Two-to-One Sunitinib Schedule Fails To Reduce Toxicity
A modified dosing schedule of sunitinib did not improve adverse events rates among patients with metastatic renal cell carcinoma.
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A modified dosing schedule of sunitinib did not improve adverse events rates among patients with metastatic renal cell carcinoma (RCC), according to a study to be presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1
Sunitinib is conventionally given 4 weeks on and 2 weeks off (4/2), but many patients experience adverse events during the third and fourth weeks of therapy. This trial sought to determine if modifying the schedule to 2 weeks on and 1 week off (2/1) would reduce toxicities without compromising efficacy.
The multicenter, single-arm, phase 2 trial (ClinicalTrials.gov Identifier: NCT02060370) treated 59 patients with metastatic RCC with 50 mg sunitinib on a 2/1 schedule.
Grade 3 or higher fatigue, diarrhea, or hand-foot syndrome (HFS) occurred in 24% (95% CI, 13.6-36.5%) of patients, which is similar to the historical rates of 25-30% with the 4/2 schedule. The rate of any grade diarrhea was 75%, fatigue was 71%, and HFS was 54%.
Dose reduction was required in 59% of patients.
The response rate to sunitinib was 37% (95% CI, 25.0-50.9%), and the median progression-free survival was 19.3 months (95% CI, 8.2 months-not reached).
The investigators stated that though the rates of grade 3 toxicities were similar between the 2/1 and 4/2 schedules, the “efficacy data showed robust response rate and a prolonged PFS, suggestive of long-term tolerability in patients receiving sunitinib on a 2/1 schedule.”
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- Jonasch E, Slack R, Geynisman DM, et al. Phase II study of alternate sunitinib schedule in patients with metastatic renal cell carcinoma. J Clin Oncol. 2017;35(suppl; abstr 4513).