A phase I combination chemotherapy study of biweekly paclitaxel and S-1 administration in patients with advanced gastric cancer.

The aim of the current study was to determine the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of a combination of paclitaxel and S-1 in patients with advanced gastric cancer. Fifteen patients were enrolled. The dose for S-1 was set at 80 mg/m2/day (days 1-14), while the dose for paclitaxel increased by 10 mg/m2 for every three patients, with a starting dose of 100 mg/m2 and was given biweekly on day 1 and 15. There was no severe toxicity (grade 4) recorded in patients receiving up to 120 mg/m2 of paclitaxel. Leukopenia/neutrophilia with grade 1 to 3 occurred in six patients up to level 3. At 130 mg/m2 of paclitaxel, grade 4 leukocytopenia and neutropenia events and grade 3 diarrhea developed in one out of three patients. One patient in another group of three patients that were enrolled at level 3, developed grade 4 granulocytopenia with fever (a body temperature higher than 38 degrees C) and grade 3 leukocytopenia. Eight patients, out of a total of 15, showed a partial response, resulting in an objective response rate of 53%. Five patients received gastrectomy. Median survival time was 428 days and the 1 year survival rate was 53%. Biweekly paclitaxel/S-1 combination chemotherapy could be safely used for the treatment of advanced gastric cancer. The recommended doses for a phase II study with paclitaxel and S-1 are 120 mg/m2 and 80 mg/m2, respectively.

Successfully treated metachronous liver metastasis of alpha-fetoprotein-producing early gastric cancer: case report.

We treated a 57-year-old male with liver metastasis derived from an alpha-fetoprotein-producing early gastric cancer. Eleven months after distal gastrectomy with D2 lymph node dissection, the patient underwent hepatectomy of segment 4 to resect a liver tumor 3 cm in diameter found by abdominal computed tomography. Immunohistochemical examination of the stomach and liver specimens, using anti-alpha-fetoprotein antibody, showed partial alpha-fetoprotein expression in both the primary gastric and metastatic hepatic tumors. The patient's serum alpha-fetoprotein level had been elevated at 302 ng/mL before hepatectomy, but the level remained below 5 ng/mL postoperatively. The patient remains alive without tumor recurrence 3 years after hepatectomy. There have been few previous reports of good outcome after curative resection of a metachronous liver metastasis derived from alpha-fetoprotein-producing gastric cancer. The assessment of serum alpha-fetoprotein level may be useful for detecting and monitoring liver metastasis in gastric cancer, especially for alpha-fetoprotein-producing tumors.