IBCSG publishes 4 groundbreaking reports from SOFT and TEXT in May 2016
IBCSG is pleased to announce the first results of three ancillary studies to IBCSG 24-02 SOFT (Suppression of Ovarian Function Trial): SOFT-EST, SOFT QoL, and Co-SOFT. In addition, a commentary on how the results of SOFT and TEXT are practice changing is now available.
The SOFT-EST substudy prospectively measured estrogen levels in triptorelin groups of the SOFT trial, using an ultra-sensitive and ultra-specific assay. This paper was selected as an “Editor’s Pick” in the May 10 issue of Journal of Clinical Oncology.
The QoL analysis of patient-reported outcomes, also featured in the May 10 issue of Journal of Clinical Oncology, includes 1722 of 2045 premenopausal patients with hormone-receptor positive breast cancer randomized to receive adjuvant treatment with 5 years of tamoxifen+OFS or tamoxifen-alone.
The Co-SOFT substudy, published in the British Journal of Cancer, assessed objective cognitive function and patient reported outcomes at randomization and 1 year later. Although limited by small sample size, the results provide no evidence that adding ovarian function suppression to adjuvant oral endocrine therapy substantially affects global cognitive function.
An additional commentary on the practice-changing impact of the SOFT and TEXT results by study co-chairs Olivia Pagani, MD (Institute of Oncology of Southern Switzerland) and Prue Francis, MD (Peter MacCallum Cancer Centre, Australia) and IBCSG Group Statistician Meredith Regan, ScD (Dana-Farber Cancer Institute, USA) is featured in The Breast. The authors conclude that the interpretation of the SOFT and TEXT trial data can facilitate better selection of appropriate endocrine therapy according to individual disease characteristics while recognizing that the complexity of this puzzle is still not complete.
The global impact of the SOFT and TEXT trials is further demonstrated in the recent ASCO Guideline Update on Ovarian Suppression: “Adjuvant Endocrine Therapy for Women with Hormone Receptor–Positive Breast Cancer.” The new treatment guideline draws its conclusions from published data, 72% of which is contributed from the SOFT and TEXT trials alone.