92717
document
Efficacy of dose-intensified MEC ( methotrexate , epirubicin and cisplatin ) chemotherapy for advanced urothelial carcinoma : a prospective randomized trial comparing MEC and M-VAC ( methotrexate , vinblastine , doxorubicin and cisplatin ) . Japanese Urothelial Cancer Research Group . BACKGROUND To evaluate the antitumor activity in patients with T3b , T4 or metastatic urothelial carcinoma treated with MEC or M-VAC chemotherapy , by performing a multi-center randomized prospective study . METHODS From 1991 to 1995 , 89 patients with T3b , T4 or metastatic urothelial carcinoma were randomly allocated to a methotrexate , epirubicin and cisplatin chemotherapy group ( arm 1 : S-MEC therapy ; n = 29 ) , a dose-intensified MEC therapy combined with G-CSF group ( arm 2 : I-MEC therapy ; n = 30 ) or a methotrexate , vinblastine , doxorubicin and cisplatin chemotherapy ( arm 3 : M-VAC therapy ; n = 30 ) . At the registration center , the patients were stratified into previously untreated patients and patients with recurrence after radical operation and then randomly allocated to the treatment groups . In each arm , two or more courses of chemotherapy ( 4-week cycles ) were performed . RESULTS Of the 88 eligible patients , four treated with S-MEC therapy and two treated with I-MEC therapy showed CR . The response rates ( CR + PR ) were 52 % ( 15/29 ) with S-MEC therapy , 76 % ( 22/29 ) with I-MEC therapy and 47 % ( 14/30 ) with M-VAC therapy . The response rate with I-MEC therapy was significantly higher than that with M-VAC therapy ( P = 0.02 ) . Although the incidence of leukopenia was low with I-MEC therapy , the incidence of thrombocytopenia was high with this therapy . CONCLUSION MEC therapy used in this study is promising in terms of the antitumor effects .
92718
Intervention_Pharmacological
MEC
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Intervention_Pharmacological
methotrexate
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Intervention_Pharmacological
epirubicin
92721
Intervention_Pharmacological
cisplatin
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Intervention_Pharmacological
MEC
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Intervention_Pharmacological
M-VAC
92724
Intervention_Pharmacological
methotrexate
92725
Intervention_Pharmacological
vinblastine
92726
Intervention_Pharmacological
doxorubicin
92727
Intervention_Pharmacological
cisplatin
92728
Intervention_Pharmacological
MEC
92729
Intervention_Pharmacological
M-VAC
92730
Intervention_Pharmacological
methotrexate
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Intervention_Pharmacological
epirubicin
92732
Intervention_Pharmacological
cisplatin
92733
Intervention_Pharmacological
MEC therapy
92734
Intervention_Pharmacological
G-CSF
92735
Intervention_Pharmacological
methotrexate
92736
Intervention_Pharmacological
vinblastine
92737
Intervention_Pharmacological
doxorubicin
92738
Intervention_Pharmacological
cisplatin
92739
Intervention_Pharmacological
M-VAC therapy
92740
Intervention_Pharmacological
S-MEC therapy
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Intervention_Pharmacological
I-MEC
92742
Intervention_Pharmacological
S-MEC therapy
92743
Intervention_Pharmacological
I-MEC
92744
Intervention_Pharmacological
M-VAC
92745
Intervention_Pharmacological
I-MEC
92746
Intervention_Pharmacological
M-VAC
92747
Intervention_Pharmacological
I-MEC
92748
Intervention_Pharmacological
MEC therapy
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Outcome_Other
Efficacy
92750
Outcome_Other
antitumor activity
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Outcome_Other
response rates
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Outcome_Other
response rate with I-MEC therapy
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Outcome_Other
I-MEC therapy
92754
Outcome_Physical
thrombocytopenia
92755
Outcome_Other
antitumor effects
92756
Participant_Condition
advanced urothelial carcinoma
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Participant_Condition
Urothelial Cancer
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Participant_Condition
T3b , T4 or metastatic urothelial carcinoma
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Participant_Sample-size
89
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Participant_Condition
T3b , T4 or metastatic urothelial carcinoma