Abstract 212P
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.
Clinical trial identification
Editorial acknowledgement
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.
Resources from the same session
87P - Negative to positive lymph node ratio-prognostic marker of survival in node positive rectal cancer
Presenter: Pavan Jonnada
Session: Poster display session
Resources:
Abstract
88P - The Sidra LUMC advanced colon cancer NGS cohort
Presenter: Wouter Hendrickx
Session: Poster display session
Resources:
Abstract
89P - A phase II trial of adjuvant chemoradiotherapy for patients with high-risk rectal submucosal invasive cancer after local resection
Presenter: Masaaki Noguchi
Session: Poster display session
Resources:
Abstract
90P - High MICB expression confers prognostic benefit in colorectal cancer
Presenter: Shanchao Yu
Session: Poster display session
Resources:
Abstract
91P - Adjuvant therapy for high-risk stage II or stage III colon adenocarcinoma: A propensity score-matched, nationwide, population-based cohort study
Presenter: Chien-Hsin Chen
Session: Poster display session
Resources:
Abstract
92P - Prospective randomized controlled study comparing primary surgery versus neoadjuvant chemotherapy followed by surgery in gastric carcinoma
Presenter: Vipin Goel
Session: Poster display session
Resources:
Abstract
93P - Biomarker selection of liver metastatic colorectal patients for anti-EGFR monoclonal antibodies: A machine learning analysis
Presenter: Yijiao Chen
Session: Poster display session
Resources:
Abstract
94P - NORTH/HGCSG1003: North Japan multicenter phase II study of oxaliplatin-containing regimen as adjuvant chemotherapy for stage III colon cancer: Final analysis
Presenter: Michio Nakamura
Session: Poster display session
Resources:
Abstract
95P - Anatomical resections improve relapse-free survival in patients with KRAS/NRAS/BRAF- mutated colorectal liver metastases
Presenter: Ye Wei
Session: Poster display session
Resources:
Abstract
96P - Incidence, characteristics and prognosis in colorectal cancer with CNS metastases
Presenter: Nicola Taylor
Session: Poster display session
Resources:
Abstract