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document
A randomized phase II trial of 5-fluorouracil , with or without human interferon-beta , for advanced colorectal cancer . This study compared the efficacy and safety of 5-fluorouracil ( 5-FU ) monotherapy to that of 5-FU combined with natural human interferon-beta ( IFN-beta ) in patients with unresectable , advanced colorectal carcinoma . Forty-nine chemotherapy-naive patients were randomized to 5-FU alone or to the combination . All patients received 750 mg m ( -2 ) day ( -1 ) 5-FU for 5 days by continuous intravenous ( i.v . ) infusion , followed after day 15 by a weekly i.v . bolus of 750 mg m ( -2 ) . IFN-beta was injected intramuscularly three times weekly at 9 M IU . Treatment continued for 52 weeks , or until disease progression or intolerable toxicity . Clinical endpoints were tumor response , time to progression , survival and toxicity . The addition of IFN-3 to 5-FU significantly improved response rate ( 33.3 % vs 4.5 % for evaluable patients ; P = 0.021 ) , time to progression ( median 7.2 vs 4.2 months ; P = 0.0435 ) , and survival time ( median 15.9 vs 7.2 months ; P = 0.038 ) without significantly increasing toxicity compared to 5-FU alone . Cumulative 5-FU dose was higher with combined therapy ( P < 0.001 ) : more patients receiving monotherapy discontinued treatment because of disease progression . Fever was more frequent with combined therapy ( P = 0.008 ) ; there were no other differences in toxicity . The only grade IV toxicity observed was neutropenia ( two patients per group ) . A randomized phase III trial has been initiated to confirm the synergy between 5-FU and IFN-beta .
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Intervention_Pharmacological
5-fluorouracil
1160
Intervention_Pharmacological
human interferon-beta
1161
Intervention_Pharmacological
5-fluorouracil ( 5-FU ) monotherapy
1162
Intervention_Pharmacological
5-FU combined with natural human interferon-beta ( IFN-beta )
1163
Intervention_Pharmacological
IFN-beta
1164
Intervention_Pharmacological
IFN-3 to 5-FU
1165
Intervention_Pharmacological
5-FU
1166
Intervention_Pharmacological
5-FU
1167
Intervention_Pharmacological
IFN-beta
1168
Outcome_Other
efficacy and safety
1169
Outcome_Physical
disease progression
1170
Outcome_Adverse-effects
intolerable toxicity
1171
Outcome_Physical
tumor response
1172
Outcome_Physical
time to progression
1173
Outcome_Physical
survival and toxicity
1174
Outcome_Physical
improved response rate
1175
Outcome_Physical
time to progression
1176
Outcome_Mortality
survival time
1177
Outcome_Physical
toxicity
1178
Outcome_Physical
Cumulative 5-FU dose
1179
Outcome_Physical
disease progression
1180
Outcome_Physical
Fever
1181
Outcome_Adverse-effects
toxicity
1182
Outcome_Adverse-effects
grade IV toxicity
1183
Participant_Condition
advanced colorectal cancer
1184
Participant_Condition
advanced colorectal carcinoma
1185
Participant_Sample-size
Forty-nine
1186
Participant_Condition
chemotherapy-naive