本文由小咖机器人翻译整理

期刊来源：N Engl J Med

原文链接：https://doi.org/10.1056/NEJMoa2402604

摘要内容如下：

背景

1-2期试验涉及可切除的肉眼III期黑色素瘤患者，结果显示新辅助免疫治疗比辅助免疫治疗更有效。

方法

在该3期试验中，我们以1:1的比例将可切除的肉眼可见的III期黑色素瘤患者随机分为两组，一组接受两个周期的新辅助ipilimumab联合nivolumab治疗，然后接受手术治疗，另一组接受手术治疗，然后接受12个周期的辅助nivolumab治疗。新辅助组中仅有部分缓解或无缓解的患者接受了后续辅助治疗。主要终点是无事件生存率。

结果

共有423名患者接受了随机分组。中位随访时间为9.9个月，新辅助组估计的12个月无事件生存率为83.7%（99.9%可信区间[CI]，73.8-94.8），辅助组为57.2%（99.9%CI，45.1-72.7）。限制性平均生存时间的差异为8.00个月（99.9%CI，4.94至11.05；P<0.001；进展、复发或死亡的风险比为0.32；99.9%置信区间，0.15至0.66）。在新辅助治疗组中，59.0%的患者出现主要病理反应，8.0%的患者出现部分反应，26.4%的患者无反应（>50%的肿瘤残留），2.4%的患者出现进展；在4.2%的患者中，手术尚未进行或被省略。在新辅助治疗组中，有主要病理反应的患者估计的12个月无复发生存率为95.1%，有部分反应的患者为76.1%，无反应的患者为57.0%。与全身治疗相关的3级或更高级别的不良事件在新辅助组中的发生率为29.7%，在辅助组中的发生率为14.7%。

结论

在可切除的、肉眼可见的III期黑色素瘤患者中，新辅助ipilimumab联合nivolumab，随后进行手术和反应驱动的辅助治疗，与手术后辅助nivolumab相比，无事件生存期更长。（由Bristol Myers Squibb和其他公司资助；Nadina ClinicalTrials.gov编号，NCT04949113。）

英文原文如下：

Abstracts

BACKGROUND  Phase 1-2 trials involving patients with resectable, macroscopic stage III melanoma have shown that neoadjuvant immunotherapy is more efficacious than adjuvant immunotherapy.

METHODS  In this phase 3 trial, we randomly assigned patients with resectable, macroscopic stage III melanoma, in a 1:1 ratio, to receive two cycles of neoadjuvant ipilimumab plus nivolumab and then undergo surgery or to undergo surgery and then receive 12 cycles of adjuvant nivolumab. Only the patients in the neoadjuvant group who had a partial response or nonresponse received subsequent adjuvant treatment. The primary end point was event-free survival.

RESULTS  A total of 423 patients underwent randomization. At a median follow-up of 9.9 months, the estimated 12-month event-free survival was 83.7% (99.9% confidence interval [CI], 73.8 to 94.8) in the neoadjuvant group and 57.2% (99.9% CI, 45.1 to 72.7) in the adjuvant group. The difference in restricted mean survival time was 8.00 months (99.9% CI, 4.94 to 11.05; P<0.001; hazard ratio for progression, recurrence, or death, 0.32; 99.9% CI, 0.15 to 0.66). In the neoadjuvant group, 59.0% of the patients had a major pathological response, 8.0% had a partial response, 26.4% had a nonresponse (>50% residual viable tumor), and 2.4% had progression; in 4.2%, surgery had not yet been performed or was omitted. The estimated 12-month recurrence-free survival was 95.1% among patients in the neoadjuvant group who had a major pathological response, 76.1% among those who had a partial response, and 57.0% among those who had a nonresponse. Adverse events of grade 3 or higher that were related to systemic treatment occurred in 29.7% of the patients in the neoadjuvant group and in 14.7% in the adjuvant group.

CONCLUSIONS  Among patients with resectable, macroscopic stage III melanoma, neoadjuvant ipilimumab plus nivolumab followed by surgery and response-driven adjuvant therapy resulted in longer event-free survival than surgery followed by adjuvant nivolumab. (Funded by Bristol Myers Squibb and others; NADINA ClinicalTrials.gov number, NCT04949113.).

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