Thinking critically about classifying adverse events: Incidence of pancreatitis in patients treated with nivolumab + ipilimumab Journal Article
| Authors: | Friedman, C. F.; Clark, V.; Raikhel, A. V.; Barz, T.; Shoushtari, A. N.; Momtaz, P.; Callahan, M. K.; Wolchok, J. D.; Chapman, P. B.; Hellmann, M. D.; Postow, M. A. |
| Article Title: | Thinking critically about classifying adverse events: Incidence of pancreatitis in patients treated with nivolumab + ipilimumab |
| Abstract: | The Common Terminology Criteria for Adverse Events (CTCAE) were developed to document the adverse effects of chemotherapy but are now also used to document immune-related adverse events (irAE). Characterization of irAE by the CTCAE has implications for determining dose-limiting toxicity (DLT) and, consequently, the recommended phase II dose (RP2D) of investigational agents. In the phase I trial of nivolumab + ipilimumab, an asymptomatic increase in lipase was the primary DLT that informed the RP2D. We performed a retrospective study of 119 patients with melanoma who were treated at Memorial Sloan Kettering Cancer Center with the combination of nivolumab + ipilimumab to investigate the relationship between asymptomatic grade 3 or higher increases in amylase and/or lipase and pancreatitis, a known irAE. Of the 119 patients, there were only two cases of pancreatitis, representing 20% of patients with grade 3 or higher amylase, 6.3% of patients with grade 3 or higher lipase, and 20% of patients with grade 3 or higher elevations of both enzymes. The application of the CTCAE, especially in grading independent lab values, should be considered carefully in clinical trials of novel immunotherapeutic agents. © The Author 2017. Published by Oxford University Press. All rights reserved. |
| Journal Title: | JNCI: Journal of the National Cancer Institute |
| Volume: | 109 |
| Issue: | 4 |
| ISSN: | 0027-8874 |
| Publisher: | Oxford University Press |
| Date Published: | 2017-04-01 |
| Start Page: | djw260 |
| Language: | English |
| DOI: | 10.1093/jnci/djw260 |
| PROVIDER: | scopus |
| PUBMED: | 28040701 |
| PMCID: | PMC5441295 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 2 June 2017 -- Source: Scopus |
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