Objective:

To compare the prognostic performance of five established scores (RMH, GRIm, LIPI, PIPO, ROPRO) in predicting early mortality in patients enrolled in phase I immunotherapy trials.

Approach:

• Study Design: Retrospective analysis of 844 patients treated with immunotherapy in phase I trials at Clínica Universidad de Navarra from 2016 to 2023.
• Prognostic Scores: Scores RMH, GRIm, LIPI, PIPO, and ROPRO were calculated according to their original definitions.
• Performance Assessment: Discriminative performance was evaluated using Harrell’s C-index, 3-month AUC, and time-dependent AUC.

Key Findings:

• Median overall survival (OS) was 9.08 months.
• All scores demonstrated statistically significant prognostic stratification.
• C-index values were: RMH 0.58, GRIm 0.55, LIPI 0.66, PIPO 0.63, and ROPRO 0.69.
• AUC at 3 months was highest for ROPRO (0.76).
• No score identified a subgroup with a median OS below 3 months.

Interpretation:

All five scores stratified prognosis but did not effectively identify patients with overall survival below 3 months.

Limitations:

• The study is retrospective and conducted at a single center.
• Scores may not be generalizable to all patient populations or treatment settings.
• No score effectively identified patients with a median OS below 3 months.

Conclusion:

The findings indicate that while the scores can stratify prognosis, they are insufficient for rigid exclusion criteria.