(P 162) PAZOPANIB IN THE REAL-WORLD SETTING: DATA FROM THE ITALIAN NATIONAL REGISTRY

Objective: Pazopanib is an oral, multitarget, tyrosine kinase inhibitor (TKI) approved for the treatment of patients with advanced non adipocytic soft-tissue sarcomas (STS) who have received prior chemotherapy. In Italy, the use of Pazopanib for STS patients has been monitored from 2013 to 2019 through a registry run by the national drug regulator (the Italian Medicines Agency AIFA).

Methods: Data on STS patients treated with Pazopanib in Italy were prospectively collected from July 2013 to December 2019 by AIFA. The primary objectives were to describe clinical characteristics, histological subtypes captured at the time of Pazopanib treatment start and clinical outcomes, assessed by measuring Time to Treatment Discontinuation (TTD), defined as the time between the initial prescription of Pazopanib and the date of treatment discontinuation for any cause, real world Progression Free survival (rw-PFS) and response to Pazopanib.

Results: In total, we analyzed data from 1,965 sarcoma patients. The most represented histological subtypes were tumors with smooth muscle differentiation (44,7%), uncertain differentiation (28.7%) and fibroblastic/myofibroblastic differentiation (13.2%). 499 patients (25.4%) required at least a dose reduction during treatment, with a median time to dose reduction of 55 days. Overall, the median TTD was 107 days while median PFS was 139 days. In the final AFT model, the variables significantly associated to longer TTD were ECOG PS0 and histological diagnosis of alveolar soft part sarcoma.

Conclusion: In this real-world survey, Pazopanib seemed to have variable effectiveness across STS histologies. These real-world data can complement data from randomized controlled trials and may help understand the actual potential of one of the few approved agents in advanced soft tissue sarcomas.