gms | German Medical Science

27th German Cancer Congress Berlin 2006

German Cancer Society (Frankfurt/M.)

22. - 26.03.2006, Berlin

KoLeDo - a prospective randomized monocenter phase 2 trial investigating 6 x CMF versus 4 x EC chemotherapy in the adjuvant setting of breast cancer therapy in postmenopausal women

Meeting Abstract

  • corresponding author presenting/speaker Martin Baeuerle - Unifrauenklinik Ulm, Deutschland
  • Swantje Berg - Unifrauenklinik Ulm
  • Elsbeth Marre - Unifrauenklinik Ulm
  • Rolf Kreienberg - Unifrauenklinik Ulm
  • Tanja Volm - Unifrauenklinik Ulm

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPE051

The electronic version of this article is the complete one and can be found online at:

Published: March 20, 2006

© 2006 Baeuerle et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.



Method: From 2001 to 2003, 50 postmenopausal patients with breast cancer (group 1 with ages 50-65 years, group 2 with ages >66 years) which had undergone surgery were randomized to receive either 4x epirubicine (90 mg/sqm)/ cyclophosphamide (600 mg/sqm) q3w (n=25) followed by radiotherapy or 6x cyclophosphamide (500 mg/sqm) / methotrexate (40 mg/sqm) / 5-FU (600 mg/sqm) day 1 and 8 q4w (n=25) interrupted by radiotherapy (sandwich protocol). Patient´s age, functional state, co-morbidity and toxicity other than hematotoxicity were evaluated by interview. Quality of life was measured by the EORTC QLQ-C30, the EORTC QLQ-BR23 and the HADS-D questionnaire. Dose intensities were calculated.

Results: From n=25 patients in the EC regimen group only 1 patient dropped out because she refused any therapy right after randomisation. All other 24 patients received full dose of chemotherapy on time (dose intensity of 98.5 %), whereas from n=25 patients in the CMF regimen, 9 patients were drop outs: 1 patients had a deep vein thrombosis, 1 patient had an arteric emboly, 1 patient underwent spine surgery due to disc prolapse, 1 patient had severe hematotoxicity, 1 patient developed a severe pulmonary infection, and 3 patients refused to continue treatment because of low quality of life. Drop outs were distributed equally to both age stratums. The other patients receiving CMF achieved a dose intensity of 97% (excluding radiotherapy) and of 76 % (including radiotherapy). Three patients of stratum 1 and 2 patients of stratum 2 developed metastases (DFS 11- 44 months), 1 had a local recurrence (stratum 2, DFS 20 months). In the CMF group, 2 patients of stratum 1 and 1 patient of stratum 2 died of metastases (OAS 30-42 months). In the EC group, 2 patients developed metastases and one a local recurrence. All other patients are still free of disease (DFS 32-52 months).

Discussion: The application of full dose intensity showed to be less feasible in the CMF regimen compared to the EC regimen which might be due to the longer duration of this therapy. Even though 6x CMF or 4x EC is no longer the standard systemic therapy of breast cancer in the adjuvant setting, our data suggest that achieving full dose intensity is not only dependent on therapy regimen but also on quality of life, patients´ functional state and co-morbidity. The sandwich radiotherapy caused severe drops of dose intensity in the CMF group. Hence, radiotherapy should follow the systemic treatment.