55 [89Zr]Zr-DFO-girentuximab and [18F]FDG PET/CT to predict WW in mccRCC patients In contrast to [18F]FDG, the per-patient gm [89Zr]Zr-DFO-girentuximab SUV max was not significantly associated with the time till RECIST PD (Table 2A). Table 2. Univariable (A) and multivariable (B) Cox regression analysis of all patients. Table 2A Univariable analysis Watchful waiting time Time until RECIST-defined PD HR (95% CI) p value HR (95% CI) p value “WW criteria”, < 2 IMDC and ≤ 2 organ sites vs. ≥ 2 IMDC and/or ≥ 2 organ sites 1.9 (1.0-3.9) 0.07* 1.3 (0.7-2.5) 0.48 IMDC criteria, per unit increase in score 1.4 (0.9-2.2) 0.1* 1.3 (0.9-2.0) 0.21 Number of organ sites, per affected site increase 1.4 (1.0-1.9) 0.087 1.0 (0.7-1.5) 0.86 [89Zr]Zr-DFO-girentuximab above-median split 1.7 (0.9-3.3) 0.14 1.3 (0.7-2.6) 0.43 [89Zr]Zr-DFO-girentuximab SUV max, per 10 units increase in geometric mean 1.3 (1.0-1.7) 0.085 1.2 (0.9-1.5) 0.3 [18F]FDG above-median split 5.6 (2.4-14.7) <0.0001 2.1 (1.0-4.4) 0.046 [18F]FDG SUV max, per 3 units increase in geometric mean 1.9 (1.4-2.6) <0.0001 1.4 (1.0-1.8) 0.026 [18F]FDG MTV above median split 2.2 (1.1-4.5) 0.03 2.5 (1.2-5.2) 0.013 [18F]FDG MTV, per 50 units increase 1.3 (1.0-1.6) 0.007 1.2 (0.9-1.5) 0.17 [18F]FDG TLG above median split 2.5 (1.2-5.2) 0.011 1.52 (0.8-3.1) 0.23 [18F]FDG TLG, per 200 units increase 1.5 (1.1-2.0) 0.006 1.3 (1.0-1.7) 0.077 Table 2B Multivariable analysis Watchful waiting time Time until RECIST-defined PD HR (95% CI) p value HR (95% CI) p value IMDC criteria, per unit increase in score 1.3 (0.81-2.00) 0.29 1.3 (0.85-2.01) 0.22 Number of organ sites, per affected site increase 0.9 (0.49-1.46) 0.55 0.7 (0.40-1.23) 0.22 [89Zr]Zr-DFO-girentuximab SUV max, per 10 units increase in geometric mean 1.2 (0.84-1.78) 0.28 1.3 (0.87-1.82) 0.21 [18F]FDG SUV max, per 3 units increase in geometric mean 1.9 (1.34-2.58) 0.0002 1.4 (1.04-1.80) 0.025 Continuous PET variables were truncated at the top 90% to reduce the influence of outliers and were represented in the analyses in such a way that the resulting hazard ratios (HRs) correspond to an amount of increase in the respective variable corresponding with approximately 1/4th of its entire distribution. This was done to make the resulting HRs for the continuous PET variables comparable with each other.*The reported p-value is two-sided, according to Waldv 3
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