SAN ANTONIOPreliminary results from an ongoing clinical
trial suggest that neoadjuvant chemotherapy of breast cancer with
paclitaxel (Taxol) alone produces response rates comparable to those
achieved with the three-drug FAC (fluorouracil, Adriamycin,
Speaking at a satellite symposium held in conjunction with the 21st
Annual San Antonio Breast Cancer Symposium, Aman Buzdar, MD,
expressed optimism for neoadjuvant use of paclitaxel, but he
cautioned that the 23-month follow-up is too brief to draw definitive
conclusions. With longer follow-up, we will know the true value
of paclitaxel in neoadjuvant breast cancer therapy, said Dr.
Buzdar, a breast medical oncologist at M.D. Anderson Cancer Center.
The current trial has its origin in an M.D. Anderson study of 25
patients with metastatic disease treated with paclitaxel. The
treatment led to objective responses in two-thirds of patients,
including complete responses in 12%. Only one patient failed to
achieve at least a minor response, Dr. Buzdar said.
Results of this small-scale evaluation subsequently were confirmed in
a similar study at Memorial Sloan-Kettering Cancer Center. Almost
three-fourths of 26 patients had major responses, including complete
responses in 12%.
174 Patients Randomized
On the basis of these encouraging results, we decided to put
paclitaxel to the test in a neoadjuvant fashion to see what the
effect would be on cytoreduction and antitumor activity, Dr.
Between 1994 and the middle of 1998, investigators randomized 174
patients to paclitaxel monotherapy or to neoadjuvant treatment with
Paclitaxel was administered at a dose of 250 mg/m²the same
dose used to treat metastatic breast cancer. Treatment was repeated
every 3 weeks for four cycles, followed by surgery, an additional
four cycles of FAC, and radiation therapy. Patients older than 50
years also will receive tamoxifen (Nolvadex) for 5 years.
Patients in the two treatment groups had identical 79.3% overall
response rates. Paclitaxel led to complete re-sponses in 26.4% of
patients vs 24.1% with FAC. FAC resulted in more patients with no
evidence of residual disease (17.2% vs 5.7%), whereas more
pacli-taxel-treated patients had DCIS only (8% vs 4.6%) or minimal
residual disease (26.4% vs 11.5%) after neoadjuvant therapy. Dr.
Buzdar also noted that paclitaxel treatment was associated with a
higher rate of breast-conserving surgery, 46% vs 37% for patients
At a median follow-up of 23 months, patients in the paclitaxel cohort
had superior disease-free survival rates at 1 year (100% vs 94%) and
2 years (94% vs 89%). Dr. Buzdar emphasized that longer follow-up is
needed to provide a true indication of the impact of the two
neoadjuvant regimens on survival.