Obese patients with advanced cancer treated with nivolumab monotherapy face a higher risk for immune-related adverse events, a new retrospective analysis suggests.
However, only obese women receiving the nivolumab monotherapy appeared to have a higher risk for grade 3 or 4 events, according to the pooled analysis of data from 3772 patients with advanced cancer across eight tumor types.
"Obesity may be associated with an increased incidence of mild or moderate immune-related adverse events among patients receiving immune checkpoint inhibitors," lead author Jennifer L. McQuade, MD, of the University of Texas MD Anderson Cancer Center, Houston, and colleagues said. These results, McQuade and colleagues added, could inform the monitoring of patients at high risk of developing immune-related adverse events during treatment.
The findings were published online December 8 in JAMA Oncology.
Previous retrospective analyses investigating the association between body mass index (BMI) and the risk for immune-related adverse events among patients with cancer have been heterogeneous. Some studies have found a higher incidence of adverse events among patients who are overweight or obese while others have found no significant association between BMI and immune-related adverse events.
In the current analysis, McQuade and colleagues aimed to clarify this potential association using existing randomized clinical trial data with prospectively collected adverse event grading and reporting.
The researchers retrospectively analyzed data from 14 multicenter CheckMate trials looking at eight tumor types. Patients with advanced cancers were treated with either nivolumab monotherapy at a dose of 3 mg/kg, or with nivolumab plus ipilimumab at doses of 1 mg/kg and 3 mg/kg, or 3 mg/kg and 1 mg/kg, respectively.
Study participants were a median age of 61 years, and 69% were men. Participants were enrolled in the trials between February 9, 2012, and May 21, 2015, and followed until May 1, 2019.
Weight categories were determined based on BMI at baseline, according to World Health Organization criteria, with BMI less than 25 considered normal weight or underweight and BMI of 30 or greater considered obese.
In 2746 patients receiving nivolumab monotherapy at a dose of 3 mg/kg, the risk for any grade immune-related adverse events was significantly greater among 543 patients with obesity, compared with 1266 normal weight or underweight patients (odds ratio [OR], 1.71).
The overall incidence of grade 3 and 4 immune-related adverse events did not differ based on weight (OR, 1.21; 95% CI, 0.92-1.61). And the incidence of immune-related adverse events in patients receiving both nivolumab and ipilimumab appeared consistent across BMI categories.
However, the risk for grade 3 or 4 immune-related adverse events was significantly higher among the subgroup of women with obesity who received nivolumab monotherapy compared with women who were normal or underweight (OR, 1.73).
The authors cautioned that this study is limited by its retrospective design and post hoc nature, and the results should be interpreted with caution.
Still, the findings "highlight the importance of BMI as a clinical covariate for patients receiving [immune checkpoint inhibitors] and support further evaluation in prospective studies," the investigators concluded.
All studies included in this pooled analysis were sponsored by Bristol Myers Squibb. Patients treated at Memorial Sloan Kettering Cancer Center were supported in part by a Memorial Sloan Kettering Cancer Center Support Grant/Core Grant. McQuade reported receiving honoraria from Bristol Myers Squibb and Roche and consulting for Merck during the conduct of the study.
JAMA Onc. Published online December 8, 2022. Full text.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at email@example.com or on Twitter: @SW_MedReporter.
Lead image: Bristol-Myers Squibb
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