Paclitaxel administration on days 1 and 8 every 21 days in anthracycline-pretreated metastatic breast cancer patients. A multicenter phase II trial

• Published in: Cancer chemotherapy and pharmacology Vol. 47; no. 5; pp. 391 - 396
• Main Authors: DONADIO, M, MANZIN, E, MORO, G, BERTETTO, O, BUMMA, C, DOGLIOTTI, L, BERRUTI, A, BOTTINI, A, GORZEGNO, G, DANESE, S, DEFABIANI, E, SAROBBA, M. G, LORUSSO, V, CASTIGLIONE, F
• Format: Journal Article
• Language: English
• Published: Berlin Springer 01-05-2001
• Subjects: Adult; Aged; Antibiotics, Antineoplastic - therapeutic use; Antineoplastic agents; Antineoplastic Agents, Phytogenic - administration & dosage; Biological and medical sciences; Breast Neoplasms - drug therapy; Breast Neoplasms - mortality; Breast Neoplasms - pathology; Chemotherapy; Drug Administration Schedule; Drug Resistance, Neoplasm; Female; Humans; Italy; Medical sciences; Middle Aged; Neoplasm Metastasis; Paclitaxel - administration & dosage; Pharmacology. Drug treatments; Survival Rate; Italy; Antineoplastic agent; Human; Intravenous administration; Toxicity; Treatment efficiency; Multicenter study; Administration schedule; Malignant tumor; Mammary gland diseases; Chemotherapy; Treatment; Taxane derivatives; Phase II trial; Paclitaxel; Remission; Advanced stage; Anthracyclins; Metastatic; Mammary gland; Pretreatment
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s002800000247

Paclitaxel is now included in second- and even first-line regimens in advanced breast cancer. The optimal dose and schedule of this drug, however, still remain a matter of investigation. A group of 57 consecutive patients with advanced breast cancer previously treated with anthracycline-containing regimens were submitted to treatment with single-agent paclitaxel administered at 130 mg/m2 on days 1 and 8 every 21 days. Of the 57 patients, 56 were fully evaluable, and of these 25 had an absolute anthracycline resistance, 14 a relative resistance and 17 were potentially sensitive. The median age of the patients was 57 years (range 33-71 years), their median performance status was 1 (0-3), and 27 (47%) had liver involvement, 17 (30%) lung involvement, 30 (53%) bone involvement and 15 (26%) skin/lymph node involvement. Toxicity was recorded in 295 cycles. This scheme was well tolerated, the dose-limiting toxicities being hematological and neurological. Grade 3/4 leukopenia was observed in 20% of patients at nadir, while grade 3 leukopenia was observed in 3% of patients at recycle. Only one patient experienced febrile neutropenia. Grade 2/3 neurotoxicity was observed in 26% of patients, leading to drug withdrawal in three. The treatment was given on an outpatient basis in all patients and the median relative dose intensity of 86.6 mg/m2 per week was 100% of the planned dose (range 75-100%). Three patients (5%) attained a complete clinical response and 12 (21%) a partial response for an overall response rate of 26% (95% confidence interval 18-38%), while 30 (53%) attained disease stabilization and 11 progressed (19%). Time to progression in responding patients was 10.3 months, and the median overall survival of the entire population was 15.4 months. To conclude, paclitaxel administration on days 1 and 8 every 21 days was active and manageable in advanced breast cancer patients previously treated with anthracyclines. The response obtained was durable.