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document
Randomized study of continuous infusion fluorouracil versus fluorouracil plus cisplatin in patients with metastatic colorectal cancer . One hundred twenty-two chemotherapy-naive patients with histologically confirmed colorectal adenocarcinoma were entered into a randomized trial comparing infusional fluorouracil ( FU ) versus cisplatin ( CDDP ) and FU . In both groups , patients received continuous infusion FU 1,000 mg/m2/d for 5 consecutive days every 4 weeks . Patients randomized to CDDP/FU also received CDDP 20 mg/m2 intravenous ( IV ) bolus on days 1 to 5 of each cycle . Patients were comparable in terms of age , performance status , baseline laboratory values , dominant sites of measurable disease , and percent of liver involvement . The partial response rate was significantly greater in patients who received CDDP/FU versus FU alone ( 25 % v 3 % , P = .001 ) . Patients who received CDDP/FU experienced significantly greater toxicity compared with FU alone : grades 3 and 4 hematologic toxicity occurred in 22 % and 0 % of patients , respectively ( P = .0001 ) ; grades 2 to 4 nausea and vomiting occurred in 80 % and 15 % of patients , respectively ( P = .0001 ) . There were no significant differences in either the duration of response ( median , 6 and 4.7 months for CDDP/FU and FU groups , respectively ) or survival ( median 10 , and 12 months , respectively ) . Compared with infusional FU alone , CDDP/FU provided a significantly greater partial response rate with increased toxicity , but it did not improve overall survival in patients with advanced colorectal carcinoma . Therefore , the use of CDDP/FU as routine therapy for the treatment of colorectal carcinoma can not be recommended .
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Intervention_Pharmacological
continuous infusion fluorouracil
61371
Intervention_Pharmacological
fluorouracil plus cisplatin
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Intervention_Pharmacological
infusional fluorouracil ( FU )
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Intervention_Pharmacological
cisplatin ( CDDP )
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Intervention_Pharmacological
FU
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Intervention_Pharmacological
FU
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Intervention_Pharmacological
CDDP/FU
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Intervention_Pharmacological
CDDP
61378
Intervention_Pharmacological
CDDP/FU
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Intervention_Pharmacological
FU
61380
Intervention_Pharmacological
CDDP/FU
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Intervention_Pharmacological
FU
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Intervention_Pharmacological
CDDP/FU
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Intervention_Pharmacological
FU
61384
Intervention_Pharmacological
FU
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Intervention_Pharmacological
CDDP/FU
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Intervention_Pharmacological
CDDP/FU
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Outcome_Other
partial response rate
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Outcome_Adverse-effects
greater toxicity
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Outcome_Adverse-effects
grades 3 and 4 hematologic toxicity
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Outcome_Adverse-effects
nausea and vomiting
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Outcome_Other
duration of response
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Outcome_Mortality
survival
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Outcome_Other
partial response rate
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Outcome_Adverse-effects
increased toxicity
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Outcome_Mortality
overall survival
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Participant_Condition
metastatic colorectal cancer
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Participant_Sample-size
One hundred twenty-two
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Participant_Condition
colorectal adenocarcinoma
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Participant_Condition
advanced colorectal carcinoma