{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T19:49:47Z","timestamp":1790624987244,"version":"4.1.0"},"reference-count":24,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"14","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2020,5,10]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> AREN0321 evaluated the activity of vincristine and irinotecan (VI) in patients with newly diagnosed diffuse anaplastic Wilms tumor (DAWT) and whether a regimen containing carboplatin (regimen UH1) in addition to regimen I agents used in the National Wilms Tumor Study 5 (NWTS-5; vincristine, doxorubicin, cyclophosphamide, and etoposide plus radiotherapy) would improve patient outcomes. <\/jats:p><\/jats:sec><jats:sec><jats:title>PATIENTS AND METHODS<\/jats:title><jats:p> Patients with stage II to IV DAWT without measurable disease received regimen UH1. Patients with stage IV measurable disease were eligible to receive VI (vincristine, 1.5 mg\/m<jats:sup>2<\/jats:sup> per day intravenously on days 1 and 8; irinotecan, 20 mg\/m<jats:sup>2<\/jats:sup> per day intravenously on days 1-5 and 8-12 of a 21-day cycle) in an upfront window; those with complete (CR) or partial response (PR) had VI incorporated into regimen UH1 (regimen UH2). The study was designed to detect improvement in outcomes of patients with stage II to IV DAWT compared with historical controls treated with regimen I. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> Sixty-six eligible patients were enrolled. Of 14 patients with stage IV measurable disease who received VI, 11 (79%) achieved CR (n = 1) or PR (n = 10) after 2 cycles. Doses of doxorubicin, cyclophosphamide, and etoposide were reduced midstudy because of nonhematologic toxicity. Four patients (6%) died as a result of toxicity. Four-year event-free survival, relapse-free survival, and overall survival rates were 67.7% (95% CI, 55.9% to 79.4%), 72.9% (95% CI, 61.5% to 84.4%), and 73.7% (95% CI, 62.7% to 84.8%), respectively, compared with 57.5% (95% CI, 47.6% to 67.4%; P = .26), 57.5% (95% CI, 47.6% to 67.4%; P = .048), and 59.2% (95% CI, 49.4% to 69.0%; P = .08), respectively, in NWTS-5. <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> VI produced a high response rate in patients with metastatic DAWT. AREN0321 treatment seemed to improve outcomes for patients with stage II to IV DAWT compared with NWTS-5, but with increased toxicity. The UH2 regimen warrants further investigation with modifications to reduce toxicity. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.19.01265","type":"journal-article","created":{"date-parts":[[2020,3,5]],"date-time":"2020-03-05T21:04:31Z","timestamp":1583442271000},"page":"1558-1568","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":86,"title":["Activity of Vincristine and Irinotecan in Diffuse Anaplastic Wilms Tumor and Therapy Outcomes of Stage II to IV Disease: Results of the Children\u2019s Oncology Group AREN0321 Study"],"prefix":"10.1200","volume":"38","author":[{"given":"Najat C.","family":"Daw","sequence":"first","affiliation":[{"name":"Division of Pediatrics, The University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yueh-Yun","family":"Chi","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, University of Florida, Gainesville, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John A.","family":"Kalapurakal","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Ann and Robert H. Lurie Children\u2019s Hospital of Chicago, Northwestern Memorial Hospital, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yeonil","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, University of Florida, Gainesville, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fredric A.","family":"Hoffer","sequence":"additional","affiliation":[{"name":"Department of Radiology, University of Washington, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James I.","family":"Geller","sequence":"additional","affiliation":[{"name":"Division of Oncology, Cincinnati Children\u2019s Hospital Medical Center, University of Cincinnati, Cincinnati, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth J.","family":"Perlman","sequence":"additional","affiliation":[{"name":"Department of Pathology, Ann and Robert H. Lurie Children\u2019s Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter F.","family":"Ehrlich","sequence":"additional","affiliation":[{"name":"Department of Pediatric Surgery, C.S. Mott Children\u2019s Hospital, University of Michigan, Ann Arbor, MI"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth A.","family":"Mullen","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology\/Oncology, Dana-Farber\/Harvard Cancer Center, Dana-Farber Cancer Institute, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne B.","family":"Warwick","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, F. Edward H\u00e9bert School of Medicine, Uniformed Services University, Bethesda, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul E.","family":"Grundy","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnold C.","family":"Paulino","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Gratias","sequence":"additional","affiliation":[{"name":"University of Tennessee College of Medicine\u2013Chattanooga, Chattanooga, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah","family":"Ward","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Services, St Jude Children\u2019s Research Hospital, Memphis, TN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James R.","family":"Anderson","sequence":"additional","affiliation":[{"name":"University of Nebraska Medical Center, Omaha, NE"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geetika","family":"Khanna","sequence":"additional","affiliation":[{"name":"Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brett","family":"Tornwall","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, University of Florida, Gainesville, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Conrad V.","family":"Fernandez","sequence":"additional","affiliation":[{"name":"Departments of Pediatrics and Bioethics, IWK Health Centre, Dalhousie University, Halifax, Nova Scotia, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey S.","family":"Dome","sequence":"additional","affiliation":[{"name":"Division of Oncology, Children\u2019s National Medical Center, Center for Cancer and Blood Disorders, George Washington University School of Medicine and Health Sciences, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the AREN0321 Study Committee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1994.12.10.2126"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1096-911X(199905)32:5<317::AID-MPO1>3.0.CO;2-F"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdh171"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.35.8747"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.04.7852"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1002\/mpo.2950220409"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1994.12.5.931"},{"key":"B8","first-page":"296","volume":"16","author":"Marina NM","year":"1994","journal-title":"Am J Pediatr Hematol Oncol"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdf028"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2008.09.017"},{"key":"B11","first-page":"432","volume":"45","author":"Dome J","year":"2005","journal-title":"Pediatr Blood Cancer"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.10.9298"},{"key":"B13","first-page":"3617","volume":"5","author":"Thompson J","year":"1999","journal-title":"Clin Cancer Res"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2017.73.7999"},{"key":"B15","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2017.77.1931"},{"key":"B16","unstructured":"Fernandez CV, Geller JI, Ehrlich PF, et al: Renal tumors, in Pizzo PA, Poplack DG (eds): Principles and Practice of Pediatric Oncology (ed 7). 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