Key result
Sequential doxorubicin, paclitaxel, and gemcitabine reached the maximum tolerated dose at the second level due to dose-limiting hematological toxicity in 3 of 9 patients.
Why the study?
What is the maximum tolerated dose and feasibility of sequential doxorubicin, paclitaxel, and gemcitabine in patients with stage IIIB-IV breast cancer?
What is the maximum tolerated dose and feasibility of sequential doxorubicin, paclitaxel, and gemcitabine in patients with stage IIIB-IV breast cancer?
A sequential regimen of doxorubicin, paclitaxel, and gemcitabine in advanced breast cancer is limited by hematological toxicity, establishing doses for a subsequent Phase II trial.
Defines MTD for sequential doxorubicin-paclitaxel-gemcitabine limited by hematologic toxicity; supports phase II evaluation but should not change practice.
Based on the synergistic interactions of the sequence doxorubicin-paclitaxel-gemcitabine obtained in our preclinical study, a Phase I trial was conducted to evaluate the feasibility of this new sequence in breast cancer. Patients with stage IIIB-IV breast cancer received doxorubicin on day 1, paclitaxel on day 2 and gemcitabine on day 6 and 13 (steps IIa, III and V) in cohorts of 3 patients. From March 1999 to December 2000, 9 patients were treated. The most important toxicity was hematological. The maximum tolerated dose was reached at the second level because dose-limiting toxicity occurred in 3 patients. Non hematological toxicities were alopecia, diarrhea, asthenia, nausea, mucositis, paresthesia and myalgia. A Phase II trial is ongoing to further investigate the activity of this new sequential treatment with doxorubicin (50 mg/m2 day 1), paclitaxel (160 mg/m2 day 2) and gemcitabine (800 mg/m2 day 6) in advanced breast cancer.
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Ibrahim et al. (2003) studied Stage IIIB-IV breast cancer (n=9). Sequential doxorubicin, paclitaxel, and gemcitabine was evaluated on Feasibility and maximum tolerated dose. Sequential doxorubicin, paclitaxel, and gemcitabine reached the maximum tolerated dose at the second level due to dose-limiting hematological toxicity in 3 of 9 patients.
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