Abstract

– 18 years of age or older – hospitalised for management of at least one episode of R/R ALL; diagnosis of Ph-negative B-precursor ALL – relapsed with first remission lasting less than 12 months – relapsed after first salvage therapy – relapsed any time after haematopoietic stem cell transplant HSCT – or refractory to primary induction or salvage therapy – electronic medical record or chart available for review and data collection – not enrolled in either blinatumomabor inotuzumab ozogamicin-related clinical trials during the study period • The study period was from 2003 to 2014. Patients with R/R ALL were screened from October 2013 going backwards until at least 30 eligible patients were identified. • Patient data were collected from the index date until the patient died or was lost to follow-up, and outcomes were evaluated during pre-specified time periods (Figure 1). – The index date was the first time the ALL patient was recorded as refractory or relapsed, according to the inclusion criteria. – The chemotherapy period was pre-specified to represent the time during which the most intensive chemotherapy is assumed to be administered but before transplant. The chemotherapy period was defined as the first chemotherapy date after the index date to the earliest of either death, loss to follow-up, last chemotherapy dose plus 30 days, or initiation of HSCT. Since the ultimate goal of therapy is to send patient to HSCT, initiation of HSCT was chosen as the end of the intensive chemotherapy period. – For patients who received HSCT after the index date, the HSCT period was defined as the time from starting HSCT to the earliest of death, loss to follow-up, or relapse of ALL. METHODS • To quantify hospitalisations and reimbursements among adults with PhR/R B-precursor ALL treated with current salvage chemotherapies in Italy.

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