Clinical trials have demonstrated the benefit of immune-checkpoint inhibitors (ICIs) for many cancer types. With the widespread use of ICIs, we are facing challenges in the management of immune-related adverse events(irAEs). It is extremely important for physicians to be aware of early recognition and immediate treatment of irAEs. In this study, we aimed to characterize the spectrum of toxicity, management, and outcomes for irAEs.
Between January 2015 and December 2018, patients who were treated with at least one ICIs in clinical trials, expanded access programs or in routine practice in Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine were included in this study. Clinical and laboratory parameters were collected retrospectively to determine the incidence of irAEs, risk factors, and their association with treatment outcomes. All irAEs were graded using the CTCAE v4.0.
A total of 255 patients were retrospectively evaluated. Of these 71 (27.8%) patients developed irAEs. 52(73.2%) of the patients were male, 19 (26.8%) were female. All patients have ECOG performance status 0 -1. More than 2 irAEs were detected in 16 (6.2%) patients. A total of 3177 doses were given with 93 episodes of any grade irAEs. There were 22 irAEs (23.7%) reported as grade 1, 49 (52.7%) as grade 2, 19 (20.4%) as grade 3, and 3 (3.2%) as grade 4. The most common among them were pneumonitis (n:15), hepatitis (n:13), hypothyroidism (n:13) and dermatitis (n:12). 3 patients were reported to develop grade 4 pneumonitis, toxic epidermal necrolysis and thrombocytopenia. There were 9 immune related deaths in our study. In 4 patients same irAEs recurred upon rechallenge of the ICIs. 39 of irAEs (41.9%) occurred after anti PD1, 47 (50.5 %) occurred after anti PDL1, 7 (7.5%) occurred after combination of anti CTLA4+ anti PDL1.
With the increased use of immunotherapeutic agents in oncology clinics, increased awareness and early recognition are required for effective management of irAEs and improved treatment outcomes. We believe that this study will have a significant impact on current and future service delivery in oncology units.
The authors.
Has not received any funding.
All authors have declared no conflicts of interest.