Jonasch E, et al. - In this trial, researchers determined the impact of an alternate 2 weeks on, 1 week off (2/1) schedule of sunitinib on toxicity and efficacy in previously untreated patients with metastatic renal cell carcinoma. An absence of grade 4 toxicity, a low patient discontinuation rate, and high efficacy was reported in association with treatment with a 2/1 sunitinib schedule, however, the primary end point of decreased grade 3 toxicity was not met.

Methods

• On a 2/1 schedule, 50 mg sunitinib was administered orally to patients, followed by schedule and dose alterations if toxicity developed.
• The primary end point was < 15% grade ≥ 3 fatigue, diarrhea, or hand-foot syndrome (HFS).
• With 60 patients, the upper bound of the CI would fall below the published 4/2 schedule grade ≥ 3 toxicity rate of 25% to 30%.

Results

• Between August 2014 and March 2016, 59 patients underwent treatment.
• According to Memorial Sloan Kettering Cancer Center criteria, 77% were intermediate or poor risk.
• Grade 3 fatigue, HFS, or diarrhea experienced by 25% of patients, need for dose reduction in 37%, and discontinuation because of toxicity in 10% was seen after a median follow-up of 17 months.
• Data showed that the overall response rate was 57%, median progression-free survival was 13.7 months, and median overall survival was not reached.
• At 12 weeks, a fall between 0% and 10% from baseline was noted in Functional Assessment of Cancer Therapy–General scores, with less reduction in patients who continued treatment longer.