title: Phase II, open label, randomized comparative trial of ondansetron alone versus the combination of ondansetron and aprepitant for the prevention of nausea and vomiting in patients with hematologic malignancies receiving regimens containing high-dose cytarabine.
abstract: Background. Aprepitant is a P/neurokinin-1 receptor antagonist approved for the prevention of CINV in moderate emetic risk chemotherapy. We explored its effectiveness in patients with leukemia receiving cytarabine-based chemotherapy. Methods. Patients were randomized to ondansetron (OND) 8 mg IV 30 minutes before cytarabine followed by 24 mg IV continuous infusion daily until 6-12 hours after the last dose of chemotherapy alone or with aprepitant (APREP) oral 125 mg 6-12 hrs before chemotherapy and 80 mg daily until 1 day after the last dose of chemotherapy. Results. Forty-nine patients were enrolled in each arm; 42 in OND and 41 in OND + APREP arm were evaluable for efficacy. The ORR with OND + APREP was 80% compared to 67% with OND alone (P = 0.11). On days 6 and 7, higher proportion of patients treated with OND + APREP were free from nausea (74%, 74% versus 68%, 67%; P = 0.27 and 0.18, resp.). Requirement of rescue medications on days 2 and 3 was fewer in OND + APREP arm 7% and 5% compared to 21% and 16% in the OND arm, respectively (P = 0.06 and P = 0.07). Conclusions. There was a trend for overall improvement in emesis with ondansetron plus aprepitant. The potential benefit of this approach with specific chemotherapy combinations remains to be determined.
authors: Department of Leukemia, MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 428, Houston, TX 77030, USA.
authors: Talha
authors: T
authors: Badar
authors: Department of Leukemia, MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 428, Houston, TX 77030, USA.
authors: Jorge
authors: J
authors: Cortes
authors: Department of Leukemia, MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 428, Houston, TX 77030, USA.
authors: Gautam
authors: G
authors: Borthakur
authors: Department of Leukemia, MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 428, Houston, TX 77030, USA.
authors: Susan
authors: S
authors: O'Brien
authors: Department of Leukemia, MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 428, Houston, TX 77030, USA.
authors: William
authors: W
authors: Wierda
authors: Department of Leukemia, MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 428, Houston, TX 77030, USA.
authors: Guillermo
authors: G
authors: Garcia-Manero
authors: Department of Leukemia, MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 428, Houston, TX 77030, USA.
authors: Alessandra
authors: A
authors: Ferrajoli
authors: Department of Leukemia, MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 428, Houston, TX 77030, USA.
authors: Tapan
authors: T
authors: Kadia
authors: Department of Leukemia, MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 428, Houston, TX 77030, USA.
authors: Rebeca
authors: R
authors: Poku
authors: Department of Leukemia, MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 428, Houston, TX 77030, USA.
authors: Hagop
authors: H
authors: Kantarjian
authors: Department of Leukemia, MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 428, Houston, TX 77030, USA.
authors: Gloria
authors: G
authors: Mattiuzzi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000077608:Aprepitant; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D019337:Hematologic Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D009325:Nausea / Q000139:chemically induced / Q000150:complications / Q000517:prevention & control*; D017294:Ondansetron / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000150:complications / Q000517:prevention & control*
chemical_list: D009025:Morpholines; D003561:Cytarabine; D000077608:Aprepitant; D017294:Ondansetron
references: Intern Med J. 2013 Jan;43(1):73-6
references: 22141732
references: Transplant Proc. 2011 Oct;43(8):3107-10
references: 21996238
references: Bone Marrow Transplant. 2011 Jun;46(6):784-9
references: 20838387
references: Cancer. 2010 Dec 15;116(24):5659-66
references: 21218459
references: Support Care Cancer. 2010 Apr;18(4):423-31
references: 19568773
references: J Natl Compr Canc Netw. 2009 May;7(5):601-5
references: 19460283
references: Support Care Cancer. 2007 May;15(5):497-503
references: 17103197
references: J Natl Compr Canc Netw. 2007 Jan;5(1):51-9
references: 17239326
references: J Natl Compr Canc Netw. 2007 Jan;5(1):35-43
references: 17239324
references: Cancer. 2005 Oct 1;104(7):1548-55
references: 16104039
references: J Clin Oncol. 2005 Apr 20;23(12):2822-30
references: 15837996
references: J Clin Oncol. 1993 Dec;11(12):2391-5
references: 8246028
references: Expert Opin Pharmacother. 2003 Dec;4(12):2279-96
references: 14640927
references: Am J Gastroenterol. 1999 Nov;94(11):3368-9
references: 10566748
references: J Clin Oncol. 1999 Sep;17(9):2971-94
references: 10561376
references: Am J Health Syst Pharm. 2013 Feb 15;70(4):343-9
references: 23370141