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SHR Neuro Cancer Cardio Lipid Metab Microb

Schmid, P; Schippinger, W; Nitsch, T; Huebner, G; Heilmann, V; Schultze, W; Hausmaninger, H; Wischnewsky, M; Possinger, K.
Up-front tandem high-dose chemotherapy compared with standard chemotherapy with doxorubicin and paclitaxel in metastatic breast cancer: results of a randomized trial.
J Clin Oncol. 2005; 23(3):432-440 Doi: 10.1200/JCO.2005.06.072 [OPEN ACCESS]
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Co-authors Med Uni Graz: Schippinger Walter
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Abstract:: PURPOSE: The role of high-dose chemotherapy (HDCT) in metastatic breast cancer remains controversial. Trials with late intensification HDCT have failed to show an advantage in overall survival. This study was initiated to compare up-front tandem HDCT and standard combination therapy in patients with metastatic breast cancer. PATIENTS AND METHODS: Patients without prior chemotherapy for metastatic disease were randomly assigned to standard combination therapy with doxorubicin and paclitaxel (AT) or double HDCT with cyclophosphamide, mitoxantrone, and etoposide followed by peripheral-blood stem-cell transplantation. HDCT was repeated after 6 weeks. Patients were stratified by menopausal and hormone-receptor status. The primary objective was to compare complete response (CR) rates. RESULTS: A total of 93 patients were enrolled onto the trial. Intent-to-treat CR rates for patients randomized to HDCT and AT were 12.5% and 11.1%, respectively (P = .84). Objective response rates were 66.7% for patients in the high-dose group and 64.4% for patients in the AT arm (P = .82). In an intent-to-treat analysis, there were no significant differences between the two treatments in median time to progression (HDCT, 11.1 months; AT, 10.6 months; P = .67), duration of response (HDCT, 13.9 months; AT, 14.3 months; P = .98), and overall survival (HDCT, 26.9 months; AT, 23.4 months; P = .60). HDCT was associated with significantly more myelosuppression, infection, diarrhea, stomatitis, and nausea and vomiting, whereas patients treated with AT developed more neurotoxicity. CONCLUSION: This trial failed to show a benefit for up-front tandem HDCT compared with standard combination therapy. HDCT was associated with more acute adverse effects.
Find related publications in this database (using NLM MeSH Indexing): Adult -; Antineoplastic Combined Chemotherapy Protocols - administration and dosage; Breast Neoplasms - drug therapy; Cyclophosphamide - administration and dosage; Disease Progression - administration and dosage; Dose-Response Relationship, Drug - administration and dosage; Doxorubicin - administration and dosage; Etoposide - administration and dosage; Female - administration and dosage; Humans - administration and dosage; Infusions, Intravenous - administration and dosage; Middle Aged - administration and dosage; Mitoxantrone - administration and dosage; Paclitaxel - administration and dosage; Peripheral Blood Stem Cell Transplantation - administration and dosage; Quality of Life - administration and dosage; Survival Analysis - administration and dosage; Treatment Outcome - administration and dosage