LAUSR

Obinutuzumab (G) in combination with chlorambucil (Chl) has been approved in Italy in 2017 as frontline treatment for patients with chronic lymphocytic leukemia (CLL) and comorbidities, following results of the CLL11 trial 1 and real-life studies. 2-4 Few studies have focused on reduction of relative dose intensity (RDI) in CLL. 5,6 The aim of this study was to evaluate the impact of reduced RDI of G-Chl on the overall response rate (ORR), progression-free survival (PFS), time to next treatment (TTNT), and overall survival (OS); we also wanted to identify patients at higher risk for dose reductions. We collected and retrospec-tively analyzed data of 130 patients diagnosed with CLL and comorbidities from the Italian centers with the highest use of the G-Chl regimen outside clinical trials between 2017 and 2020. Patients ’ characteristics are shown in supplemental Table 1. The study was conducted according to the Helsinki Declara-tion, Good Clinical Practice, and the applicable national regulations; all patients provided written informed consent, and the study was approved by the Institutional Ethical Committee of the Fondazione Policlinico Agostino Gemelli IRCCS. The RDI was calculated as the ratio between the dose actually delivered over time and the expected correct dose: a dose reduction of 20% was considered the best