Phase II of doxorubicin/taxol in metastatic breast cancer. Argentine Multicenter Taxol Group

• Published in: Breast cancer research and treatment Vol. 55; no. 1; p. 91
• Main Authors: Pazos, C, Mickiewicz, E, Di Notto, M R, Cóppola, F, Ventriglia, M, Jovtis, S, Balbiani, L, Lewi, D, Róndinón, M, Témperley, G, Trigo, M, Bertoncín, A M, Pascual, M, Uranga, G, Cazap, E, Breier, S, Grasso, S, Estévez, R, Triguboff, E, Alvarez, A, Suárez, A
• Format: Journal Article
• Language: English
• Published: Netherlands 01-05-1999
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Argentina; Breast Neoplasms - drug therapy; Breast Neoplasms - mortality; Breast Neoplasms - pathology; Dose-Response Relationship, Drug; Doxorubicin - administration & dosage; Doxorubicin - adverse effects; Drug Administration Schedule; Female; Humans; Middle Aged; Neoplasm Metastasis; Neutropenia - chemically induced; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Stroke Volume - drug effects; Survival Analysis; Treatment Outcome; Argentina
• ISSN: 0167-6806

To assess the response rate, survival, and toxicity of Taxol (paclitaxel) as 1-h infusion plus doxorubicin as first-line treatment for patients with metastatic breast cancer (MBC).
Seventy-six patients with untreated MBC were recruited. All of them had measurable disease and were evaluable for toxicity. Fifty-five percent of the patients had visceral involvement. The dose of doxorubicin was fixed at 50 mg/m2 as a short intravenous infusion, followed by 200 mg/m2 of Taxol as a 1-h intravenous infusion. Doxorubicin was administered during the first seven cycles, continuing with Taxol only up to a maximum of ten cycles.
Neutropenia was the most important toxicity: 30% grade 3 and 18% grade 4. Only 2 patients showed a decrease in the left ventricular ejection fraction (LVEF) which caused discontinuing the treatment. No clinical congestive heart failure (CHF) was observed. Seventy-four patients were eligible for response evaluation: 10 (14%) achieved complete response (CR) and 46 (62%) achieved partial response (PR). The mean duration of response was 13.47+/-1.35 months (95% confidence interval (CI): 10.82; 16.12) and the mean survival was 21.50+/-1.42 months (95% CI: 18.72; 24.29).
The overall response (OR) rate was 76%. No CHF was assessed and 2 patients stopped treatment due to LVEF decrease. Although doxorubicin 50 mg/m2 followed by Taxol 200 mg/m2 in 1-h intravenous infusion presents a toxicity profile which demands a close follow-up, it represents a convenient outpatient schedule with similar activity rate compared to longer Taxol infusions.