Real-world utilization and safety of ipilimumab plus nivolumab (I+N) in metastatic renal cell carcinoma (mRCC) patients: Results from the Canadian Kidney Cancer Information System (CKCis).

Authors

null

Myuran Thana

Dalhousie University, Halifax, NS, Canada

Myuran Thana , Naveen S. Basappa , Sunita Ghosh , Christian K. Kollmannsberger , Daniel Yick Chin Heng , Jeffrey Graham , Denis Soulieres , Aaron Hansen , Aly-Khan A. Lalani , Vincent Castonguay , M. Neil Reaume , Georg A. Bjarnason , Rodney H. Breau , Frederic Pouliot , Anil Kapoor , Lori Wood

Organizations

Dalhousie University, Halifax, NS, Canada, Cross Cancer Institute, Edmonton, AB, Canada, Cross Cancer Institute/University of Alberta, Edmonton, AB, Canada, British Columbia Cancer Agency, Vancouver Centre, Vancouver, BC, Canada, University of Calgary, Calgary, AB, Canada, University of Manitoba, Winnipeg, MB, Canada, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada, Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Hotel Dieu de Quebec, Quebec, QC, Canada, Ottawa Hospital Cancer Centre, Ottawa, ON, Canada, Sunnybrook Research Institute, Toronto, ON, Canada, University of Ottawa, Ottawa, ON, Canada, Cancer Research Center, Centre Hospitalier Universitaire (CHU) de Québec-Université Laval, Quebec City, QC, Canada, Juravinski Cancer Centre, McMaster University, Hamilton, ON, Canada

Research Funding

No funding received
None.

Background: I+N is now standard of care for first line treatment of intermediate/poor risk mRCC patients (pts). Real world data is vital to understand drug usage, toxicity and outcomes in non-trial pts. This project describes the amount and tolerability of treatment delivered including discontinuation rates, reasons for discontinuation and outcomes from the CKCis database. Methods: Pts in CKCis, a prospective Canadian database from 15 academic centers, who received first line I+N were included. The number of doses of I+N, number of pts who received single-agent nivolumab (N) and duration of single agent N were determined. Reasons for treatment discontinuation, including the rate, type, and grade of toxicities were identified. Efficacy outcomes included time to failure (TTF – time to progression, death, or second line therapy), overall response rate (ORR) and overall survival (OS). Results: The cohort consists of 182 pts. Median age was 63 yrs, 71% had clear cell histology, 11% were on a clinical trial, the IMDC risk distribution was 5% good, 63% intermediate, 32% poor. Median follow up was 8.8 m. All 4 I+N doses were received by 30% of pts of which 78% went on to receive single-agent N. Less than 4 doses of I+N were received by 70% of pts of which 28% went on to receive single-agent N. The median time on single agent N was 5.7 m. In the entire cohort, 21% of patients discontinued therapy due to toxicity. The most common toxicity events were colitis (56% of all events), pneumonitis (19%), and hepatitis (8%). There were no toxicity-related deaths. Median OS has not been reached (22 events to date). Median TTF was 12.4 m. ORR was 32% (5% complete responses). 26% of pts received second line treatment, the most common being sunitinib in 79%. Conclusions: In this real world cohort, the majority of mRCC pts did not receive all 4 doses of I+N, contrasting with clinical trial reporting, yet many of these pts went on to receive single agent N. Discontinuation rates due to toxicity were similar to those reported in CheckMate 214. Further follow up is ongoing and efficacy outcomes analyzed on the basis of treatment quantity/duration will be presented.

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Abstract Details

Meeting

2020 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer

Track

Renal Cell Cancer

Sub Track

Patient-Reported Outcomes and Real-World Evidence

Citation

J Clin Oncol 38, 2020 (suppl 6; abstr 633)

Abstract #

633

Poster Bd #

D19

Abstract Disclosures

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