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 metastatic gastric cancer treated with an intensive weekly regimen: cisplatin 40 mg/m², epirubicin 35 mg/m², 5-fluorouracil 500 mg/m², 6S-stereoisomer of leucovorin at a dose of 250 mg/m², and glutathione at a dose of 1.5 g/m², with the support of G-CSF, 5 μg/kg, from the day after to the day before each chemotherapy administration. The variables used for analysis were: age, sex, ECOG performance status, a weight loss > 10%, site of primary tumor, metastatic disease and number of sites, disease free interval patients undergone curative resections only), dose intensity of the three drugs, 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 intensity of the three drugs (p = 0.0038). Regarding response of the primary tumor, site (cardia versus other sites) was the only prognostic factor (p = 0.0028). From these data, clinical condition of the patients and cytotoxic drug doses seem to be the main prognostic features. We recommend description of these factors in reports of phase II studies of new treatments.