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.
Eur J Cancer
; 58: 122-9, 2016 May.
Article
em En
| MEDLINE
| ID: mdl-26994459
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. PATIENTS ANDMETHODS:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vômito
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Neoplasias da Mama
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Protocolos de Quimioterapia Combinada Antineoplásica
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Morfolinas
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Ciclofosfamida
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Taxoides
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Prevenção Secundária
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Antieméticos
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Náusea
Tipo de estudo:
Clinical_trials
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Guideline
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Incidence_studies
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Observational_studies
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Qualitative_research
Limite:
Adult
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Aged
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Aged80
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Female
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Humans
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Middle aged
País/Região como assunto:
Europa
Idioma:
En
Revista:
Eur J Cancer
Ano de publicação:
2016
Tipo de documento:
Article