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Title: Pooled Analysis Safety Profile of Nivolumab and Ipilimumab Combination Therapy in Patients With Advanced Melanoma.
Austin Authors: Sznol, Mario;Ferrucci, Pier Francesco;Hogg, David;Atkins, Michael B;Wolter, Pascal;Guidoboni, Massimo;Lebbé, Celeste;Kirkwood, John M;Schachter, Jacob;Daniels, Gregory A;Hassel, Jessica;Cebon, Jonathan S ;Gerritsen, Winald;Atkinson, Victoria;Thomas, Luc;McCaffrey, John;Power, Derek;Walker, Dana;Bhore, Rafia;Jiang, Joel;Hodi, F Stephen;Wolchok, Jedd D
Affiliation: Parker Institute and Ludwig Center at Memorial Sloan Kettering Cancer Center, New York, NY
Bristol-Myers Squibb, Princeton, NJ
Dana-Farber Cancer Institute, Boston, MA
Yale Comprehensive Cancer Center, New Haven, CT
Istituto Europeo di Oncologia, Milan
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC
University Hospitals Leuven, Leuven, Belgium; Celeste Lebbé, Université Paris Diderot, Paris
Centre Hospitalier Lyon-Sud, Pierre-Bénite, France
Hillman Cancer Center, Pittsburgh, PA
Sheba Medical Center, Ramat Gan, Israel
University of California San Diego, Moores Cancer Center, La Jolla, CA
University Hospital, Heidelberg, Germany
Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australia
University of Queensland, St Lucia
Gallipoli Medical Research Foundation, Greenslopes
Princess Alexandra Hospital, Brisbane, Queensland, Australia
Radboud University Medical Center, Nijmegen, the Netherlands
Irish Clinical Oncology Research Group, Dublin; Derek Power, Irish Clinical Oncology Research Group, Cork, Ireland
Issue Date: 1-Dec-2017 2017-09-15
Publication information: Journal of Clinical Oncology 2017; 35(34): 3815-3822
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.
DOI: 10.1200/JCO.2016.72.1167
ORCID: 0000-0002-3898-950X
PubMed URL: 28915085
Type: Journal Article
Appears in Collections:Journal articles

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