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作者：SCI天天读
SCI
18 June 2023
Association Between Duration of Immunotherapy and Overall Survival in Advanced Non-Small Cell Lung Cancer.
(JAMA Oncol, IF: 33.006)
Sun Lova,Bleiberg Benjamin,Hwang Wei-Ting et al. Association Between Duration of Immunotherapy and Overall Survival in Advanced Non-Small Cell Lung Cancer.[J] .JAMA Oncol, 2023, undefined: undefined.
IMPORTANCE 重要性
For patients with advanced non-small cell lung cancer (NSCLC) treated with frontline immunotherapy-based treatment, the optimal duration of immune checkpoint inhibitor (ICI) treatment is unknown.
对于接受一线免疫治疗的晚期非小细胞肺癌（NSCLC）患者，免疫检查点抑制剂（ICI）治疗的最佳持续时间尚不明确。
OBJECTIVE 目标
To assess practice patterns surrounding ICI treatment discontinuation at 2 years and to evaluate the association of duration of therapy with overall survival in patients who received fixed-duration ICI therapy for 2 years vs those who continued therapy beyond 2 years.
评估在2年内停用ICI治疗的治疗模式，并评估接受固定持续时间为2年的ICI治疗与继续治疗超过2年的患者的治疗持续时间与总生存率的关联。
DESIGN, SETTING, AND PARTICIPANTS 设计、背景和受试者
This retrospective, population-based cohort study included adult patients in a clinical database diagnosed with advanced NSCLC from 2016 to 2020, who received frontline immunotherapy-based treatment. The data cutoff was August 31, 2022; data analysis was conducted from October 2022 to January 2023.
本回顾性的基于人群的队列研究包括2016年至2020年诊断为晚期NSCLC的成年患者，这些患者接受了一线免疫治疗。数据截止日期为2022年8月31日；数据分析从2022年10月至2023年1月进行。
EXPOSURES 暴露
Treatment discontinuation at 2 years (between 700 and 760 days, fixed duration) vs continued treatment beyond 2 years (greater than 760 days, indefinite duration).
在2年内停止治疗（在700至760天之间，固定持续时间）与继续治疗超过2年（超过760天，持续时间不确定）。
MAIN OUTCOMES AND MEASURES 主要结果和测量指标
Overall survival from 760 days was analyzed using Kaplan-Meier methods. Multivariable Cox regression that adjusted for patient-specific and cancer-specific factors was used to compare survival beyond 760 days between the fixed-duration group and the indefinite-duration group.
使用Kaplan-Meier方法分析自760天后的总生存率。采用校正了患者特异性和癌症特异性因素的多变量Cox回归方法，比较固定持续时间组和不确定持续时间组在760天后的生存情况。
RESULTS 结果
Of 1091 patients in the analytic cohort who were still on ICI treatment at 2 years after exclusion criteria for death and progression were applied, 113 patients (median [IQR] age, 69 [62-75] years; 62 [54.9%] female; 86 [76.1%] White) were in the fixed-duration group, and 593 patients (median [IQR] age, 69 [62-76] years; 282 [47.6%] female; 414 [69.8%] White) were in the indefinite-duration group. Patients in the fixed-duration group were more likely to have a history of smoking (99% vs 93%; P = .01) and be treated at an academic center (22% vs 11%; P = .001). Two-year overall survival from 760 days was 79% (95% CI, 66%-87%) in the fixed-duration group and 81% (95% CI, 77%-85%) in the indefinite-duration group. There was no statistically significant difference in overall survival between patients in the fixed-duration and indefinite-duration groups, either on univariate (hazard ratio [HR] 1.26; 95% CI, 0.77-2.08; P = .36) or multivariable (HR 1.33; 95% CI, 0.78-2.25; P = .29) Cox regression. Approximately 1 in 5 patients discontinued immunotherapy at 2 years in the absence of progression.
在应用死亡和进展的排除标准后，分析队列中仍在2年后接受ICI治疗的1091名患者中，113名患者（中位数[IQR]年龄，69 [62-75]岁；62名[54.9%]女性；86名[76.1%]白人）属于固定持续时间组，593名患者（中位数[IQR]年龄，69 [62-76]岁；282名[47.6%]女性；414名[69.8%]白人）属于不确定持续时间组。固定持续时间组的患者更有可能有吸烟史（99%对93%；P = .01），并在学术性中心接受治疗（22%对11%；P = .001）。固定持续时间组在760天后的2年总生存率为79%（95% CI，66%-87%），不确定持续时间组为81%（95% CI，77%-85%）。无论是在单变量（风险比[HR] 1.26；95% CI，0.77-2.08；P = .36）还是多变量（HR 1.33；95% CI，0.78-2.25；P = .29）Cox回归分析中，固定持续时间组和不确定持续时间组之间的总生存率差异都没有统计学意义。约1/5的患者在没有进展的情况下在2年内停止免疫治疗。
CONCLUSIONS AND RELEVANCE 结论和相关性
In a retrospective clinical cohort of patients with advanced NSCLC who were treated with immunotherapy and were progression-free at 2 years, approximately only 1 in 5 discontinued treatment. The lack of statistically significant overall survival advantage for the indefinite-duration cohort on adjusted analysis provides reassurance to patients and clinicians who wish to discontinue immunotherapy at 2 years.
在接受免疫治疗且在2年内没有进展的晚期NSCLC患者的回顾性临床队列中，大约只有五分之一的患者停止治疗。调整分析中不确定持续时间组没有统计学上显著的整体生存优势，这为希望在2年内停止免疫治疗的患者和临床医生提供了保障。
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原文地址：http://mp.weixin.qq.com/s?src=11×tamp=1687107098&ver=4598&signature=Uu3XnJvlaVnnNhCc978Dvnk9nhp-43eGnh7zS24N96Pq0NQXcHolQgQ1Egz0ulqi1324nlSKdLdbTHYyR0eAil4wtH7wZBF9xRiLzUt52dzlLnOjHjkVZZ9wTbZHwYiN&new=1 |
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