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Treatment of Advanced Gastric Cancer with Oral Idarubicin, Leucovorin, and Tegafur

Background: Until today, an optimal palliative treatment regimen has not been defined for patients with metastatic gastric cancer. Since an acceptable therapeutic index has been reported for various 5-FU/leucovorin-based regimens including its combination with anthracyclines and an oral mode of drug administration would implicate several advantages, the present phase II trial of tegafur, leucovorin, and idarubicin was initiated. Patients and Methods: 20 previously untreated patients with metastatic gastric cancer were treated with 25 mg/day idarubicin on days 1, 8 and 15 as well as 3 × 30 mg/day leucovorin and 3 × 200 mg/day tegafur both given for 14–21 days. Treatment courses were repeated every 4–5 weeks. Results: A partial response was noted in only 1 patient (5%), stable disease occurred in 7 (35%), whereas the remaining patients progressed during therapy. The median time to progression was 2.5 months (range 1.5–8.5 months), and median overall survival time was 5.5 months (range 2.5–12.0+ months). The most commonly observed adverse reactions comprised mild to moderate nausea/emesis (55%) and alopecia (45%). Hematological toxicity was also generally mild; only 3 patients experienced afebrile WHO grade 3 granulocytopenia, and only 1 patient each had grade 3 thrombocytopenia and anemia, respectively. Conclusions: In view of the disappointing treatment results, which might be explained by the prognostically unfavorable pretreatment characteristics of our study population, the choice of a suboptimal dose regimen, or simply by the marginal antitumor efficacy of the anticancer drug medication, this particular regimen should not be considered for treatment or further investigation in patients with advanced gastric cancer.