• V Dieras.
• Department of Medical Oncology, Institut Curie, Paris, France.
• Semin. Oncol. 1998 Oct 1; 25 (5 Suppl 12): 18-22.

AbstractGiven their high level of activity when used as single agents in metastatic breast cancer, the combination of docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) with doxorubicin is a logical development in the search for regimens that will improve prognosis in this disease. In a phase I trial conducted at the Institut Curie and Hospital Paul-Brousse (Paris, France), 42 women with previously untreated metastatic breast cancer received a total of 286 cycles of the combination at six dose levels. Prophylactic steroids and H1 and H2 blockers were given. The maximum tolerated dose was 85 mg/m2 docetaxel plus 50 mg/m2 doxorubicin. Except for neutropenia, no grade 3-4 or severe nonhematologic toxicities were seen. The incidence of fluid retention was low: moderate toxicity in only 19% of patients and no severe cases. No cases of congestive heart failure or symptomatic decrease in left ventricular ejection fraction occurred (median cumulative doxorubicin dose, 392 mg/m2; range, 240 to 559 mg/m2). High activity was observed at all dose levels. For patients receiving one of the four highest dose levels, the overall response rate was 81% (95% confidence intervals, 63% to 93%); comparable levels of response were seen at all disease sites. The doses recommended for phase II/III studies of this active and well-tolerated combination are either 50 mg/m2 doxorubicin plus 75 mg/m2 docetaxel or 60 mg/m2 of both drugs. Encouraging response rates also have been seen in studies in which paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) was combined with doxorubicin, although cardiotoxicity was a significant factor in some studies.

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