BACKGROUND: The purpose of this study was to determine the best tolerated and efficacious dose of @entity1206 given once or twice in 3-week cycles in combination with @entity1499 and @entity1487 (VMF). @entity1 AND METHODS: @entity1206 40 mg/m(2) was given as follows: 20 mg/m(2) on days 1 and 8 (group 1); 30 mg/m(2) on day 1 and 10 mg/m(2) on day 8 (group 2); or 40 mg/m(2) on day 1 (not exeeding 60 mg/m(2)) (group 3). The @entity1499 dose was 40 mg/m(2) on day 1 and the @entity1487 dose 600 mg/m(2) on days 1 and 8. Thirty @entity1 with evaluable @entity3 were randomly allocated to the groups (first step). The second step was to exclude the worst tolerated regimen and then to expand the study to 60 @entity1 . Thus, group 1 had 26 @entity1 , group 2 had 24 @entity1 and group 3 had 10 @entity1 . RESULTS: World Health Organization (WHO) grade 3 hematological @entity137 occurred in 23%, 36% and 50% of @entity1 and grade 4 in 39%, 32% and 50% of @entity1 in groups 1, 2 and 3, respectively; grade 3 @entity281 were observed in 15%, 9% and 10% of @entity1 in groups 1, 2 and 3, and grade 4 @entity281 in 5% and 10% of @entity1 in groups 2 and 3, respectively. Nonhematological @entity137 included a mild to moderate @entity2359 manifesting as @entity1142 , abdominal colics and @entity925 in the majority of @entity1 . One @entity1 in group 3 had serious @entity410 after @entity1206 administration; she also developed @entity1398 ; all symptoms were reversible. No @entity1 died from side-effects. The objective response rates were 50%, 55% and 44% for groups 1, 2 and 3, respectively. Median time to progression was 7, 10 and 8 months and median survival time was 26, 23 and 16 months in groups 1, 2 and 3, respectively. CONCLUSION: VMF regimens where the @entity1206 dose (40 mg/m(2)) is divided (20 + 20 mg/m(2) and 30 + 10 mg/m(2)) between days 1 and 8 of a 3-week cycle are equally well tolerated and the efficacy is comparable to other modern first line regimens used in the treatment of metastatic @entity0 .

@entity1206 , XXXX and @entity1487 (VMF) as first-line therapy in metastatic @entity0 : a randomized phase II trial.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient', 'PATIENTS'] @entity410 :: ('MESH:D012640', 'Disease') :: ['convulsions'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer'] @entity2359 :: ('MESH:D020258', 'Disease') :: ['neurotoxicity'] @entity1206 :: ('MESH:C030852', 'Chemical') :: ['vinorelbine', 'Vinorelbine'] @entity281 :: ('MESH:D007239', 'Disease') :: ['infections'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenic sepsis'] @entity925 :: ('MESH:D063806', 'Disease') :: ['myalgia'] @entity3 :: ('MESH:D009362', 'Disease') :: ['metastases'] @entity1499 :: ('MESH:D008727', 'Chemical') :: ['methotrexate'] @entity1142 :: ('MESH:D003248', 'Disease') :: ['constipation'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['fluorouracil']
@entity1499 :: (MESH:D008727,Chemical) :: ['methotrexate']
