Long-term effect in outcomes of intensified primary chemotherapy in poor prognosis LABC T4 patients: Results of a multicenter Italian study

Abstract

10518 Background: Recent data showed that anthracycline-based chemotherapy with increased dose-intensity improves clinical outcomes as compared to conventional regimens in adjuvant setting, particularly in high risk patients with HR negative tumors. Nevertheless dose-intensity in neoadjuvant setting remain controversial. The aim of this study was to evaluate the outcome between two different primary regimens and, furthermore, among soubgroups identified by HR status. Methods: Between 1996 and 2001, 72 consecutive LABC patients, (77% T4abc; 23% T4d; 88% axillary nodes involvement) median age 51 (29–70), ER neg 39%; PgR neg 71%, were treated with PEV regimen (cisplatin 50 mg/m2; epirubicin 100 mg/m2; vinorelbine 25 mg/m2) as primary chemotherapy. The regimen was delivered with different number of cycles and treatment intervals (3 wks × 4 cycles in the first 24 pts as PEV21 × 4; 2 wks × 6 cycles in the subsequent 48 pts as PEV14 × 6); the entire treatment in both groups lasted 12 weeks. All 72 patients received adjuvant CMF, RT and Hormonal treatment when indicated. Results: after a median follow up of 76 months (46–111), higher DFS and OS were observed in the intensified PEV14 × 6 group as compared to the counterpart (69% vs 42% p = 0.02 and 78% vs 58% p = 0.05 respectively). Statistically better DFS and OS were observed in the group ER/ PgR negative which received intensified PEV 14 × 6, whereas no statistically difference was found among ER/ PgR postive patients, regardless of the type of regimen. Conclusions: Our results suggest that primary intensified chemotherapy is associated with a better clinical outcome in poor prognosis LABC T4 patients,and that HR negative tumors benefit greatly from intensified regimen. Further prospective randomized studies are needed to confirm our data. [Table: see text] No significant financial relationships to disclose.