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494
High Complete Pathologic Response Rate of
Locally Advanced Breast Cancers (LABC) to Neoadjuvant (NEO)
Docetaxel and Cisplatin Chemotherapy. Judith Hurley, P
Doliny, C Gomez, L Raez, J Boggs, S Franco, Y Lee, Univ of Miami,
Miami, FL.
This was a phase II trial where 25 patients (pts) with LABC were
treated with 4 cycles of primary chemotherapy with docetaxel and
cisplatin (DC), both at 70 mg/m2 IV given every 21 days,
followed by surgery and standard adjuvant chemotherapy Eligible
patients had T3–4,N0–2, M0 biopsy-proven breast cancers. There were
14 pre-menopausal and 11post menopausal pts, with median age of 49
years (range 32 – 63). The median largest tumor dimension was 9 cm
(range 5 –25 cm): 14 (56%) pts had T3 tumors,7(28%)were inoperable
T4 lesions, and 4 (16%) were inflammatory breast cancers. Seventeen
pts had palpable axillary lymph nodes of varying sizes (range 1 –4
cm), five of them with N2 disease: All but one patient had clinical
response to Neo chemotherapy: 13 (52%) complete clinical response,
11 (44%) partial response, for a response rate (CR+PR) of 96%. Five
pts (20%) achieved pathologic complete responses (pCR), defined as
no evidence of invasive carcinoma in the breast and axilla. The
median residual tumor size on histologic examination was <1 cm
(range 0 – 8) with five cases of only microscopic residual tumor.
The median number of positive nodes was 1.5 (range 0 – 42). Estrogen
receptor (ER) status was available in 22 pts,16 (72%) were ER+ and 6
(28%) were ER-. Her2/neu status was available for 24 pts, 8 (35%)
were Her2+ and 16 (65%) were Her2-. Only 1 out of 8 Her2+ pts
achieved pCR (12.5%); whereas 4 out of 16 Her2- pts achieved pCR
(25%). All pts were able to receive all 4 Neo chemotherapy courses,
there was no delay in treatment due to toxicity. Granulocyte-colony
stimulating factor was administered for 5 days following each Neo
chemotherapy. Alopecia was universal, and the most common toxicity
was grade I/II anemia which affected 60% of pts. Complete pathologic
response to Neo chemotherapy is probably the best surrogate marker
for improved disease-free survival in LABC. Our study showed DC is
very active regimen in the treatment of breast cancer, 96% clinical
response and 20% pCR rate is one of the highest reported in the
primary chemotherapy literature. More studies are warranted to
confirm the effectiveness of this regimen as well as to elucidate
further the role of cisplatin as first line therapy of LABC, since
the combination produced higher response rate than that reported
with docetaxel alone or in combination with doxorubicin.
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