Real-world data on incidence of acute adverse reactions (AARs) reported in clinical practice.

Abstract

e18814 Background: AARs are a significant concern in cancer treatment practice. The exact mechanisms underlying AARs are not fully understood. Their occurrence, even if rare, is unpredictable.This study updates the incidence of AARs in our large cohort of administrations as well as the impact on AARs of the increased number of targeted therapy drugs entered the clinical routine.Several new oncologic drugs have been rapidly developed in the last decade and many of them approved through a fast-track process.Medical Day Hospital of the Fondazione IRCCS Istituto Nazionale dei Tumori provides parenteral treatments for adult oncologic and hematological outpatients of the Medical Oncology Department, with a yearly average of 20,000 treatments, 25% of which are represented by investigational new drugs. Methods: A retrospective analysis of the AARs occurred between January 2020 and December 2022 was conducted.Overall, 61,096 treatments were performed. Therapeutic schemes included chemotherapies, targeted therapies, or both.Excluding the 14,667 investigational treatments, we analyzed 46,429 therapeutic regimens recorded in our database corresponding to 55,895 preparations of non-investigational drugs. Sixty % (33,580) of these preparations were chemotherapies and 40 % targeted therapies (22,315).All patients receiving chemotherapies were premedicated with steroids, while targeted therapies premedication was not always used.As part of the pharmacovigilance program, AARs occurring during injections of approved drugs were registered and reported to AIFA and Eudravigilance.It’s noteworthy that Covid-19 emergency interfered only marginally ( < 10 %) with the amount of administrations performed during that period. Results: A total of 496 AARs out of 55,895 administrations were registered (0,9 %), of which 358 (72 %) were reported with chemotherapies and 138 (28 %) with targeted therapies.The great majority of AARs reported was not severe. Fourteen reactions ( 3% ) were classified as severe, six of them in the targeted therapy group.In order of frequency, among chemotherapies, reactions were more often associated with oxaliplatin, liposomal doxorubicin, etoposide, paclitaxel, vinflunin, docetaxel, cabazitaxel, fludarabine, cisplatin (relative incidence ≥ 1,5 %), while among targeted therapies with rituximab and isatuximab (2,5 % respectively) and TDM1, panitumumab, daratumumab, durvalumab (≥ 0,5 %). Conclusions: This single institutional study suggests useful informations to support safe management of current oncological treatments.Compared to published data, our findings show a low incidence of AARs.Better recognition of potential risk factors and recommendations about premedications, infusions rate and infusion reactions’ management could improve treatment outcome and healthcare drug delivery-related cost.