Seminars in oncology
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Seminars in oncology · Dec 1998
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialPhase III studies of single-agent docetaxel in patients with metastatic breast cancer who have progressed despite previous chemotherapy regimens: preliminary results.
A recent large phase III trial has for the first time demonstrated that choice of treatment can influence survival duration in patients with metastatic breast cancer who have progressed despite previous anthracycline-containing therapy. In a multicenter study, patients who received docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) experienced a longer median survival time (II.4 months v 8.7 months; P = .0097) as well as a longer time to progression (19 weeks v II weeks; P < .001) and higher overall response rate (30% v II.6%; P < .0001) than patients receiving treatment with mitomycin C and vinblastine. The toxicity profile was manageable and tolerable for both arms. ⋯ In this study, the duration of survival was not influenced by treatment. However, the higher response rate with docetaxel was achieved without the risk of potentially fatal cardiac toxicity seen in some patients who received doxorubicin. To date, docetaxel is the only single agent shown to have a potential superior activity when compared with doxorubicin in patients with progressive metastatic disease.
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The weekly administration of docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) at doses up to and including 40 mg/m2 induces low levels of hematologic and nonhematologic toxicity. In particular, weekly scheduling appears to markedly reduce the incidence of neutropenia compared with regimens in which an equivalent dose rate (mg/m2/wk) is given once every 3 weeks. Encouraging responses have been reported in patients with a range of tumor types, including breast cancer, treated with weekly docetaxel. Further trials of weekly docetaxel are in progress, and it appears that this schedule may prove particularly valuable in certain elderly patients who are unsuited to more aggressive chemotherapy.
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Seminars in oncology · Dec 1998
Compilation of phase I and II trial data of docetaxel and doxorubicin in the treatment of advanced breast cancer and other malignancies.
Doxorubicin and docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) are the most active cytotoxic agents in the treatment of advanced breast cancer. In the pre-taxane era, randomized trials demonstrated that doxorubicin-containing chemotherapy regimens are associated with higher response rates and improved survival compared with non-doxorubicin-containing regimens. Doxorubicin-containing regimens were therefore considered the standard of care at that time. ⋯ The regimen was highly effective and did not seem to be associated with an increased risk of congestive heart failure. These findings justify further evaluation of the doxorubicin/docetaxel combination in patients with advanced and operable breast cancer. Such trials are currently in progress and will define the role for this combination in the management of patients with breast cancer.