[A case of complete response for advanced gastric cancer with liver metastasis treated with combination chemotherapy of weekly paclitaxel and doxifluridine].

A 68-year-old man underwent total gastrectomy for Type 3 gastric cancer with liver metastasis. The final finding was T3(SE), N1, H1, P0, CY0(class IV), Stage IV, Cur C. After surgery, he was treated with combination chemotherapy of weekly paclitaxel(PTX)/doxifluridine(5'-DFUR). Paclitaxel was administered at a dose of 80 mg/m(2) on day 1, 8 and 15, and doxifluridine was orally administered at a dose of 533 mg/m(2) day for five days followed by withdrawal for two days. This regimen was repeated every four weeks. After 2 courses, the tumor marker level normalized, and the size of the liver metastasis was remarkably decreased. After 5 courses, a CT scan revealed the liver metastasis had disappeared, and he has now survived without recurrence after the disappearance of the liver metastasis. No severe adverse reactions were observed, and the man can be treated as an outpatient. This therapy may thus be effective in the treatment of advanced gastric cancer following non-curative operation.

A combination phase I study of weekly paclitaxel and doxifluridine in advanced gastric cancer patients.

BACKGROUND: Preclinical studies have shown that paclitaxel and doxifluridine can act synergistically without overlapping toxicity for the treatment of advanced gastric cancer. The objectives of this study were to determine the maximum tolerated dose (MTD), the dose-limiting toxicity and the recommended Phase II dose for this drug combination. PATIENTS AND METHODS: Patients with histologically confirmed gastric cancer were eligible for the study. The paclitaxel dose (days 1, 8, 15) was augmented with a fixed dose of for treatments (1-3). doxifluridine (533 mg/m2, 5 days/week) on a 28-day cycle. RESULTS: Eighteen patients were enrolled. The MTD was not reached until the highest dose level. One patient had Grade 3 myelosuppression. The responses of the 13 suitable patients included 1 complete response and 5 partial responses. CONCLUSION: Although the MTD level could not be definitively which is a established, upon consideration of the lengthy administration time and the effectiveness, the recommended Phase II dose of paclitaxel was concluded to be 80 mg/m2 in combination with doxifluridine at 533 mg/m2.

Adjuvant therapy with protein-bound polysaccharide K and tegafur uracil in patients with stage II or III colorectal cancer: randomized, controlled trial.

PURPOSE: Intravenous fluorouracil and leucovorin for six to eight months is currently a standard adjuvant treatment for Stage III colon cancer; however, this regimen is complex, inconvenient, and has a high intolerability. Adjuvant chemotherapies are claimed for objective response rates with an acceptable safety profile and complexity. We investigated the benefits of oral protein-bound polysaccharide K added to oral tegafur/uracil on curatively resected Stage II or III colorectal cancer. METHODS: We prospectively randomized 207 patients to treatments of either oral 3.0 g protein-bound polysaccharide K plus 300 mg tegafur/uracil or 300 mg tegafur/uracil alone for two years following 12 mg/m2 and 8 mg/m2 mitomycin treatment on postoperative Days 1 and 2, respectively. The primary end points were disease-free and overall survival, and recurrence rates. RESULTS: Three (1.4 percent) patients were declared ineligible, and three patients did not start treatment. In total, 201 patients were analyzed. The three-year, disease-free survival rate was 80.6 percent (standard error = 3.4 percent) in the protein-bound polysaccharide K group (P = 0.02) compared with 68.7 percent (SE = 5.7 percent) in the control group after a median follow-up of 3.7 years. The estimated relative risk of recurrence in the control group was 1.87 (95 percent confidence interval, 1.10-3.20) at three years. The three-year, overall survival rate was 87.3 percent (standard error = 2.9 percent) in the protein-bound polysaccharide K group and 80.6 percent (standard error = 4.8 percent) in the control group (P = 0.24). The three-year, overall survival rate in 80 pathological TNM Stage III patients was 83.0 percent (standard error = 5.2 percent) in the protein-bound polysaccharide K group and 59.3 percent (standard error = 9.5 percent) in the control group (P = 0.02). Protein-bound polysaccharide K prevented distant metastases (P = 0.05), particularly lung metastases (P = 0.01). The incidence of adverse effects was minimal, and compliance was good. CONCLUSION: Adjuvant therapy using a combination of oral protein-bound polysaccharide K and tegafur/uracil is highly effective in preventing the recurrence of colorectal cancer in Stage II or III patients, and increases overall survival in pathological TNM Stage III. These results will be a sufficient proof to conduct a larger study to compare tegafur/uracil/protein-bound polysaccharide K with 5-fluorouracil/leucovorin.

Malignant gastrointestinal stromal tumor of the jejunum with liver metastasis.

Primary malignant tumors of the small intestine are rare. Malignant gastrointestinal stromal tumors are the third most common neoplasm among primary malignant small bowel tumors. A 56-year-old woman was admitted to our hospital because of appetite loss and dyspnea with movement. On admission, physical examination revealed severe anemia in her conjunctiva and a tumor in her left abdomen. Her hemoglobin level was 6.2 g/dL and other laboratory data were normal. Abdominal ultrasonograms and computed tomograms revealed a 55 x 70-mm heterogeneous mass and multiple low-density masses in the liver. Superior mesenteric arteriograms revealed a hypervascular tumor fed by the jejunal arteries. A malignant gastrointestinal stromal tumor arising from the jejunum with liver metastases was suspected. Partial resection of the affected jejunum and left trisegmentectomy of the liver were performed. The resected primary tumor was 120 x 45 x 65 mm. The tumor was mainly submucosal, but extended outside the jejunum; it was elastically firm and multiloculated. A small ulcer was seen on the mucosal side. The metastatic liver tumors were solid or cystic with diameters of 20 to 40 mm. Histopathological examination revealed that the tumors were characterized by fascicular proliferation of spindle-shaped cells. Immunohistochemical staining was positive for CD34 and c-kit, and negative for S-100 protein and smooth muscle actin. This case was a malignant gastrointestinal stromal tumor originating in the jejunum with liver metastases. The primary tumor and liver metastases were successfully resected simultaneously.

Breast-conserving therapy versus modified radical mastectomy in the treatment of early breast cancer in Japan.

BACKGROUND: Breast-conserving therapy has been widely utilized as a treatment option for women with early breast cancer. However, no randomized study comparing modified radical mastectomy and breast-conserving therapy has been conducted in Japan. METHODS: Two hundred and twenty-eight Japanese women with early breast cancer enrolled in the Gunma Breast Conserving Therapy Study between 1991 and 1994 were examined to determine whether there is any difference in disease-free survival or overall survival between radical mastectomy and breast-conserving therapy. After informed consent was obtained, a total of 119 patients underwent breast-conserving therapy and 109 underwent mastectomy. RESULTS: Mastectomy was a more frequently utilized treatment than breast-conserving therapy in patients with clinical stage II lesions, older age, larger tumor size or shorter distance between tumor and nipple. The mean follow-up period for all patients was 81 months (median 86 months). There was no significant difference in overall survival or disease-free survival between breast-conserving therapy and mastectomy even after adjusting for the clinical stage of the disease. A multivariate analysis of tumor size, lymph node status, estrogen receptor status and operation method using the Cox proportion hazard model confirmed that only lymph node status was an independent prognostic factor. CONCLUSION: Breast-conserving therapy is comparable to modified radical mastectomy in overall survival and disease-free survival.