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Poster Display session 1

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).


28 Sep 2019


Poster Display session 1


Clinical Research

Tumour Site


Ghassan Al Darazi


Annals of Oncology (2019) 30 (suppl_5): v159-v193. 10.1093/annonc/mdz244


G. Al Darazi1, E. Martin2, J. Delord1, I. Korakis1, S. Betrian1, M. Poublanc2, F. Ollivier3, T. Filleron2, C.A. Gomez-Roca1

Author affiliations

  • 1 Medical Oncology & Clinical Research, Institut Claudius Regaud, 31100 - Toulouse/FR
  • 2 Statistics, Institut Claudius Regaud, 31100 - Toulouse/FR
  • 3 Clinical Research Department, Institut Claudius Regaud, 31100 - Toulouse/FR


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Abstract 4451


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).


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


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:


Sites of metastases > 2
LDH > 466
Albumin < 35 G/L
Gastrointestinal tumor
PS ≥ 1
PS > 1
Age > 52 years
Platelet count > 300
ANC > 4.9
ALC < 1.8
liver metastases
NLR > 6
dNLR > 3
R² adj0.0960.1760.1360.1860.145


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.


Has not received any funding.


All authors have declared no conflicts of interest.

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