The DOI matches its Crossref record; 40 of the 40 references it cites were found in a registry or an index.
Neurologic Serious Adverse Events Associated with Nivolumab Plus Ipilimumab or Nivolumab Alone in Advanced Melanoma, Including a Case Series of Encephalitis
Open accessAbstract
Background: Despite unprecedented efficacy across multiple tumor types, immune checkpoint inhibitor therapy is associated with a unique and wide spectrum of immune-related adverse events (irAEs), including neurologic events ranging from mild headache to potentially life-threatening encephalitis. Here, we summarize neurologic irAEs associated with nivolumab and ipilimumab melanoma treatment, present cases of treatment-related encephalitis, and provide practical guidance on diagnosis and management. Methods: We searched a Global Pharmacovigilance and Epidemiology database for neurologic irAEs reported over an 8-year period in patients with advanced melanoma receiving nivolumab with or without ipilimumab from 12 studies sponsored by Bristol-Myers Squibb. Serious neurologic irAEs were reviewed, and relationship to nivolumab or ipilimumab was assigned. Results: In our search of 3,763 patients, 35 patients (0.93%) presented with 43 serious neurologic irAEs, including neuropathy (n = 22), noninfective meningitis (n = 5), encephalitis (n = 6), neuromuscular disorders (n = 3), and nonspecific adverse events (n = 7). Study drug was discontinued (n = 20), interrupted (n = 8), or unchanged (n = 7). Most neurologic irAEs resolved (26/35 patients; 75%). Overall, median time to onset was 45 days (range 1–170) and to resolution was 32 days (2–809+). Median time to onset of encephalitis was 55.5 days (range 18–297); four cases resolved and one was fatal. Conclusion: Both oncologists and neurologists need to be aware of signs and symptoms of serious but uncommon neurologic irAEs associated with checkpoint inhibitors. Prompt diagnosis and management using an established algorithm are critical to minimize serious complications from these neurologic irAEs.
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Citations
Cites
PD-1 and PD-L1 Immune Checkpoint Blockade to Treat Breast Cancer
Hartkopf, A. D., Taran, F.-A., Wallwiener, M., Walter, C. B., Krämer, B., Grischke, E.-M., & Brucker, S. Y. (2016) · Breast Care · doi:10.1159/000453569 · Cited by 30,845
Adverse Renal Effects of Immune Checkpoint Inhibitors: A Narrative Review
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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-citationCombined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma
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Self-citationPembrolizumab versus Ipilimumab in Advanced Melanoma
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Self-citationNivolumab in Previously Untreated Melanoma without BRAF Mutation
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Nivolumab plus Ipilimumab in Advanced Melanoma
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“3–10 mg/kg1 IPI 1– 10 mg/kg Sequential regimen: NIVO 1 or 3 mg/kg after previous (prestudy) IPI 127 [38]”
Nivolumab and ipilimumab versus ipilimumab in untreated melanoma
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Self-citationImmune Checkpoint Blockade in Cancer Therapy
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Cited by
Neoadjuvant versus adjuvant ipilimumab plus nivolumab in macroscopic stage III melanoma
Blank, C. U., Rozeman, E. A., Fanchi, L. F., Sikorska, K., van de Wiel, B., Kvistborg, P., Krijgsman, O., van den Braber, M., Philips, D., Broeks, A., et al. (2018) · Nature Medicine · doi:10.1038/s41591-018-0198-0 · Cited by 880
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Johnson, D. B., McDonnell, W. J., Gonzalez-Ericsson, P. I., Al-Rohil, R. N., Mobley, B. C., Salem, J.-E., Wang, D. Y., Sanchez, V., Wang, Y., Chastain, C. A., et al. (2019) · Nature Medicine · doi:10.1038/s41591-019-0523-2 · Cited by 176
Central Nervous System Infections in Immunocompromised Patients
Pruitt, A. A. (2021) · Current Neurology and Neuroscience Reports · doi:10.1007/s11910-021-01119-w · Cited by 55
Metadata
- Authors
- Larkin, J., Chmielowski, B., Lao, C. D., Hodi, F. S., Sharfman, W., Weber, J., Suijkerbuijk, K. P. M., Azevedo, S., Li, H., Reshef, D., Avila, A., & Reardon, D. A.
- Venue
- The Oncologist
- Publisher
- Oxford University Press (OUP)
- Published
- 2017-05-11
- Volume
- 22
- Issue
- 6
- Pages
- 709-718
- ISSN
- 1083-7159 (ISSN-L)
- 1549-490X
- OpenAlex
- W2612010935
- Cited by
- 267
- References
- 40
- FWCI
- 12.82
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Larkin, J., Chmielowski, B., Lao, C. D., Hodi, F. S., Sharfman, W., Weber, J., Suijkerbuijk, K. P. M., Azevedo, S., Li, H., Reshef, D., Avila, A., & Reardon, D. A. (2017). Neurologic Serious Adverse Events Associated with Nivolumab Plus Ipilimumab or Nivolumab Alone in Advanced Melanoma, Including a Case Series of Encephalitis. The Oncologist. https://doi.org/10.1634/theoncologist.2016-0487
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