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Archives of Gynecology and Obstetrics

, Volume 291, Issue 3, pp 631–640 | Cite as

Is guideline-adherent adjuvant treatment an equal alternative for patients aged >65 who cannot participate in adjuvant clinical breast cancer trials? A retrospective multi-center cohort study of 4,142 patients

  • R. Van Ewijk
  • A. Wöckel
  • T. Gundelach
  • K. Hancke
  • W. Janni
  • S. Singer
  • R. Kreienberg
  • M. Blettner
  • L. Schwentner
Gynecologic Oncology

Abstract

Introduction

It is well accepted that innovation in oncology is transported through randomized clinical trials (CT), furthermore there is some evidence that patients profit from participation in CT. However, especially elderly patients aged >65 usually do not have access to clinical trials; we therefore used an unselected patient cohort to investigate the following questions:
  1. (1)

    Is there a difference in survival parameters between study participants <65 and elderly 65–80 non-participants?

     
  2. (2)

    Is guideline-adherent adjuvant treatment an equal alternative for elderly patients aged 65–80?

     

Materials and methods

This German retrospective multi-center cohort study included 4,142 patients (study participants <65 and elderly breast cancer patients 65–80) with primary breast cancer recruited from 1992 to 2008 in 17 participating breast cancer centers.

Results

Applying the exclusion criteria, we included 960 (23.2 %) study participants (PA) <65 and 3,182 (76.8 %) elderly >65. Elderly non-participants (NPA) >65 demonstrate a significantly inferior RFS [RFS: HR = 1.67; p < 0.001] and OS [OS: HR = 1.98; p < 0.001] compared to PA <65. Within the elderly group, 1,868 (58.7 %) patients received guideline-adherent adjuvant treatment. When comparing guideline conform elderly >65 versus PA <65, we found no significant difference in RFS [RFS: HR = 1.17; p = 0.218] and OS [OS: HR = 1.34; p = 0.054]. In contrast, non-guideline-adherent elderly demonstrated significantly inferior survival parameters [RFS: HR = 2.06; p < 0.001] [OS: HR = 2.50; p < 0.001] compared to <65 PA.

Conclusion

Guideline-adherent adjuvant treatment seems to be an equivalent option for elderly breast cancer patients. There is a strong association between guideline adherence and improved outcome parameters in elderly breast cancer patients.

Keywords

Breast cancer Study participation Guideline adherence Survival Elderly 

Notes

Acknowledgments

We express our thanks to the following persons for their contributions to the BRENDA study: Karsten Gnauert (Ostalbklinikum, Aalen), Steffen Fritz (Kreisklinik Biberach), Ulf Göretzlehner (Kreiskrankenhaus Ehingen), Hans-Walter Vollert (Städt. Krankenhaus Friedrichshafen), Peter Jakob Albert (Klinikum Heidenheim), Ricardo Felberbaum (Klinikum Kempten), Andreas Zorr (Klinikum Konstanz), Felix Flock (Klinikum Memmingen), Erik Schlicht (Stauferklinik, Mutlangen), Martina Gropp-Meier (Oberschwabenklinik Ravensburg), Gerhard Bartzke (Kreiskrankenhaus Rottweil), Andreas Rempen (Diakonie-Krankenhaus, Schwäbisch Hall), Edgar Schelble (Kreiskrankenhaus Sigmaringen), Theodor Dinkelacker (Helfenstein-Klinik Geislingen), Andreas Grüneberger (Oberschwabenklinik Wangen) and Thorsten Kühn (Städt. Kliniken, Esslingen). This study was supported by the German Federal Ministry of Education and Research (BMBF-Grant-01ZP0505).

Conflict of interest

All authors declare that there are no potential conflicts of interest including any financial, personal or other relationships with other people or organizations within that could inappropriately influence this work.

Ethical standard

This study and the project BRENDA have been approved by the ethics committee of the University of Ulm.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • R. Van Ewijk
    • 1
  • A. Wöckel
    • 2
  • T. Gundelach
    • 3
  • K. Hancke
    • 3
  • W. Janni
    • 3
  • S. Singer
    • 1
  • R. Kreienberg
    • 3
  • M. Blettner
    • 1
  • L. Schwentner
    • 3
  1. 1.Institute for Medical Biostatistics, Epidemiology and Informatics, University Medical CentreJohannes Gutenberg University MainzMainzGermany
  2. 2.Department of Gynaecology and ObstetricsUniversity WürzburgWürzburgGermany
  3. 3.Department of Gynaecology and ObstetricsUniversity UlmUlmGermany

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