{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T23:09:07Z","timestamp":1790809747425,"version":"4.1.0"},"reference-count":28,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"12","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2018,4,20]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> Uveal melanoma is the most common primary intraocular malignancy in adults with no effective systemic treatment option in the metastatic setting. Selumetinib (AZD6244, ARRY-142886) is an oral, potent, and selective MEK1\/2 inhibitor with a short half-life, which demonstrated single-agent activity in patients with metastatic uveal melanoma in a randomized phase II trial. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p> The Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Metastatic Uveal Melanoma (SUMIT) study was a phase III, double-blind trial ( ClinicalTrial.gov identifier: NCT01974752) in which patients with metastatic uveal melanoma and no prior systemic therapy were randomly assigned (3:1) to selumetinib (75 mg twice daily) plus dacarbazine (1,000 mg\/m<jats:sup>2<\/jats:sup> intravenously on day 1 of every 21-day cycle) or placebo plus dacarbazine. The primary end point was progression-free survival (PFS) by blinded independent central radiologic review. Secondary end points included overall survival and objective response rate. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> A total of 129 patients were randomly assigned to receive selumetinib plus dacarbazine (n = 97) or placebo plus dacarbazine (n = 32). In the selumetinib plus dacarbazine group, 82 patients (85%) experienced a PFS event, compared with 24 (75%) in the placebo plus dacarbazine group (median, 2.8 v 1.8 months); the hazard ratio for PFS was 0.78 (95% CI, 0.48 to 1.27; two-sided P = .32). The objective response rate was 3% with selumetinib plus dacarbazine and 0% with placebo plus dacarbazine (two-sided P = .36). At 37% maturity (n = 48 deaths), analysis of overall survival gave a hazard ratio of 0.75 (95% CI, 0.39 to 1.46; two-sided P = .40). The most frequently reported adverse events (selumetinib plus dacarbazine v placebo plus dacarbazine) were nausea (62% v 19%), rash (57% v 6%), fatigue (44% v 47%), diarrhea (44% v 22%), and peripheral edema (43% v 6%). <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> In patients with metastatic uveal melanoma, the combination of selumetinib plus dacarbazine had a tolerable safety profile but did not significantly improve PFS compared with placebo plus dacarbazine. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2017.74.1090","type":"journal-article","created":{"date-parts":[[2018,3,12]],"date-time":"2018-03-12T19:56:03Z","timestamp":1520884563000},"page":"1232-1239","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":259,"title":["Selumetinib in Combination With Dacarbazine in Patients With Metastatic Uveal Melanoma: A Phase III, Multicenter, Randomized Trial (SUMIT)"],"prefix":"10.1200","volume":"36","author":[{"given":"Richard D.","family":"Carvajal","sequence":"first","affiliation":[{"name":"Richard D. Carvajal and Gary K. Schwartz, Columbia University Medical Center; Paul B. Chapman and Alexander N. Shoushtari, Memorial Sloan Kettering Cancer Center, New York, NY; Sophie Piperno-Neumann and Manuel J. Rodrigues, Institut Curie, Paris; Lauris Gastaud, Centre Antoine-Lacassagne, Nice, France; Ellen Kapiteijn, Leiden University Medical Center, Leiden, the Netherlands; Stephen Frank, Hebrew University Hadassah Medical School \u2013 The Sharett Institute of Oncology, Jerusalem; Jacob Schachter, Sheba..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Piperno-Neumann","sequence":"additional","affiliation":[{"name":"Richard D. Carvajal and Gary K. Schwartz, Columbia University Medical Center; Paul B. Chapman and Alexander N. Shoushtari, Memorial Sloan Kettering Cancer Center, New York, NY; Sophie Piperno-Neumann and Manuel J. 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