BACKGROUND: In response to the national @entity4181 shortage in 2008, our institution adjusted the modified FOLFOX6 ( @entity4181 , @entity1487 , and @entity901 ) protocol to utilize a lower dose of @entity4181 (20   mg/m(2)). This adjustment was based on prospective studies suggesting that lower doses of @entity4181 may be equally effective in other @entity1487 containing regimens. This retrospective study evaluates outcomes in metastatic @entity14 (mCRC) @entity1 treated with low- (20   mg/m(2)) vs. high-dose (400   mg/m(2)) @entity4181 in the FOLFOX6 regimen for mCRC. METHODS: This retrospective analysis included consecutive mCRC @entity1 from 2004 to 2011 if they received at least one cycle of modified FOLFOX6 as first line therapy. @entity1 who received an initial @entity4181 dose other than 20   mg/m(2) or 400   mg/m(2) on their first cycle were excluded. @entity1 characteristics included demographics, metastatic site at initial diagnosis, and treatment history including chemotherapy and surgery. Primary outcome was date of @entity204 or last contact. Cox proportional hazards regression analysis and Kaplan-Meier survival curves were utilized to evaluate the effect of @entity4181 dose on overall survival. Log-rank tests were used to compare median survival times by dose group. RESULTS: Of the 93 mCRC @entity1 who received first line modified FOLFOX6, @entity4181 400   mg/m(2) was administered to 47 (51%) @entity1 and 20   mg/m(2) to 46 (49%) @entity1 . There were no differences of baseline characteristics between the groups with exception of primary site of @entity5 (p   =   0.038). The overall survival time was 22.5 months (95% CI 16.6-29.6). The median survival time in the @entity4181 400   mg/m(2) group was 23.1 months (95% CI 16.2-35.7) compared to @entity4181 20   mg/m(2) which was 20.5 months (95% CI 14.2-34.2); p   =   0.573. The median survival times in @entity1 with one versus two or more sites with @entity3 were statistically different (26.9 vs. 16.2 months, p   =   0.009). Metastatic site removal or ablation showed differences in the median survival, 34.2 months (95% CI 20.8-50.9) vs. 16.6 months (95% CI 14.1-23.6) without @entity3 removal (p   =   0.004). The odds of dying for @entity1 with two metastatic sites was higher compared with the odds of those @entity1 with one site, HR 1.8 (95% CI 1.08-3.0). @entity1 without metastatic site removal or ablation had higher odds of dying compared to those @entity1 without this procedure, HR 0.47 (95% CI 0.27-0.81). CONCLUSION: In this single center retrospective study, there was no difference in overall survival for mCRC @entity1 treated with first line FOLFOX6 with low- vs. high-dose @entity4181 .

High- versus low-dose @entity4181 in the modified FOLFOX6 regimen for first-line treatment of metastatic XXXX .

@entity4181 :: ('MESH:D002955', 'Chemical') :: ['leucovorin'] @entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'Patient'] @entity901 :: ('MESH:C030110', 'Chemical') :: ['oxaliplatin'] @entity5 :: ('MESH:D009369', 'Disease') :: ['cancer'] @entity14 :: ('MESH:D015179', 'Disease') :: ['colorectal cancer'] @entity3 :: ('MESH:D009362', 'Disease') :: ['metastasis', 'metastatic disease'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['fluorouracil']
@entity14 :: (MESH:D015179,Disease) :: ['colorectal cancer']
