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A Journal on Internal Medicine

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Panminerva Medica 1999 March;41(1):35-8

language: English

A pilot study of adju­vant chem­o­ther­a­py with dou­ble mod­ula­tion of 5-Fluorouracil by Methotrexate and Leucovorin in gas­tric can­cer ­patients

De Vita F., Orditura M., Auriemma A., Infusino S., Catalano g.

From the Department of Internal and Experimental Medicine “F. Magrassi” Chair of Clinical Oncology II University Medical School of Naples, Naples, Italy


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/m2 d. 1, LFA 250 mg/m2 d.2, 5FU 600 mg/m2 d.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.

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