Abstract PS5-38: Short course of preoperative tamoxifen in premenopausal breast cancer patients: Biomarker changes and survival
Authors: Frolova Mona , Stenina Marina , Petrovsky Alexander , Krohina Olga , Tjulandin Sergei 
Published: February 2021

Abstract
Background: Luminal HER2 negative breast cancer is a highly heterogeneous disease, which complicates the choice of optimal systemic treatment in early stage disease. It is known that in postmenopausal patients (pts) Ki67 level after short course of preoperative endocrine therapy (PET) correlates with survival in contrast to baseline level. We performed the trial of PET in premenopausal early stage breast cancer pts.Patients and methods: This is a non-randomized, open-label, single-arm, phase II study of short course of preoperative tamoxifen in premenopausal pts. Primary objective was a decline in Ki67 level below 10%, secondary objectives were biomarker changes and disease free survival. Between 2011 and 2017 74 pts with T1-2N0-1M0 ER+ HER2 negative breast cancer were included in the study, median age was 45 (range, 32-55), median baseline Ki67 30% (range, 5-96), median stromal TILs 5% (range, 0-40). All pts were treated with tamoxifen for 2-3 weeks before surgery. Median follow-up was 56 months (range, 29.6-124.3).Results: There was a statistically significant decline in Ki67 during the short course of endocrine therapy (p&lt;0,001), median Ki67 level after PET was 20% (range 3-75). Also we noticed significant decline in estrogen receptor (ER) expression level (p=0,001), but not in progesterone receptor (PR) expression. There was an increase in the level of stromal TILs (p=0.09). Baseline level of Ki67 and tumor grade had significant impact on decline in Ki67 below 10%. None of 28 pts with baseline Ki67&gt;30% had post-PET Ki67&lt;10% in comparison with 20,5% (9/44) with baseline Ki67 10-30%. No pts with baseline TILs≥20% had decline in Ki67 below 10%. Baseline level of Ki67 did not correlate with survival, 3-year DFS with baseline Ki67≤30 was 94,4%, Ki67&gt;30% - 92,6% (p=0.54). Also there was no difference in survival according to Ki67 level after the course of endocrine therapy: with post-PET Ki67&lt;10% 3-year DFS was 100% (none of pts was treated with chemotherapy), 10-30 – 92,4%, &gt;30 – 94,4% (p=0.61). We explain this with the changes in adjuvant treatment in pts with high (&gt;30%) level of Ki67 after endocrine therapy – all pts were receiving adjuvant chemotherapy and, what is more important, they also had ovarian suppression and tamoxifen has been changed to aromatase inhibitors (AI). Conclusion: to our knowledge this is the first study of the short course of PET in premenopausal pts. We demonstrated that post-PET Ki67 level can be used for individualization of adjuvant therapy (intensification with chemotherapy, ovarian suppression, AI in poor responders and avoiding of chemotherapy in good responders). Further prospective randomized trials are warranted.
Citation Format: Mona Frolova, Marina Stenina, Alexander Petrovsky, Olga Krohina, Sergei Tjulandin. Short course of preoperative tamoxifen in premenopausal breast cancer patients: Biomarker changes and survival [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS5-38.