The DOI matches its Crossref record; 30 of the 30 references it cites were found in a registry or an index.
Pembrolizumab in Patients With Extensive-Stage Small-Cell Lung Cancer: Results From the Phase Ib KEYNOTE-028 Study
Abstract
Purpose: The safety and efficacy of pembrolizumab, a humanized monoclonal antibody against programmed death 1 (PD-1), were assessed in patients with programmed death ligand 1 (PD-L1)–expressing extensive-stage small-cell lung cancer (SCLC) in the multicohort, phase Ib open-label KEYNOTE-028 study ( ClinicalTrials.gov identifier: NCT02054806). Methods: Patients with SCLC received pembrolizumab 10 mg/kg every 2 weeks for 24 months or until disease progression or intolerable toxicity occurred. PD-L1 expression was assessed by immunohistochemistry. PD-L1–positive patients had membranous PD-L1 expression in ≥ 1% of tumor and associated inflammatory cells or positive staining in stroma. Response was assessed by investigator per Response Evaluation Criteria in Solid Tumors version 1.1 every 8 weeks for the first 6 months and every 12 weeks thereafter. Adverse events (AEs) were reported per the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. Primary end points were safety, tolerability, and objective response rate (ORR). Secondary end points included progression-free survival, overall survival, and duration of response. Results: Twenty-four patients with PD-L1–expressing SCLC were enrolled and received at least one pembrolizumab dose. At the data cutoff date (June 20, 2016), the median follow-up duration was 9.8 months (range, 0.5 to 24 months). All 24 patients experienced AEs; the most common were asthenia (n = 7), fatigue (n = 7), and cough (n = 6). Two patients experienced grade 3 to 5 treatment-related AEs: one patient had elevated bilirubin, and one patient had asthenia, grade 5 colitis, and intestinal ischemia. One patient had a complete response, and seven patients had partial responses, resulting in an ORR of 33% (95% CI, 16% to 55%). Conclusion: The safety of pembrolizumab was consistent with the known safety profile in other tumor types. Pembrolizumab demonstrated promising antitumor activity in patients with pretreated, PD-L1–expressing SCLC.
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Self-citationPembrolizumab for the Treatment of Non–Small-Cell Lung Cancer
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Lung cancer immunotherapy: progress, pitfalls, and promises
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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-citation
Metadata
- Authors
- Ott, P. A., Elez, E., Hiret, S., Kim, D.-W., Morosky, A., Saraf, S., Piperdi, B., & Mehnert, J. M.
- Venue
- Journal of Clinical Oncology
- Published
- 2017-12-01
- Volume
- 35
- Issue
- 34
- Pages
- 3823-3829
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2745840031
- Cited by
- 521
- References
- 30
- FWCI
- 27.04
- Type
- journal article
- Language
- en
- Open access
- closed
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- Ott, P. A., Elez, E., Hiret, S., Kim, D.-W., Morosky, A., Saraf, S., Piperdi, B., & Mehnert, J. M. (2017). Pembrolizumab in Patients With Extensive-Stage Small-Cell Lung Cancer: Results From the Phase Ib KEYNOTE-028 Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2017.72.5069
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