{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T07:20:08Z","timestamp":1790061608490,"version":"4.0.1"},"reference-count":20,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"16","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2018,6,1]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p> 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 &lt; 15% grade \u2265 3 fatigue, diarrhea, or HFS. With 60 patients, the upper bound of the CI would fall below the published 4\/2 schedule grade \u2265 3 toxicity rate of 25% to 30%. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> 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\u2013General scores dropped between 0% and 10% from baseline, with less reduction in patients who continued treatment longer. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2017.77.1485","type":"journal-article","created":{"date-parts":[[2018,4,11]],"date-time":"2018-04-11T19:55:24Z","timestamp":1523476524000},"page":"1588-1593","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":33,"title":["Phase II Study of Two Weeks on, One Week off Sunitinib Scheduling in Patients With Metastatic Renal Cell Carcinoma"],"prefix":"10.1200","volume":"36","author":[{"given":"Eric","family":"Jonasch","sequence":"first","affiliation":[{"name":"Eric Jonasch, Rebecca S. Slack, Summer Stovall, Donna Juarez, Troy R. Gilchrist, Lisa Pruitt, and Nizar M. Tannir, The University of Texas MD Anderson Cancer Center; Elshad Hasanov, The University of Texas Health Science Center, Houston, TX; Daniel M. Geynisman and Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Matthew I. Milowsky, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC; W. Kimryn Rathmell, Vanderbilt Ingram Cancer Center, Nashville, TN; and..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca S.","family":"Slack","sequence":"additional","affiliation":[{"name":"Eric Jonasch, Rebecca S. Slack, Summer Stovall, Donna Juarez, Troy R. Gilchrist, Lisa Pruitt, and Nizar M. Tannir, The University of Texas MD Anderson Cancer Center; Elshad Hasanov, The University of Texas Health Science Center, Houston, TX; Daniel M. Geynisman and Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Matthew I. Milowsky, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC; W. Kimryn Rathmell, Vanderbilt Ingram Cancer Center, Nashville, TN; and..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel M.","family":"Geynisman","sequence":"additional","affiliation":[{"name":"Eric Jonasch, Rebecca S. Slack, Summer Stovall, Donna Juarez, Troy R. Gilchrist, Lisa Pruitt, and Nizar M. Tannir, The University of Texas MD Anderson Cancer Center; Elshad Hasanov, The University of Texas Health Science Center, Houston, TX; Daniel M. Geynisman and Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Matthew I. Milowsky, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC; W. Kimryn Rathmell, Vanderbilt Ingram Cancer Center, Nashville, TN; and..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elshad","family":"Hasanov","sequence":"additional","affiliation":[{"name":"Eric Jonasch, Rebecca S. Slack, Summer Stovall, Donna Juarez, Troy R. Gilchrist, Lisa Pruitt, and Nizar M. Tannir, The University of Texas MD Anderson Cancer Center; Elshad Hasanov, The University of Texas Health Science Center, Houston, TX; Daniel M. Geynisman and Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Matthew I. Milowsky, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC; W. Kimryn Rathmell, Vanderbilt Ingram Cancer Center, Nashville, TN; and..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew I.","family":"Milowsky","sequence":"additional","affiliation":[{"name":"Eric Jonasch, Rebecca S. Slack, Summer Stovall, Donna Juarez, Troy R. Gilchrist, Lisa Pruitt, and Nizar M. Tannir, The University of Texas MD Anderson Cancer Center; Elshad Hasanov, The University of Texas Health Science Center, Houston, TX; Daniel M. Geynisman and Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, PA; Matthew I. 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