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.
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.