The DOI matches its Crossref record; 12 of the 12 references it cites were found in a registry or an index.
Survival, Durable Response, and Long-Term Safety in Patients With Previously Treated Advanced Renal Cell Carcinoma Receiving Nivolumab
Open accessAbstract
Purpose: Blockade of the programmed death-1 inhibitory cell-surface molecule on immune cells using the fully human immunoglobulin G4 antibody nivolumab mediates tumor regression in a portion of patients with advanced treatment-refractory solid tumors. We report clinical activity, survival, and long-term safety in patients with advanced renal cell carcinoma (RCC) treated with nivolumab in a phase I study with expansion cohorts. Patients and Methods: A total of 34 patients with previously treated advanced RCC, enrolled between 2008 and 2012, received intravenous nivolumab (1 or 10 mg/kg) in an outpatient setting once every two weeks for up to 96 weeks and were observed for survival and duration of response after treatment discontinuation. Results: Ten patients (29%) achieved objective responses (according to RECIST [version 1.0]), with median response duration of 12.9 months; nine additional patients (27%) demonstrated stable disease lasting > 24 weeks. Three of five patients who stopped treatment while in response continued to respond for ≥ 45 weeks. Median overall survival in all patients (71% with two to five prior systemic therapies) was 22.4 months; 1-, 2-, and 3-year survival rates were 71%, 48%, and 44%, respectively. Grade 3 to 4 treatment-related adverse events occurred in 18% of patients; all were reversible. Conclusion: Patients with advanced treatment-refractory RCC treated with nivolumab demonstrated durable responses that in some responders persisted after drug discontinuation. Overall survival is encouraging, and toxicities were generally manageable. Ongoing randomized clinical trials will further assess the impact of nivolumab on overall survival in patients with advanced RCC.
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Cites
New Guidelines to Evaluate the Response to Treatment in Solid Tumors
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Improved Survival with Ipilimumab in Patients with Metastatic Melanoma
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Self-citationSafety, activity, and immune correlates of anti–PD-1 antibody in cancer
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Self-citationSafety and activity of anti-PD-L1 antibody in patients with advanced cancer
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Self-citationIntratumor Heterogeneity and Branched Evolution Revealed by Multiregion Sequencing
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“Importantly, the significant heterogeneity seen in kidney cancers may make the development of predictive biomarkers challenging.(34) For example, preliminary correlative studies have demonstrated that although tumor PD-L1 expression by immunohistochemistry may increase the likelihood of benefit with anti–PD-1, it fail…”
BackgroundPD-1 and Its Ligands in Tolerance and Immunity
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Tumor-associated B7-H1 promotes T-cell apoptosis: A potential mechanism of immune evasion
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Nivolumab plus Ipilimumab in Advanced Melanoma
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Self-citationTopalian, S. L., Sznol, M., McDermott, D. F., Kluger, H. M., Carvajal, R. D., Sharfman, W. H., Brahmer, J. R., Lawrence, D. P., Atkins, M. B., Powderly, J. D., et al. (2014) · Journal of Clinical Oncology · doi:10.1200/jco.2013.53.0105 · Cited by 2,222
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Cited by
Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade
Le, D. T., Durham, J. N., Smith, K. N., Wang, H., Bartlett, B. R., Aulakh, L. K., Lu, S., Kemberling, H., Wilt, C., Luber, B. S., et al. (2017) · Science · doi:10.1126/science.aan6733 · Cited by 6,645
Self-citationImmune Checkpoint Blockade: A Common Denominator Approach to Cancer Therapy
Topalian, S. L., Drake, C. G., & Pardoll, D. M. (2015) · Cancer Cell · doi:10.1016/j.ccell.2015.03.001 · Cited by 4,229
Self-citationCTLA-4 and PD-1 Pathways: Similarities, Differences, and Implications of Their Inhibition
Buchbinder, E. I., & Desai, A. (2016) · American Journal of Clinical Oncology · doi:10.1097/coc.0000000000000239 · Cited by 2,360
“Unconventional response patterns have also been observed in patients with lung cancer or RCC receiving PD-1 pathway inhibitors.(56,64,65,70) These atypical responses have led to the development of modified response criteria called immunerelated response criteria (Supplemental Table 1, Supplemental Digital Content 1, h…”
BackgroundSafety Profile of Nivolumab Monotherapy: A Pooled Analysis of Patients With Advanced Melanoma
Weber, J. S., Hodi, F. S., Wolchok, J. D., Topalian, S. L., Schadendorf, D., Larkin, J., Sznol, M., Long, G. V., Li, H., Waxman, I. M., et al. (2017) · Journal of Clinical Oncology · doi:10.1200/jco.2015.66.1389 · Cited by 1,158
Self-citationTowards personalized, tumour-specific, therapeutic vaccines for cancer
Hu, Z., Ott, P. A., & Wu, C. J. (2018) · Nature Reviews Immunology · doi:10.1038/nri.2017.131 · Cited by 1,067
Metadata
- Authors
- McDermott, D. F., Drake, C. G., Sznol, M., Choueiri, T. K., Powderly, J. D., Smith, D. C., Brahmer, J. R., Carvajal, R. D., Hammers, H. J., Puzanov, I., Hodi, F. S., Kluger, H. M., Topalian, S. L., Pardoll, D. M., Wigginton, J. M., Kollia, G. D., Gupta, A., McDonald, D., Sankar, V., Sosman, J. A., & Atkins, M. B.
- Venue
- Journal of Clinical Oncology
- Published
- 2015-06-20
- Volume
- 33
- Issue
- 18
- Pages
- 2013-2020
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2125112000
- Cited by
- 439
- References
- 12
- FWCI
- 33.41
- Type
- journal article
- Language
- en
- Open access
- green
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- McDermott, D. F., Drake, C. G., Sznol, M., Choueiri, T. K., Powderly, J. D., Smith, D. C., Brahmer, J. R., Carvajal, R. D., Hammers, H. J., Puzanov, I., Hodi, F. S., Kluger, H. M., Topalian, S. L., Pardoll, D. M., Wigginton, J. M., Kollia, G. D., Gupta, A., McDonald, D., Sankar, V., . . . Atkins, M. B. (2015). Survival, Durable Response, and Long-Term Safety in Patients With Previously Treated Advanced Renal Cell Carcinoma Receiving Nivolumab. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2014.58.1041
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
