title: Randomized pharmacokinetic study comparing subcutaneous and intravenous palonosetron in cancer patients treated with platinum based chemotherapy.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01046240.
authors.affiliation: Clinical Pharmacology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
authors.forename: Belen
authors.initials: B
authors.lastname: Sadaba
authors.affiliation: Oncology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
authors.forename: Anabel
authors.initials: A
authors.lastname: del Barrio
authors.affiliation: Clinical Pharmacology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Campanero
authors.affiliation: Clinical Pharmacology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
authors.forename: Jose Ramon
authors.initials: JR
authors.lastname: Azanza
authors.affiliation: Clinical Pharmacology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
authors.forename: Almudena
authors.initials: A
authors.lastname: Gomez-Guiu
authors.affiliation: Oncology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
authors.forename: Jose Maria
authors.initials: JM
authors.lastname: Lopez-Picazo
authors.affiliation: Oncology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
authors.forename: Salvador Martin
authors.initials: SM
authors.lastname: Algarra
authors.affiliation: Department of Preventive Medicine, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Guillén Grimá
authors.affiliation: Department of Pharmacy and Pharmaceutical Technology, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
authors.forename: Maria
authors.initials: M
authors.lastname: Blanco Prieto
authors.affiliation: Oncology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Perez-Gracia
authors.affiliation: Oncology Department, School of Pharmacy, Clinica Universidad Navarra, University of Navarra, Pamplona, Spain.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Gurpide
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D007546:Isoquinolines / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy; D000077924:Palonosetron; D010984:Platinum / Q000008:administration & dosage; D011812:Quinuclidines / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D016896:Treatment Outcome; D014839:Vomiting / Q000188:drug therapy* / Q000209:etiology*
chemical_list: D000932:Antiemetics; D007546:Isoquinolines; D011812:Quinuclidines; D010984:Platinum; D000077924:Palonosetron