To compare characteristics and outcomes of patients included versus those not in adjuvant therapy trials post complete resection of renal cell carcinoma (RCC).
Adult patients following complete resection for clear cell RCC between January 1, 2011, and March 31, 2021, were included. Patients had intermediate high, high risk nonmetastatic disease (modified UCLA Integrated Staging System) or fully resected metastatic (M1) disease as per the inclusion criteria of adjuvant studies. Demographic, clinical, and outcomes between trial and nontrial patients were compared.
Of 1,459 eligible patients, 63 (4.3%) participated in an adjuvant trial. Disease characteristics were similar between groups. Trial patients were younger (mean age 58.1 vs. 63.6 years; P < 0.0001) and had lower Charlson Comorbidity Index scores (mean 4.2 vs. 4.9; P = 0.009). Unadjusted disease-free survival (DFS) at 5 years for trial patients was 48.6% and 39.2% for nontrial patients (HR 0.71, 0.48-1.05, P = 0.08). Median DFS was higher for trial patients in comparison to nontrial patients (4.4 years, IQR 1.7- not reached; vs. 3.0 years, IQR 0.8-8.6; P = 0.08). Cancer specific survival (CSS) at 5 years for trial patients was 85.2% in comparison to 78.6% for nontrial patients (HR 0.45, 0.22-0.92, P = 0.03). Unadjusted estimated overall survival (OS) at 5 years was 80.8% for trial patients and 74.8% (HR 0.42, 0.18-0.94; P = 0.04) for nontrial patients.
Patients in adjuvant trials were younger and healthier with longer CSS and OS in comparison to those not included in adjuvant trials. These findings may have implications when we generalize trial results to real world patients.
Urologic oncology. 2023 May 16 [Epub ahead of print]
Braden Millan, Rodney H Breau, Ranjeeta Mallick, Lori Wood, Ricardo Rendon, Antonio Finelli, Alan I So, Luke T Lavallée, Frédéric Pouliot, Bimal Bhindi, Daniel Heng, Darrel Drachenberg, Simon Tanguay, Lucas Dean, Naveen S Basappa, Jean-Baptiste Lattouf, George Bjarnason, Aly-Khan Lalani, Anil Kapoor
Division of Urology, McMaster Institute of Urology, McMaster University, Hamilton, Ontario, Canada. Electronic address: ., Division of Urology, University of Ottawa, Ottawa, Ontario, Canada., School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada., Division of Medical Oncology, QEII Health Sciences Center, Halifax, Nova Scotia, Canada., Department of Urology, Dalhousie University, Halifax, Nova Scotia, Canada., Division of Urology, University of Toronto, Toronto, Ontario, Canada., Department of Urologic Sciences, The University of British Columbia, Vancouver, British Columbia, Canada., Division of Urology, CHU of Québec and Laval University, Montreal, Quebec, Canada., Division of Urology, University of Calgary, Calgary, Alberta, Canada., Division of Medical Oncology, University of Calgary, Calgary, Alberta, Canada., Division of Urology, University of Manitoba, Winnipeg, Manitoba, Canada., Department of Surgery, McGill University, Montreal, Quebec, Canada., Department of Surgery, Alberta Urology Institute Research Center, University of Alberta, Edmonton, Alberta, Canada., Department of Oncology, University of Alberta, Cross Cancer Institute, Edmonton, Alberta. Edmonton, Canada., Department of Surgery, University of Montreal, Montreal, Quebec, Canada., Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada., Division of Medical Oncology, McMaster University, Hamilton, Ontario, Canada., Division of Urology, McMaster Institute of Urology, McMaster University, Hamilton, Ontario, Canada.