0012, a randomized phase III comparison of standard doxorubicin (A) and
cyclophosphamide (C) followed by weekly paclitaxel (T) versus weekly
doxorubicin and daily oral cyclophosphamide plus G-CSF (G) followed by
weekly paclitaxel as neoadjuvant therapy for inflammatory and locally
advanced breast cancer
2006 ASCO Annual Meeting Abstract No: LBA537
Citation: Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: LBA537
G. K. Ellis, S. J. Green, C. A. Russell, M. E. Royce, E. A. Perez, R. B. Livingston
Between 10-1-02 and 12-01-05, SWOG 0012 accrued patients to a two-arm
randomized trial, with formal participation from NCCTG and CTSU
participation by other cooperative groups. Arm 1 gave A at 60 mg/m2 and
C at 600 mg/m2 q 3 wk IV for 5 cycles, arm 2 A at 24 mg/m2/wk X 15 IV
and C at 60 mg/m2/day PO for 15 wk with G at 5 mcg/kg/day X 6/7 weekly.
Both groups then received T at 80 mg/m2/wk X 12, and proceeded to
surgery with pCR by NSABP criteria at the primary site as the endpoint.
total of 372 were randomized, and we report here on 265 patients (pts)
evaluable for outcome, including those who did not proceed to surgery.
In arm 1, pCR was seen in 17% vs 27% in arm 2 (p=.06); when adjusted
for hormone receptor status (ER-PR- in 49% on arm 1, 41% on arm 2) and
disease type (locally advanced vs inflammatory), the odds ratio in
favor of arm 2 is 1.98 (95% CI 1.05-3.74, p=.034). For ER- PR- pts, pCR
rates for Arm 1 vs 2 were 26 vs 43%, while for those with ER or PR+,
pCR rates were 9 vs 14%.
Inflammatory pts showed a striking difference
in pCR rates for arm 1 vs arm 2 (12 vs 33%, p=.033). HER 2 status (+ in
29%) did not predict response or interact with treatment. Grade 3/4
toxicities (arm 1 vs 2, %) were as follows: hand-foot syndrome (0 vs
13), neutropenia (47 vs 16), neutropenic infection (1.8 vs 0.6),
stomatitis (2 vs 11), and nausea/vomiting (11 vs 5).
Toxicity from T
was grade 3 neuropathy in 10%, with grade 3 or 4 neutropenia in 12%.
There were no treatment-related deaths. Continuous or “metronomic”
chemotherapy with AC is superior to standard intermittent AC, and the
pCR rate reported for the continuous arm is the highest reported in a
cooperative group experience for this patient population.