PURPOSE: In 1990, @entity1487 (FU) plus @entity7305 for 1 year became standard adjuvant treatment for @entity1 with high-risk stages II and III @entity694 . Intergroup (INT) 0089 assessed the relative contributions of @entity4181 and @entity7305 in such @entity1 . @entity1 AND METHODS: From 1988 to 1992, 3,794 @entity1 were randomly assigned. Experimental treatment consisted of one of three chemotherapy regimens: the low-dose @entity4181 plus FU (Mayo Clinic; LDLV) regimen, the high-dose @entity4181 plus FU (Roswell Park; HDLV) regimen, and the low-dose @entity4181 plus @entity7305 plus FU (LDLV plus LEV) regimen, each administered for 30 to 32 weeks. The control arm was @entity7305 plus FU (LEV) for 1 year. RESULTS: After a median follow-up of 10 years, of 3,561 eligible @entity1 , 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 @entity1 (13%) died without evidence of recurrence, and 1,723 (48%) are alive and disease free. Although there were @entity137 differences among the four arms, none was statistically superior in disease-free or overall survival. CONCLUSION: The 6- to 8-month regimens of LDLV and HDLV without @entity7305 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 @entity1 with high-risk @entity694 , documenting not only the durability of the treatment effects, but also the natural history of @entity1 with high-risk @entity694 , and analyses of treatment based on age, race, and comorbid conditions such as @entity28 , @entity6 , and second @entity5 .

Phase III study of @entity1487 , @entity4181 , and @entity7305 in high-risk stage II and III XXXX : final report of Intergroup 0089.

@entity1 :: ('9606', 'Species') :: ['patients', 'PATIENTS'] @entity4181 :: ('MESH:D002955', 'Chemical') :: ['leucovorin'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity28 :: ('MESH:D009765', 'Disease') :: ['obesity'] @entity6 :: ('MESH:D003920', 'Disease') :: ['diabetes'] @entity5 :: ('MESH:D009369', 'Disease') :: ['primary cancers'] @entity7305 :: ('MESH:D007978', 'Chemical') :: ['levamisole'] @entity694 :: ('MESH:D003110', 'Disease') :: ['colon cancer'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['fluorouracil']
@entity694 :: (MESH:D003110,Disease) :: ['colon cancer']
