The DOI matches its Crossref record; 10 of the 10 references it cites were found in a registry or an index.
Pooled Analysis Safety Profile of Nivolumab and Ipilimumab Combination Therapy in Patients With Advanced Melanoma
Abstract
Purpose: The addition of nivolumab (anti–programmed death-1 antibody) to ipilimumab (anti–cytotoxic T-cell lymphocyte–associated 4 antibody) in patients with advanced melanoma improves antitumor response and progression-free survival but with a higher frequency of adverse events (AEs). This cross-melanoma study describes the safety profile of the approved nivolumab plus ipilimumab regimen. Methods: This retrospective safety review on data from three trials (phase I, II, and III) included patients with advanced melanoma who received at least one dose of nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks × 4 and then nivolumab 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity while following established guidelines for AE management. Analyses were of all treatment-related AEs, select (immune-related) AEs, time to onset and resolution, and use of immune-modulating agents and their effects on outcome. Results: Among 448 patients, median duration of follow-up was 13.2 months. Treatment-related grade 3/4 AEs occurred in 55.5% of patients; 35.7% had treatment-related AEs that led to discontinuation. The most frequent treatment-related select AEs of any grade were skin (64.3%) and GI (46.7%) and of grade 3/4, hepatic (17.0%) and GI (16.3%); 30.1% developed a grade 2 to 4 select AE in more than one organ category. Median time to onset of grade 3/4 treatment-related select AEs ranged from 3.1 (skin) to 16.3 (renal) weeks, and with the exclusion of endocrine AEs, median time to resolution from onset ranged from 1.9 (renal) to 4.5 (pulmonary) weeks, with resolution rates between 79% and 100% while using immune-modulating agents. Four (< 1%) on-study deaths were attributed to therapy. Conclusion: Frequency of grade 3/4 treatment-related AEs was higher with nivolumab plus ipilimumab and occurred earlier than historical experience with either agent alone, but resolution rates were similar.
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Citations
Cites
Improved Survival with Ipilimumab in Patients with Metastatic Melanoma
Hodi, F. S., O'Day, S. J., McDermott, D. F., Weber, R. W., Sosman, J. A., Haanen, J. B., Gonzalez, R., Robert, C., Schadendorf, D., Hassel, J. C., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1003466 · Cited by 15,155
Self-citationCombined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
Larkin, J., Chiarion-Sileni, V., Gonzalez, R., Grob, J. J., Cowey, C. L., Lao, C. D., Schadendorf, D., Dummer, R., Smylie, M., Rutkowski, P., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1504030 · Cited by 8,157
Self-citationIpilimumab plus Dacarbazine for Previously Untreated Metastatic Melanoma
Robert, C., Thomas, L., Bondarenko, I., O'Day, S., Weber, J., Garbe, C., Lebbe, C., Baurain, J.-F., Testori, A., Grob, J.-J., et al. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1104621 · Cited by 4,496
Self-citationNivolumab and ipilimumab versus ipilimumab in untreated melanoma
Postow, M. A., Chesney, J., Pavlick, A. C., Robert, C., Grossmann, K., McDermott, D., Linette, G. P., Meyer, N., Giguere, J. K., Agarwala, S. S., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1414428 · Cited by 2,781
Self-citationFulminant Myocarditis with Combination Immune Checkpoint Blockade
Johnson, D. B., Balko, J. M., Compton, M. L., Chalkias, S., Gorham, J., Xu, Y., Hicks, M., Puzanov, I., Alexander, M. R., Bloomer, T. L., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1609214 · Cited by 2,308
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Management of Immune-Related Adverse Events and Kinetics of Response With Ipilimumab
Weber, J. S., Kähler, K. C., & Hauschild, A. (2012) · Journal of Clinical Oncology · doi:10.1200/jco.2012.41.6750 · Cited by 1,415
Horvat, T. Z., Adel, N. G., Dang, T.-O., Momtaz, P., Postow, M. A., Callahan, M. K., Carvajal, R. D., Dickson, M. A., D'Angelo, S. P., Woo, K. M., et al. (2015) · Journal of Clinical Oncology · doi:10.1200/jco.2015.60.8448 · Cited by 1,064
Self-citationHodi, F. S., Chesney, J., Pavlick, A. C., Robert, C., Grossmann, K. F., McDermott, D. F., Linette, G. P., Meyer, N., Giguere, J. K., Agarwala, S. S., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(16)30366-7 · Cited by 968
Self-citationFreeman-Keller, M., Kim, Y., Cronin, H., Richards, A., Gibney, G., & Weber, J. S. (2016) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-15-1136 · Cited by 863
Cited by
Brahmer, J. R., Lacchetti, C., Schneider, B. J., Atkins, M. B., Brassil, K. J., Caterino, J. M., Chau, I., Ernstoff, M. S., Gardner, J. M., Ginex, P., et al. (2018) · Journal of Clinical Oncology · doi:10.1200/jco.2017.77.6385 · Cited by 3,713
Self-citationFundamental Mechanisms of Immune Checkpoint Blockade Therapy
Wei, S. C., Duffy, C. R., & Allison, J. P. (2018) · Cancer Discovery · doi:10.1158/2159-8290.cd-18-0367 · Cited by 3,088
Myocarditis in Patients Treated With Immune Checkpoint Inhibitors
Mahmood, S. S., Fradley, M. G., Cohen, J. V., Nohria, A., Reynolds, K. L., Heinzerling, L. M., Sullivan, R. J., Damrongwatanasuk, R., Chen, C. L., Gupta, D., et al. (2018) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2018.02.037 · Cited by 1,608
Yau, T., Kang, Y.-K., Kim, T.-Y., El-Khoueiry, A. B., Santoro, A., Sangro, B., Melero, I., Kudo, M., Hou, M.-M., Matilla, A., et al. (2020) · JAMA Oncology · doi:10.1001/jamaoncol.2020.4564 · Cited by 1,273
Thompson, J. A., Schneider, B. J., Brahmer, J., Andrews, S., Armand, P., Bhatia, S., Budde, L. E., Costa, L., Davies, M., Dunnington, D., et al. (2019) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2019.0013 · Cited by 570
Metadata
- Authors
- Sznol, M., Ferrucci, P. F., Hogg, D., Atkins, M. B., Wolter, P., Guidoboni, M., Lebbé, C., Kirkwood, J. M., Schachter, J., Daniels, G. A., Hassel, J., Cebon, J., Gerritsen, W., Atkinson, V., Thomas, L., McCaffrey, J., Power, D., Walker, D., Bhore, R., Jiang, J., Hodi, F. S., & Wolchok, J. D.
- Venue
- Journal of Clinical Oncology
- Published
- 2017-12-01
- Volume
- 35
- Issue
- 34
- Pages
- 3815-3822
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2754843476
- Cited by
- 286
- References
- 10
- FWCI
- 13.03
- Type
- journal article
- Language
- en
- Open access
- closed
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- Sznol, M., Ferrucci, P. F., Hogg, D., Atkins, M. B., Wolter, P., Guidoboni, M., Lebbé, C., Kirkwood, J. M., Schachter, J., Daniels, G. A., Hassel, J., Cebon, J., Gerritsen, W., Atkinson, V., Thomas, L., McCaffrey, J., Power, D., Walker, D., Bhore, R., . . . Wolchok, J. D. (2017). Pooled Analysis Safety Profile of Nivolumab and Ipilimumab Combination Therapy in Patients With Advanced Melanoma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2016.72.1167
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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