{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T11:55:16Z","timestamp":1792670116085,"version":"4.5.0"},"reference-count":32,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"34","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2005,12,1]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>In 1990, fluorouracil (FU) plus levamisole for 1 year became standard adjuvant treatment for patients with high-risk stages II and III colon cancer. Intergroup (INT) 0089 assessed the relative contributions of leucovorin and levamisole in such patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>From 1988 to 1992, 3,794 patients were randomly assigned. Experimental treatment consisted of one of three chemotherapy regimens: the low-dose leucovorin plus FU (Mayo Clinic; LDLV) regimen, the high-dose leucovorin plus FU (Roswell Park; HDLV) regimen, and the low-dose leucovorin plus levamisole plus FU (LDLV plus LEV) regimen, each administered for 30 to 32 weeks. The control arm was levamisole plus FU (LEV) for 1 year.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>After a median follow-up of 10 years, of 3,561 eligible patients, 1,691 (47%) have died and 1,330 (37%) have experienced disease recurrence; 137 (10%) of those experiencing recurrence are still alive. A total of 481 patients (13%) died without evidence of recurrence, and 1,723 (48%) are alive and disease free. Although there were toxicity differences among the four arms, none was statistically superior in disease-free or overall survival.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The 6- to 8-month regimens of LDLV and HDLV without levamisole used in this trial, rather than the previous standard regimen of 12 months of LEV, have become widely used. INT-0089 has long-term follow-up of the largest clinical trial of patients with high-risk colon cancer, documenting not only the durability of the treatment effects, but also the natural history of patients with high-risk colon cancer, and analyses of treatment based on age, race, and comorbid conditions such as obesity, diabetes, and second primary cancers.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.2004.00.5686","type":"journal-article","created":{"date-parts":[[2005,11,28]],"date-time":"2005-11-28T18:52:33Z","timestamp":1133203953000},"page":"8671-8678","source":"Crossref","is-referenced-by-count":297,"title":["Phase III Study of Fluorouracil, Leucovorin, and Levamisole in High-Risk Stage II and III Colon Cancer: Final Report of Intergroup 0089"],"prefix":"10.1200","volume":"23","author":[{"given":"Daniel G.","family":"Haller","sequence":"first","affiliation":[{"name":"From the University of Pennsylvania, Philadelphia, PA; Dana-Farber Cancer Institute, Department of Biostatistics, Boston, MA; 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Dean Medical Center, Madison, WI; and Ashville Hematology and Oncology, Asheville, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark A.","family":"O'Rourke","sequence":"additional","affiliation":[{"name":"From the University of Pennsylvania, Philadelphia, PA; Dana-Farber Cancer Institute, Department of Biostatistics, Boston, MA; St Vincent's Hospital and Medical Center, New York, NY; Cancer Centers of the Carolinas-Eastside, Greenville, SC; Dean Medical Center, Madison, WI; and Ashville Hematology and Oncology, Asheville, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael S.","family":"Frontiera","sequence":"additional","affiliation":[{"name":"From the University of Pennsylvania, Philadelphia, PA; Dana-Farber Cancer Institute, Department of Biostatistics, Boston, MA; St Vincent's Hospital and Medical Center, New York, NY; Cancer Centers of the Carolinas-Eastside, Greenville, SC; Dean Medical Center, Madison, WI; and Ashville Hematology and Oncology, Asheville, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Don V.","family":"Jackson","sequence":"additional","affiliation":[{"name":"From the University of Pennsylvania, Philadelphia, PA; 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