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document
Cisplatin , epirubicin , leucovorin and 5-fluorouracil ( PELF ) is more active than 5-fluorouracil , doxorubicin and methotrexate ( FAMTX ) in advanced gastric carcinoma . BACKGROUND 5-Fluorouracil ( 5-FU ) , doxorubicin and methotrexate ( FAMTX ) and cisplatin , epirubicin , leucovorin and 5-FU ( PELF ) have both been reported to be superior to the combination 5-FU , doxorubicin and mitomycin C ( FAM ) in advanced gastric carcinoma . On the basis of the presence and dose intensity of the included agents , we hypothesised that PELF would be superior to FAMTX . PATIENTS AND METHODS Two hundred patients with untreated advanced gastric carcinoma were randomised to receive PELF or FAMTX for a maximum of six cycles or until disease progression . RESULTS The complete response ( CR ) rates to PELF and FAMTX were , respectively , 13 % [ 95 % confidence intervals ( CI ) 6 % to 20 % ] and 2 % ( 95 % CI 0 % to 5 % ; P = 0.003 ) , and the objective response rates [ CR plus partial response ( PR ) rates ] 39 % ( 95 % CI 29 % to 49 % ) and 22 % ( 95 % CI 13 % to 30 % ; P = 0.009 ) , thus significantly favouring the PELF combination . The survival rates after 12 months ( 30.8 % versus 22.4 % ) and 24 months ( 15.7 % versus 9.5 % ) were also higher among patients receiving PELF , but these differences were not statistically significant . The toxicities were qualitatively different but quantitatively similar . Both regimens seem to be feasible provided that careful patient monitoring is assured . CONCLUSIONS PELF is significantly more active than FAMTX and deserves further research in the adjuvant setting .
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Intervention_Pharmacological
Cisplatin , epirubicin , leucovorin and 5-fluorouracil ( PELF )
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Intervention_Pharmacological
5-fluorouracil , doxorubicin and methotrexate ( FAMTX )
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Intervention_Pharmacological
5-Fluorouracil ( 5-FU ) , doxorubicin and methotrexate ( FAMTX )
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Intervention_Pharmacological
cisplatin , epirubicin , leucovorin and 5-FU ( PELF )
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Intervention_Pharmacological
FAMTX
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Intervention_Pharmacological
PELF
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Intervention_Pharmacological
FAMTX
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Intervention_Pharmacological
FAMTX
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Intervention_Pharmacological
PELF
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Intervention_Pharmacological
FAMTX
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Outcome_Physical
complete response ( CR ) rates
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Outcome_Physical
objective response rates
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Outcome_Physical
partial response
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Outcome_Mortality
survival rates
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Outcome_Adverse-effects
toxicities
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Participant_Condition
advanced gastric carcinoma
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Participant_Condition
advanced gastric carcinoma
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Participant_Sample-size
Two hundred
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Participant_Condition
untreated advanced gastric carcinoma