ABSTRACT
PURPOSE: The INTENS study was designed to determine whether delivering neoadjuvant chemotherapy at a higher dose in a shorter period of time improves outcome of breast cancer patients. METHODS: Women with newly diagnosed breast cancer were randomly assigned to neoadjuvant chemotherapy consisting of four cycles of doxorubicin and cyclophosphamide followed by four cycles of docetaxel (AC 60/600-T 100 mg/m2) or six cycles of TAC as triplet chemotherapy (75/50/500 mg/m2) every 3 weeks. The primary outcome was the pathologic complete response (pCR), with disease-free and overall survival as secondary endpoints. RESULTS: In total, 201 patients were included. The pCR rates were 28% for patients treated with AC-T and 19% for patients treated with TAC, with an odds ratio of 1.60 (95% CI 0.90-3.21). With a median follow-up of 6 years (range 0.04-8.41 years), the five-year disease-free survival was 81% for patients treated with sequentially AC-T and 71% for patients treated with concurrent triplet TAC chemotherapy with a stratified hazard ratio (HR) of 0.50 (95% CI 0.29-0.86). Five-year overall survival was 84% versus 76%, respectively, with a stratified HR of 0.55 (95% CI 0.29-1.03). CONCLUSIONS: No differences were observed between the two treatment arms with respect to pCR rate, but the sequentially delivered chemotherapy outperformed the triplet combination chemotherapy in terms of survival, despite a lower cumulative dose per agent. GOV nr NCT00314977.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/mortality , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Biomarkers, Tumor , Breast Neoplasms/pathology , Female , Humans , Middle Aged , Neoadjuvant Therapy , Neoplasm Staging , Survival Analysis , Treatment Outcome , Young AdultABSTRACT
BACKGROUND: This study was designed to determine whether delivering neo-adjuvant chemotherapy at a higher dose in a shorter period of time improves outcome of breast cancer patients. PATIENTS AND METHODS: Women with newly diagnosed breast cancer were randomly assigned to neoadjuvant chemotherapy of four cycles of doxorubicin and cyclophosphamide followed by four cycles of docetaxel (AC 60/600 - T 100 mg/m(2)) or six cycles of TAC (75/50/500 mg/m(2)) every 3 weeks. The primary endpoint was the pathologic complete response (pCR) rate, defined as no invasive tumour present in the breast. RESULTS: In total, 201 patients were included. Baseline characteristics were well balanced. AC-T resulted in pCR in 21% and TAC in 16% of patients (odds ratio 1.44 (95% confidence interval (CI) 0.67-3.10). AC-T without primary granulocyte-colony stimulating factor (G-CSF) prophylaxis was associated with more febrile neutropenia compared to TAC with primary G-CSF prophylaxis (23% versus 9%), and with more grade 3/4 sensory neuropathy (5% versus 0%). CONCLUSIONS: With a higher cumulative dose for the concurrent arm, no differences were observed between the two treatment arms with respect to pCR rate. The differential toxicity profile could partly be explained by different use of primary G-CSF prophylaxis.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms/drug therapy , Adolescent , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/pathology , Chemotherapy, Adjuvant , Cyclophosphamide/administration & dosage , Cyclophosphamide/adverse effects , Disease-Free Survival , Docetaxel , Doxorubicin/administration & dosage , Doxorubicin/adverse effects , Drug Administration Schedule , Female , Humans , Middle Aged , Neoadjuvant Therapy , Survival Rate , Taxoids/administration & dosage , Taxoids/adverse effects , Young AdultABSTRACT
OBJECTIVE: The aim of this study was to assess the quality of diet of rural Zambian pre-school children, and to compare the dietary intake of stunted and non-stunted children. DESIGN: Cross-sectional study, in which dietary intake was assessed with a 24-h recall method. Height and weight were measured according to standard procedures. SETTING: Twelve villages in Samfya District, Zambia. SUBJECTS: Children aged 6-9 months ('infants') and 14-20 months ('toddlers'), attending Mother-and-Child Health Clinics, were eligible for study. Excluded were: 12 wasted, and 18 for other reasons. In total 106 infants and 99 toddlers were included. RESULTS: In infants and toddlers, total daily intake of energy, calcium, iron, and vitamin A was insufficient compared to recommended daily intakes. Only infants had insufficient protein intake. Compared to intake from weaning foods, breast milk was the main source of energy and most nutrients for infants. For toddlers, weaning foods were more important. Stunted infants and toddlers tended to have lower intakes of energy compared to non-stunted age-mates. Daily energy intake per kg bodyweight showed no difference between stunted and non-stunted children. CONCLUSIONS: Overall quality of weaning foods was inadequate. Stunted infants and toddlers showed a tendency of lower energy intakes compared to non-stunted age-mates.
