Randomized pharmacokinetic study comparing subcutaneous and intravenous palonosetron in cancer patients treated with platinum based chemotherapy.
<h4>Background</h4>Palonosetron is a potent second generation 5- hydroxytryptamine-3 selective antagonist which can be administered by either intravenous (IV) or oral routes, but subcutaneous (SC) administration of palonosetron has never been studied, even though it could have useful cli...
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Public Library of Science (PLoS)
2014-01-01
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| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0089747&type=printable |
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| author | Belen Sadaba Anabel del Barrio Miguel Angel Campanero Jose Ramon Azanza Almudena Gomez-Guiu Jose Maria Lopez-Picazo Salvador Martin Algarra Francisco Guillén Grimá Maria Blanco Prieto Jose Luis Perez-Gracia Alfonso Gurpide |
| author_facet | Belen Sadaba Anabel del Barrio Miguel Angel Campanero Jose Ramon Azanza Almudena Gomez-Guiu Jose Maria Lopez-Picazo Salvador Martin Algarra Francisco Guillén Grimá Maria Blanco Prieto Jose Luis Perez-Gracia Alfonso Gurpide |
| author_sort | Belen Sadaba |
| collection | DOAJ |
| description | <h4>Background</h4>Palonosetron is a potent second generation 5- hydroxytryptamine-3 selective antagonist which can be administered by either intravenous (IV) or oral routes, but subcutaneous (SC) administration of palonosetron has never been studied, even though it could have useful clinical applications. In this study, we evaluate the bioavailability of SC palonosetron.<h4>Patients and methods</h4>Patients treated with platinum-based chemotherapy were randomized to receive SC or IV palonosetron, followed by the alternative route in a crossover manner, during the first two cycles of chemotherapy. Blood samples were collected at baseline and 10, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 12 and 24 h after palonosetron administration. Urine was collected during 12 hours following palonosetron. We compared pharmacokinetic parameters including AUC0-24h, t1/2, and Cmax observed with each route of administration by analysis of variance (ANOVA).<h4>Results</h4>From October 2009 to July 2010, 25 evaluable patients were included. AUC0-24h for IV and SC palonosetron were respectively 14.1 and 12.7 ng × h/ml (p=0.160). Bioavalability of SC palonosetron was 118% (95% IC: 69-168). Cmax was lower with SC than with IV route and was reached 15 minutes following SC administration.<h4>Conclusions</h4>Palonosetron bioavailability was similar when administered by either SC or IV route. This new route of administration might be specially useful for outpatient management of emesis and for administration of oral chemotherapy.<h4>Trial registration</h4>ClinicalTrials.gov NCT01046240. |
| format | Article |
| id | doaj-art-732bd83ce7fe475ebabe0fd50f2fd1e3 |
| institution | OA Journals |
| issn | 1932-6203 |
| language | English |
| publishDate | 2014-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj-art-732bd83ce7fe475ebabe0fd50f2fd1e32025-08-20T02:28:54ZengPublic Library of Science (PLoS)PLoS ONE1932-62032014-01-0192e8974710.1371/journal.pone.0089747Randomized pharmacokinetic study comparing subcutaneous and intravenous palonosetron in cancer patients treated with platinum based chemotherapy.Belen SadabaAnabel del BarrioMiguel Angel CampaneroJose Ramon AzanzaAlmudena Gomez-GuiuJose Maria Lopez-PicazoSalvador Martin AlgarraFrancisco Guillén GrimáMaria Blanco PrietoJose Luis Perez-GraciaAlfonso Gurpide<h4>Background</h4>Palonosetron is a potent second generation 5- hydroxytryptamine-3 selective antagonist which can be administered by either intravenous (IV) or oral routes, but subcutaneous (SC) administration of palonosetron has never been studied, even though it could have useful clinical applications. In this study, we evaluate the bioavailability of SC palonosetron.<h4>Patients and methods</h4>Patients treated with platinum-based chemotherapy were randomized to receive SC or IV palonosetron, followed by the alternative route in a crossover manner, during the first two cycles of chemotherapy. Blood samples were collected at baseline and 10, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 12 and 24 h after palonosetron administration. Urine was collected during 12 hours following palonosetron. We compared pharmacokinetic parameters including AUC0-24h, t1/2, and Cmax observed with each route of administration by analysis of variance (ANOVA).<h4>Results</h4>From October 2009 to July 2010, 25 evaluable patients were included. AUC0-24h for IV and SC palonosetron were respectively 14.1 and 12.7 ng × h/ml (p=0.160). Bioavalability of SC palonosetron was 118% (95% IC: 69-168). Cmax was lower with SC than with IV route and was reached 15 minutes following SC administration.<h4>Conclusions</h4>Palonosetron bioavailability was similar when administered by either SC or IV route. This new route of administration might be specially useful for outpatient management of emesis and for administration of oral chemotherapy.<h4>Trial registration</h4>ClinicalTrials.gov NCT01046240.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0089747&type=printable |
| spellingShingle | Belen Sadaba Anabel del Barrio Miguel Angel Campanero Jose Ramon Azanza Almudena Gomez-Guiu Jose Maria Lopez-Picazo Salvador Martin Algarra Francisco Guillén Grimá Maria Blanco Prieto Jose Luis Perez-Gracia Alfonso Gurpide Randomized pharmacokinetic study comparing subcutaneous and intravenous palonosetron in cancer patients treated with platinum based chemotherapy. PLoS ONE |
| title | Randomized pharmacokinetic study comparing subcutaneous and intravenous palonosetron in cancer patients treated with platinum based chemotherapy. |
| title_full | Randomized pharmacokinetic study comparing subcutaneous and intravenous palonosetron in cancer patients treated with platinum based chemotherapy. |
| title_fullStr | Randomized pharmacokinetic study comparing subcutaneous and intravenous palonosetron in cancer patients treated with platinum based chemotherapy. |
| title_full_unstemmed | Randomized pharmacokinetic study comparing subcutaneous and intravenous palonosetron in cancer patients treated with platinum based chemotherapy. |
| title_short | Randomized pharmacokinetic study comparing subcutaneous and intravenous palonosetron in cancer patients treated with platinum based chemotherapy. |
| title_sort | randomized pharmacokinetic study comparing subcutaneous and intravenous palonosetron in cancer patients treated with platinum based chemotherapy |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0089747&type=printable |
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