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Eleven patients with chemotherapeutically pretreated advanced gastric cancer were treated in a phase II study with a combination of 5-fluorouracil (5-FU) and Leucovorin (LV, folinic acid). 5-FU (1,200 mg/m2) and LV (100 mg/m2) were given as a parallel continuous intravenous infusion over 48 h every 2 weeks for at least 8 weeks. Toxicity and response rates were evaluated. Results show that this chemotherapeutic regimen is well tolerable, without any side effects exceeding WHO grade 1 toxicity, but that it has no considerable effects on tumor growth. None of the patients achieved disease remission. In 8 out of the 11 study patients therapy had to be discontinued prematurely because of disease progression. Therefore we conclude that the studied protocol of 5-FU/LV as second-line treatment of advanced gastric cancer although well tolerable is not effective.
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Schmitz et al. (2009) studied this question.
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