Three new active cisplatin-containing combinations in the neoadjuvant treatment of locally advanced and locally recurrent breast carcinoma: a randomized phase II trial
G. Cocconi et al., Three new active cisplatin-containing combinations in the neoadjuvant treatment of locally advanced and locally recurrent breast carcinoma: a randomized phase II trial, BREAST CANC, 56(2), 1999, pp. 125-132
We designed three new four-drug cisplatin-containing combinations and evalu
ated their activity in a randomized phase II study including patients with
locally advanced (stage III) and locally recurrent breast carcinoma.
All combinations included methotrexate (M) on day 1 and cisplatin (P) on da
y 2 (MVAC-like combinations) and differed from one another by the addition
of Epirubicin (Epi), Vincristine (V), Etoposide (E), Mitomycin (Mi). Based
on the administered agents, they were named MPEMi, MPEpiE, MPEpiV. The comb
inations were randomly assigned to 101 patients, 57 with locally advanced a
nd 44 with locally recurrent breast carcinoma. Response was evaluated after
4 cycles.
The complete response (CR) rates were 7 and 43 and the CR plus partial resp
onse (PR) rates were 84 and 89 in locally advanced and in locally recurrent
disease, respectively. In locally advanced disease, a pathologic CR (pCR)
was assessed in seven of 57 patients (12). There were no significant differ
ences among the three combinations. The toxicities were at times severe, bu
t generally tolerable, as demonstrated by the high cumulative doses of the
drugs received by the patients.
In conclusion, these three innovative chemotherapy regimens induced high CR
plus PR rates in the neoadjuvant treatment of stage III and of locally rec
urrent breast carcinoma, and a high rate of pCR in stage III disease. These
regimens warrant testing in phase III trials.