Japanese Journal of Clinical Oncology Advance Access published online on August 2, 2007
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hym054
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© 2007 Foundation for Promotion of Cancer Research
Phase II Study of Biweekly Paclitaxel and Cisplatin Combination Chemotherapy in Advanced Gastric Cancer: Korea–Japan Collaborative Study Group Trial
1 Department of Hemato-Oncology, Korea University, College of Medicine, Seoul, Korea
2 Department of Gastroenterology, Saitama Cancer Center, Kita-Adachi gun, Saitama, Japan
3 Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea
4 Department of Gastroenterology, Osaka Medical College, Takatsuki, Osaka, Japan
5 Division of Hematology–Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
6 Department of Gastroenterology, Toyosu Hospital, Showa University School of Medicine, Tokyo, Japan
7 Division of Oncology, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
8 Young Leaders Program, Department of Social Life Science, Nagoya University, Nagoya, Japan
9 Department of Epidemiological and Clinical Research Information Management, Kyoto University Graduate School of Medicine, Kyoto, Japan
10 Department of Internal Medicine, Misawa City Hospital, Misawa, Aomori, Japan
For reprints and all correspondence: Yuh Sakata, Department of Internal Medicine, Misawa City Hospital, Aomori, Japan. E-mail: ysakatam-101{at}r15.7-dj.com
Received November 22, 2006; accepted March 5, 2007
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.
Key Words: gastric cancer • paclitaxel • cisplatin • combination chemotherapy
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