OBJECTIVES

To estimate HRU associated with severe AEs of interest in adults with R/R B-precursor ALL in EU-4 countries (France, Italy, Spain and UK).

METHODS

A Delphi-based methodology was employed which comprised two phases: a questionnaire administered to clinicians (phase 1) and a country-specific panel to discuss the phase 1 results to generate robust point estimates (phase 2). Physicians must be board certified and have at least 5-years’ experience with R/R ALL. Four types of grade 3/4 AEs (vascular events, infections, cytopenia and gastrointestinal events) were evaluated. Outcomes included number of outpatient day visits, length of stay (LOS) in hospital and LOS in intense care unit (ICU) (in days).

RESULTS

Four clinicians from UK, and three clinicians from Spain, France, and Italy were enrolled with a median of 10 years’ experience treating R/R ALL. In France, average number of outpatient day visits was highest for diarrhea (2.5), while veno-occlusive disease (VOD) and septic shock (SS) led to longest average LOS in hospital (17.5). SS also required longest LOS in ICU (4.5). In Italy, viral infection needed highest number of outpatient day visits (7.3) and VOD had longest inpatient LOS (22.5). SS had longest LOS in ICU (13.7). In Spain, thrombocytopenia incurred highest number of outpatient day visits (3.3) and VOD had longest inpatient LOS (16.0). SS led to highest LOS in ICU (9). In the UK, fungal infection incurred highest average number of outpatient day visits (3.8) while VOD led to longest inpatient LOS (16.8). Again, SS needed longest LOS in ICU (7.5).

CONCLUSIONS

In the EU-4 countries, severe VOD universally incurred the highest LOS in hospital (16~22.5 days) and severe SS had highest LOS in ICU (4~13.7 days) among adults with R/R B-precursor ALL. Novel therapies that can improve outcomes while reducing the incidence of these AEs are needed.