246O - Dose-dense sequential adjuvant chemotherapy with epirubicin, paclitaxel and CMF versus epirubicin, CMF and weekly docetaxel or paclitaxel followed b...

Date 30 September 2012
Event ESMO Congress 2012
Session Breast cancer, early stage
Topics Anticancer agents
Breast Cancer
Biological therapy
Presenter George Fountzilas
Authors G. Fountzilas1, H. Gogas2, N. Pavlidis2, A. Eleftheraki3, D. Skarlos2, A. Koutras3, E. Timotheadou4, C. Papandreou3, D.G. Pectasides5, M. Dimopoulos3
  • 1Medical Oncology Clinic, Hellenic Cooperative Oncology Group (HeCOG), Athens/GR
  • 2Hellenic Cooperative Oncology Group (HeCOG), Athens/GR
  • 3Data Office, Hellenic Cooperative Oncology Group (HeCOG), Athens/GR
  • 4Medical Oncology, Hellenic Cooperative Oncology Group (HeCOG), Athens/GR
  • 52nd. Dep. Int. Medicine, Hellenic Cooperative Oncology Group (HeCOG), Athens/GR




Dose-dense sequential chemotherapy including anthracyclines and taxanes has been well established in the adjuvant setting of high-risk operable breast cancer. However, the preferable taxane and optimal schedule of administration have not been defined, as yet.

Patients and methods

From July 2005 until November 2008, 1,001 patients (990 eligible) were randomized to receive 3 cycles of epirubicin 110 mg/m2 followed by 3 cycles of paclitaxel 200 mg/m2 followed by 3 cycles of CMF (cyclophosphamide 840 mg/m2; methotrexate 57 mg/m2; fluorouracil 840 mg/m2) with G-CSF support (Group A; 333 patients) or to 3 cycles of epirubicin followed by 3 cycles of CMF, as in Group A, followed 3 weeks later by 9 weekly cycles of docetaxel 35 mg/m2 (Group B; 331 patients) or 9 weekly cycles of paclitaxel 80 mg/m2 (Group C; 328 patients). Radiation and hormonal therapy were given after the completion of chemotherapy. Trastuzumab was administered for 1 year to all HER2-positive patients post radiation.


At a median follow-up of 60 months, 123 patients had documented disease relapse (51 in Group A, 37 in Group B and 35 in Group C) and 81 deaths (30 in group A, 22 in group B and 29 in group C) had been observed. The 3-year disease-free survival (DFS) rate was 86%, 91% and 89%, with overall survival (OS) rates of 96%, 97% and 96%, respectively. No differences were found in DFS or OS between the three treatment groups (log-rank, p = 0.38 and p = 0.48, respectively). The most frequently reported severe adverse events were neutropenia (29% vs 27% vs 24%, p = 0.31) and leucopenia (12% vs 13% vs 10%, p = 0.66). Febrile neutropenia occurred in fifty patients (6%, vs 5% vs 5%, p = 0.81). Severe mucositis was more frequent in Group B (3% vs 6% vs 1%, p = 0.001), while severe neuropathy was more frequent in Group A (4% vs 0% vs 1%, p < 0.001).


No significant differences in DFS and OS between the three regimens were identified. Taxane regimen and schedule of administration preferentially influenced the type of severe toxicities. HER2-positive patients demonstrated comparable 3-year DFS and OS rates with those reported in other similar studies.


All authors have declared no conflicts of interest.