Predictors of response to an intensive weekly chemotherapy in advanced gastric cancer patients. A report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD)

We describe the results of a prognostic factor analysis in patients with me tastatic gastric cancer treated with an intensive weekly regimen: cisplatin 40 mg/m(2), epirubicin 35 mg/m(2), 5-fluorouracil 500 mg/m(2), 6S-stereois omer of leucovorin at a dose of 250 mg/m(2), and glutathione at a dose of 1 .5 g/m(2), with the support of G-CSF, 5 mu g/kg, from the day after to the day before each chemotherapy administration. The variables used for analysi s were: age, sex, ECOG performance status, a weight loss >10%, site of prim ary tumor, metastatic disease and number of sites, disease free interval (p atients undergone curative resections only), dose intensity of the three dr ugs, expressed as percentage of planned dose intensity (80-100% versus <79% ), initial hemoglobin, albumin, SGOT, SGPT, LDH, alkaline phosphatase. The variables predictive of response were: ECOG performance status (p = 0.04), weight loss (p = 0.0042), disease free survival (p = 0.002) and dose intens ity of the three drugs (p = 0.0038). Regarding response of the primary tumo r, site (cardia versus other sites) was the only prognostic factor (p = 0.0 028). From these data, clinical condition of the patients and cytotoxic dru g doses seem to be the main prognostic features. We recommend description o f these factors in reports of phase II studies of new treatments.