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Jonasch E , Slack RS , Geynisman DM , Hasanov E , Milowsky MI , Rathmell WK , Stovall S , Juarez D , Gilchrist TR , Pruitt L , Ornstein MC , Plimack ER , Tannir NM , Rini BI
Phase II Study of Two Weeks on, One Week off Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma
J Clin Oncol. 2018 Jun 1;36(16) :1588-1593
PMID: 29641297    PMCID: PMC6804828    URL: https://www.ncbi.nlm.nih.gov/pubmed/29641297
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Purpose Standard frontline treatment of patients with metastatic renal cell carcinoma currently includes sunitinib. A barrier to long-term treatment with sunitinib includes the development of significant adverse effects, including diarrhea, hand-foot syndrome (HFS), and fatigue. This trial assessed the effect 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. Methods Patients started with oral administration of 50 mg sunitinib on a 2/1 schedule and underwent schedule and dose alterations if toxicity developed. The primary end point was < 15% grade >/= 3 fatigue, diarrhea, or 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 Fifty-nine patients were treated between August 2014 and March 2016. Seventy-seven percent were intermediate or poor risk per Memorial Sloan Kettering Cancer Center criteria. With a median follow-up of 17 months, 25% of patients experienced grade 3 fatigue, HFS, or diarrhea; 37% required a dose reduction, and 10% discontinued because of toxicity. The overall response rate was 57%, median progression-free survival was 13.7 months, and median overall survival was not reached. At 12 weeks, Functional Assessment of Cancer Therapy-General scores dropped between 0% and 10% from baseline, with less reduction in patients who continued treatment longer. Conclusion The primary end point of decreased grade 3 toxicity was not met; however, treatment with a 2/1 sunitinib schedule is associated with a lack of grade 4 toxicity, a low patient discontinuation rate, and high efficacy.
1527-7755 Jonasch, Eric Slack, Rebecca S Geynisman, Daniel M Hasanov, Elshad Milowsky, Matthew I Rathmell, W Kimryn Stovall, Summer Juarez, Donna Gilchrist, Troy R Pruitt, Lisa Ornstein, Moshe C Plimack, Elizabeth R Tannir, Nizar M Rini, Brian I Journal Article United States J Clin Oncol. 2018 Apr 11:JCO2017771485. doi: 10.1200/JCO.2017.77.1485.