Two-to-One Sunitinib Schedule Fails To Reduce Toxicity

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A modified dosing schedule of sunitinib did not improve adverse events rates among patients with metastatic renal cell carcinoma.
A modified dosing schedule of sunitinib did not improve adverse events rates among patients with metastatic renal cell carcinoma.
The following article features coverage from the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Click here to read more of Cancer Therapy Advisor's conference coverage.

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.”

RELATED: In Focus: Cabozantinib for Renal Cell Carcinoma

Read more of Cancer Therapy Advisor's coverage of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting by visiting the conference page.

Reference

  1. 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).

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