PD-1阻断试验中耐久无进展生存患者在黑色素瘤或非小细胞肺癌方面的进一步进展或死亡风险:对影像监测的启示。
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.
发表日期:2023 Sep 08
作者:
Lei Deng, Changchuan Jiang, Kristopher Attwood, Joseph J Zhao, Stuthi Perimbeti, Chen Hu, Igor Puzanov, Grace K Dy
来源:
Cell Death & Disease
摘要:
报道了黑色素瘤或非小细胞肺癌(NSCLC)患者在接受PD-(L)1免疫疗法后具有持续无进展存活(dPFSors)超过2年。然而,仍存在进展风险,最佳影像监测间隔尚不清楚。从至少5年的PD-1阻断临床试验中提取了患者的无进展生存期(PFS)个体数据。PFS至少为2年的患者被认为是dPFSors。计算了每个后续年度中每3、4、6和12个月的进展/死亡(P/D)的条件风险。我们预先设定了3个不同的扫描风险水平(10%、15%或20%),以便临床医生和患者基于影像频率和风险承受能力来确定扫描间隔。如果每次扫描的95% CI的上限低于预先设定的水平,则间隔被认为是可接受的。
在1,495例黑色素瘤和3,752例NSCLC患者中,分别有474例(31.7%)和586例(15.6%)为dPFSors。其中,额外3年的PFS概率分别为76.4%和48.1%。在3年中,不超过8%的患者在任何一个季度中出现P/D。对于黑色素瘤dPFSors,以10%的风险阈值,第三年可以每6个月扫描一次,第四和第五年则每12个月扫描一次。对于NSCLC,第三年的间隔为每3个月一次,第四和第五年则为每4个月一次。15%和20%的更高风险承受能力将允许更少的扫描频率。
根据其自身的风险承受水平,我们的研究结果允许临床医生和dPFSors基于数据做出关于影像监测时间表的决策,超过每3个月一次的情况。
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.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.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.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.