LAUSR

Abstract Background We aimed to compare the performance of 5 prognostic scores (RMH: Royal Marsden Hospital, MDACC: MD Anderson Clinical Center, MDA-ICI: MD Anderson Immune Checkpoint Inhibitors, GRIm: Gustave Roussy Immune Score and LIPI: Lung Immune Prognostic Index) in predicting overall survival (OS) in phase 1 patients treated with immune checkpoint inhibitors (ICI). Methods We reviewed records of patients with advanced solid tumors enrolled in phase 1 ICI trials between 2015 and 2018 at IUCT-O. We compared the performance of prognostic scores using Akaike criterion, discriminatory ability (Harrell’s C, the Royston’s D) and proportion of explained variation (R²) statistics. Primary endpoint was OS. ANC: Absolute Neutrophil Count ALC: Absolute Lymphocyte count (d)NLR: (Derived) Neutrophil / Lymphocyte ratio PS: Performance status Table . 493P RMH MDACC MDA-ICI GRIm LIPI Sites of metastases > 2 ✓ ✓ LDH > ULN ✓ ✓ ✓ ✓ LDH > 466 ✓ Albumin ✓ ✓ ✓ Gastrointestinal tumor ✓ PS ≥ 1 ✓ PS > 1 ✓ Age > 52 years ✓ Platelet count > 300 ✓ ANC > 4.9 ✓ ALC ✓ liver metastases ✓ NLR > 6 ✓ dNLR > 3 ✓ AIC 1310.7 1290.0 1296.4 1293.5 1296.9 CH 0.60 0.67 0.64 0.66 0.65 Dadj 0.67 0.94 0.81 0.98 0.84 R² adj 0.096 0.176 0.136 0.186 0.145 Results A total of 259 patients were included. Median age was 63 years (range 18-83). Main primary cancers were melanoma (18.5%), head and neck (16.2%), lung (12.7%) and bladder (9.7%). With a median follow up of 15 months (95% CI: [11.6;17.5]), median OS was 12.5 months (95%CI = [10.3;16.0]). All scores were associated with OS: Hazard Ratio (HR)=1.98 [1.41;2.78] for RMH score 2-3 vs 0-1, HR = 1.68 [1.09;2.60] for MDA score 2 and 3.65 [2.42;5.51] for score 3-5 vs 0-1, HR = 1.18 [0.77;1.81] for MDA-ICI score 3; HR = 2.70 [1.74;4.17] for score 4 and HR = 4.85 [2.62;8.98] for 5-6 vs 0-2, HR = 2.70 [1.92;3.79] for GRIm score 2-3 vs 0-1 and finally 1.86 [1.25;2.78] for LIPI score 1 and HR = 3.86[2.43;6.13] for score 2 vs 0. MDA and GRIm scores obtained more significant results for discrimination than RMH, MDA-ICI and LIPI (Table). Conclusions The utilization of theses scores could allow a better patients selection in early trials, especially during the critical periods of dose escalation and proof-of-concept expansion cohorts. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.