A phase I trial demonstrated that monthly docetaxel (Taxotere) and
weekly gemcitabine (Gemzar) had both acceptable toxicity and
encouraging antineoplastic activity in patients with previously
treated advanced breast cancer. This phase II trial will determine
the efficacy and toxicity of this regimen in advanced breast cancer
patients who have measurable disease refractory to, or relapsed
after, first-line or adjuvant chemotherapy.
Therapy consists of docetaxel 100 mg/m² on day 1, and
gemcitabine 800 mg/m² on days 1, 8, and 15, every 4 weeks. Tumor
assessments are performed after cycles 2 and 4. Thirty-two of the 39
registered patients are evaluable, and 7 are too early. Their median
age is 58 years (range: 3880 years). All have stage IV disease
and a performance status of 0/1. Eleven patients have received prior
irradiation and 29 received anthracycline-based combination chemotherapy.
To date, 151 cycles have been administered to 32 patients. Grade 4
neutropenia has been reported in 44% of cycles with fever in 3% of
cycles. Grade 3 nonhematologic toxicities consisted of the following:
3 patients with dehydration, 2 with transient edema, 1 each with
mucositis and nausea, and 10 with fatigue. Most patients have
required permanent dose reductions of both gemcitabine and docetaxel
due to neutropenia. Thus far, responses have been confirmed in 19
(60%) of the 32 patients. At 22 months, median survival has not yet
CONCLUSION: We await complete results from this ongoing trial.