title: Clinical usefulness of oral granisetron hydrochloride for alleviation of delayed nausea and vomiting induced by CPT-11.
abstract: This open label pilot study evaluated the safety and efficacy of the oral 5-HT3 receptor antagonist granisetron for prophylaxis of delayed chemotherapy-induced nausea and vomiting (CINV) in 30 patients with advanced or recurrent colorectal cancer. Patients were studied during two cycles of a 5-week regimen with irinotecan (CPT-11) and UFT. Patients received prophylactic anti-emetic therapy that included intravenous granisetron. If Grade 1 or higher severity gastrointestinal symptoms occurred during 6 days after CPT-11 administration in Cycle 1, then oral granisetron was administered daily for the following 5 days of CPT-11 in Cycle 2. Sixteen patients (53.3%) experienced delayed CINV in Cycle 1. The incidence of Grade 2 or higher vomiting was 32.1% and 27.7% in Cycles 1 and 2 in males (P = 0.554) respectively, and 54.6% and 32.4% in females (P = 0.001) respectively. Granisetron is effective against delayed Grade 2 or higher vomiting induced by CPT-11/UFT in female patients, although granisetron alone may not sufficiently control nausea induced by this regimen.
authors.affiliation: Department of Surgery and Clinical Oncology, Graduate School of Medicine, Osaka University, Osaka, Japan. mikeda@surg2.med.osaka-u.ac.jp
authors.forename: M
authors.initials: M
authors.lastname: Ikeda
authors.forename: M
authors.initials: M
authors.lastname: Yasui
authors.forename: H
authors.initials: H
authors.lastname: Fukunaga
authors.forename: I
authors.initials: I
authors.lastname: Seshimo
authors.forename: O
authors.initials: O
authors.lastname: Takayama
authors.forename: M
authors.initials: M
authors.lastname: Ikenaga
authors.forename: H
authors.initials: H
authors.lastname: Yamamoto
authors.forename: M
authors.initials: M
authors.lastname: Ohue
authors.forename: M
authors.initials: M
authors.lastname: Sekimoto
authors.forename: M
authors.initials: M
authors.lastname: Monden
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives*; D015179:Colorectal Neoplasms / Q000188:drug therapy; D005260:Female; D017829:Granisetron / Q000627:therapeutic use*; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy*; D010865:Pilot Projects; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy*
chemical_list: D000932:Antiemetics; D002166:Camptothecin; D017829:Granisetron; D000077146:Irinotecan