MedicalResearch.com Interview with:
Georg A. Bjarnason, MD, FRCP(C)
The Anna-Liisa Farquharson Chair in Renal Cell Cancer Research
Associate Professor, Faculty of Medicine, University of Toronto
Division of Medical Oncology, Sunnybrook Odette Cancer Centre
Toronto, ONT, Canada
Medical Research: What is the background for this study?
Dr. Bjarnason: Higher sunitinib drug exposure is associated with better response (RR), progression free (PFS) and overall survival (OS). Retrospective data show poorer PFS and OS in patients with minimum toxicity on the 28 day (d)/14 d schedule vs patients needing dose/schedule changes. We hypothesized that toxicity-driven dose/schedule changes would optimize drug exposure.
Medical Research: What are the main findings?
Dr. Bjarnason: The main findings of this report include:
- Individualized Sunitinib therapy is safe and feasible in a multicenter setting (13 study canters).
- Response rates (CR+PR+ SD rate of 89.2%) are among the best for any tyrosine-kinase inhibitor (TKI) in renal cell cancer with implications for dosing of sunitinib in other indications and for the dosing of other TKI’s. Only 10% of patients were refractory to Sunitinib. This has been around 20% in other studies.3. Dose intensity was improved in 65% of patients vs. the standard dosing schema for Sunitinib. 20% of patients were dose escalated, and much fewer patients needed dose reductions or stopped due to toxicity.
- The primary endpoint is PFS and the data are too early for this but: 37/102 (36.3%) patients have been on therapy longer than the 8.5 Mo PFS in the EFFECT comparator trial and 25/83 (30.1%) of these patients are still on therapy. For 49 patients with CR+PR the median time on therapy is 14.3 months (29 patients (59%) still on treatment). For 42 patients with standard treatment the median time in therapy is 6.8 months (15 patients (34%) still on treatment).
Medical Research: What should clinicians and patients take away from your report?
Dr. Bjarnason: Many oncologists are already using alternate schedules for sunitinib because of the toxicity associated with the standard 4/2 schedule. These data provide them with an algorithm for individualized sunitinib therapy that is safe and associated with a very good response rate and time on therapy.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Bjarnason: The safety and activity of other targeted drugs might be optimized by individualizing therapy based on toxicity.
Presented at 2015 ASCO Meeting:
Phase II study of individualized sunitinib as first-line therapy for metastatic renal cell cancer
J Clin Oncol 33, 2015 (suppl; abstr 4555)
Georg A. Bjarnason, Jennifer J. Knox, Christian K. Kollmannsberger, Denis Soulieres, D. Scott Ernst, Christina M. Canil, Eric Winquist, Pawel Zalewski, Sebastien J. Hotte, Scott A. North, Daniel Yick Chin Heng, Robyn Jane Macfarlane, Peter M. Venner, Ian Tannock, Anil Kapoor, Bernhard J. Eigl, Aaron Richard Hansen, Piotr Czaykowski, Ben Boyd, Naveen S. Basappa; Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada; Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada; BC Cancer Agency, Vancouver Cancer Centre, Vancouver, BC, Canada; Centre Hospitalier de l’Université de Montréal, Montreal, QC, Canada; London Regional Cancer Centre, London, ON, Canada; Ottawa Reg Cancer Centre, Manotick, ON, Canada; London Health Sciences Centre, London, ON, Canada; Lakeridge Health, Oshawa, ON, Canada; Juravinski Cancer Centre, Hamilton, ON, Canada; Cross Cancer Institute, Edmonton, AB, Canada; Tom Baker Cancer Center, University of Calgary, Calgary, AB, Canada; Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada; Cross Cancer Inst, Edmonton, AB, Canada; Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada; BC Cancer Agency, Vancouver, BC, Canada; Princess Margaret Hospital, Toronto, ON, Canada; CancerCare Manitoba, Winnipeg, MB, Canada; Ozmosis Research Inc, Toronto, ON, Canada
MedicalResearch.com Interview with: Georg A. Bjarnason, MD, FRCP(C) (2015). Individualized Sunitinib Dosing Improved Response Rate in Renal Cell Cancer