Open AccessRandomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Granisetron in Cancer Patients Treated with Platinum‐Based Chemotherapy
Author(s) -
Gurpide Alfonso,
Sadaba Belen,
MartinAlgarra Salvador,
Azanza Jose R.,
LopezPicazo Jose M.,
Campanero Miguel A.,
Cabello Juan P.,
GilAldea Isabel,
de la Cruz Susana,
Gallego Victor Fernandez,
Reyna Carmen,
Garate Clara Olier,
BlancoPrieto María J.,
Ceballos Jaime,
GarciaFoncillas Jesus,
PerezGracia Jose L.
Publication year - 2007
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.12-9-1151
Subject(s) - medicine , granisetron , crossover study , randomized controlled trial , pharmacokinetics , chemotherapy , oncology , anesthesia , antiemetic , placebo , alternative medicine , pathology
Background. 5‐HT 3 ‐receptor antagonists are one of the mainstays of antiemetic treatment, and they are administered either i.v. or orally. Nevertheless, sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective was to evaluate the bioavailability of s.c. granisetron. Patients and Methods. Patients receiving platinum‐based chemotherapy were randomized to receive 3 mg of granisetron either s.c. or i.v. in a crossover manner during two cycles. Blood and urine samples were collected after each cycle. Pharmacokinetic parameters observed with each administration route were compared by analysis of variance. Results. From May to November 2005, 31 patients were included and 25 were evaluable. Subcutaneous granisetron resulted in a 27% higher area under the concentration–time curve for 0–12 hours (AUC 0–12h ) and higher levels at 12 hours, with similar values for AUC 0–24h . The maximum concentration was lower with the s.c. than with the i.v. route and was observed 30 minutes following s.c. administration. Conclusion. Granisetron administered s.c. achieves complete bioavailability. This is the first study that shows that s.c. granisetron might be a valid alternative to i.v. delivery. Further trials to confirm clinical equivalence are warranted. This new route of administration might be especially relevant for outpatient management of emesis in cancer patients.