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dc.contributor.authorBajars, Marcis
dc.contributor.authorBarlesi, Fabrice
dc.contributor.authorYang, James C-H
dc.contributor.authorRuisi, Mary
dc.contributor.authorManitz, Juliane
dc.contributor.authorPark, Keunchil
dc.contributor.authorÖZGÜROĞLU, Mustafa
dc.contributor.authorVansteenkiste, Johan
dc.contributor.authorSpigel, David
dc.date.accessioned2021-12-10T11:45:04Z
dc.date.available2021-12-10T11:45:04Z
dc.identifier.citationPark K., ÖZGÜROĞLU M., Vansteenkiste J., Spigel D., Yang J. C. , Bajars M., Ruisi M., Manitz J., Barlesi F., "Impact of subsequent immune checkpoint inhibitor treatment on overall survival with avelumab vs docetaxel in platinum-treated advanced NSCLC: Post hoc analyses from the phase 3 JAVELIN Lung 200 trial", LUNG CANCER, cilt.154, ss.92-98, 2021
dc.identifier.issn0169-5002
dc.identifier.othervv_1032021
dc.identifier.otherav_92603e4d-6d28-4227-9c45-fcfcd918e442
dc.identifier.urihttp://hdl.handle.net/20.500.12627/172546
dc.identifier.urihttps://doi.org/10.1016/j.lungcan.2021.01.026
dc.description.abstractObjectives: The JAVELIN Lung 200 phase 3 trial did not meet its primary endpoint of improving overall survival (OS) with avelumab vs docetaxel in patients with platinum-treated PD-L1+ NSCLC. We report post hoc analyses assessing the effects of subsequent immune checkpoint inhibitor (ICI) treatment on OS. Material and methods: Patients with stage IIIB/IV NSCLC progressed following platinum-doublet therapy were randomized to receive avelumab or docetaxel. OS was analyzed in the PD-L1+ population (?1% of tumor cells) and full analysis set (PD-L1+ or PD-L1-). Effects of subsequent ICI (after permanent discontinuation of study treatment) on OS were analyzed using a preplanned naive sensitivity analysis and post hoc inverse probability of censoring weighting (IPCW) analysis. Subgroups with or without subsequent ICI treatment were analyzed using descriptive statistics. Results: In the avelumab and docetaxel arms, a subsequent ICI was received by 16/396 (4.0 %) and 104/396 (26.3 %) after a median of 10.5 months (range, 3.9?20.4) and 5.7 months (range, 0.1?24.4), respectively. Some subgroups showed trends for higher subsequent ICI treatment, including patients with non-squamous NSCLC (avelumab arm, 4.3 % vs docetaxel arm, 32.1 %) or with a baseline ECOG performance status of 0 (6.3 % vs 31.3 %); those enrolled in the early recruitment wave (11.6 % vs 54.3 %), or enrolled in the US/Western Europe (2.8 % vs 45.5 %) or Asia (11.0 % vs 35.4 %); and non-white patients (10.1 % vs 35.0 %). The hazard ratio for OS with avelumab vs docetaxel was lower in the IPCW analysis than in the naive sensitivity analysis (PD-L1+ population: 0.80 [95 % CI, 0.62-1.04] vs 0.86 [95 % CI, 0.68-1.09], respectively). Conclusion: In the JAVELIN Lung 200 trial, avelumab showed clinical activity as second-line treatment for patients with advanced NSCLC. Post hoc analyses suggest that the primary OS analysis may have been confounded by subsequent ICI use in the docetaxel arm. ClinicalTrials.gov identifier: NCT02395172.
dc.language.isoeng
dc.subjectGöğüs Hastalıkları ve Allerji
dc.subjectİç Hastalıkları
dc.subjectOnkoloji
dc.subjectOncology
dc.subjectRespiratory Care
dc.subjectPulmonary and Respiratory Medicine
dc.subjectHealth Sciences
dc.subjectTıp
dc.subjectSağlık Bilimleri
dc.subjectDahili Tıp Bilimleri
dc.subjectSOLUNUM SİSTEMİ
dc.subjectKlinik Tıp (MED)
dc.subjectKlinik Tıp
dc.subjectONKOLOJİ
dc.titleImpact of subsequent immune checkpoint inhibitor treatment on overall survival with avelumab vs docetaxel in platinum-treated advanced NSCLC: Post hoc analyses from the phase 3 JAVELIN Lung 200 trial
dc.typeMakale
dc.relation.journalLUNG CANCER
dc.contributor.departmentSungkyunkwan University (SKKU) , ,
dc.identifier.volume154
dc.identifier.startpage92
dc.identifier.endpage98
dc.contributor.firstauthorID2633292


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