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High intakes of phytochemical-rich foods might have beneficial effects on reducing breast cancer risk. In this study, we assessed the association between the dietary phytochemical index (PI) and breast cancer risk in a sample of premenopausal Turkish women. This case-control study was conducted on 70 newly diagnosed breast cancer cases and matched 70 healthy controls. Dietary intake was assessed using a validated food frequency questionnaire and dietary phytochemical indexes were calculated with two different methods. The mean PI score of participants was 19.9 ± 9.52 and 23.0 ± 8.95 in cases and controls, respectively (

WOS:000518031100008 PMID: 31970972 Background: The synthesis of CDK4/6 inhibitors with endocrine treatment in two series of treatment has been widely accepted as the standard for patients with estrogen receptor-positive metastatic breast cancer. In spite of this, the activity of CDK4/6 inhibitors in patients with metastatic breast cancer who have progressed despite receiving multiple lines of treatment is not well understood. Aims: To report the activity and safety of a CDK4/6 inhibitor (palbociclib) in patients in whom at least three lines of treatment for ER+ metastatic breast cancer had failed. Study Design: Multicenter retrospective observational cohort study. Methods: In this retrospective observational cohort study, we included 43 patients who received palbociclib after at least three lines of systemic treatment for ER+/HER2- metastatic breast cancer. Results: The median progression-free survival in our population was 7 months (25th-75th percentile, 4-10), and the median overall survival was 11 months (25th-75th percentile, 6-19). Although there were some adverse events, palbociclib was generally well tolerated, so dose reduction was needed for only six patients (14%). Conclusion: The efficacy of palbociclib among heavily treated hormone receptor-positive/HER2- patients with advanced breast cancer was acceptable in terms of clinical benefit, and it was generally well tolerated among this population.

Background: MONALEESA-7 is a Phase III study (NCT02278120) and the only dedicated trial of endocrine therapy (ET) ± a cyclin-dependent kinase 4/6 inhibitor in premenopausal patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC). The study demonstrated that the addition of ribociclib (RIB) to a nonsteroidal aromatase inhibitor (NSAI) or tamoxifen (TAM) + goserelin (GOS) significantly extended both progression-free survival (PFS; hazard ratio, 0.55; Tripathy D et al. Lancet Oncol. 2018) and overall survival (OS; hazard ratio, 0.71; Im S-A et al. N Engl J Med. 2019). Health-related quality of life (HRQOL) and work productivity are other important aspects of clinical benefit, especially in the premenopausal population. We present analyses of QOL and work productivity from MONALEESA-7. Methods: Premenopausal or perimenopausal patients with HR+/HER2− ABC were treated with RIB or placebo (PBO) + GOS with either an NSAI (letrozole or anastrozole) or TAM. A secondary endpoint was evaluation of patient-reported outcomes (PROs) for HRQOL using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire core 30 (QLQ-C30). Assessments included global health status as well as social, emotional, and physical functioning. Description of Work Productivity and Activity Impairment (WPAI) was an exploratory endpoint and was measured using the WPAI Questionnaire: General Health (WPAI:GH; V2.0). Results: Time to deterioration (TTD) ≥ 10% in EORTC QLQ-C30 global health status was prolonged with RIB vs PBO (median, 35.8 vs 23.3 months; hazard ratio, 0.665 [95% CI, 0.517-0.855]). TTD ≥ 10% in emotional functioning was also prolonged with RIB vs PBO (hazard ratio, 0.636 [95% CI, 0.488-0.828]), as was TTD ≥ 10% in social functioning (hazard ratio, 0.813 [95% CI, 0.610-1.084]) and TTD ≥ 10% in physical functioning (hazard ratio, 0.715 [95% CI, 0.526-0.972]). Compliance rates with the WPAI:GH were > 99% at baseline and > 98% at the end of treatment. Neither arm had an increase from baseline to the end of treatment in mean percentage of work missed due to overall health. Change in percent activity impairment due to overall health was comparable between treatment arms, as were change in percent impairment while working due to overall health and percent overall work impairment due to overall health. The trends observed with RIB vs PBO in the EORTC QLQ-C30 and WPAI:GH in the overall population were generally similar in the NSAI cohort. Conclusions: WPAI and global health are important considerations in the premenopausal patient population. Analysis of PROs demonstrated that TTD ≥ 10% in global health status and emotional functioning were prolonged with RIB vs PBO. Social and physical functioning were maintained in both treatment arms. Results in various WPAI domains demonstrated that productivity was also maintained in both groups. These QOL and WPAI results, in addition to the significantly longer PFS and OS results with RIB vs PBO, indicate a substantial clinical benefit with RIB treatment in premenopausal patients with HR+/HER2− ABC. Citation Format: Nadia Harbeck, Sara Hurvitz, Aditya Bardia, Fabio Franke, K. Gonvind Babu, Paul Wheatley-Price, Young-Hyuck Im, Kadri Altundag, Antonia Ridolfi, David Chandiwana, Brad Lanoue, Lakshmi Menon, Debu Tripathy. Patient-reported outcomes, including work productivity, from the MONALEESA-7 trial of ribociclib plus endocrine therapy in patients with HR+/HER2− advanced breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P1-19-06.