Tuesday, April 15, 2008

Chemotherapy versus ovarian ablation as adjuvant therapy for breast cancer: impact on health-related quality of life in a randomized trial

Mogens Groenvold1, 2, 6 , Peter M. Fayers3, 4, Morten Aagaard Petersen1 and Henning T. Mouridsen5

(1) The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Copenhagen, Denmark
(2) Department of Health Services Research, Institute of Public Health, University of Copenhagen, Copenhagen, Denmark
(3) Department of Public Health, University of Aberdeen Medical School, Aberdeen, UK
(4) Unit for Applied Clinical Research, Norwegian University of Science and Technology, Trondheim, Norway
(5) Department of Oncology ONK, The Finsen Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
(6) The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, Bispebjerg Bakke 23, DK-2400 Copenhagen, Denmark

Received: 28 December 2005 Accepted: 2 January 2006 Published online: 16 March 2006

Summary
Background Ovarian ablation is an effective adjuvant therapy for primary breast cancer but little is known about its quality of life impact relative to the more widely used adjuvant chemotherapy. This randomized study compared quality of life outcomes of adjuvant ovarian ablation versus cyclophosphamide, methotrexate, fluoracil (CMF) chemotherapy.
Methods The Danish Breast Cancer Cooperative Group (DBCG) trial 89-b randomized premenopausal patients with receptor-positive, primary breast cancer between nine cycles of CMF chemotherapy given every 3 weeks and ovarian ablation by oophorectomy. In total, 317 randomized patients were invited to take part in a longitudinal quality of life study with assessments at 1, 3, 5, 9, 15, and 24 months after randomization. The questionnaire included the EORTC QLQ-C30, the Hospital Anxiety and Depression Scale, and additional items assessing potential symptoms not included in the standard instruments.
Results After 2 years, 260 women were alive and recurrence-free, and 196 of these (75%) had completed all six questionnaires. Overall, patients in the chemotherapy group had more symptomatology at the first three assessments (i.e., during the 6 months treatment period), except for hot flushes/sweats. There were few differences between groups at later assessments. In chemotherapy patients, the likelihood of preserving ovarian function decreased steeply with increasing age. CMF chemotherapy and ovarian ablation have similar impact on recurrence and survival.
Conclusion Chemotherapy had more negative impact on health-related quality of life but preserved ovarian function in some younger patients.
Keywords breast neoplasms - chemotherapy - outcomes - ovarian ablation - quality of life - randomized trial

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