Real world experience on patterns of usage and toxicity profile of immunotherapy drugs in Indian patients: A prospective observational study

Background

Immune checkpoint inhibitors (ICIs) are now considered revolutionary agents in the treatment of various cancers. Prospective data are limited on the patterns of usage and toxicity profile of these drugs. We planned this study for addressing the same in Indian patients.

Methods

This prospective study was conducted over a period of 2 years. All patients who were treated with Nivolumab, pembrolizumab, atezolizumab, and durvalumab were included. Immune-related adverse events were recorded. Toxicities were graded and number of patients experiencing dose limiting toxicities was recorded.

Results

A total of 53 patients received one of the above four agents. Majority of patients were less than 60 years of age. Carcinoma lung was the most frequent malignancy followed by renal cell carcinoma, Hodgkin's Lymphoma, Urinary Bladder cancers, Malignant Melanoma, and Recurrent/Metastatic Head and neck cancer. Nivolumab was used in most of the study population followed by pembrolizumab. Majority of agents were used in second line. The frequency of all grade adverse events for fatigue, anemia, pneumonitis, skin rash, dyspnea, diarrhea, and hypothyroidism were (in %) 73.58, 62.26, 16.9, 11.32, 9.43, 9.43, and 7.55, respectively. No grade 5 toxicity was observed. None of the grade 3 or 4 toxicities led to treatment discontinuation. Statistically, no difference was found for all grade toxicities among ICI drugs and among the various lines of use.

Conclusion

Nivolumab was the commonest drug used in our cohort. Most of ICIs were used in second-line setting. Toxicities are in line with the published literature.