Luteal versus follicular phase surgical oophorectomy plus tamoxifen in premenopausal women with metastatic hormone receptor-positive breast cancer
Affiliation:
1. Alan Edwards Centre for Research on Pain, McGill University, Montreal, QC H3G 0G1, Canada;2. Division of Intramural Research, National Center for Complementary and Alternative Medicine, National Institutes of Health, Bethesda, MD 20892, USA;3. Small Animal Imaging Lab, McConnell Brain Imaging Centre, Montreal Neurological Institute, McGill University, Montreal, QC H3A 2B4, Canada;4. Faculty of Dentistry, McGill University, Montreal, QC H3A 2T5, Canada;5. Department of Neural and Pain Sciences, University of Maryland School of Dentistry, Baltimore, MD 21201, USA;6. Department of Neurology & Neurosurgery, McGill University, Montreal, QC H3A 2B4, Canada;7. Integrated Program in Neuroscience, McGill University, Montreal, QC H3A 2T5, Canada;1. Department of Biology, École Normale Supérieure de Lyon, Lyon, France;2. Nordwest Hospital Frankfurt, Frankfurt am Main, Germany;3. IMS Health, Epidemiology, Frankfurt, Germany
Abstract:
PurposeIn premenopausal women with metastatic hormone receptor-positive breast cancer, hormonal therapy is the first-line therapy. Gonadotropin-releasing hormone analogue + tamoxifen therapies have been found to be more effective. The pattern of recurrence risk over time after primary surgery suggests that peri-operative factors impact recurrence. Secondary analyses of an adjuvant trial suggested that the luteal phase timing of surgical oophorectomy in the menstrual cycle simultaneous with primary breast surgery favourably influenced long-term outcomes.MethodsTwo hundred forty-nine premenopausal women with incurable or metastatic hormone receptor-positive breast cancer entered a trial in which they were randomised to historical mid-luteal or mid-follicular phase surgical oophorectomy followed by oral tamoxifen treatment. Kaplan–Meier methods, the log-rank test, and multivariable Cox regression models were used to assess overall and progression-free survival (PFS) in the two randomised groups and by hormone-confirmed menstrual cycle phase.ResultsOverall survival (OS) and PFS were not demonstrated to be different in the two randomised groups. In a secondary analysis, OS appeared worse in luteal phase surgery patients with progesterone levels <2 ng/ml (anovulatory patients; adjusted hazard ratio 1.46, 95% confidence interval [CI]: 0.89–2.41, p = 0.14) compared with those in luteal phase with progesterone level of 2 ng/ml or higher. Median OS was 2 years (95% CI: 1.7–2.3) and OS at 4 years was 26%.ConclusionsThe history-based timing of surgical oophorectomy in the menstrual cycle did not influence outcomes in this trial of metastatic patients.ClinicalTrials.gov number NCT00293540.
