Subject(s)
Adenocarcinoma/drug therapy , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Cicatrix , Erythema/chemically induced , Lung Neoplasms/drug therapy , Neoplasms, Second Primary/drug therapy , Aged , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/adverse effects , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma/surgery , Cisplatin/administration & dosage , Cisplatin/adverse effects , Humans , Male , Paclitaxel/administration & dosage , Paclitaxel/adverse effects , Thyroid Neoplasms/surgery , Thyroidectomy/adverse effectsABSTRACT
BACKGROUND: Recent studies have shown a good activity/tolerability for weekly paclitaxel and 5-fluorouracil in protracted continuous infusion (p.c.i.) in metastatic breast cancer patients pretreated with anthracyclines. MATERIALS AND METHODS: To define the MTD of weekly paclitaxel (days 1-8-15-22, every 4 weeks with a starting dose of 75 mg/m2 and subsequent dose escalation: 90 mg/m2 and 105 mg/m2) in combination with a fixed dose of 5-fluorouracil in p.c.i. (250 mg/m2/day for 3 weeks + 1 week of rest). RESULTS: Eleven patients were enrolled; on Step III two patients experienced DLT (1 G 3 mucositis and 1 febrile neutropenia). G 3-4 toxicities were: G 3 mucositis (2 out of 11), G 3-4 neutropenia (1 out of 11). CONCLUSION: The recommended schedule for phase II studies is: paclitaxel 90 mg/m2/w + 5-fluorouracil 250 mg/m2 in p.c.i. for 21 days. This is the first phase I trial with the combination of weekly paclitaxel and 5-fluorouracil p.c.i. in advanced breast cancer patients.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/drug therapy , Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/pathology , Dose-Response Relationship, Drug , Drug Administration Schedule , Female , Fluorouracil/administration & dosage , Fluorouracil/adverse effects , Humans , Middle Aged , Neoplasm Metastasis , Paclitaxel/administration & dosage , Paclitaxel/adverse effectsABSTRACT
A 46-year-old woman had an episode of atrial fibrillation during infusion of docetaxel as adjuvant chemotherapy for an infiltrating ductal carcinoma of the breast. All cardiological tests performed before treatment were normal and there was no evidence of thyroid dysfunction nor any objective or anamnestic data indicating acute or chronic cardiovascular disease. None of the drugs administered has ever shown any proarrhythmic activity. In controlled clinical trials docetaxel was found to have a very low cardiotoxicity.
