title: Post-marketing surveillance (PMS) of all patients treated with irinotecan in Japan: clinical experience and ADR profile of 13,935 patients.
abstract: OBJECTIVE
  The actual condition of drug utilization and the adverse drug reactions profile of irinotecan hydrochloride hydrate (irinotecan), an antitumor drug, were examined on the basis of all the case survey results from April 1995 to January 2000.
  
  
  METHODS
  Drug utilization and the adverse drug reactions profile of irinotecan were figured out by checking of the patient conditions at the start of therapy and monitoring during on-therapy period in this survey.
  
  
  RESULTS
  Among the 13 935 patients investigated, 32% had non-small cell lung cancer, 16% had colorectal cancer, 15% had ovarian cancer and 14% had small cell lung cancer, all principal cancers in which irinotecan was domestically approved for use. Most frequent regimens of each cancer were concomitant use with cisplatin for non-small cell lung cancer and small cell lung cancer (38 and 46%, respectively), concomitant use with cisplatin or mitomycin for ovarian cancer (each 30%) and irinotecan alone for colorectal cancer (51%). The major (grade 3 or more) adverse drug reactions were myelosuppressions such as leukopenia (23.8 and 38.3% for lone and concomitant use, respectively) thrombocytopenia (6.5 and 14.3%) and gastrointestinal tract disorders such as diarrhea (10.2 and 10.0%).
  
  
  CONCLUSIONS
  It was reconfirmed that the incidences of serious leukopenia, thrombocytopenia and diarrhea were high among the patients with contraindication or careful administration of its use prescribed in the drug package insert. Therefore, for proper use of irinotecan, it is important to discriminate the patient on the basis of risk status.
authors.affiliation: Yakult Honsha Co., Ltd., 4F Ginza-Kobiki Bldg., 16-21, Ginza 7-Chome, Chuo-ku, Tokyo 104-0061, Japan. junichi-tadokoro@yakult.co.jp
authors.forename: Jun-Ichi
authors.initials: J
authors.lastname: Tadokoro
authors.forename: Koji
authors.initials: K
authors.lastname: Kakihata
authors.forename: Minoru
authors.initials: M
authors.lastname: Shimazaki
authors.forename: Tomoo
authors.initials: T
authors.lastname: Shiozawa
authors.forename: Shuji
authors.initials: S
authors.lastname: Masatani
authors.forename: Fumie
authors.initials: F
authors.lastname: Yamaguchi
authors.forename: Yuh
authors.initials: Y
authors.lastname: Sakata
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Ariyoshi
authors.forename: Masahiro
authors.initials: M
authors.lastname: Fukuoka
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy; D018288:Carcinoma, Small Cell / Q000188:drug therapy; D015179:Colorectal Neoplasms / Q000188:drug therapy; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy; D014453:Glucuronosyltransferase / Q000235:genetics; D006801:Humans; D015994:Incidence; D007262:Infusions, Intravenous; D000077146:Irinotecan; D007564:Japan; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D018579:Patient Selection; D011110:Polymorphism, Genetic; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013921:Thrombocytopenia / Q000139:chemically induced; D000099148:UGT1A1 Enzyme
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D002166:Camptothecin; D014453:Glucuronosyltransferase; D000077146:Irinotecan; D000099148:UGT1A1 Enzyme