Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 517
© 2008 American Society of Clinical Oncology

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Untch, M. Articles by Von Minckwitz, G. Search for Related Content PubMed Articles by Untch, M. Articles by Von Minckwitz, G.

Abstract

PREPARE trial. A randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel and CMF with a standard dosed epirubicin/cyclophosphamide followed by paclitaxel ± darbepoetin alfa in primary breast cancer: A preplanned interim analysis of efficacy at surgery

Helios Kliniken Berlin Buch, Berlin, Germany; University Hospital Erlangen, Erlangen, Germany; University Hospital München, München, Germany; St. Barbara Klinik, Hamm, Germany; University Hospital Jena, Jena, Germany; Hämato-onkologische Parxis, Wuppertal, Germany; University Hospital Ulm, Ulm, Germany; University Hospital Hannover, Hannover, Greece; German Breast Group, Neu-Isenburg, Germany

517

Background: The PREPARE trial evaluates the effect of preoperative dose-dense and dose-intensified chemotherapy with anthracycline and taxane ± darbepoetin alfa in breast cancer patients. Methods: Patients (pts) with histologically confirmed primary breast cancer received preoperatively either 4 cycles epirubicin 90 mg/m² and cyclophosphamide 600mg/m² q3w followed by 4 cycles paclitaxel 175mg/m² q3w (EC-T; arm A) or dose-dense and -intensified treatment with 3 cycles epirubicin 150mg/m² q2w followed by 3 cycles paclitaxel 225mg/m² q2w with G-CSF support followed by 3 cycles CMF (cyclophosphamide 500mg/m², methotrexate 40mg/m², fluorouracil 600mg/m² day 1, 8 q4w) (ET-CMF; arm B). A second randomization was performed ± darbepoetin alfa every 2 weeks. Primary endpoints: disease-free and overall survival. Secondary endpoints: pathological complete response (pCR), rate of breast conserving surgery (BCS), safety. Results: Between June 2002 and February 2005, 733 pts were randomized (370 pts arm A, 363 arm B; 377 without and 356 with darbepoetin). The median tumor size was 2.8cm, 8% of the pts had T4. The pCR in arm B was significantly higher than in arm A (18% vs 12%; p=0.018). BCS was comparable in the two arms (67% vs. 65%). Darbepoetin did not influence pCR ratePts in arm B had more sensory neuropathy grade 1–4 (83% vs 63%), mucositis grade 2 (28% vs 14%), fever grade1–4 (20% vs 13%) and skin reactions grade1–4 (34% vs. 22%). Hematological toxicity was not different between the arms. Pts in the darbepoetin group maintained a mean Hb level of 13.6g/dl, pts in the control group had a decreased mean Hb level of 12.6g/dl. At a median follow-up of 3.2 years patients in standard arm A had a numerical excess of events compared to intensified arm B (93/370 vs 83/363) and there was a numerical excess of events (97/356 vs.79/377) and deaths (50/356 vs. 32/377) in pts with darbepoetin treatment. Conclusions: The dose dense, dose-intensified chemotherapy ET-CMF is superior in terms of pCR. Darbepoetin adds no benefit to tumor response or progression. Long term results are not available yet.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Amgen, Bristol-Myers Squibb Amgen, Bristol-Myers Squibb Amgen

Abstract presentation from the 2008 ASCO Annual Meeting