54.3% versus 23.5%).

3至5级治疗相关不良事件的发生率在持续治疗组中更高（54.3%对比23.5%）。

Median time until definitive quality-of-life deterioration was 15.5 months (95% CI: 10.0-NR) for the continuation arm but NR in the experimental arm (hazard ratio= 0.36, 95% CI: 0.14-0.92, p = 0.03).

持续治疗组的最终生活质量恶化中位时间为15.5个月（95%置信区间：10.0-未达到），而在实验组中为未达到（风险比=0.36，95%置信区间：0.14-0.92，p=0.03）。

Conclusions

Stopping Nivo-Ipi combination at 6 months in DC patients demonstrated no survival harm at 4 years, reduced severe immune-related adverse events, and delayed quality-of-life deterioration.

在DC患者中，6个月时停止使用Nivo-Ipi联合疗法在4年时未显示生存损害，减少了严重免疫相关不良事件，并延迟了生活质量的恶化。