Phase II study of biweekly paclitaxel and cisplatin combination chemotherapy in advanced gastric cancer: Korea Japan Collaborative Study Group Trial.
BACKGROUND
Benefits of chemotherapy have generally been modest in gastric cancer, although those regimens developed more recently have produced higher response rates. Paclitaxel plus cisplatin is one such regimen and divided administration of paclitaxel has been suggested to be associated with lower neurological and hematologic toxicities and be able to achieve higher paclitaxel dose intensities than paclitaxel administration at 175 mg/m2 every 3 weeks. This study was undertaked to assess the efficacy and toxicity of a biweekly paclitaxel and cisplatin combination treatment in advanced gastric cancer.


METHODS
Twenty-five patients from Japan and Korea, 50 patients in total, were entered into this trial which was conducted from October 2004 to June 2005. Median age of the patients was 57 years (range: 26-78). Paclitaxel 140 mg/m2 was administered intravenously on days 1 and 15 of each 4-week cycle. Cisplatin 30 mg/m2 was also administered on days 1 and 15 with standard hydration. A total of 278 courses of treatment (two treatment courses per cycle) were conducted for 50 patients. The median number of treatment cycles per patient was two with a range of one to six.


RESULTS
Nine of the 50 patients responded to the treatment, with an overall objective response rate of 18% (95% CI, 12-41), which included one complete response. Two patients were not evaluable and 14 patients had stable disease as best response. The median survival duration of the 50 patients was 333 days (range: 52-637+ days). The main toxicity was neutropenia. Significant toxicity (NCI-CTC grade 3 or 4) included neutropenia in 19 patients (38%), anorexia in four (8%), infection in three (6%), anemia in three (6%), and abdominal pain in three (6%).


CONCLUSIONS
Biweekly paclitaxel and cisplatin combination chemotherapy showed modest activity in advanced gastric carcinoma with a favorable toxicity pattern.