title: Post-marketing safety evaluation of S-1 in patients with inoperable or recurrent breast cancer: especially in patients treated with S-1 + trastuzumab.
abstract: OBJECTIVE
  The purpose of this study was to assess the safety of S-1 in Japanese in inoperable or recurrent breast cancer patients.
  
  
  METHODS
  A prospective post-marketing surveillance was performed at 313 sites in Japan in patients with inoperable or recurrent breast cancer treated with S-1. We examined 1361 patients between January 2006 and December 2007 with regard to the incidence of adverse drug reactions graded by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
  
  
  RESULTS
  At least one adverse drug reaction was encountered by 858 patients, with an overall incidence of 63.0% (858/1361). The incidence of Grade 3 or higher adverse drug reactions in a descending order was 14.7% (200/1361). In this study, the most common combination drug was trastuzumab. The overall incidence of adverse drug reactions was 63.5% (431/679 patients) in patients treated with S-1 alone, and 55.9% (66/118 patients) in patients treated with S-1 + trastuzumab.
  
  
  CONCLUSIONS
  Monotherapy with S-1 or combination therapy with S-1 + trastuzumab was well tolerated for inoperable or recurrent breast cancer patients.
authors.affiliation: Department of Breast and Endocrine Surgery, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa 259-1193, Japan. yu-ki@is.icc.u-tokai.ac.jp
authors.forename: Yuki
authors.initials: Y
authors.lastname: Saito
authors.forename: Risa
authors.initials: R
authors.lastname: Oshitanai
authors.forename: Mayako
authors.initials: M
authors.lastname: Terao
authors.forename: Mizuho
authors.initials: M
authors.lastname: Terada
authors.forename: Banri
authors.initials: B
authors.lastname: Tsuda
authors.forename: Takuho
authors.initials: T
authors.lastname: Okamura
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Suzuki
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tokuda
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D044466:Asian People / Q000706:statistics & numerical data*; D001943:Breast Neoplasms / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D016015:Logistic Models; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012720:Severity of Illness Index; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects*; D000068878:Trastuzumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000068878:Trastuzumab