Paclitaxel May Improve Inflammatory Breast Cancer Outcomes and Help Patients Resistant to Induction FAC

HOUSTON--Adding paclitaxel (Taxol) to adjuvant therapy may improve survival in inflammatory breast cancer, Massimo Cristofanilli, MD, of M.D. Anderson Cancer Center, reported at the ASCO meeting.

The study also showed that when patients who were unresponsive to induction with FAC [fluorouracil/doxorubicin (Adriamycin)/cyclophosphamide] were crossed over to induction paclitaxel, "62.5% had a significant tumor regression, and their tumors became surgically resectable," Dr. Cristofanilli said.

Multimodality treatment with induction and adjuvant chemotherapy plus radiation has improved 10-year survival in inflammatory breast cancer to about 30%.

In 1994, researchers at M.D. Anderson started a protocol to evaluate the value of adding paclitaxel to a standard regimen for inflammatory breast cancer. Patients treated in 1994 and 1995 received the paclitaxel-containing regimen. Dr. Cristofanilli reported data comparing the results in these 43 patients with historical data on 178 patients treated on previous protocols from 1973 to 1993.

All patients underwent diagnostic core biopsy before starting treatment. Mammographic and ultrasonographic studies were done at baseline and then after every 2 to 4 courses to evaluate response.

Patients were treated with four cycles of FAC; then total mastectomy; then sequential adjuvant chemotherapy with four cycles of FAC and four cycles of paclitaxel; then radiotherapy.

Patients who had less than a partial response to FAC induction therapy were switched to preoperative paclitaxel, then given four more cycles of paclitaxel after total mastectomy.

Response Rates

From 1994 to 1997, 43 patients were included in this research protocol. Median age was 48 years (range, 33 to 78). Forty-one patients were evaluable for response to induction chemotherapy (two were enrolled after primary surgery), with a median follow-up of 20 months (range, 6 to 50 months).

The overall response rate was 76%, with 3 complete responses (7%) and 28 partial responses (68%). Sixteen patients (39%) were crossed over to induction paclitaxel, and 10 of these (62.5%) became resectable.

At a median follow-up of 20 months, 12 patients had recurrence (28%), and 7 had died of inflammatory breast cancer (16%). "The estimated disease-free survival (DFS) rates at 2 and 3 years were 61% and 51%, respectively. Estimated overall survival (OS) at 2 and 3 years was 78%," he said.

In comparison with the 178 patients treated in the previous four protocols, a trend toward improvement in estimated DFS and OS was observed, he said (see Table), although these differences were not statistically significant.