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PD-1 阻断试验中黑色素瘤或非小细胞肺癌持久无进展生存者的进一步进展或死亡风险:对影像学监测的影响。

Risk of Further Progression or Death Among Durable Progression-Free Survivors With Melanoma or Non-Small-Cell Lung Cancer in PD-1 Blockade Trials: Implications for Imaging Surveillance.

机构信息

Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY.

Division of Medical Oncology, University of Washington School of Medicine, Seattle, WA.

出版信息

JCO Oncol Pract. 2023 Oct;19(10):871-881. doi: 10.1200/OP.23.00353. Epub 2023 Sep 8.

Abstract

PURPOSE

Durable progression-free survivors (dPFSors) over 2 years have been reported among patients with melanoma or non-small-cell lung cancer (NSCLC) who received PD-(L)1 therapy. However, risk of progression still exists and the optimal imaging surveillance interval is unknown.

METHODS

Individual patient data for progression-free survival (PFS) were extracted from PD-1 blockade clinical trials with a follow-up of at least 5 years. Patients with a PFS of at least 2 years were considered as dPFSors. Conditional risks of progression/death (P/D) every 3, 4, 6, and 12 months in each subsequent year were calculated. We prespecified three different levels of risk between scans (10%, 15%, or 20%) to allow clinicians and patients to decide on the scanning interval on the basis of considerations of imaging frequency and risk tolerance. An interval is considered acceptable if the upper bound of the 95% CI of the risk at each scan is lower than a prespecified level.

RESULTS

Of 1,495 and 3,752 patients with melanoma and NSCLC, 474 (31.7%) and 586 (15.6%) were dPFSors, respectively. Among them, the PFS probability for an additional 3 years was 76.4% and 48.1%, respectively. Not more than 8% of patients had P/D in any quarter in the 3 years. With a risk threshold of 10%, melanoma dPFSors can be scanned every 6 months during the third year and then every 12 months in years 4 and 5. The interval for NSCLC would be every 3 months in the third year and every 4 months in years 4 and 5. The higher risk tolerance of 15% and 20% would allow for less frequent scans.

CONCLUSION

On the basis of their own risk tolerance level, our findings allow clinicians and dPFSors make data-driven decisions regarding the imaging surveillance schedule beyond every 3 months.

摘要

目的

接受 PD-(L)1 治疗的黑色素瘤或非小细胞肺癌(NSCLC)患者,报告了超过 2 年的持久无进展生存(dPFSors)。然而,进展的风险仍然存在,且最佳影像学监测间隔时间未知。

方法

从 PD-1 阻断临床试验中提取至少随访 5 年的无进展生存(PFS)的个体患者数据。将 PFS 至少 2 年的患者视为 dPFSors。计算每个后续年份中每 3、4、6 和 12 个月的进展/死亡(P/D)的条件风险。我们预先指定了三种不同的扫描间隔风险水平(10%、15%或 20%),以便临床医生和患者可以根据影像学频率和风险承受能力的考虑因素来决定扫描间隔。如果每次扫描的风险 95%CI 的上限低于预设水平,则认为间隔时间是可接受的。

结果

在 1495 例黑色素瘤和 3752 例 NSCLC 患者中,分别有 474(31.7%)和 586(15.6%)例患者为 dPFSors。其中,额外 3 年的 PFS 概率分别为 76.4%和 48.1%。在 3 年内任何一个季度,患者的 P/D 不超过 8%。如果风险阈值为 10%,则黑色素瘤 dPFSors 可以在第 3 年每 6 个月扫描一次,然后在第 4 和第 5 年每年扫描一次。对于 NSCLC,第 3 年每 3 个月扫描一次,第 4 和第 5 年每 4 个月扫描一次。如果风险容忍度更高(15%和 20%),则可以减少扫描次数。

结论

基于自身的风险容忍水平,我们的研究结果使临床医生和 dPFSors 能够针对每 3 个月以上的影像学监测计划做出数据驱动的决策。

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