Background: Interactions between nutrition and inflammation have been investigated and body mass index (BMI) has historically been considered the major surrogate of nutritional status. Patients and methods: Baseline BMI was evaluated in advanced cancer patients consecutively treated with the anti-PD-1 Immune Check Point Inhibitors Nivolumab and Pembrolizumab monotherapy. Uni/ multivariate analyses were performed to correlate BMI with clinical outcomes. Results: Median age was 67.8 years (range 27–83). Primary tumors were: renal cell carcinoma (22 patients, 14.7%), melanoma (30 patients, 20%), NSCLC (90 patients, 60%), others (6 patients, 5.3%). Female/ Male ratio was 45/105. 92 patients (61.3%) had an “high” BMI (≥ 25). All patients’ features are summarized in Table 1. Median follow-up was 9.9 months (range 1–38); median PFS was 7.9 months (95% CI 4.8– 25.4; 48 events) among patients with BMI ≥ 25, and 3.9 months (95% CI 3.1–8.0; 35 events) among patients with BMI < 25. At multivariate analysis BMI < 25 was significantly related to a shorter PFS (HR = 1.73; 95% CI 1.09–2.74; p = 0.0184) (Table 2, Fig. 1). Survival data are still immature, with 96 censored patients at the data cut-off; the median OS was 12.4 months (95% CI 4.7–23.8) among patients with BMI < 25, while it was not-reached for patients with BMI ≥ 25; (HR = 1.57; 95% CI 0.92–2.70; p = 0.0974). No significant differences were observed in ORR and incidence of irAEs between the two subgroups. Conclusion: It is known that nutritional status could affect immune responses: this preliminary report suggests a positive predictive impact of a high BMI on clinical outcomes of patients treated with anti-PD-1 ICIs. Further studies on the topic are required.
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