Authors: HansJoachim Lück Andreas Du Bois Sibylle Loibl Iris Schrader Jens Huober Volker Heilmann Matthias Beckmann Ann Stähler Christian Jackisch Michael Hubalek Barbara Richter Elmar Stickeler Holger Eidtmann Christoph Thomssen Michael Untch Kerstin Wollschläger Tibor Schuster Gunter von Minckwitz
Publish Date: 2013/06/15
Volume: 139, Issue: 3, Pages: 779-787
Abstract
Capecitabine/taxane combinations are highly active in metastatic breast cancer MBC We conducted a randomized phase III noninferiority trial comparing capecitabine plus paclitaxel XP with epirubicin plus paclitaxel EP as firstline therapy for MBC regarding progressionfree survival PFS as primary efficacy endpoint Females who had received no prior chemotherapy for MBC were randomized to six 3weekly cycles of XP capecitabine 1000 mg/m2 bid days 1–14 paclitaxel 175 mg/m2 3h infusion day 1 or EP epirubicin 60 mg/m2 1h infusion day 1 paclitaxel as above Secondary endpoints included response rate overall survival tolerability and quality of life QoL Each arm included 170 patients most of whom received all six cycles as planned The difference in means of logarithmic PFS times −0205 did not meet the predefined level for noninferiority −0186 However PFS was similar in the two arms HR XP vs EP 1012 95 CI 0785–1304 median 104 months XP vs 92 months EP Overall survival was also similar HR 1027 95 CI 0740–1424 median 220 vs 261 months and response rate was 47 versus 42 Both regimens were tolerable there were more grade 3/4 diarrhea and grade 3 hand–foot syndromes with XP and more grade 3/4 hematologic toxicities with EP There were no major differences in QoL Although noninferiority of XP to EP was formally not proven firstline XP was active and feasible XP is a valid firstline alternative to anthracycline/taxane regimens especially in patients previously treated with adjuvant anthracyclinesThe authors would like to acknowledge the work of our advisory board consisting of the following persons Prof Dr G Emons Prof Dr F Jänicke Prof Dr M Kaufmann Prof Dr H Kühnle Prof Dr HG Meerpohl advisory board and AGO principal investigators Dr B Brückner Dr H Eidtmann Prof Dr V Möbus Prof Dr W Schröder Prof Dr C Thomssen Prof Dr M Untch Dr T Volm This study is sponsored by the Arbeitsgemeinschaft Gynäkologische Onkologie AGO metastatic breast cancer study group Financial support is provided by F HoffmannLa Roche and BristolMyers Squibb
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