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Title: A Novel and Effective Regimen for Advanced Gastric Cancer: Presented at ESMO

"A Novel and Effective Regimen for Advanced Gastric Cancer: Presented at ESMO"

By David J.E. Candlish NICE, FRANCE -- October 21, 2002 -- A novel combination of docetaxel, 5-fluorouracil (5-FU), and epirubicin has proved effective in the treatment of previously untreated advanced cancer, according to researchers. In a study presented at the 27th Congress of the European Society for Medical Oncology, Dr Andre Murad of the Brazilian Gastric Cancer Study Group, Belo-Horizonte, Brazil, described the study results. The regimen has demonstrated its effectiveness in the treatment to date of 37 patients with histologically confirmed stage IIIB or IV gastric cancer, albeit with a safety profile that needs to be monitored carefully. Patients received docetaxel (Taxotere®) 75mg/m2 intravenously, 5-FU 500 mg/m2intravenous bolus, and epirubicin 50mg/m2 intravenous bolus, given every 3 weeks for a maximum of six cycles. The median age of these patients was 56 (range, 22-73 years), and 68 percent were male. All had at least one evaluable/measurable lesion, and none had received prior treatment with radiotherapy or chemotherapy. The patients were evaluated every cycle for toxicity and every two cycles for tumour response. Clinical benefit was assessed by a three-component system: pain (analgesic use), Karnofsky performance status scale, and weight gain, assessed at baseline and regularly through the study period. Clinical benefit response was defined as an improvement in at least one parameter with no worsening in any other. Progression was defined as clinical progression or death due to any cause. Progression and survival times were counted from the time the consent form was signed until an event occurred. Of the 25 patients who were evaluable for response, one (4 percent) achieved a complete response, while 12 (48 percent) achieved a partial response. Clinical benefit, assessed on the basis of analgesic consumption, Karnofsky scale improvement, and weight gain, was observed in 11 patients (30 percent). The median time to progression was 7.4 months (range, 5.2 to 11.4). Median overall survival time was 11.4 months (range, 7.8 to 13.4). The 1-year survival rate was 45 percent in this study. With regard to safety, febrile neutropenia occurred in a total of 10 patients (27 percent). The most frequent World Health Organization grade 3 or 4 toxicities were neutropenia (68 percent of patients), alopecia (11 percent), diarrhoea (11 percent), and vomiting (8 percent). Four patients (11 percent) withdrew due to adverse events. In three of these cases, the adverse event was considered related to study medication. Dr. Murad concluded that this novel combination regimen appears to be effective in the treatment of gastric cancer with the proviso that the safety profile needs to be monitored carefully.

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