title: Incidence of chemotherapy-induced nausea and vomiting associated with docetaxel and cyclophosphamide in early breast cancer patients and aprepitant efficacy as salvage therapy. Results from the Spanish Breast Cancer Group/2009-02 study.
abstract: BACKGROUND
  Docetaxel-cyclophosphamide (TC) has become a common regimen in moderate-high-risk early breast cancer (EBC), but the incidence of chemotherapy-induced nausea and vomiting (CINV) with this regimen is not well established. This trial investigates the effect of guideline-consistent prophylaxis on CINV related to TC regimen and explores the efficacy of aprepitant among resistant patients.
  
  
  METHODS
  This prospective multicentre study enrolled 212 chemotherapy-naïve EBC patients receiving T-75 mg/m(2) and C-600 mg/m(2). Antiemetic therapy on the first cycle consisted of dexamethasone for 3 d plus 5-hydroxytryptamine (5-HT3) antagonists on day 1, according to Multinational Association of Supportive Care in Cancer guidelines. The primary end-point was complete response (CR) (no emesis and no need of rescue treatment within the initial 120 h). Patients failing CR on cycle 1 entered in a single-arm study exploring the efficacy of aprepitant on the second cycle. Patients' diaries and Functional Living Index-Emesis (FLIE) questionnaires were collected in cycles 1 and 2.
  
  
  RESULTS
  Among the 185 evaluable patients on cycle 1, 161 (87%, 95% confidence interval [CI]: 82.2-91.8) achieved a CR. Twenty-three patients received aprepitant on cycle 2, and 12 reached a CR (52.2%, 95% CI: 31.8-72.6). The absence of CR had a very substantial impact on quality of life on cycles 1 (FLIE before and after: 23.8-38.1, p = 0.0124) and 2 (18.3-42.9, p = 0.0059).
  
  
  CONCLUSIONS
  Guideline-consistent antiemetic prophylaxis for the TC regimen is associated with a low incidence of CINV. Aprepitant is effective as secondary prevention of CINV and should be considered as rescue therapy in patients treated with moderate emetogenic chemotherapy.
authors.affiliation: Hospital Arnau de Vilanova de Valencia, Valencia, Spain. Electronic address: allombart1@yahoo.com.
authors.forename: Antonio
authors.initials: A
authors.lastname: Llombart-Cussac
authors.affiliation: Centro Oncológico de Galicia, A Coruña, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Ramos
authors.affiliation: Corporació Sanitarià Parc Tauli, Sabadell, Barcelona, Spain.
authors.forename: Elsa
authors.initials: E
authors.lastname: Dalmau
authors.affiliation: Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: José A
authors.initials: JA
authors.lastname: García-Saenz
authors.affiliation: Hospital Clinic i Provincial, Barcelona, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: González-Farré
authors.affiliation: Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: Murillo
authors.affiliation: Complejo Hospitalario Universitario A Coruña, A Coruña, Spain.
authors.forename: Lourdes
authors.initials: L
authors.lastname: Calvo
authors.affiliation: Hospital Arnau de Vilanova de Lleida, Lleida, Spain.
authors.forename: Serafín
authors.initials: S
authors.lastname: Morales
authors.affiliation: Hospital Arnau de Vilanova de Valencia, Valencia, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Carañana
authors.affiliation: Centro Oncológico de Galicia, A Coruña, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: González
authors.affiliation: Corporació Sanitarià Parc Tauli, Sabadell, Barcelona, Spain.
authors.forename: Luis A
authors.initials: LA
authors.lastname: Fernández-Morales
authors.affiliation: Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Moreno
authors.affiliation: GEICAM (Spanish Breast Cancer Research Group), San Sebastián de los Reyes, Madrid, Spain.
authors.forename: M Isabel
authors.initials: MI
authors.lastname: Casas
authors.affiliation: GEICAM (Spanish Breast Cancer Research Group), San Sebastián de los Reyes, Madrid, Spain.
authors.forename: M Del Mar
authors.initials: Mdel M
authors.lastname: Angulo
authors.affiliation: GEICAM (Spanish Breast Cancer Research Group), San Sebastián de los Reyes, Madrid, Spain.
authors.forename: M Carmen
authors.initials: MC
authors.lastname: Cámara
authors.affiliation: GEICAM (Spanish Breast Cancer Research Group), San Sebastián de los Reyes, Madrid, Spain.
authors.forename: Ana I
authors.initials: AI
authors.lastname: Garcia-Mace
authors.affiliation: GEICAM (Spanish Breast Cancer Research Group), San Sebastián de los Reyes, Madrid, Spain.
authors.forename: Eva
authors.initials: E
authors.lastname: Carrasco
authors.affiliation: Hospital Universitario Fundación Alcorcón-Universidad Rey Juan Carlos, Madrid, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Jara-Sánchez
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D000077608:Aprepitant; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003520:Cyclophosphamide / Q000009:adverse effects*; D003907:Dexamethasone / Q000627:therapeutic use; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009367:Neoplasm Staging; D011446:Prospective Studies; D011788:Quality of Life; D016879:Salvage Therapy; D055502:Secondary Prevention / Q000379:methods*; D058831:Serotonin 5-HT3 Receptor Antagonists / Q000627:therapeutic use; D013030:Spain; D011795:Surveys and Questionnaires; D043823:Taxoids / Q000009:adverse effects*; D013997:Time Factors; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D009025:Morpholines; D058831:Serotonin 5-HT3 Receptor Antagonists; D043823:Taxoids; D000077143:Docetaxel; D000077608:Aprepitant; D003907:Dexamethasone; D003520:Cyclophosphamide
keywords: Antiemesis; Aprepitant; CINV; Docetaxel–cyclophosphamide; Early breast cancer