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Meredith M. Regan, ScD
Associate Professor of Medicine,
Department of Biostatistics and Computational Biology
Dana-Farber Cancer Institute and Harvard Medical School
International Breast Cancer Study Group
- Seeking to validate clinical recommendations for anti-estrogen treatment in premenopausal women.
- Studies are ongoing to assess long-term effects and survival benefits of anti-estrogen therapies in women participating in SOFT and TEXT clinical trials.
- Longer-term follow-up of these two landmark studies will improve the ability to detect treatment effects on recurrence and overall survival, as well as late toxicities and side effects of treatment for estrogen-dependent breast cancers.
Results from two international clinical trials, the Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT), led to new guidelines for treatment of estrogen receptor (ER)-positive breast cancer in premenopausal women. The initial results from the trials supported the use of ovarian suppression drugs in addition to anti-estrogen therapy to preserve fertility in women who intended to have children after treatment. With support from BCRF, the trial investigators are able to extend the follow-up out to 10 years in order to definitively determine the benefit of ovarian suppression for this group of women.
Full Research Summary
The American Society of Clinical Oncology (ASCO) Clinical Practice Guideline Update on Ovarian Suppression, published in the Journal of Clinical Oncology in May 2016, provided recommendations regarding adjuvant endocrine therapy for premenopausal women with hormone receptor-positive early breast cancer.
The Guidelines Panel noted that further follow-up of the women in the trials was required to fully understand the implications of treatment decisions on overall survival and late side effects of therapy.
Two International Breast Cancer Study Group (IBCSG) clinical trials, the Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT), contributed 72 percent of the clinical trial participants whose experience informed the Guidelines Panel and had practice-changing impact on their recommendations. However, the Panel noted that the follow-up of the women in SOFT and TEXT was very short, with a median of only 5.5 years in the 2014 reports.
After 8.5 years of follow-up, results showed improved survival for young breast cancer patients treated with ovarian suppression compared to tamoxifen alone, with those at higher risk receiving a greater benefit. Women and doctors can now better discuss if benefits of more intensive treatment are worth the side effects. Longer follow-up remains critical to ensure reduction of late recurrence.
With support from BCRF, Dr. Regan and her IBCSG colleagues will extend the follow-up of women participating in SOFT and TEXT until the year 2020, to a minimum of 10 years for all participants. A final report is expected in 2021. This long-term follow-up is enabled by support from a consortium of organizations committed to curing breast cancer.
Long-term follow-up will improve the ability to detect treatment effects on distant recurrence and overall survival and define associated late toxicities and side effects of these therapies. Longer follow-up will also enhance the reliability of biomarker research studies to be conducted using the SOFT and TEXT biobank.
Dr. Meredith Regan is Associate Professor of Medicine, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute and Harvard Medical School. She is the Group Statistician for the International Breast Cancer Study Group (IBCSG), a Swiss non-profit research organization dedicated for over 30 years to innovative clinical research to improve treatment options and the quality of life of breast cancer patients.
Since 2003 she has been the lead statistician for the IBCSG’s practice-changing SOFT and TEXT international phase III clinical trials investigating adjuvant endocrine therapies for premenopausal women with hormone receptor-positive early-stage breast cancer. The trials enrolled 5738 premenopausal women in 510 institutions across 27 countries. Together with the trials’ co-chairs, she has led the analysis and reporting of the trials’ primary efficacy results —supporting the use of aromatase inhibitor (AI) with ovarian function suppression (OFS) as a new adjuvant endocrine therapy option for premenopausal women, and clarifying the role of OFS in addition to tamoxifen—as well as the trials quality-of-life, cognitive function and estradiol substudies. She continues in this role as the trials continue to collect longer-term patient follow-up to understand the impact of these therapies on late recurrence and survival and any associated late side effects of the therapies.
Dr. Regan’s research interests extend to clinical-translational investigations to individualize endocrine therapy treatment selection, as well as the statistical analysis of long-term follow-up of randomized trials with selective crossover, motivated by the BIG 1-98 and HERA adjuvant breast cancer trials.
BCRF Investigator Since
The ANN INC. Award (a division of ascena retail group inc.)