Japanese Journal of Clinical Oncology Advance Access published online on February 16, 2008
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyn003
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© The Author (2008). Published by Oxford University Press. All rights reserved
Multi-Center Phase II Study for Combination Therapy with Paclitaxel/Doxifluridine to Treat Advanced/Recurrent Gastric Cancer Showing Resistance to S-1 (OGSG 0302)
1 Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Osaka
2 Department of Surgery, Sakai City Hospital, Sakai, Osaka
3 Department of Surgery, Kinki University School of Medicine, Osakasayama, Osaka
4 Department of Surgery, NTT West Osaka Hospital, Osaka
5 Department of Surgery, Osaka Seamen's Insurance Hospital, Osaka
6 Department of Surgery, National Hospital Organization Osaka National Hospital, Osaka
7 Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka
8 Data Center of Osaka Gastrointestinal Cancer Chemotherapy Study Group, Osaka, Japan
For reprints and all correspondence: Hiroya Takiuchi, Cancer Chemotherapy Center, Osaka Medical College Hospital, 2-7 Daigakucho, Takatsuki, Osaka, 569-8686 Japan. E-mail: in2028{at}poh.osaka-med.ac.jp
Received September 7, 2007; accepted January 2, 2008
Background: A pre-clinical study demonstrated that paclitaxel induced thymidine phosphorylase in the tumor tissues. The combination of paclitaxel and doxifluridine is expected to exert extra anti-tumor effects. We evaluated the efficacy of this combination in patients with unresectable or recurrent gastric cancer who had been previously treated with S-1.
Methods: Registration was started to enroll 35 patients with advanced/recurrent gastric cancer, who were selected among those with measurable lesions fitting to response evaluation criteria in solid tumors, and with resistant to S-1 treatment. This regimen is consisted of paclitaxel, 80 mg/m2, iv on days 1 and 8; and doxifluridine, 600 mg/m2, po on days 1–14. The treatment was repeated every three weeks. Primary endpoint was response rate (RR); and secondary endpoints were overall survival (OS), progression free survival (PFS) and onset rate of adverse events.
Results: From September 2003 to March 2005, 35 patients were registered: including 28 men; 7 women; median age of 66 years (range, 49–75 years); and performance status (PS) levels were, zero with 21 and one with 14 patients. In 33 eligible patients, except two, clinical usefulness was evaluated resulting in RR of 18.2% (partial response, 6; stable disease, 15; progressive disease, 10; and not evaluable, 2 patients). Median survival time was 321 days and median PFS was 119 days. Severe adverse events were found in three patients to discontinue the present treatment.
Conclusions: The combination of paclitaxel and doxifluridine might be a treatment of choice as a second line chemotherapy for patient undergone S-1 treatment.
Key Words: gastric cancer • paclitaxel • doxifluridine • second line chemotherapy • S-1