Authors (including presenting author) :
Cheung TSJ(1), Zhou R(2), So KH(3), Lim WL(1)
Affiliation :
(1)Pharmacy Department, Prince of Wales Hospital, (2)School of Pharmacy, The Chinese University of Hong Kong, (3)Pharmacy Department, Tuen Mun Hospital
Introduction :
There is a paucity of data on the local patient profile for immune-related adverse events (irAEs) associated with PD-1/PD-L1 inhibitor use. A more comprehensive understanding can allow the formulation of appropriate monitoring and treatment guidelines.
Objectives :
This study aimed to describe the safety profile of the checkpoint inhibitors atezolizumab, durvalumab, nivolumab, and pembrolizumab. By determining the rate, time frame, and management of irAEs, this study sought to design accurate monitoring protocols. Additionally, it identified differences between patients receiving monotherapy immune-oncology (IO) treatments and those receiving concomitant systemic therapy to evaluate the need for distinct monitoring guidelines.
Methodology :
This study reviewed NSCLC patients who received PD-1/PD-L1 inhibitors between June 2016 and August 2022 at the Prince of Wales Hospital under the care of the Department of Oncology. The incidence of irAEs was reported using descriptive statistics. The time to onset of irAEs was described using Kaplan-Meier curves. The relationship between potential risk factors and the rate of irAEs was evaluated using Poisson regression. Cox regression was used to determine the correlation between the rate of irAEs and overall survival (OS). Proportions of patients experiencing irAEs categorized by organ system and the mean time to onset of first any-grade and grade III/IV irAEs were also compared.
Result & Outcome :
This study reviewed 138 patients across 7 years, identifying 215 irAE, which had a median time to onset of 56 days (Range 4 – 702 days). irAE were classified by organ system. The most common grade III/IV was pneumonitis, which led to permanent discontinuation of immunotherapy in all cases. Systemic steroids were the mainstay for treating grade III/IV irAE, with doses ranging from 350mg to 5550mg (Median = 1533.75mg) and treatment durations ranging from 21 to 138 days. Male gender (IRR 1.423, P=0.050), active infection (IRR 2.081, P=0.004), and drinking (IRR 1.760, P< 0.001) were found to be significant predictive risk factors. The rate of adverse events was weakly and positively correlated with the overall survival of patients receiving immunotherapy. The rate of irAE was higher in patients concomitantly receiving systemic therapy compared to immunotherapy alone, and there was a small to moderate association between the treatment received and the proportions of irAE categorized by organ system. No significant difference was found in the time to onset of irAEs between patients receiving immunotherapy alone (P=0.672) and those receiving immunotherapy concomitantly with systemic anti-cancer therapy (P=0.648).
