Dose-finding study of docetaxel and doxorubicin in first-line treatment of patients with metastatic breast cancer

摘要: Summary Purpose: To determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT) and recommended of docetaxel in combination with doxorubicin, to evaluate activity patients advanced breast cancer. Patients methods: Forty-two women untreated metastatic cancer (79% visceral metastases; 52% prior adjuvant anthracycline therapy) were treated doxorubicin (40-60 mg/m 2 ) i.v. bolus followed one hour later by (50-85 one-hour infusion every three weeks, without G-CSF support. Results: The MTD occurred at level combining 85 50 DLT being neutropenic sepsis. Neutropenia /or its complications manageable no grade 3-4 or severe nonhematological toxicities observed. Fluid retention was frequent but never severe. With a median cumulative 392 (240-559 follow-up time 29 months (9+-41), congestive heart failure High observed all levels, particularly last four, response rate 81% (95% confidence interval CI): 62.5-92.5). Median progression 46 weeks (6+-62). Two-year survival 66%, has not yet been reached. Conclusions: Docetaxel-doxorubicin is feasible, safe highly active. incidence febrile neutropenia requires careful monitoring acceptable this setting. There does appear be an increase cardiac doxorubicin. either 75 60 , administered weeks.