Originally published as JCO Early Release 10.1200/JCO.2003.11.064 on November 10 2003

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Quality of Life in Goserelin-Treated Versus Cyclophosphamide + Methotrexate + Fluorouracil–Treated Premenopausal and Perimenopausal Patients With Node-Positive, Early Breast Cancer: The Zoladex Early Breast Cancer Research Association Trialists Group

H. de Haes, M. Olschewski, M. Kaufmann, M. Schumacher, W. Jonat, W. Sauerbrei

From the Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Institute for Medical Biometry and Informatics, University Hospital, Freiburg; Johann Wolfgang Goethe University, Frankfurt; and Klinik fur Gynakologie und Geburtshilfe, University of Kiel, Kiel, Germany.

Address reprint requests to Hanneke de Haes, PhD, Academic Medical Center, University of Amsterdam, 1105 AZ Amsterdam, the Netherlands; e-mail: mpsecret{at}amc.uva.nl.

Purpose: To compare quality of life (QoL) in premenopausal and perimenopausal patients with node-positive, early breast cancer treated with the endocrine agent goserelin (Zoladex; AstraZeneca Pharmaceuticals LP, Wilmington, DE) or cyclophosphamide + methotrexate + fluorouracil (CMF).

Patients and Methods: Patients from 86 centers worldwide were randomly assigned to receive either goserelin (3.6 mg every 28 days for 2 years; n = 514) or CMF (six 28-day cycles; n = 496), and were included in the QoL study. QoL was assessed using a self-administered patient questionnaire that consisted of 39 items from the Rotterdam Symptom Checklist, including dimensions evaluating physical and psychological symptom distress, activities of daily living, hormonal effects, and an assessment of overall QoL.

Results: Early benefits were noted during months 3 to 6 of treatment, for goserelin compared with CMF. Significant differences were found for changes in overall QoL (eg, 6.96 ± 0.88 v 0.69 ± 0.92 at 6 months; P < .0001) and for physical symptom distress, activity levels, and "effort to cope with illness" dimensions. At 1, 2, and 3 years, there were no significant differences in overall QoL or specific QoL dimensions. Scores for hormonal symptoms were worse with goserelin during the 2-year goserelin treatment period; however, this trend was reversed at 3 years.

Conclusion: Goserelin offers improved overall QoL during the first 6 months of therapy compared with CMF chemotherapy in premenopausal and perimenopausal patients with early breast cancer. Coupled with equivalent efficacy in estrogen receptor-positive patients, these data support the use of goserelin as an alternative to CMF in premenopausal and perimenopausal patients with estrogen receptor-positive, node-positive early breast cancer.

The ZEBRA (Zoladex Early Breast Cancer Research Association) study is supported by a grant from AstraZeneca, Macclesfield, UK. Zoladex is a trademark and the property of the AstraZeneca group of companies.

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