The impact of excess weight and body fat on clinical outcomes of immune checkpoint inhibitors according to gender.
[BACKGROUND] The impact of body-mass index (BMI) on immune checkpoint inhibitor efficacy and toxicity has not been clearly characterized.
APA
García-Goñi M, Olmedo M, et al. (2026). The impact of excess weight and body fat on clinical outcomes of immune checkpoint inhibitors according to gender.. Journal of endocrinological investigation, 49(1), 187-196. https://doi.org/10.1007/s40618-025-02722-1
MLA
García-Goñi M, et al.. "The impact of excess weight and body fat on clinical outcomes of immune checkpoint inhibitors according to gender.." Journal of endocrinological investigation, vol. 49, no. 1, 2026, pp. 187-196.
PMID
41144103
Abstract
[BACKGROUND] The impact of body-mass index (BMI) on immune checkpoint inhibitor efficacy and toxicity has not been clearly characterized. We analyzed the association between BMI, and body fat (%BF), with the efficacy and toxicity of ICIs across three solid tumors in a real-life setting.
[METHODS] Melanoma, lung and urothelial cancer patients treated with ICIs at our institution were included. BMI (kg/m2) and %BF (CUN-BAE) were calculated retrospectively. We studied the association between BMI/%BF and objetive-response-rate (ORR), progression-free survival (PFS), overall survival (OS) and immune-related adverse events (irAEs).
[RESULTS] Among the 356 patients included, 177 (49.7%) had a BMI ≥ 25 kg/m2. Mean BMI was 25.3 ± 4.2 kg/m2, and %BF 30.5 ± 6.3%. ORR was achieved in 155 patients (46.8%). Median PFS and OS was 4 and 11 months, respectively. There were no differences in ORR across BMI categories. In contrast, normal %BF was associated with better ORR in men (81.8% vs. 41.7%, = 0.024), but not in women ( = 0.074). Additionally, no association was observed between BMI/%BF and irAEs ( = 0.762). Notably, those developing any-grade irAEs showed better ORR ( < 0.001), PFS (HR 1.6, < 0.001) and OS (HR 1.7, < 0.001), even adjusting by BMI/%BF, age, gender, primary tumor or ICI regimen.
[CONCLUSIONS] Our results suggest that in patients with advanced cancers treated with ICIs, BMI was not correlated with clinical outcomes or survival. However, men with normal %BF showed better ORR compared to men with excess-%BF, but this pattern was not observed in women. These findings support to consider gender and body composition as stratification factors in trials.
[METHODS] Melanoma, lung and urothelial cancer patients treated with ICIs at our institution were included. BMI (kg/m2) and %BF (CUN-BAE) were calculated retrospectively. We studied the association between BMI/%BF and objetive-response-rate (ORR), progression-free survival (PFS), overall survival (OS) and immune-related adverse events (irAEs).
[RESULTS] Among the 356 patients included, 177 (49.7%) had a BMI ≥ 25 kg/m2. Mean BMI was 25.3 ± 4.2 kg/m2, and %BF 30.5 ± 6.3%. ORR was achieved in 155 patients (46.8%). Median PFS and OS was 4 and 11 months, respectively. There were no differences in ORR across BMI categories. In contrast, normal %BF was associated with better ORR in men (81.8% vs. 41.7%, = 0.024), but not in women ( = 0.074). Additionally, no association was observed between BMI/%BF and irAEs ( = 0.762). Notably, those developing any-grade irAEs showed better ORR ( < 0.001), PFS (HR 1.6, < 0.001) and OS (HR 1.7, < 0.001), even adjusting by BMI/%BF, age, gender, primary tumor or ICI regimen.
[CONCLUSIONS] Our results suggest that in patients with advanced cancers treated with ICIs, BMI was not correlated with clinical outcomes or survival. However, men with normal %BF showed better ORR compared to men with excess-%BF, but this pattern was not observed in women. These findings support to consider gender and body composition as stratification factors in trials.