Seminars in oncology
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There has been a gradual evolution in the philosophy of treatment for metastatic breast cancer. It has long been known that endocrine therapy, radiotherapy, and chemotherapy could offer substantial palliative benefits to patients with symptomatic metastases. While these quality of life issues remain crucially important, it is increasingly recognized that the survival of patients with this condition also appears to be improving as a result of therapeutic advances. ⋯ The results of phase II studies suggest that of these agents, used at the recommended doses, docetaxel (Taxotere, Rhône-Poulenc Rorer, Antony, France) may be the most active, achieving an objective response rate of 59% in minimally pretreated patients and 47% when used in second-line treatment. In these studies, docetaxel was given at the standard dose of 100 mg/m2 over 1 hour. Recent results from phase III studies in which individual studies with docetaxel and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) have been compared with standard therapies indicate that docetaxel is the most active single agent in metastatic breast cancer.
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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 TrialTaxoids in combination with epirubicin: the search for improved outcomes in breast cancer.
The combination of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and either doxorubicin or epirubicin has significant activity against metastatic breast cancer. However, the optimal schedule in terms of activity and toxicity is still under investigation. The use of docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) in combination with anthracyclines is also active and could represent a safe and favorable alternative. ⋯ Severe fluid retention and symptomatic cardiotoxicity were not seen. Responses occurred at doses of 75 mg/m2 docetaxel plus 90 mg/m2 epirubicin and above. However, the proportion of responders did not increase with increasing dose, and the 75 mg/m2 docetaxel/90 mg/m2 epirubicin combination has been selected for further phase II study.
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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.