ORLANDO—Weekly paclitaxel(Drug information on paclitaxel) (Taxol) given as a neoadjuvant therapy for patients with locally advanced breast cancer resulted in regression of the primary tumor in 60% of patients. Albert S. Braverman, MD, professor of medicine, Downstate Medical Center of the State University of New York, Brooklyn, presented the results at the 38th Annual Meeting of the American Society of Clinical Oncology (abstract 278).
"We’re very impressed by what Taxol could do, because of the completeness of the pathologic responses," Dr. Braver-man said. "On the other hand, we would really like to see a higher response rate than 60%." The investigators compared the results with 194 historical patients with T3/T4 disease treated with Downstate Medical Center’s standard neoad-juvant regimen of cyclophosphamide(Drug information on cyclophosphamide) (Cytoxan)/doxorubicin (Adriamycin)/fluorouracil (CAF). More than half of their stage IV patients had responded to paclitaxel in the past, so the researchers decided to try it as a neoadjuvant therapy for stage III patients.
"This is particularly important because CAF includes Adriamycin, which is contraindicated in older women with cardiac problems," Dr. Braverman said.
Twenty-three stage III patients and five stage IV patients, with T3 or T4 primary tumors, received weekly paclitaxel, 80 to 100 mg/m2. After four courses, investigators evaluated response by physical examination and mammography. Clinical response was similar in the 194 historical CAF patients (63%) and the 28 paclitaxel patients (57%).
"The results have been reasonable but not truly exciting, in that we are not seeing a higher response rate than we do with CAF," Dr. Braverman said. However, the pathologic response at mastectomy or tumorectomy showed complete regression in some patients. "Of the 13 patients who had tumorectomy or mastectomy, seven (54%) had virtually no tumor left," Dr. Braverman said. "These were patients with huge tumors, infiltrating the chest wall or the skin, maybe 10 cm to 12 cm in size."
In comparison, among the 140 historical patients who had surgery after receiving CAF as neo-adjuvant therapy, only 19% (26) had an almost complete pathologic remission (microscopic residual disease). Even with the small number of paclitaxel patients, Dr. Braverman said the difference was significant (P = .008). He noted that Dr. Jeremy Weedon performed the statistical analysis.
Dr. Braverman is considering treating patients with weekly paclitaxel plus doxorubicin(Drug information on doxorubicin). "I think there is little doubt that these two drugs are the most active single agents for the treatment of breast cancer. They have been used in combination with fairly good response rates, but toxicity has been severe," he said. He speculated that if each drug is given weekly at a lower dose, the combination would be more tolerable and more active than paclitaxel or CAF alone.
