The DOI matches its Crossref record; 7 of the 7 references it cites were found in a registry or an index.
Clinical Utility of the Combined Positive Score for Programmed Death Ligand-1 Expression and the Approval of Pembrolizumab for Treatment of Gastric Cancer
Open accessAbstract
Context.—: Regulatory approval of pembrolizumab for treatment of gastric and gastroesophageal junction (G/GEJ) adenocarcinoma required a reproducible scoring method for use of programmed death ligand-1 (PD-L1) protein expression as a companion diagnostic to identify likely responders to therapy. Objective.—: To develop an immunohistochemical scoring algorithm that includes PD-L1 expression for tumor and immune cells, that is, the combined positive score. Design.—: Four previously treated tumor types in the KEYNOTE-012 and KEYNOTE-028 studies were analyzed descriptively with a version of the PD-L1 immunohistochemical 22C3 pharmDx assay labeled for investigational use only to determine the relative importance of PD-L1 expression in tumor versus immune cells as a biomarker for pembrolizumab response. A combined positive score was developed as a novel scoring method and was compared with the tumor proportion score in cohort 1 from the KEYNOTE-059 study (G/GEJ cancer). External reproducibility was assessed. Results.—: Per combined positive score cutoff of 1 or more, the prevalence of PD-L1 expression in patients with G/GEJ cancer was 57.6% (148 of 257 patients), with reasonable enrichment of responses (odds ratio, 2.8). Per tumor proportion score cutoff of 1% or more, prevalence was 12.5% (32 of 257 patients), with minimal enrichment (odds ratio, 1.4). External reproducibility assessments demonstrated interpathologist overall agreement of 96.6% (591 of 612; 95% CI, 94.0%–98.7%) and intrapathologist overall agreement of 97.2% (595 of 612; 95% CI, 95.3%–98.9%). Conclusions.—: Combined positive score is a robust, reproducible PD-L1 scoring method that predicts response to pembrolizumab in patients with G/GEJ cancer. This novel scoring method supported US Food and Drug Administration approval of pembrolizumab as third-line therapy for G/GEJ cancer and has facilitated investigation in other indications.
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Safety, activity, and immune correlates of anti–PD-1 antibody in cancer
Topalian, S. L., Hodi, F. S., Brahmer, J. R., Gettinger, S. N., Smith, D. C., McDermott, D. F., Powderly, J. D., Carvajal, R. D., Sosman, J. A., Atkins, M. B., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1200690 · Cited by 12,628
Pembrolizumab for the Treatment of Non–Small-Cell Lung Cancer
Garon, E. B., Rizvi, N. A., Hui, R., Leighl, N., Balmanoukian, A. S., Eder, J. P., Patnaik, A., Aggarwal, C., Gubens, M., Horn, L., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1501824 · Cited by 6,198
Self-citationPredictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients
Herbst, R. S., Soria, J.-C., Kowanetz, M., Fine, G. D., Hamid, O., Gordon, M. S., Sosman, J. A., McDermott, D. F., Powderly, J. D., Gettinger, S. N., et al. (2014) · Nature · doi:10.1038/nature14011 · Cited by 5,231
Nivolumab plus Ipilimumab in Advanced Melanoma
Wolchok, J. D., Kluger, H., Callahan, M. K., Postow, M. A., Rizvi, N. A., Lesokhin, A. M., Segal, N. H., Ariyan, C. E., Gordon, R.-A., Reed, K., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1302369 · Cited by 4,230
Analysis of 100,000 human cancer genomes reveals the landscape of tumor mutational burden
Chalmers, Z. R., Connelly, C. F., Fabrizio, D., Gay, L., Ali, S. M., Ennis, R., Schrock, A., Campbell, B., Shlien, A., Chmielecki, J., et al. (2017) · Genome Medicine · doi:10.1186/s13073-017-0424-2 · Cited by 3,519
Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma
Bellmunt, J., de Wit, R., Vaughn, D. J., Fradet, Y., Lee, J.-L., Fong, L., Vogelzang, N. J., Climent, M. A., Petrylak, D. P., Choueiri, T. K., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1613683 · Cited by 3,395
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Burtness, B., Harrington, K. J., Greil, R., Soulières, D., Tahara, M., de Castro, G., Psyrri, A., Basté, N., Neupane, P., Bratland, Å., et al. (2019) · The Lancet · doi:10.1016/s0140-6736(19)32591-7 · Cited by 3,336
PD-L1 as a biomarker of response to immune-checkpoint inhibitors
Doroshow, D. B., Bhalla, S., Beasley, M. B., Sholl, L. M., Kerr, K. M., Gnjatic, S., Wistuba, I. I., Rimm, D. L., Tsao, M. S., & Hirsch, F. R. (2021) · Nature Reviews Clinical Oncology · doi:10.1038/s41571-021-00473-5 · Cited by 1,575
Luo, H., Lu, J., Bai, Y., Mao, T., Wang, J., Fan, Q., Zhang, Y., Zhao, K., Chen, Z., Gao, S., et al. (2021) · JAMA · doi:10.1001/jama.2021.12836 · Cited by 803
Self-citationRudin, C. M., Awad, M. M., Navarro, A., Gottfried, M., Peters, S., Csőszi, T., Cheema, P. K., Rodriguez-Abreu, D., Wollner, M., Yang, J. C.-H., et al. (2020) · Journal of Clinical Oncology · doi:10.1200/jco.20.00793 · Cited by 760
The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer
Janjigian, Y. Y., Kawazoe, A., Yañez, P., Li, N., Lonardi, S., Kolesnik, O., Barajas, O., Bai, Y., Shen, L., Tang, Y., et al. (2021) · Nature · doi:10.1038/s41586-021-04161-3 · Cited by 720
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Metadata
- Authors
- Kulangara, K., Zhang, N., Corigliano, E., Guerrero, L., Waldroup, S., Jaiswal, D., MS, M. J., Shah, S., Hanks, D., Wang, J., Lunceford, J., Savage, M. J., Juco, J., & Emancipator, K.
- Venue
- Archives of Pathology & Laboratory Medicine
- Published
- 2018-07-20
- Volume
- 143
- Issue
- 3
- Pages
- 330-337
- ISSN
- 0003-9985 (ISSN-L)
- 1543-2165
- OpenAlex
- W2884883038
- Cited by
- 536
- References
- 7
- FWCI
- 19.38
- Type
- journal article
- Language
- en
- Open access
- diamond
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- Kulangara, K., Zhang, N., Corigliano, E., Guerrero, L., Waldroup, S., Jaiswal, D., MS, M. J., Shah, S., Hanks, D., Wang, J., Lunceford, J., Savage, M. J., Juco, J., & Emancipator, K. (2019). Clinical Utility of the Combined Positive Score for Programmed Death Ligand-1 Expression and the Approval of Pembrolizumab for Treatment of Gastric Cancer. Archives of Pathology & Laboratory Medicine. https://doi.org/10.5858/arpa.2018-0043-oa
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