Journal article
Impact of Label Restriction on Checkpoint-Inhibitor Use in Bladder Cancer and Changes in Mortality
JNCI cancer spectrum, v 6(4), 050
01 Jul 2022
PMID: 35809072
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
In 2018, the US Food and Drug Administration (FDA) limited the indication for immune checkpoint inhibitors (ICI) in metastatic bladder cancer to patients with programmed cell death protein ligand-1 (PD-L1)-positive tumors. The impact of the label change on survival outcomes remains unknown. We conducted a controlled interrupted time series analysis using a nationwide electronic health record-derived oncology dataset. We used Cox regression to compare mortality in the post- vs prelabel change periods among affected (initiators of ICI or carboplatin-based chemotherapy) vs unaffected (initiators of cisplatin-based chemotherapy) patients. The use of ICI, carboplatin, and cisplatin was similar pre- and postlabel change, but PD-L1 testing increased postlabel change. In adjusted models, survival did not differ after the FDA label change policy compared with prior to the label change in any of the groups. The FDA label restriction on immunotherapy was associated with increased PD-L1 testing but not with changes in treatment patterns or mortality among patients with metastatic bladder cancer.
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Details
- Title
- Impact of Label Restriction on Checkpoint-Inhibitor Use in Bladder Cancer and Changes in Mortality
- Creators
- Daniel T. Vader - University of PennsylvaniaRavi B. Parikh - University of PennsylvaniaHaojie Li - Merck & Co., Inc., Rahway, NJ, USA (United States)Kentaro Imai - Merck & Co., Inc., Rahway, NJ, USA (United States)Rebecca A. Hubbard - University of PennsylvaniaRonac Mamtani (Corresponding Author) - University of Pennsylvania
- Publication Details
- JNCI cancer spectrum, v 6(4), 050
- Publisher
- Oxford Univ Press
- Number of pages
- 3
- Grant note
- Merck Co.; Merck & Company
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Epidemiology and Biostatistics
- Web of Science ID
- WOS:000841392800001
- Scopus ID
- 2-s2.0-85142372176
- Other Identifier
- 991021965446104721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- Web of Science research areas
- Oncology