• George Fountzilas, Urania Dafni, Christos Papadimitriou, Eleni Timotheadou, Helen Gogas, Anastasia G Eleftheraki, Ioannis Xanthakis, Christos Christodoulou, Angelos Koutras, Christos N Papandreou, Pavlos Papakostas, Spyros Miliaras, Christos Markopoulos, Constantine Dimitrakakis, Panagiotis Korantzopoulos, Charisios Karanikiotis, Dimitrios Bafaloukos, Paris Kosmidis, Epaminontas Samantas, Ioannis Varthalitis, Nicholas Pavlidis, Dimitrios Pectasides, and Meletios-Athanassios Dimopoulos.
• Department of Medical Oncology, "Papageorgiou" Hospital, Aristotle University of Thessaloniki School of Medicine, Thessaloniki Ring Road, 564 03 Thessaloniki, Macedonia, Greece. fountzil@auth.gr.
• Bmc Cancer. 2014 Jul 15; 14: 515.

BackgroundDose-dense sequential chemotherapy including anthracyclines and taxanes has been established in the adjuvant setting of high-risk operable breast cancer. However, the preferable taxane and optimal schedule of administration in a dose-dense regimen have not been defined yet.MethodsFrom July 2005 to November 2008, 1001 patients (990 eligible) were randomized to receive, every 2 weeks, 3 cycles of epirubicin 110 mg/m2 followed by 3 cycles of paclitaxel 200 mg/m2 followed by 3 cycles of intensified CMF (Arm A; 333 patients), or 3 cycles of epirubicin followed by 3 cycles of CMF, as in Arm A, followed 3 weeks later by 9 weekly cycles of docetaxel 35 mg/m2 (Arm B; 331), or 9 weekly cycles of paclitaxel 80 mg/m2 (Arm C; 326). Trastuzumab was administered for one year to HER2-positive patients post-radiation.ResultsAt a median follow-up of 60.5 months, the 3-year disease-free survival (DFS) rate was 86%, 90% and 88%, for Arms A, B and C, respectively, while the 3-year overall survival (OS) rate was 96% in all arms. No differences were found in DFS or OS between the combined B and C Arms versus Arm A (DFS: HR = 0.81, 95% CI: 0.59-1.11, P = 0.20; OS: HR = 0.84, 95% CI: 0.55-1.30, P = 0.43). Among the 255 patients who received trastuzumab, 189 patients (74%) completed 1 year of treatment uneventfully. In all arms, the most frequently reported severe adverse events were neutropenia (30% vs. 27% vs. 26%) and leucopenia (12% vs. 13% vs. 12%), while febrile neutropenia occurred in fifty-one patients (6% vs. 4% vs. 5%). Patients in Arm A experienced more often severe pain (P = 0.002), neurological complications (P = 0.004) and allergic reactions (P = 0.004), while patients in Arm B suffered more often from severe skin reactions (P = 0.020).ConclusionsNo significant differences in survival between the regimens were found in the present phase III trial. Taxane scheduling influenced the type of severe toxicities. HER2-positive patients demonstrated comparable 3-year DFS and OS rates with those reported in other similar studies.Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12610000151033.

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