3997
document
5-fluorouracil plus folinic acid with or without ifosfamide in advanced colorectal cancer : a phase II randomized trial . AIM This phase II trial evaluated the biomodulation of 5-fluorouracil ( 5-FU ) plus folinic acid ( FA ) with or without ifosfamide ( IFO ) in chemotherapy-naive patients with colorectal cancer . PATIENTS AND METHODS Forty-eight patients were randomized to receive : FA ( 25 mg/m2 iv bolus days 1 to 3 ) , followed by 5-FU ( 750 mg/m2 iv bolus days 1 to 3 ) , arm A ; or FA ( 25 mg/m2 iv bolus days 1 to 3 ) , followed by 5-FU ( 750 mg/m2 iv bolus days 1 to 3 ) plus IFO ( 2,000 mg/m2 in 1000 mL 5 % dextrose in a 2-hr infusion , days 1 to 3 ) , arm B. Mesna was added during and after IFO to prevent hemorrhagic cystitis . Treatment was repeated every 21 days in both arms . RESULTS Forty-five patients were assessable for response : in arm A , 5 patients achieved a partial response ( overall response , 25 % ) , and in arm B , 2 patients achieved a complete and 1 a partial response ( overall response , 12 % ) . Time to failure was 3.5 months ( range , 1-38 ) in patients treated with 5-FU plus FA , and 3 months ( range , 1-21 ) in patients treated with the IFO combination . The median survival time was 13.5 months ( range , 1-49 months ) in arm A and 16 months ( range , 1-43 months ) in arm B . Diarrhea , stomatitis and vomiting were the most common nonhematologic toxicities in both arms . The most notable hematologic toxicity was leukopenia ; 15 % and 20 % of patients experienced grade 4 in arm A and arm B , respectively . CONCLUSIONS IFO does not increase the activity of the 5-FU plus FA combination in advanced colorectal cancer .
3998
Intervention_Pharmacological
5-fluorouracil
3999
Intervention_Pharmacological
folinic acid
4000
Intervention_Pharmacological
ifosfamide
4001
Intervention_Pharmacological
5-fluorouracil ( 5-FU )
4002
Intervention_Pharmacological
folinic acid ( FA
4003
Intervention_Pharmacological
ifosfamide
4004
Intervention_Pharmacological
FA
4005
Intervention_Pharmacological
5-FU
4006
Intervention_Pharmacological
FA
4007
Intervention_Pharmacological
5-FU
4008
Intervention_Pharmacological
IFO
4009
Outcome_Physical
partial response
4010
Outcome_Physical
complete
4011
Outcome_Physical
partial response
4012
Outcome_Physical
Time to failure
4013
Outcome_Physical
median
4014
Outcome_Mortality
survival time
4015
Outcome_Adverse-effects
Diarrhea
4016
Outcome_Adverse-effects
stomatitis
4017
Outcome_Adverse-effects
vomiting
4018
Outcome_Physical
nonhematologic toxicities
4019
Outcome_Physical
hematologic toxicity
4020
Outcome_Physical
leukopenia
4021
Outcome_Physical
advanced colorectal cancer
4022
Participant_Condition
colorectal cancer
4023
Participant_Sample-size
Forty-eight
4024
Participant_Sample-size
Forty-five