Seminars in oncology
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Seminars in oncology · Oct 1998
Randomized Controlled Trial Comparative Study Clinical TrialDocetaxel versus doxorubicin in patients with metastatic breast cancer who have failed alkylating chemotherapy: a preliminary report of the randomized phase III trial. 303 Study Group.
Three hundred twenty-six patients who had failed prior alkylating agents, given either as adjuvant therapy or therapy for advanced breast cancer or both, were randomly assigned to treatment with up to seven cycles of doxorubicin 75 mg/m2 or docetaxel (Taxotere, Rhône-Poulenc Rorer, Antony, France) 100 mg/m2 given every 3 weeks. The two arms of the study were well-matched for age, performance status, previous therapy, and the nature of the metastatic disease. Forty-seven percent of the docetaxel-treated patients and 49% of the doxorubicin-treated patients were defined as having disease that showed primary or secondary resistance. ⋯ Overall median time to response was 12 weeks with docetaxel and 23 weeks with doxorubicin. Febrile neutropenia, grade 3/4 nausea and vomiting, and cardiotoxicity were significantly more common among the doxorubicin-treated patients, while diarrhea grade 3-4, skin toxicity, neurologic toxicity, fluid retention, and allergy of any grade were significantly more likely in the docetaxel-treated patients. This study demonstrates for the first time the superiority in terms of response rate of a taxoid over an anthracycline in the treatment of advanced breast cancer.
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Seminars in oncology · Oct 1998
Randomized Controlled Trial Comparative Study Clinical TrialEfficacy of paclitaxel or doxorubicin used as single agents in advanced breast cancer: a literature survey.
The anthracyclines are among the most active agents in the treatment of breast cancer. In recent years, the taxoids have produced promising results as single agents in breast cancer. ⋯ Based on the known activity of doxorubicin and the single-agent phase II results of paclitaxel, two phase III randomized trials comparing these drugs as monotherapy in first-line, with crossover on progression, were conducted by the European Organization for Research and Treatment of Cancer and the Intergroup. The preliminary results of these studies were presented at international congresses and will be discussed here.
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Seminars in oncology · Oct 1998
ReviewPrevention and treatment of oral mucositis following cancer chemotherapy.
The administration of many chemotherapy regimens may be complicated by toxicities that limit clinicians' abilities to deliver the most effective doses of active agents. Oral mucositis remains the dose-limiting toxicity of a variety of chemotherapeutic regimens and may result in significant morbidity, impaired nutrition, treatment delays, and dose reductions. In this report, the mechanisms of both direct and indirect stomatotoxicity are reviewed and efforts are made to help identify patient-related and treatment-related factors that predispose patients to oral mucositis. Last, various approaches to prevent and treat chemotherapy-induced mucositis are reviewed.
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Seminars in oncology · Oct 1998
Clinical TrialTaxane-based three-drug combination in metastatic and adjuvant treatment of breast cancer.
Considering the recommended dose of the docetaxel/doxorubicin combination (75 mg/m2 and 50 mg/m2, respectively), we decided to proceed with a pilot program in untreated metastatic breast cancer aimed at defining a multidrug regimen that could be later randomly compared with a standard doxorubicin-containing polychemotherapy regimen with equidoses of doxorubicin such as the FAC protocol (5-fluorouracil 500 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2) in first-line metastatic and adjuvant treatment of breast cancer patients. We proceeded with a pilot phase II study of the TAC combination, which consists of docetaxel 75 mg/m2 as a 1-hour infusion preceded by doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2, both given as an intravenous bolus. Three hundred seventy courses were delivered in 54 anthracycline-naive patients, among whom 62% had visceral metastases. ⋯ The major response rate was 73% overall and 79% in measurable disease. Time to progression and survival are still under evaluation. The TAC combination is an active and well-tolerated regimen that is the basis of two currently open, pivotal, randomized phase III trials comparing TAC with FAC in the metastatic and adjuvant treatment of breast cancer.
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Seminars in oncology · Oct 1998
Clinical TrialTaxanes in combination with doxorubicin in the treatment of metastatic breast cancer.
Given 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. ⋯ 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.