A pilot study of adjuvant chemotherapy with double modulation of 5-fluorouracil by methotrexate and leucovorin in gastric cancer patients.
BACKGROUND
Thirty-four patients with gastric cancer in stage II and III were enrolled, after curative resection, in a pilot study to assess the feasibility and the impact on relapse of a double modulation of 5-Fluorouracil (5FU) by Methotrexate (MTX) and 1-Leucovorin (LFA) as adjuvant chemotherapy.


METHODS
The schedule was: MTX 500 mg/m2d. 1, LFA 250 mg/m2d.2, 5FU 600 mg/m2d.2. Cycles were repeated every two weeks for 16 times. Quality of life during treatment was evaluated with the EORTC QLQ-C30.


RESULTS
At a median follow-up of 24 months, 21 (61%) patients treated with postoperative chemotherapy, were disease-free. Toxicity was primarily gastrointestinal, but its intensity was usually mild. The feasibility of treatment was also confirmed from the results of QLQ-C30 questionnaire.


CONCLUSIONS
This study demonstrates that the schedule tested is feasible as postoperative treatment in curatively resected gastric cancer patients and prompts the initiation of a randomized trial with a no-treatment control arm.
De Vita
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Department of Internal and Experimental Medicine F. Magrassi Chair of Clinical Oncology, II University Medical School of Naples, Italy.
Orditura
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Auriemma
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Infusino
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Catalano
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D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D010865:Pilot Projects; D013274:Stomach Neoplasms / Q000188:drug therapy*
D002955:Leucovorin; D005472:Fluorouracil; D008727:Methotrexate