Design and development of new combinations of the CMF agents with taxanes (paclitaxel or docetaxel) in advanced breast cancer: a feasibility study
Cocconi, G.; Salvagni, S.; Passalacqua, R.; Ferrozzi, F.; Camisa, R.
Tumori 90(3): 280-284
2004
ISSN/ISBN: 0300-8916 PMID: 15315305 Document Number: 581425
Aims and background: We previously designed and tested combinations made up of the CMF agents, two at a time by rotation, and of doxorubicin or epirubicin. The present study was aimed to similarly test new combinations made up of the CMF agents, two at a time by rotation, and paclitaxel or docetaxel. Methods: The doses of each taxane were escalated with the objective of reaching at least a single dose level of go mg/m2 of paclitaxel and 45 mg/m2 of docetaxel on days 1 and 8 of each four-week cycle. Thirty-two patients with advanced breast carcinoma were randomized to receive increasing doses of paclitaxel (45, 65, 80, 90 and loo mg/m2) or docetaxel (30, 35, 40, 45 and 50 mg/m2) together with the CMF agents at the same dose as that used in the conventional regimen. Each dose level was administered to a triplet of patients. No direct comparison of the two taxanes was made. Results: The fourth dose level was reached for paclitaxel and docetaxel. The most important toxicities were grade 4 neutropenia and grade 1-2 nausea/vomiting and stomatitis. The objective response rate, assessed only after the third cycle at any dose level, was 31% (95% CI, 15-47%). Conclusions: The combinations of the CMF agents (two at a time in rotation) with paclitaxel (go mg/m2) or docetaxel (45 mg/m2) on days 1 and 8 of each four-week cycle are feasible and lead to definite signs of therapeutic activity, and the side effects are generally mild. Further studies are therefore warranted.