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Annals of Oncology Advance Access originally published online on June 9, 2006
Annals of Oncology 2006 17(8):1205-1212; doi:10.1093/annonc/mdl135
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© 2006 European Society for Medical Oncology

Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen

M. Martín1,*, A. Lluch2, M. A. Seguí3, A. Ruiz4, M. Ramos5, E. Adrover6, Á. Rodríguez-Lescure7, R. Grosse8, L. Calvo9, C. Fernandez-Chacón10, M. Roset11, A. Antón12, D. Isla13, P. Martínez del Prado14, L. Iglesias15, J. Zaluski16, A. Arcusa17, J. M. López-Vega18, M. Muñoz19 and J. R. Mel20

1 Hospital Universitario San Carlos, Madrid, Spain; 2 H. Clínico Universitario de Valencia, Valencia, Spain; 3 Corporación Sanitaria Parc Taulí, Sabadell, Spain; 4 Instituto Valenciano de Oncología, Valencia, Spain; 5 Centro Oncolígico de Galicia, La Coruña, Spain; 6 H. General Universitario de Alicante, Alicante, Spain; 7 H. General Universitario de Elche, Elche, Spain; 8 Klinik und Poliklinik Gynäkologie, Halle, Germany; 9 C.H. Universitario Juan Canalejo, La Coruña, Spain; 10 PIVOTAL, Madrid, Spain; 11 HORE, Barcelona, Spain; 12 H. Universitario Miguel Servet, Zaragoza, Spain; 13 H. Clínico Universitario Lozano Blesa, Zaragoza, Spain; 14 H. De Basurto, Bilbao, Spain; 15 H. Universitario Virgen del Rocío, Sevilla, Spain; 16 Wielkopolskie Centrum Onkologii, Poznan, Poland; 17 H. de Terrassa, Terrasa, Spain; 18 H. Universitario Marqués de Valdecilla, Santander, Spain; 19 H. Clinic i Provincial, Barcelona, Spain; 20 C. H. Xeral-Calde, Lugo, Spain

* Correspondence to: Dr M. Martin, Servicio de Oncologia Medica, Hospital Universitario San Carlos, Spain. Tel: +34-91-3303546; Fax: +34-91-5436223; E-mail: mmartin{at}geicam.org

Background: The aim of the study was to analyse the toxicity and health related quality of life (HRQoL) of breast cancer patients treated with FAC (5-fluorouracil, doxorubicin, cyclophosphamide) and TAC (docetaxel, doxorubicin, cyclophosphamide) with and without primary prophylactic G-CSF (PPG).

Patients and methods: This was a phase III study to compare FAC and TAC as adjuvant treatment of high-risk node-negative breast cancer patients. After the entry of the first 237 patients, the protocol was amended to include PPG in the TAC arm due to the high incidence of febrile neutropenia. A total of 1047 evaluable patients from 49 centres in Spain, two in Poland and four in Germany were included in the trial. Side-effects and the scores of the EORTC QLQ-C30 and QLQ BR-23 questionnaires were compared in the three groups (FAC, TAC pre-amendment and TAC post-amendment).

Results: The addition of PPG to TAC significantly reduced the incidence of neutropenic fever, grade 2–4 anaemia, asthenia, anorexia, nail disorders, stomatitis, myalgia and dysgeusia. Patient QoL decreased during chemotherapy, more with TAC than FAC, but returned to baseline values afterwards. The addition of PPG to TAC significantly reduced the percentage of patients with clinically relevant Global Health Status deterioration (10 or more points over baseline value) at the end of chemotherapy (64% versus 46%, P < 0.03).

Conclusions: The addition of PPG significantly reduces the incidence of neutropenic fever associated with TAC chemotherapy as well as that of some TAC-induced haematological and extrahaematological side-effects. The HRQoL of patients treated with TAC is worse than that of those treated with FAC but improves with the addition of PPG, particularly in the final part of chemotherapy treatment.

Key words: adjuvant chemotherapy, docetaxel, TAC, G-CSF, filgrastim, lenograstim, operable breast cancer


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