271P - Prospective study on toxicity profile of immunotherapy in a Indian population: A real-world experience

Background

Immune checkpoint inhibitors are now considered revolutionary agents in the treatment of various cancers in the upfront and metastatic setting. The low toxicity and improved quality of life seen with these drugs are an added advantage. However, the real world data regarding their toxicities is limited. The currently published Indian data are restricted to isolated case reports. We planned this study of addressing toxicity profile of various Immunotherapy agents among Indian patients.

Methods

This prospective study was conducted at a tertiary care Hospital in Delhi from Aug 2019 till Nov 2021 after ethics approval. All patients included were treated with Nivolumab, Pembrolizumab, Atezolizumab and Durvalumab. All lines of therapy were allowed for enrolment. Immune Related adverse events were recorded for individual agents and therapy continued until progression or unacceptable toxicity. Toxicities were graded according to NCI:CTCAE criteria ver 4.0. Statistical analysis was done with the use of SPSS software ver 21.0.

Results

A total of 53 patients received Nivolumab, Pembrolizumab, Atezolizumab and Durvalumab. Majority of patients were less than 60 years of age (64.15%). ECOG PS was 1 in 66.04% and PS 2 in 32.08%. Carcinoma(Ca) Lung was the most frequent malignancy (n=18) followed by renal cell carcinoma (15.09%), Relapsed/Refractory Hodgkin’s Lymphoma ( 15.09%), Ca Urinary Bladder ( 11.32%), Malignant Melanoma (7.55%), Recurrent /Metastatic Head and neck cancer ( 7.55%), one each patient of Hepatocellular Ca, Ca Oesophagus, Stomach, Endometrium and Rectum.Nivolumab was used in the majority of study population (49.06%) followed by Pembrolizumab (37.74%), Atezolizumab (9.43%) and Durvalumab (3.77%). Majority of agents were used in 2nd line (52.83%) across various malignancies followed by 1st line usage in 22.64%, 3rd line in 11.32%, 4th line in 7.55% and 5th line usage in 5.66%. All grade adverse events were fatigue (73.58%), anaemia (62.26%), pneumonitis (16.98%), rash (11.32%), dyspnoea (9.43%), diarrhoea (9.43%) and hypothyroidism (7.55%) in majority of patients. Hyperglycaemia, pleural effusion, arthritis, arthralgia and infusion reaction comprising 1.89% each. Severe Grade 3 anaemia was seen in 1 patient (1.89%). None of these led to treatment discontinuation. Details of toxicities are depicted in the table. Table: 271P

Distribution of adverse events in total and in each drugs

Conclusions

Overall, the toxicity seen in Indian patients largely comparable with international experiences and Oncologists should feel reassured using these agents in similar settings in India.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.