Combined anti-microtubule therapy: A phase II study of weekly docetaxel plus estramustine in patients with metastatic breast cancer

S. E. Soule, K. D. Miller, R. Ansari, F. Fata, J. McClean, R. Zon, P. Porcu, G. Sledge, L. H. Einhorn

Research output: Contribution to journalArticle


Docetaxel and estramustine exert anti-tumor effects by inhibiting microtubule function. In vitro data demonstrate synergism with this combination. This phase II study evaluated the response rate and toxicity of this combination in patients with metastatic breast cancer (MBC). Eligible patients had received no more than one non-taxane chemotherapy regimen for metastatic disease; adjuvant taxane therapy was allowed if completed one year prior to enrollment. Patients were treated with docetaxel 35 mg/m2 d2 and estramustine phosphate 280 mg po TID d1-d3, weekly for 3 of 4 weeks. Patients were not treated with prophylactic anticoagulation. Thirty-six patients were enrolled between August 1999 and March 2001. Three patients discontinued therapy prior to disease assessment for reasons other than disease progression or dose limiting toxicity: one patient discontinued due to treatment-related toxicity. Median patient age was 54.8 years; the mean KPS was 90%. Six patients had received adjuvant taxane therapy and two patients had been treated with prior chemotherapy for MBC. Toxicity data is available in all patients. Myelosuppression was limited, with only two episodes of grade 4 neutropenia and no neutropenic fevers. One patient had grade 3 thrombocytopenia. Thromboembolic events occured in 11 % of patients, including 3 episodes of deep venous thrombosis and one treatment-related death due to a pulmonary embolus. Three patients had grade 3 fatigue or myalgias; two patients had grade 3 diarrhea and two patients had grade 3 nausea and vomiting. One patient was removed from the study due to grade 4 dyspnea. Responses were seen in 12 patients (40%) with confirmed partial remissions and two patients (7%) with complete remission; 10 patients (33%) had progressive disease; six (20%) had stable disease for ≥2 months; evaluation is not yet available in one patient. This combination has modest activity in patients with metastatic breast cancer hut has unacceptable thromboembolic toxicity.

Original languageEnglish (US)
Pages (from-to)273
Number of pages1
JournalBreast Cancer Research and Treatment
Issue number3
StatePublished - 2001

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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