title: Open-label observational study to assess the efficacy and safety of aprepitant for chemotherapy-induced nausea and vomiting prophylaxis in Indian patients receiving chemotherapy with highly emetogenic chemotherapy/moderately emetogenic chemotherapy regimens.
abstract: BACKGROUND
  Currently, there is limited data on the prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian population with aprepitant containing regimens.
  
  
  OBJECTIVE
  The aim was to assess the Efficacy and Safety of Aprepitant for the prevention of nausea and vomiting associated with highly emetogenic chemotherapy/moderately emetogenic chemotherapy (HEC/MEC) regimens.
  
  
  METHODS
  Investigator initiated, multicentric, open-label, prospective, noncomparative, observational trial.
  
  
  METHODS
  Triple drug regimen with aprepitant, palonosetron, and dexamethasaone administration was assessed for the prevention of CINV during acute, delayed, and the overall phase (OP) for HEC/MEC Regimens. The primary endpoint was complete response (CR; no emesis and no use of rescue medication) and the key secondary endpoint was the complete control (CC; no emesis, no rescue medication and no more than mild nausea) during the OP.
  
  
  METHODS
  Perprotocol efficacy was analyzed for the first cycle with results represented in terms of CR/CC rates using descriptive statistics.
  
  
  RESULTS
  Seventy-five patients were included in the study with median age of 49.7 years and 89.7% being females. The CR rate (OP) for patients administered HEC or MEC regimens during the first cycle were 92% and 90.9%, respectively. Similarly, the CC rates (OP) were 75% and 90% for these regimens, respectively. 7 (9.2%) patients reported adverse drug reactions that were mild and transient with no reports of any serious adverse events.
  
  
  CONCLUSIONS
  Use of aprepitant containing regimen for patients receiving HEC/MEC regimen resulted in significantly high CR and CC response rates, which further consolidate its potential role to improve patient quality of life and compliance to disease management.
authors.affiliation: Department of Medical Oncology, Deenanath Mangeshkar Hospital, Pune, India.
authors.forename: Sachin
authors.initials: S
authors.lastname: Hingmire
authors.affiliation: Department of Medical Oncology, Holy Spirit Hospital, Andheri East, Mumbai, Maharashtra, India.
authors.forename: Nirmal
authors.initials: N
authors.lastname: Raut
keywords: Aprepitant; chemotherapy-induced nausea and vomiting; dexamethasone; highly emetogenic chemotherapy regimens; moderately emetogenic chemotherapy regimens; palonosetron
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