[Japanese nationwide post-marketing survey of S-1 in patients with advanced gastric cancer].
BACKGROUND
The aim of this survey was to confirm the safety and efficacy of S-1 for advanced gastric cancer after market release.


METHODS
All patients had to be registered with the manufacturer for a post-marketing survey, according to the government recommendation. All patients were monitored for safety and survival.


RESULTS
During this survey, a total of 4,177 patients with advanced gastric cancer were registered. The incidences of all adverse events and of grade 3 or worse events in the 3,808 patients evaluable for safety were 74% and 25%, respectively. In patients with lower creatinine clearance at baseline, the incidences of adverse reactions were higher for all grades combined, as well as for grade 3 or worse. There were 90 (2.4%) early deaths (within 30 days of the initiation of the treatment) and 5 (0.1%) deaths possibly related to the treatment. The median survival time and the 1-year survival rate for all patients evaluable for efficacy (n=3,801) were 8.3 months (95% CI: 8.0-8.6 months) and 33.3% (95% CI: 31.8-34.9%), respectively.


CONCLUSIONS
This nationwide survey confirmed that the safety and efficacy profiles of S-1 were similar to those seen in the registration study.
Ohtsu
Atsushi
A
Division of Digestive Endoscopy/Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
D000368:Aged; D000855:Anorexia / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D007564:Japan; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D010094:Oxonic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012042:Registries / Q000706:statistics & numerical data; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use*
D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid