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Abstract
Background Body mass index (BMI) and serum albumin are common measurements used to evaluate nutritional status. Recent studies have shown conflicting results correlating nutritional status with immune checkpoint inhibitor (ICI) therapy outcomes.1,2 In this study, we investigate if baseline and change in BMI and serum albumin levels correlate with survival outcomes in advanced stage melanoma patients treated with anti-PD-1 therapy.
Methods We conducted a single-center, retrospective review of unresectable stage III and IV melanoma patients treated with anti-PD-1 monotherapy (nivolumab or pembrolizumab) or ipilimumab/nivolumab (I/N) between 2011 and 2022. Overall survival (OS) and progression-free survival (PFS) were measured from the first dose of treatment to date of death and clinical or radiographic progression, respectively. The effect of baseline BMI, serum albumin levels, and their respective percentage change at 3 months from treatment initiation on PFS and OS was assessed on a continuum level. Multivariate analyses were performed using Cox proportional hazard models, accounting for the following covariates: Age, gender, anti-PD-1 therapy type, primary melanoma type, pre-treatment LDH, BRAF status, presence of brain or liver metastasis, and prior adjuvant or non-anti-PD-1 treatment for advanced-stage melanoma.
Results 202 patients were identified. Mean BMI was 30.1 and mean albumin level was 3.63 g/dL. Higher baseline BMI (HR 0.9825, 95% CI: 0.9657–0.9996, p=0.0445) and lower baseline albumin level (HR 2.4498, 95% CI: 1.2606–4.7619, p=0.0082) was associated with worse PFS [table 1]. Change in BMI and albumin level at 3 months was not associated with PFS outcomes. Lower baseline albumin level was associated with worse OS outcomes [HR 2.4814, 95% CI: 1.1161–5.5157 p=0.0258]. Higher change in albumin level at 3 months was also associated with worse OS [HR 0.9389, 95% CI: 0.9109–0.9677, p=0.00004]. Our univariate analysis showed lower baseline albumin level and decreasing albumin change from the baseline mean at 3 months was associated with worse PFS and OS [figure 1].
Conclusions Nutritional status may have a predictive role on survival in advanced melanoma patients treated with anti-PD-1 therapy. Baseline albumin and decreasing albumin levels at 3 months is associated with worse survival. Unlike previous studies, we found that higher baseline BMI may lead to worse PFS outcomes in immunotherapy treated patients. Interventional studies are warranted to see if nutritional status optimization prior to and during anti-PD-1 therapy can affect clinical outcomes.
References
Kondo T, Nomura M, Otsuka A, et al. (2019). Predicting marker for early progression in unresectable melanoma treated with nivolumab. Int J Clin Oncol. 2019 Mar;24(3):323–327.
McQuade JL, Daniel CR, Hess KR, et al. Association of body-mass index and outcomes in patients with metastatic melanoma treated with targeted therapy, immunotherapy, or chemotherapy: a retrospective, multicohort analysis. Lancet Oncol. 2018 Mar;19(3):310–322.
Ethics Approval The study was approved by the University of Wisconsin institutional ethical guidelines and patients‘ consents were waived following Institutional Review Board protocol review (UW21110).
Kaplan-Meier curves of progression-free survival (PFS) and overall survival (OS) comparing patients based on baseline albumin levels and percent albumin change at 3 months. Mean albumin level was 3.63 g/dL. A) PFS difference between patients with baseline albumin below the mean and those with baseline albumin above the mean. B) OS difference between patients with baseline albumin below the mean and those with baseline albumin above the mean. C) PFS difference between patients with percent albumin change 3 months below the mean and those with percent albumin change 3 months above the mean. D) OS difference between patients with percent albumin change 3 months below the mean and those with percent albumin change 3 months above the mean