Docetaxel vs Doxorubicin in Metastatic Breast Cancer Resistant to Alkylating Chemotherapy
Single-agent docetaxel (Taxotere) has been shown to be highly active in metastatic breast cancer, with an overall response rate of 47%, median time to progression of 4 months, and survival of 10 months when administered as
ABSTRACT: Single-agent docetaxel (Taxotere)has been shown to be highly active in metastatic breast cancer, with anoverall response rate of 47%, median time to progression of 4 months, andsurvival of 10 months when administered as second-line therapy. These datacompare favorably with those reported for doxorubicin (Adriamycin), whichhas been considered the most active single agent in this setting. Thisnonblinded, multicenter, randomized phase III study compared the mediantime to progression, response rate, quality of life, toxicity, and survivalafter treatment with docetaxel or doxorubicin in patients with metastaticbreast cancer in whom previous alkylating chemotherapy failed. Patientswere randomized to receive an intravenous infusion of either docetaxel,100 mg/m², for 1 hour once every 3 weeks or doxorubicin, 75 mg/m²,for 15 to 20 minutes once every 3 weeks. This preliminary analysis presentsdata on 200 of 326 patients recruited. It was performed after the completionof patient accrual. The median time to progression was greater in the docetaxelgroup than in the doxorubicin group (29 vs 21 weeks, respectively; P =not significant). Overall response rates were higher with docetaxel (47%vs 27%), and fewer patients in the docetaxel group had progressive diseaseas their best overall response (10% vs 22%). Both regimens caused the sameincidence and severity of neutropenia, yet patients treated with doxorubicinhad a higher incidence of infection and febrile neutropenia. In addition,doxorubicin produced a higher incidence of grade 3 to 4 thrombocytopenia.Cardiac toxicity led to discontinuation in 7 patients and death in 2 patientsin the doxorubicin group; fluid retention led to discontinuation in 1 patientin the docetaxel group. Based on this preliminary analysis, docetaxel wasmore active and safer than doxorubicin in patients with metastatic breastcancer in whom previous alkylating chemotherapy failed. [ONCOLOGY 11(Suppl 8):19-24,1997]
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