ABSTRACT
BACKGROUND: Combinations of anthracycline, taxane and fluoropyrimidine are highly active in advanced breast cancer (ABC). In a phase II study of epirubicin 50 mg/m(2), docetaxel 75 mg/m(2), and infusional 5-FU 200 mg/m(2)/day, we found dose-limiting neutropenia and frequent central venous catheter complications. An alternative approach has been tested using weekly fractionation of docetaxel, and oral capecitabine. METHODS: Initially, six women with ABC were treated with epirubicin 60 mg/m(2) day 1, docetaxel 25 mg/m(2) days 1,8,15, and capecitabine 1,000 mg/m(2) twice daily days 1-14, every 21 days. Six further patients received the above with capecitabine escalated to 1,500 mg/m(2) RESULTS: Four DLTs occurred in six patients at the second dose level (febrile neutropenia in 2). There were frequent dose delays/reductions, and fatigue, nausea/vomiting, and diarrhoea were common. Overall, six of ten assessable patients achieved a partial response. CONCLUSIONS: An active regimen, but significant haematological toxicity precluded dose further escalation.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Bone Neoplasms/drug therapy , Breast Neoplasms/drug therapy , Liver Neoplasms/drug therapy , Lung Neoplasms/drug therapy , Soft Tissue Neoplasms/drug therapy , Administration, Oral , Adolescent , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Bone Neoplasms/secondary , Breast Neoplasms/pathology , Capecitabine , Deoxycytidine/administration & dosage , Deoxycytidine/adverse effects , Deoxycytidine/analogs & derivatives , Docetaxel , Dose-Response Relationship, Drug , Epirubicin/administration & dosage , Epirubicin/adverse effects , Female , Fluorouracil/administration & dosage , Fluorouracil/adverse effects , Fluorouracil/analogs & derivatives , Humans , Infusions, Intravenous , Liver Neoplasms/secondary , Lung Neoplasms/secondary , Middle Aged , Neoplasm Staging , Prognosis , Soft Tissue Neoplasms/secondary , Survival Rate , Taxoids/administration & dosage , Taxoids/adverse effects , Treatment Outcome , Young AdultABSTRACT
PURPOSE: Systematic quality-of-life (QOL) assessment may have value in oncology practice by increasing awareness of a wide range of issues, possibly increasing detection of psychologic morbidity, social problems, and changes in physical status, and improving care and its outcomes. However, logistic problems are substantial. Automated systems solve many of these problems. We field-tested the feasibility and compliance that can be achieved using a computer touchscreen system in two consecutive studies. PATIENTS AND METHODS: In study 1, a prospective cohort of 272 patients was offered QOL assessment at each clinic appointment for 6 months. In study 2, all patients (N = 1,291) were offered QOL assessment as part of clinic routine during a 12-week period. RESULTS: In study 1, 82% of patients agreed to take part, but over time, compliance was poor (median, 40%; mean, 43%) and deteriorated with longer follow-up. In study 2, the overall compliance was greatly increased (median, 100%; mean, 70%), and compliance was retained over multiple visits. In study 1, compliance was better in younger patients, males, and socially advantaged patients, but was not affected by the presence of depression or anxiety, or QOL. In the second study, building on experience in the first study, data collection and storage in the computer system was excellent, achieving 98% of collected data stored in one center. In general, patients were comfortable with the computers and the approach. Data collection on the wards was more difficult and less complete than in clinics, especially for patients undergoing acute admissions. CONCLUSION: Feasibility with higher compliance was demonstrated in study 2, in which the data collection was integrated into routine care, and can be improved with further technical initiatives and education of staff.
