Originally published as JCO Early Release 10.1200/JCO.2005.04.5393 on December 11 2006

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Adjuvant Chemotherapy Followed By Goserelin Compared With Either Modality Alone: The Impact on Amenorrhea, Hot Flashes, and Quality of Life in Premenopausal Patients—The International Breast Cancer Study Group Trial VIII

Jürg Bernhard, David Zahrieh, Monica Castiglione-Gertsch, Christoph Hürny, Richard D. Gelber, John F. Forbes, Elizabeth Murray, John Collins, Stefan Aebi, Beat Thürlimann, Karen N. Price, Aron Goldhirsch, Alan S. Coates

From the International Breast Cancer Study Group (IBCSG); IBCSG Coordinating Center, Swiss Group for Clinical Cancer Research (SAKK), Department of Medical Oncology, Bern; Bürgerspital and Kantonsspital, St Gallen; Oncology Institute of Southern Switzerland, Bellinzona, Switzerland; IBCSG Statistical Center, Dana-Farber Cancer Institute, Frontier Science and Technology Research Foundation, Harvard School of Public Health, Boston, MA; Australian New Zealand Breast Cancer Trials Group and Newcastle Mater Misericordiae Hospital, Newcastle; Department of Surgery, The Royal Melbourne Hospital, Melbourne; the University of Sydney, Sydney, Australia; Groote Schuur Hospital and University of Cape Town, South Africa; and the European Institute of Oncology, Milan, Italy.

Address reprint requests to Jürg Bernhard, PhD, International Breast Cancer Study Group Coordinating Center, Effingerstr 40, 3008 Bern, Switzerland; e-mail: juerg.bernhard{at}ibcsg.org

PURPOSE: The purpose of this article is to compare quality of life (QOL) and menopausal symptoms among premenopausal patients with lymph node-negative breast cancer receiving chemotherapy, goserelin, or their sequential combination, and to investigate differential effects by age.

PATIENTS AND METHODS: We evaluated QOL data from 874 pre- and perimenopausal women with lymph node-negative breast cancer who were randomly assigned to receive six courses of classical cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy, ovarian suppression with goserelin for 24 months, or six courses of classical CMF followed by 18 months of goserelin. We report QOL data collected during 3 years after random assignment in patients without disease recurrence.

RESULTS: Overall, patients receiving goserelin alone showed a marked improvement or less deterioration in QOL measures over the first 6 months than those patients treated with CMF. There were no differences at 3 years after random assignment according to treatment except for hot flashes. As reflected in the hot flashes scores, patients in all three treatment groups experienced induced amenorrhea, but the onset of ovarian function suppression was slightly delayed for patients receiving chemotherapy. Younger patients (< 40 years) who received goserelin alone returned to their premenopausal status at 6 months after the cessation of therapy, while those who received CMF showed marginal changes from their baseline hot flashes scores.

CONCLUSION: Age-adjusted risk profiles that consider patient-reported outcomes enable patients to adapt to their disease and treatment, such as considering the trade-offs between delayed endocrine symptoms, but higher risk of permanent menopause with chemotherapy, and immediate but reversible endocrine symptoms with goserelin, in younger premenopausal patients.

published online ahead of print at www.jco.org on December 11, 2006.

Supported by Swiss Group for Clinical Cancer Research (SAKK), Frontier Science and Technology Research Foundation, The Cancer Council Australia, Australian New Zealand Breast Cancer Trials Group, Australian National Health and Medical Research Council (project 920876), National Cancer Institute Grant No. CA-75362; Bethesda, MD, Swedish Cancer Society, Cancer Association of South Africa, and Foundation for Clinical Research of Eastern Switzerland (OSKK). Astra-Zeneca provided the Zoladex free of charge.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.