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Dose‐ranging antiemetic evaluation of the serotonin antagonist tropisetron in patients receiving anti‐cancer chemotherapy
Author(s) -
Pisters Katherine M. W.,
Kris Mark G.,
Tyson Leslie B.,
Clark Rebecca A.,
Gralla Richard J.
Publication year - 1993
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19930101)71:1<226::aid-cncr2820710135>3.0.co;2-t
Subject(s) - tropisetron , medicine , antiemetic , dose ranging study , chemotherapy , cancer , antagonist , cancer chemotherapy , chemotherapeutic drugs , oncology , anesthesia , pharmacology , pathology , receptor , double blind , alternative medicine , placebo
Background . Tropisetron (ICS 205–930) antagonizes the serotonin type 3 receptor and has antiemetic activity in animals given cisplatin. Its mean serum half‐life is 11.1 hours. Methods . In this dose‐ranging trial, 22 patients undergoing anti‐cancer chemotherapy received 24 courses of a single intravenous infusion of tropisetron beginning 30 minutes before chemotherapy. Four dose levels were explored (range, 12–48 mg/m 2 ). Results . Toxicities were mild and included headache, transient elevations of serum alanine transaminase and/or aspartate transaminase levels, and sedation. No akathisia or acute dystonic reactions were observed. Thirty‐six percent of patients had no emesis, and 58% had two or fewer emetic episodes. Ten patients received high‐dose cisplatin (dose, ⩾ 100 mg/m 2 ) as initial chemotherapy. Of these, 30% had no emesis, and 60% had two or fewer episodes. Conclusions . Tropisetron can be administered safely in the doses tested with no dose‐limiting toxicities. The encouraging antiemetic efficacy, mild toxicities, lack of extrapyramidal effects, and convenience of a single 15‐minute infusion regimen make this drug appropriate for study in additional trials. Cancer 1993; 71:226‐30.