Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer.

PURPOSE: This phase III study compared docetaxel and doxorubicin in patients with metastatic breast cancer who had received previous alkylating agent-containing chemotherapy. PATIENTS AND METHODS: Patients were randomized to receive an intravenous infusion of docetaxel 100 mg/m(2) or doxorubicin 75 mg/m(2) every 3 weeks for a maximum of seven treatment cycles. RESULTS: A total of 326 patients were randomized, 165 to receive doxorubicin and 161 to receive docetaxel. Overall, docetaxel produced a significantly higher rate of objective response than did doxorubicin (47.8% v 33.3%; P =.008). Docetaxel was also significantly more active than doxorubicin in patients with negative prognostic factors, such as visceral metastases (objective response, 46% v 29%) and resistance to prior chemotherapy (47% v 25%). Median time to progression was longer in the docetaxel group (26 weeks v 21 weeks; difference not significant). Median overall survival was similar in the two groups (docetaxel, 15 months; doxorubicin, 14 months). There was one death due to infection in each group, and an additional four deaths due to cardiotoxicity in the doxorubicin group. Although neutropenia was similar in both groups, febrile neutropenia and severe infection occurred more frequently in the doxorubicin group. For severe nonhematologic toxicity, the incidences of cardiac toxicity, nausea, vomiting, and stomatitis were higher among patients receiving doxorubicin, whereas diarrhea, neuropathy, fluid retention, and skin and nail changes were higher among patients receiving docetaxel. CONCLUSION: The observed differences in activity and toxicity profiles provide a basis for therapy choice and confirms the rationale for combination studies in early breast cancer.

Weekly high-dose infusion of 5-fluorouracil in advanced colorectal cancer.

18 patients with advanced colorectal cancer entered a phase I-II study of high-dose 48 h continuous infusion 5-fluorouracil (5-FU) for 6 weeks. 7 patients were included at the first dose level (3 g/m2) and only 1 had serious toxicity (grade 3 diarrhoea and mucositis). 7 patients were included at the second dose level (3.5 g/m2). 6 had a good tolerance to treatment, while the remaining patient had grade 4 leukopenia. 4 patients received 4 g/m2: 3 had severe toxicity (grade 4 diarrhoea, myelosuppression, mucositis, central nervous system), such that the entry of new patients was stopped. Anti-tumour activity was seen in 33% (95% confidence interval 13-59%) of the overall population. Only patients who had not had previous chemotherapy responded to treatment (response rate in this subgroup [43%, 18-71%]). The optimal dose of 5-FU was 3.5 g/m2 weekly for six cycles.

Initialization of adjuvant hormonal treatment for breast cancer.

The introduction of aromatase inhibitors (AI) has resulted in practice change approaches in the treatment of early breast cancer. In this paper, we analyze the most relevant studies including the ATAC, BIG 1-98, TEAM, MA-17, NSABP B-33, and ABSCG-6 studies. Postmenopausal patients with hormone receptor-positive early breast cancer should be treated with AI for 5 years. For patients who have been initiated with tamoxifen (TAM), switching to an AI to complete 5 years of treatment is also recommended. The results of the extended adjuvant therapy studies recommend the use of an AI (anastrozole, letrozole, or exemestane) after the completion of standard TAM treatment. With regards to premenopausal women, TAM is the recommended adjuvant hormonal treatment for pre- and perimenopausal women. There is no indication for the use of AI in these subgroups of patients. Finally, determination of CYP 2D6 polymorphisms could be considered when choosing the best adjuvant hormonal treatment option.

Mediastinal schwannoma mimicking lymph node metastasis from locally advanced breast cancer in a 18F-FDG PET/CT study / Schwannoma mediastínico imitando metástasis linfática de cáncer de mama localmente avanzado en un estudio PET/TC con 18F-FDG

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A phase II trial of weekly high dose continuous infusion 5-fluorouracil plus oral leucovorin in patients with advanced colorectal cancer. The Spanish Cooperative Group for Gastrointestinal Tumor Therapy (TTD).

BACKGROUND: In a previous Phase II trial, the authors showed that a weekly continuous infusion of 5-fluorouracil (5-FU) at a dose of 3.5 g/m2 for 48 hours is an active treatment for advanced colorectal cancer. The overall response rate was 38.5%, and the median survival was 12 months. These data were comparable to those achieved by biochemical modulation of 5-FU with leucovorin. To study the modulation of this weekly, high dose, continuous infusion 5-FU with oral leucovorin, a new Phase II trial was planned. METHODS: From December 1991 to July 1992, 43 previously untreated patients with measurable advanced colorectal cancer were included in a multicenter study. They received on an outpatient basis 5-FU at a weekly dose of 3 g/m2 by continuous infusion for 48 hours until progression or toxicity. Oral leucovorin (60 mg every 6 hours) also was given during the infusion of 5-FU. RESULTS: Patients received a median dose intensity of 5-FU of 2.2 g/m2/week (range, 0.76-3 g/m2/week). One complete response and 11 partial responses were observed. The overall response rate was 29% (95% confidence interval [CI], 16-45%). Median time to progression was 7 months, and the median survival was 15 months. World Health Organization Grades 3 and 4 diarrhea were observed in 19 (45%) and 6 (14%) patients, respectively. Grade 3 mucositis also was observed in 10 (24%) patients, and Grade 4 mucositis was observed in 1. Grade 3 nausea and vomiting were reported in seven (17%) patients. Grade 3 hand-foot syndrome was detected in only two (2.5%) patients. No leukopenia or thrombocytopenia was observed. CONCLUSIONS: Oral leucovorin modulation of a weekly 48-hour infusion of 5-FU at a dose of 3 g/m2 of leucovorin is a toxic regimen, always requiring dose reduction, with diarrhea and mucositis as the main limiting toxicities. Its antitumor activity does not seem superior to that observed with a weekly 48-hour infusion of 5-FU alone at a dose of 3.5 g/m2.