212PImmunotherapy with nivolumab in metastatic renal cell carcinoma patients in India: Bringing a change in clinical practice. (24th November 2019) - Rauthan, A
Abstract: Background: The standard practice for management of metastatic renal cell cancer (mRCC) patients in India has been sunitinib or pazopanib in the first line setting, and everolimus at progression. Nivolumab in the second line setting, showed a median overall survival (OS) of 26 months, 2year OS rate of 52% and objective response rate(ORR) of 26%; which was better than everolimus in the Checkmate 025 study. There is sparse data about nivolumab in Indian RCC patients. Methods: This is a single centre, retrospective analysis, which included mRCC patients who received nivolumab between April 2016 to April 2019. The endpoints were ORR, OS and adverse events (AEs). Results: 31 patients of mRCC received nivolumab at 3 mg/kg or flat dose of 240mg. Median age was 60 years (22-82 years). There were 27 males and 4 females. 4 patients received first line nivolumab, and 27 patients as second line. 16 patients had earlier received sunitinib, 10 pazopanib, and 1 sorafinib. 3 patients (9.7%) achieved complete response(CR), 8(25.8%) achieved partial response, 8(25.8%)had stable disease and 12(38.7%)had progressive disease. The 3 patients with CR, received 18 doses, after which their treatment was stopped; and they continue to be in CR at followup of 36, 32 and 26 months respectively. 10 patients have completed more than 12 cycles. OS at 1 year is 60% and median OS has not been reached. The common AEs were fatigue in 8(25.8%), hypothyroidism in 6(19.3%), skin rash in 4(12.9%) and pneumonitis in 3(9.7%) patients. Colitis, arthritis, immune retinopathy, and myocarditis was each seen in 1 patient. Treatment was discontinued in 3 patients who developed grade 3 AEs. Conclusions: With an ORR of 35.5%, nivolumab has replaced everolimus, and has become our standard second line regimen in mRCC. Achieving an OS at 1 year of 60% is the best we have seen in the second line setting. The most exciting impact has been the durable long lasting response seen (duration ranging 2-3 years) even after discontinuing treatment, in our 3 CR patients. This has prompted us to make 1 year of treatment as a standard duration of nivolumab for responding patients at our center; enabling us to reduce cost of treatment. It is very well tolerated; but a careful watch should be kept for immune related AEs. Legal entity responsible for the study: Amit Rauthan. Funding: Has not received any funding. Disclosure: A. Rauthan: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Roche; Advisory / Consultancy: MSD; Advisory / Consultancy: Pfizer. All other authors have declared no conflicts of interest.