Clinical Scorecard: Evaluating the Prognostic Utility of Established Scoring Systems for Early Mortality in Phase I Immunotherapy Trials: A Comparative Real-World Cohort Analysis

At a Glance

Key Highlights

• Study included 844 patients treated with immunotherapy in phase I trials.
• Median overall survival (OS) was 9.08 months.
• ROPRO score showed the highest 3-month AUC at 0.76.
• No score identified a subgroup with median OS below 3 months.
• All scores demonstrated statistically significant prognostic stratification.

Guideline-Based Recommendations

Diagnosis

• Utilize established prognostic scores (RMH, GRIm, LIPI, PIPO, ROPRO) for patient stratification.

Management

• Consider integrating dynamic clinical or molecular biomarkers into prognostic models.

Monitoring & Follow-up

• Regularly assess the performance of prognostic scores in clinical practice.

Risks

• Be aware of the potential for premature death in up to 15% of enrolled patients.

Patient & Prescribing Data

Patients with advanced malignancies enrolled in phase I trials.

Prognostic scores can aid in identifying patients unlikely to benefit from trial participation.

Clinical Best Practices

• Use prognostic scores as stratification factors rather than rigid exclusion criteria.
• Maintain clinical judgment alongside the use of prognostic tools.

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