PMID- 24369195
OWN - NLM
STAT- MEDLINE
DCOM- 20150828
LR  - 20181202
IS  - 1998-4774 (Electronic)
IS  - 0019-509X (Linking)
VI  - 50
IP  - 4
DP  - 2013 Oct-Dec
TI  - A phase 3, randomized, double-blind study of single-dose fosaprepitant for 
      prevention of cisplatin-induced nausea and vomiting: results of an Indian 
      population subanalysis.
PG  - 285-91
LID - 10.4103/0019-509X.123580 [doi]
AB  - CONTEXT: Currently, there is limited data on the prevention of 
      chemotherapy-induced nausea and vomiting (CINV) in Indian patients. AIMS: This 
      post hoc study assessed the efficacy and safety of fosaprepitant compared with 
      aprepitant for prevention of CINV in the Indian population. A subgroup analysis 
      was performed from data collected in a phase 3 study of intravenous (IV) 
      fosaprepitant or oral aprepitant, plus the 5-HT 3 antagonist ondansetron and the 
      corticosteroid dexamethasone, in cisplatin-naomicronve patients with solid 
      malignancies. MATERIALS AND METHODS: Patients scheduled to receive cisplatin (>/=70 
      mg/m 2 ) were administered a single IV dose of fosaprepitant dimeglumine (150 mg) 
      on day 1 or a 3-day dosing regimen of oral aprepitant (day 1:125 mg, days 2 and 
      3:80 mg) with standard doses of ondansetron and dexamethasone. Patients recorded 
      nausea and/or vomiting episodes and their use of rescue medication and were 
      monitored for adverse events (AEs) and tolerability. STATISTICAL ANALYSIS USED: 
      Differences in response rates between fosaprepitant and aprepitant were 
      calculated using the Miettinen and Nurminen method. RESULTS: In the Indian 
      subpopulation (n = 372), efficacy was similar for patients in both the 
      fosaprepitant or aprepitant groups; complete response in the overall, acute, and 
      delayed phases and no vomiting in all phases were approximately 4 percentage 
      points higher in the fosaprepitant group compared with the aprepitant group. 
      Fosaprepitant was generally well-tolerated; common AEs were similar to oral 
      aprepitant. CONCLUSIONS: IV fosaprepitant is as safe and effective as oral 
      aprepitant in the Indian subpopulation and offers an alternative to the oral 
      formulation.
FAU - Maru, A
AU  - Maru A
AD  - Medical Oncology, SEAROC Cancer Center, S.K. Soni Hospital Premise, Jaipur, 
      India.
FAU - Gangadharan, V P
AU  - Gangadharan VP
FAU - Desai, C J
AU  - Desai CJ
FAU - Mohapatra, R K
AU  - Mohapatra RK
FAU - Carides, A D
AU  - Carides AD
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - India
TA  - Indian J Cancer
JT  - Indian journal of cancer
JID - 0112040
RN  - 0 (Antiemetics)
RN  - 0 (Morpholines)
RN  - 1NF15YR6UY (Aprepitant)
RN  - 6L8OF9XRDC (fosaprepitant)
RN  - Q20Q21Q62J (Cisplatin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antiemetics/administration & dosage
MH  - Aprepitant
MH  - Cisplatin/administration & dosage/*adverse effects
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions/*drug therapy/pathology
MH  - Female
MH  - Humans
MH  - India
MH  - Male
MH  - Middle Aged
MH  - Morpholines/*administration & dosage
MH  - Nausea/chemically induced/drug therapy
MH  - Neoplasms/*drug therapy/pathology
EDAT- 2013/12/27 06:00
MHDA- 2015/09/01 06:00
CRDT- 2013/12/27 06:00
PHST- 2013/12/27 06:00 [entrez]
PHST- 2013/12/27 06:00 [pubmed]
PHST- 2015/09/01 06:00 [medline]
AID - IndianJournalofCancer_2013_50_4_285_123580 [pii]
AID - 10.4103/0019-509X.123580 [doi]
PST - ppublish
SO  - Indian J Cancer. 2013 Oct-Dec;50(4):285-91. doi: 10.4103/0019-509X.123580.