Treatment of advanced gastric cancer with oral idarubicin, leucovorin, andtegafur

Background: Until today, an optimal palliative treatment regimen has not be en defined for patients with metastatic gastric cancer. Since an acceptable therapeutic index has been reported for various 5-FU/leucovorin-based regi mens including its combination with anthracyclines and an oral mode of drug administration would implicate several advantages, the present phase II tr ial of tegafur, leucovorin, and idarubicin was initiated. Patients and Meth ods: 20 previously untreated patients with metastatic gastric cancer were t reated with 25 mg/day idarubicin on days 1, 8 and 15 as well as 3 x 30 mg/d ay leucovorin and 3 x 200 mg/day tegafur both given for 14-21 days. Treatme nt courses were repeated every 4-5 weeks. Results: A partial response was n oted in only 1 patient (5%), stable disease occurred in 7 (35%), whereas th e remaining patients progressed during therapy. The median time to progress ion 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 advers e reactions comprised mild to moderate nausea/emesis (55%) and alopecia (45 %). Hematological toxicity was also generally mild; only 3 patients experie nced afebrile WHO grade 3 granulocytopenia, and only 1 patient each had gra de 3 thrombocytopenia and anemia, respectively. Conclusions: In view of the disappointing treatment results, which might be explained by the prognosti cally unfavorable pretreatment characteristics of our study population, the choice of a suboptimal dose regimen, or simply by the marginal antitumor e fficacy of the anticancer drug medication, this particular regimen should n ot be considered for treatment or further investigation in patients with ad vanced gastric cancer.