1. 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.
- Author
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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
- Subjects
- Adult, Aged, Aged, 80 and over, Antiemetics adverse effects, Aprepitant, Breast Neoplasms pathology, Dexamethasone therapeutic use, Docetaxel, Female, Humans, Middle Aged, Morpholines adverse effects, Nausea chemically induced, Neoplasm Staging, Prospective Studies, Quality of Life, Salvage Therapy, Serotonin 5-HT3 Receptor Antagonists therapeutic use, Spain, Surveys and Questionnaires, Time Factors, Treatment Outcome, Vomiting chemically induced, Antiemetics therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Breast Neoplasms drug therapy, Cyclophosphamide adverse effects, Morpholines therapeutic use, Nausea prevention & control, Secondary Prevention methods, Taxoids adverse effects, Vomiting prevention & control
- 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 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., (Copyright © 2016. Published by Elsevier Ltd.)
- Published
- 2016
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