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.
Por:
Llombart-Cussac A, Ramos M, Dalmau E, García-Saenz JA, González-Farré X, Murillo L, Calvo L, Morales S, Carañana V, González A, Fernández-Morales LA, Moreno F, Casas MI, Angulo Mdel M, Cámara MC, Garcia-Mace AI, Carrasco E and Jara-Sánchez C
Publicada:
1 may 2016
Ahead of Print:
17 mar 2016
Resumen:
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. PATIENTS AND 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.
Filiaciones:
:
Hospital Arnau de Vilanova de Valencia, Valencia, Spain.
Ramos M:
Centro Oncológico de Galicia, A Coruña, Spain
Dalmau E:
Corporació Sanitarià Parc Tauli, Sabadell, Barcelona, Spain
García-Saenz JA:
Hospital Clínico San Carlos, Madrid, Spain
González-Farré X:
Hospital Clinic i Provincial, Barcelona, Spain
Murillo L:
Hospital Clinico Universitario Lozano Blesa, Zaragoza, Spain
Calvo L:
Complejo Hospitalario Universitario A Coruña, A Coruña, Spain
Morales S:
Hospital Arnau de Vilanova de Lleida, Lleida, Spain
:
Hospital Arnau de Vilanova de Valencia, Valencia, Spain
González A:
Centro Oncológico de Galicia, A Coruña, Spain
Fernández-Morales LA:
Corporació Sanitarià Parc Tauli, Sabadell, Barcelona, Spain
Moreno F:
Hospital Clínico San Carlos, Madrid, Spain
Casas MI:
GEICAM (Spanish Breast Cancer Research Group), San Sebastián de los Reyes, Madrid, Spain
Angulo Mdel M:
GEICAM (Spanish Breast Cancer Research Group), San Sebastián de los Reyes, Madrid, Spain
Cámara MC:
GEICAM (Spanish Breast Cancer Research Group), San Sebastián de los Reyes, Madrid, Spain
Garcia-Mace AI:
GEICAM (Spanish Breast Cancer Research Group), San Sebastián de los Reyes, Madrid, Spain
Carrasco E:
GEICAM (Spanish Breast Cancer Research Group), San Sebastián de los Reyes, Madrid, Spain
Jara-Sánchez C:
Hospital Universitario Fundación Alcorcón-Universidad Rey Juan Carlos, Madrid, Spain
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