4451 - Improving patient selection for immuno-oncology phase 1 trials: an external validation of five prognostic scores at Claudius Regaud Institute of Toulouse, Oncopôle (IUCT-O).

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

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).Table:

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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.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.