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Randomized crossover pharmacokinetic evaluation of subcutaneous versus intravenous granisetron in cancer patients treated with platinum-based chemotherapy

Randomized crossover pharmacokinetic evaluation of subcutaneous versus intravenous granisetron in cancer patients treated with platinum-based chemotherapy

Authors :
María J. Blanco-Prieto
Isabel Gil-Aldea
José María López-Picazo
Jose Luis Perez-Gracia
Clara Olier Garate
Miguel Angel Campanero
Alfonso Gurpide
Carmen Reyna
Victor Fernandez Gallego
José Ramón Azanza
Juan P. Cabello
Susana De La Cruz
Jesús García-Foncillas
Belén Sádaba
Salvador Martín-Algarra
Jaime Ceballos
Source :
The oncologist. 12(9)
Publication Year :
2007

Abstract

Background. 5-HT3-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 (AUC0–12h) and higher levels at 12 hours, with similar values for AUC0–24h. 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.

Details

ISSN :
10837159
Volume :
12
Issue :
9
Database :
OpenAIRE
Journal :
The oncologist
Accession number :
edsair.doi.dedup.....d123b6335a72806f1aecd7b7da5caa0e