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      Paclitaxel and Carboplatin Combination Effective Second-line Therapy in Advanced Gastric Cancer: Presented at ESMO

      By Adrian Burton

      NICE, FRANCE -- October 19, 2002 -- A phase II study suggests that combined paclitaxel and carboplatin could be an effective and safe treatment for locally advanced/metastatic gastric cancer. The data were presented at the 27th Congress of the European Society for Medical Oncology.

      "The median survival of patients with advanced gastric cancer is about 6 months," said George Samelis, Sub-director of the Oncology Unit, Hippokration Hospital, Athens, Greece. "Surgery is often very difficult, and first-line chemotherapy frequently fails after 3 months or so. Second-line alternatives are therefore needed."

      Samelis' team investigated the use of this new combination with 19 patients (median age, 62 years; range, 45-75 years) all of whom had histologically confirmed adenocarcinoma of the stomach, and all had failed on first-line therapy. Thirty one percent of patients had metastases in the liver, 10 percent in the lung, 5 percent in the bones, 31 percent in the lymph nodes, and 26 percent in other sites, and 42 percent had suffered local recurrence. ECOG performance status ranged from 0 to 3.

      The experimental treatment regimen consisted of paclitaxel 175 mg/mē (3-hour infusion) and carboplatin 6 area under the curve on day 1 (1-hour infusion), once every 3 weeks for as long as possible.

      Of the 18 patients evaluable for response, 2 showed a complete responses, 3 had partial responses and another 2 showed stable disease. Objective responses were seen at all metastatic sites.

      The toxicity of the regimen was manageable. Granulocytopenia was observed in 50 percent of patients at grade 1-2 and in 5 percent at grade 3, allergic reactions were seen in 11 percent at grade 2 and 5 percent at grade 3. All patients showed grade 3 alopecia.

      "These good results were not really expected," said Dr. Samelis, "and these responses have lasted 6 months or so. Median survival is 8 months up to now. After normal surgery and failure on first-line therapy you might expect a patient to live 3 or 4 months but certainly no more."

      "We also saw an improvement in performance status, so patients' quality of life was also improved. This combination appears feasible and toxicity is manageable. In second-line treatment there really is nothing else, so I would recommend it," concluded Dr. Samelis.



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