Aa. Ezzat et al., High complete pathological response in locally advanced breast cancer using paclitaxel and cisplatin, BREAST CANC, 62(3), 2000, pp. 237-244
Background. In an earlier study, we have demonstrated a high response rate
in metastatic breast cancer using paclitaxel (P) and cisplatin (C). A phase
II study using the same regimen (PC) has been conducted in locally advance
d breast cancer (LABC).
Methods. A total of 72 consecutive patients with non-inflammatory LABC (T2
greater than or equal to 4 cm, T3 or T4, N0-N2, M0). Patients were schedule
d to receive 3-4 cycles of the neoadjuvant PC (paclitaxel 135 mg/m(2) and c
isplatin 75 mg/m(2) on day 1) every 21 days. Patients were then subjected t
o surgery and subsequently received 6 cycles of FAC (5-fluorouracil 500 mg/
m(2), doxorubicin 50 mg/m(2), and cyclophosphamide 500 mg/m(2)) or 4 cycles
of AC (doxorubicin 60 mg/m(2), and cyclophosphamide 600 mg/m(2)). Patients
then received radiation therapy, and those with hormone receptor positive
tumors were given adjuvant tamoxifen intended for 5 years.
Results. The median age was 39 years (range, 24-78). Clinically, 7%, 58%, a
nd 35% of patients had T2 greater than or equal to 4 cm, T3, and T4, respec
tively. Disease stage at diagnosis was IIB (33%), IIIA (27%), and IIIB (40%
). Complete and partial clinical response to PC was demonstrated in 13 (18%
), and 52 (72%) patients, respectively. Of those patients with evaluable pa
thologic response (68 patients), complete pathologic response (pCR) was ach
ieved in 15 (22%) patients. At a median follow-up of 22 (+/- 3.5) months, 5
8 (81%) were alive with no recurrence, nine (12%) were alive with evidence
of disease, and five (7%) were dead. None of the patients achieving pCR has
developed any relapse. The median overall survival has not been reached fo
r all 72 patients with a projected 3-year survival (+/- SE) of 90% (+/- 4%)
. The median progression-free survival (PFS) was 42.1 (+/- 4.8) months with
a projected PFS of 74% +/- 7% at 3-years (for 68 patients).
Conclusions. PC regimen in LABC produced a high pCR. The contribution of th
e other added modalities to survival could not be assessed.