Currently, sunitinib is a standard of care in first-line treatment for metastatic renal cell carcinoma (mRCC). However, with the standard 4/2 schedule (sunitinib 50 mg/day; 4 consecutive weeks on treatment; 2 weeks' rest), 50% of patients require dose reductions to mitigate toxicity, highlighting the need to investigate alternative dosing schedules that improve tolerability without compromising efficacy. Areas covered: We present a concise critical review of published studies comparing the efficacy and safety of the 4/2 and 2/1 schedule (2 weeks on treatment; 1 week rest) for sunitinib. While all studies evaluating the 2/1 schedule have a low level of evidence, the results indicate that the 2/1 schedule improves tolerability compared with the 4/2 schedule, including significant reductions in the incidence of specific adverse events. It was not possible to make any definitive conclusions regarding efficacy due to methodologic limitations of these studies. Expert commentary: In the absence of strong evidence supporting the safety and efficacy of the 2/1 schedule, we recommend that patients should be initiated on sunitinib therapy with the standard 4/2 schedule and only be switched to the 2/1 schedule after the development of dose-limiting toxicities from weeks 3-4 (cycle 1) of the 4/2 schedule cycle.
Expert review of anticancer therapy. 2017 Jan 03 [Epub ahead of print]
Sergio Bracarda, Sylvie Negrier, Jochen Casper, Camillo Porta, Manuela Schmidinger, James Larkin, Marine Gross Goupil, Bernard Escudier
a Ospedale San Donato , USL Toscana Sud-Est , Arezzo , Italy., b Leon Berard Cancer Center , Lyon , France., c Klinikum Oldenburg , Oldenburg , Germany., d IRCCS San Matteo University Hospital Foundation , Pavia , Italy., e Clinical Division of Oncology, Department of Medicine I , Medical University of Vienna , Vienna , Austria., f Melanoma Unit , The Royal Marsden NHS Foundation Trust , London , UK., g Department of Medical Oncology , Bergonié Cancer Institute , Bordeaux , France., h Institut Gustave Roussy , Villejuif , France.