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

• Published in: European journal of cancer (1990) Vol. 58; pp. 122 - 129
• Main Authors: Llombart-Cussac, Antonio, Ramos, Manuel, Dalmau, Elsa, García-Saenz, José A., González-Farré, Xavier, Murillo, Laura, Calvo, Lourdes, Morales, Serafín, Carañana, Vicente, González, Ana, Fernández-Morales, Luis A., Moreno, Fernando, Casas, Mª Isabel, Angulo, Mª del Mar, Cámara, Mª Carmen, Garcia-Mace, Ana I., Carrasco, Eva, Jara-Sánchez, Carlos
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.05.2016
• Subjects: Adult; Aged; Aged, 80 and over; Antiemesis; Antiemetics - adverse effects; Antiemetics - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Aprepitant; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; CINV; Cyclophosphamide - adverse effects; Dexamethasone - therapeutic use; Docetaxel–cyclophosphamide; Early breast cancer; Female; Hematology, Oncology and Palliative Medicine; Humans; Middle Aged; Morpholines - adverse effects; Morpholines - therapeutic use; Nausea - chemically induced; Nausea - prevention & control; Neoplasm Staging; Prospective Studies; Quality of Life; Salvage Therapy; Secondary Prevention - methods; Serotonin 5-HT3 Receptor Antagonists - therapeutic use; Spain; Surveys and Questionnaires; Taxoids - adverse effects; Time Factors; Treatment Outcome; Vomiting - chemically induced; Vomiting - prevention & control; Spain; Aprepitant; CINV; Early breast cancer; Docetaxel–cyclophosphamide; Antiemesis
• ISSN: 0959-8049; 1879-0852; 1879-0852
• DOI: 10.1016/j.ejca.2016.01.015

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. This prospective multicentre study enrolled 212 chemotherapy-naïve EBC patients receiving T-75 mg/m2 and C-600 mg/m2. 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. 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). 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. •Proper use of standard antiemetic therapy for docetaxel–cyclophosphamide provides a high chemotherapy-induced nausea and vomiting (CINV) control rate.•Aprepitant as secondary prophylaxis induced a high CINV control rate.•The absence of good CINV control rate negatively impacts quality of life.