title: Aprepitant, dexamethasone, and palonosetron in the prevention of doxorubicin/cyclophosphamide-induced nausea and vomiting.
abstract: OBJECTIVE
  This study evaluated the efficacy and tolerability of aprepitant, dexamethasone, and palonosetron in the prevention of nausea and vomiting in breast cancer patients receiving their initial cycle of doxorubicin and cyclophosphamide (AC).
  
  
  METHODS
  Patients with breast cancer, ≥ age 18, with a performance status of ≤ 2, receiving doxorubicin (≥ 60 mg/m(2)) and cyclophosphamide (≥ 500 mg/m(2)) for the first time were eligible. Prior to chemotherapy patients received aprepitant 125 mg orally (PO), dexamethasone 8-10 mg PO/intravenously (IV), and palonosetron 0.25 mg IV. On days 2-3, dexamethasone 4 mg PO and aprepitant 80 mg PO were given. Outcomes were recorded in patient diaries for the 120-h study period following chemotherapy. Primary endpoint was the proportion of patients achieving complete response (no emesis or rescue) for the 120-h study period.
  
  
  RESULTS
  Thirty-six patients were enrolled and all are evaluable. The median age was 53 (33-75) and 36 are females. Eighteen patients (50%) achieved a complete response during the 120-h study period. Acute (≤ 24 h) and delayed (24-120 h) complete response rates were 81% (27/36) and 61% (22/36), respectively. No emesis rates for the acute, delayed, and overall study periods were 97% (35/36), 94% (34/36), and 92% (33/36), respectively. Treatment was well tolerated.
  
  
  CONCLUSIONS
  The combination of aprepitant, dexamethasone, and palonosetron prevented emesis in more than 90% of breast cancer patients receiving their initial cycle of AC chemotherapy. Nausea was less well controlled. Overall complete response was achieved in one half of the study patients. Further improvement in the prevention of AC-induced chemotherapy-induced nausea and vomiting will require more effective antinausea treatments.
authors.affiliation: Department of Hematology Oncology, Lahey Clinic Medical Center, 41 Mall Road, Burlington, MA 01805, USA. Paul.Hesketh@Lahey.org
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Hesketh
authors.forename: Pedro
authors.initials: P
authors.lastname: Sanz-Altamira
mesh_terms: D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D000077608:Aprepitant; D001943:Breast Neoplasms / Q000188:drug therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D003907:Dexamethasone / Q000627:therapeutic use*; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000627:therapeutic use*; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use*; D009325:Nausea / Q000139:chemically induced* / Q000517:prevention & control*; D000077924:Palonosetron; D010865:Pilot Projects; D011812:Quinuclidines / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced* / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D007546:Isoquinolines; D009025:Morpholines; D011812:Quinuclidines; D000077608:Aprepitant; D000077924:Palonosetron; D003907:Dexamethasone; D004317:Doxorubicin; D003520:Cyclophosphamide
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