BACKGROUND: Three different therapeutic regimens of @entity2600 ( @entity2600 ) in combination with @entity1487 ( @entity1487 ) and @entity4181 (FA) were evaluated for efficacy and safety in the first-line therapy of advanced @entity14 . @entity1 AND METHODS: @entity1 were randomly assigned to receive intravenously either: @entity2600 125 mg/m(2), FA 20 mg/m(2) followed by @entity1487 500 mg/m(2) bolus, weekly for 4 weeks (arm A, Saltz regimen); or @entity2600 180 mg/m(2) day 1 then FA 200 mg/m(2) over 2 h and @entity1487 400 mg/m(2) bolus and @entity1487 600 mg/m(2) 22-h infusion on days 1 and 2, every 2 weeks (arm B, Douillard regimen); or @entity2600 350 mg/m(2) (days 1 and 43) alternating with FA 20 mg/m(2)/day followed by @entity1487 bolus 425 mg/m(2)/day during 5 days (days 22-26) (arm C, Mayo Clinic regimen). RESULTS: A total of 154 @entity1 were included in the study (arm A, 51 @entity1 ; arm B, 53; arm C, 50). Overall response rates for the intention-to-treat populations were 33% [95% confidence interval (CI) 21% to 48%], 42% (95% CI 28% to 56%) and 30% (95% CI 18% to 45%) for arms A, B and C, respectively. Median times to progression were 6, 8 and 7 months for arms A, B and C, respectively. Median survival times were 15, 12 and 17 months for arms A, B and C, respectively. Overall response rates for the evaluable @entity1 populations were 40% (95% CI 24% to 58%) in arm A, 44% (95% CI 29% to 60%) in arm B and 31% (95% CI 17% to 47%) in arm C. @entity1398 was the main serious adverse event in arms A (30% of @entity1 ) and C (22% of @entity1 ) but occurred in only 8% of @entity1 in arm B. Delayed @entity294 was the main severe adverse event for the three regimens, from 15% to 22%. CONCLUSION: All three regimens were highly active. The biweekly combination of @entity2600 and @entity1487 /FA (arm B) was notable for its low incidence of grade 3/4 @entity1398 . The incidence of grade 3/4 delayed @entity294 was equivalent for the three treatment arms.

A randomized phase II trial of @entity2600 in combination with infusional or two different bolus @entity1487 and @entity4181 regimens as first-line therapy for advanced XXXX .

@entity4181 :: ('MESH:D002955', 'Chemical') :: ['folinic acid'] @entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'PATIENTS'] @entity2600 :: ('MESH:C051890', 'Chemical') :: ['irinotecan', 'CPT-11'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['Neutropenia', 'neutropenia'] @entity14 :: ('MESH:D015179', 'Disease') :: ['colorectal cancer'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['5-FU', '5-fluorouracil']
@entity14 :: (MESH:D015179,Disease) :: ['colorectal cancer']
