The DOI matches its Crossref record; 8 of the 8 references it cites were found in a registry or an index.
Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1–Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study
Abstract
Purpose: To establish the safety profile and antitumor activity of the anti–programmed death 1 receptor monoclonal antibody, pembrolizumab, in patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) that expressed programmed death-ligand 1 (PD-L1). Patients and Methods: KEYNOTE-028 (NCT02054806) is a nonrandomized, multicohort, phase Ib trial of pembrolizumab in patients with PD-L1–positive advanced solid tumors. Key eligibility criteria for the NPC cohort included unresectable or metastatic disease, failure on prior standard therapy, and PD-L1 expression in 1% or more of tumor cells or tumor-infiltrating lymphocytes. Patients received pembrolizumab 10 mg/kg every 2 weeks up to 2 years or until disease progression or unacceptable toxicity. Primary end point was objective response rate (ORR) per investigator review. Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) every 8 weeks for the first 6 months and every 12 weeks thereafter. Results: Twenty-seven patients received pembrolizumab. Median age was 52.0 years (range, 18 to 68 years); 92.6% received prior therapies for RM-NPC; 70.4% had received three or more therapies. Partial response and stable disease were observed in seven and 14 patients, respectively, for an ORR of 25.9% (95% CI, 11.1 to 46.3) over a median follow-up of 20 months. ORR by central review was similar (26.3%). Drug-related adverse events that occurred in 15% or more of patients included rash (25.9%), pruritus (25.9%), pain (22.2%), hypothyroidism (18.5%), and fatigue (18.5%). Grade ≥ 3 drug-related adverse events occurred in eight patients (29.6%), and there was one drug-related death (sepsis). As of the data cutoff (June 20, 2016), two patients remained on pembrolizumab treatment. Conclusion: Pembrolizumab demonstrated antitumor activity and a manageable safety profile in patients with RM-NPC.
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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
Fehrenbacher, L., Spira, A., Ballinger, M., Kowanetz, M., Vansteenkiste, J., Mazieres, J., Park, K., Smith, D., Artal-Cortes, A., Lewanski, C., et al. (2016) · The Lancet · doi:10.1016/s0140-6736(16)00587-0 · Cited by 2,756
PD-L1 expression as a predictive biomarker in cancer immunotherapy
Patel, S. P., & Kurzrock, R. (2015) · Molecular Cancer Therapeutics · doi:10.1158/1535-7163.mct-14-0983 · Cited by 2,291
Seiwert, T. Y., Burtness, B., Mehra, R., Weiss, J., Berger, R., Eder, J. P., Heath, K., McClanahan, T., Lunceford, J., Gause, C., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(16)30066-3 · Cited by 1,745
Self-citationLanger, C. J., Gadgeel, S. M., Borghaei, H., Papadimitrakopoulou, V. A., Patnaik, A., Powell, S. F., Gentzler, R. D., Martins, R. G., Stevenson, J. P., Jalal, S. I., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(16)30498-3 · Cited by 1,404
PD-1 Blockade with pembrolizumab in advanced Merkel-cell carcinoma
Nghiem, P. T., Bhatia, S., Lipson, E. J., Kudchadkar, R. R., Miller, N. J., Annamalai, L., Berry, S., Chartash, E. K., Daud, A., Fling, S. P., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1603702 · Cited by 1,258
Association of Pembrolizumab With Tumor Response and Survival Among Patients With Advanced Melanoma
Ribas, A., Hamid, O., Daud, A., Hodi, F. S., Wolchok, J. D., Kefford, R., Joshua, A. M., Patnaik, A., Hwu, W.-J., Weber, J. S., et al. (2016) · JAMA · doi:10.1001/jama.2016.4059 · Cited by 1,069
Self-citationDaud, A. I., Wolchok, J. D., Robert, C., Hwu, W.-J., Weber, J. S., Ribas, A., Hodi, F. S., Joshua, A. M., Kefford, R., Hersey, P., et al. (2016) · Journal of Clinical Oncology · doi:10.1200/jco.2016.67.2477 · Cited by 665
Cited by
Chen, Y.-P., Chan, A. T. C., Le, Q.-T., Blanchard, P., Sun, Y., & Ma, J. (2019) · The Lancet · doi:10.1016/s0140-6736(19)30956-0 · Cited by 3,077
Ott, P. A., Bang, Y.-J., Piha-Paul, S. A., Razak, A. R. A., Bennouna, J., Soria, J.-C., Rugo, H. S., Cohen, R. B., O’Neil, B. H., Mehnert, J. M., et al. (2019) · Journal of Clinical Oncology · doi:10.1200/jco.2018.78.2276 · Cited by 969
Self-citationCohen, E. E. W., Bell, R. B., Bifulco, C. B., Burtness, B., Gillison, M. L., Harrington, K. J., Le, Q.-T., Lee, N. Y., Leidner, R., Lewis, R. L., et al. (2019) · Journal for ImmunoTherapy of Cancer · doi:10.1186/s40425-019-0662-5 · Cited by 722
NCCN Guidelines Insights: Head and Neck Cancers, Version 1.2018
Colevas, A. D., Yom, S. S., Pfister, D. G., Spencer, S., Adelstein, D., Adkins, D., Brizel, D. M., Burtness, B., Busse, P. M., Caudell, J. J., et al. (2018) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2018.0026 · Cited by 614
Fang, W., Yang, Y., Ma, Y., Hong, S., Lin, L., He, X., Xiong, J., Li, P., Zhao, H., Huang, Y., et al. (2018) · The Lancet Oncology · doi:10.1016/s1470-2045(18)30495-9 · Cited by 489
Metadata
- Authors
- Hsu, C., Lee, S.-H., Ejadi, S., Even, C., Cohen, R. B., Le Tourneau, C., Mehnert, J. M., Algazi, A., van Brummelen, E. M. J., Saraf, S., Thanigaimani, P., Cheng, J. D., & Hansen, A. R.
- Venue
- Journal of Clinical Oncology
- Published
- 2017-12-20
- Volume
- 35
- Issue
- 36
- Pages
- 4050-4056
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2747272999
- Cited by
- 464
- References
- 8
- FWCI
- 15.73
- Type
- journal article
- Language
- en
- Open access
- closed
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- Hsu, C., Lee, S.-H., Ejadi, S., Even, C., Cohen, R. B., Le Tourneau, C., Mehnert, J. M., Algazi, A., van Brummelen, E. M. J., Saraf, S., Thanigaimani, P., Cheng, J. D., & Hansen, A. R. (2017). Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1–Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2017.73.3675
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