Randomized study testing as adjuvant chemotherapy the same primary (neoadjuvant) epirubicin/vinorelbine (EN) regimen versus docetaxel (TXT) in inflammatory breast cancer (IBC)

Abstract

590 Background: The multimodal approach of IBC resulted in improved survival but the IBC still remains the most aggressive form of breast cancer. The endpoints of the study were to a) evaluate the efficacy and safety of primary chemotherapy (EN), b) evaluate a better chemotherapy sequence (primary and adjuvant), and c) analyze the predictive value and changes of some biomarkers (ER, PR, Ki67 and HER2 status) in IBC. Methods: From 4/2002 to 10/2007, 56 patients with IBC entered the study. The molecular markers were obtained from tumor specimens before chemotherapy by biopsy and surgery after. After diagnosis the pts were randomized to the following sequence: EN (E 120 mg/m2 d 1 plus N 25 mg/m2 d 1 & 8) x 4 cycles -> surgery or radiotherapy -> adjuvant TXT (100 mg/m2) x 4 cycles (Group A) or EN x 4 cycles (Group B), all regimens q 3 wks. After adjuvant therapy all pts received RT and endocrine therapy in ER/PgR+ tumors. From 6/2006 the pts with HER2+ status also received trastuzumab adjuvant x 1 yr. The characteristics of the evaluable pts (28 group A and 26 group B) were well balanced between the groups (A/B): median age (53/53.5 yrs), premenopausal (12/10 pts), ER- (15/15 pts), PgR- (15/17), and HER2+ (20/21). Results: Also the overall clinical objective responses to induction chemotherapy were well balanced between group A vs. B: 89% vs. 85%. One patient in group A and 3 pts in group B underwent local-regional radiotherapy instead of surgery. The pathologic objective responses between group A vs. B were: cCR (7 vs. 11%) and cPR (82 vs. 73%). At median 36 months of follow-up, we observed 10 vs. 16 relapses and 3 vs. 9 deaths. Both sequential chemotherapies were manageable, feasible and well tolerated. One patient showed an anaphylactic reaction to TXT after the first cycle. Better results in group A with 5yrs DFS odds ratio rates 0.50 (95%CI 1.1–0.3, p 0.8), and OS odds ratio 0.30 (95% CI 1.0–01, p.06). Conclusions: The data suggest that the sequential use of two non- cross resistance chemotherapy schedules is well tolerated, active and feasible. This monocentric study demonstrates for the first time an improvement of the principal survival endpoints by means of an adjuvant regimen different from the primary one. No significant financial relationships to disclose.