An observational study to evaluate pattern of usage of immune checkpoint inhibitors in the 1st line treatment of various advanced solid tumors, their efficacy and their toxicity profile.

Abstract

e14617 Background: With the increasing evidences of immunotherapy, use of immune checkpoint inhibitors have been increased in various advanced malignancies with various toxicity profile. Thus, the present study evaluated the pattern of ICIs usage in the first-line treatment, the efficacy and toxicity profile of ICIs. Methods: This is an observational study was done at a tertiary cancer care centre, over a period of 24 months (April 2022 to March 2024). All adult patients diagnosed with solid tumours eligible for ICIs as per NCCN guidelines were taken. Various demographic and clinical data were collected from hospital records. Following treatment initiation, treatment response and adverse events were collected from patients on subsequent visits by interviewing as per pre-specified Performa. Results: The total number of patient included in the study is 64 . The patients were predominantly males (71.88%) and the mean age was 59 years. Non-small cell lung cancer (39.06%) was the most common solid tumor. Most of the patients had stage IV disease (79.69%). The PDL1 positive is taken as > 1%. The PDL1 positive rate was 60.00%. Around 72% of patients received immunotherapy alongside chemotherapy, whereas 18% of patient received immunotherapy with targeted therapy and around 10% of patient received immunotherapy as single agent. On assessment, most of the patients had partial response (31.25%). Around 70% patients had adverse effects of any grade, of which only non-haematological adverse effects (37.78%) were most frequent. Moreover, 21.88% patients had grade 3/4 adverse effects. Of total patients, the adverse events of interest/ immunotherapy, 23.44% patients had rashes, 28.13% had pneumonitis, 10.94% had diarrhea, and another 10.94% had thyroiditis. The majority of patients with adverse effects discontinued the treatment and required supportive care (48.39%) [Out of this 15 patient in which immunotherapy was discontinued, there was permanent discontinuation of immunotherapy in total 9 patients and immunotherapy was with-holded in 6 patients and was restarted after patient recovered] which was followed by supportive care (35.48%), and around 16% patient required no intervention. There was no grade 5 adverse event/ death related to treatment seen . Conclusions: we conclude that immunotherapy is fairly tolerable in Indian patient and toxicity profile is quite similar as observed in various clinical trials reported. Distribution of patients according to treatment of immunotherapy related side effect. Treatment of immunotherapy related side effect N=31 % No intervention 5 16.13 Supportive care 11 35.48 Discontinuation of immunotherapy + Supportive care 15 48.39