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Taxotere: How I Use It in Breast Cancer

The Johns Hopkins Oncology Center, 600 North Wolfe Street, Baltimore, MD 21287-0001

The clinical development of taxotere has resulted in an agent with substantial single-agent activity in women with both untreated and resistant metastatic breast cancer. The drug is thus currently being rapidly integrated into the oncologists armamentarium. In a study of taxotere as first-line therapy, Hudis and colleagues from Memorial Sloan-Kettering reported an overall response rate of 54% in 37 patients treated with 100 mg/m² every three weeks and the median duration of response was six months. A response rate of 63% in a similar population was observed by Trudeau and colleagues from the NCI-Canada Clinical trials group. In that study the median progression-free survival was 4.5 months. In this latter trial a second group of 16 patients was subsequently treated with a lower dose of taxotere (75 mg/m²) because of the high rate of admission for febrile neutropenia in the initial population treated at 100 mg/m². In this second cohort the response rate was 40%, a result which was not statistically significantly lower than in the cohort who received taxotere at 100 mg/m².

The development of novel agents for the treatment of metastatic breast cancer in the past few years has focused on drugs with activity in patients with resistant disease. While definitions of resistance may vary between studies, the recently reported phase II studies of taxotere have clearly identified a population of patients with disease which is resistant to anthracyclines and have observed response rates in these patients of up to 50%. Ravdin and colleagues noted complete and partial responses in 20 of 35 women with measurable breast cancer which had progressed on an anthracycline (administered either adjuvantly or for metastatic disease), who were treated with taxotere 100 mg/m² every three weeks. In a similar population, Valero and colleagues observed a 53% response rate. These initial studies have established the activity of this agent in patients with breast cancer which is truly refractory to anthracyclines. Neutropenia is the major side-effect of single-agent therapy with taxotere. In both studies mentioned above, grade IV neutropenia occurred in the majority of courses in which the drug was administered at full dose. Admissions for neutropenic fever and subsequent dose reductions were common.

Combination regimens containing taxotere are in early stages of development. Preliminary data suggest that taxotere and doxorubicin is an extremely active combination when administered as first-line therapy for metastatic breast cancer. Combinations with vinorelbine, cyclophosphamide and a variety of other agents are also under evaluation. No information is yet available on the role of taxotere in the adjuvant setting.

Taxotere is an active agent in the treatment of refractory breast cancer. Neutropenia may limit its use in heavily pretreated patients, for whom a starting dose of less than 100 mg/m² may be considered. Combination therapy with other agents both in the metastatic and adjuvant settings should be pursued in the context of clinical trials and several such trials are ongoing and will be discussed.

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