Background: Cyclin-dependent kinase (CDK) 4/6 inhibitors have revolutionized the treatment landscape of hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2 −) metastatic breast cancer (MBC). Here, we present the real-world clinical outcomes and toxicity data of patients treated at a single cancer center. Methods: A retrospective analysis was conducted on patients with HR+/HER2− MBC treated with ribociclib plus endocrine therapy (ET). Outcomes measured included progression-free survival (PFS), overall survival (OS), and adverse events. Results: A total of 356 patients (median age 52, range 27– 91 years) were enrolled, all with metastatic disease; 204 (57.5%) had de novo metastasis, and 183 (51.4%) had visceral metastasis. Ribociclib was combined with aromatase inhibitors in 321 patients (90.2%) and with fulvestrant in 35 patients (9.8%). Dose reduction was needed in 101 patients (28.4%), primarily due to neutropenia (21.3%) and abnormal liver enzymes (5.9%). After a median follow-up of 36.3 months, median PFS was 27.3 months (95% CI: 21.3– 31.7). PFS was significantly better in patients receiving ribociclib as first-line therapy (32.1 months, 95% CI: 27.7– 42.1, p < 0.0001) and those with non-visceral metastasis (38.6 months, 95% CI: 29.8–NR, p < 0.0001). Similarly, OS was significantly better in first-line treatment (48.6 months, 95% CI: 39.1–NR) and non-visceral metastasis cases (NR, 95% CI: 40.6–NR, p < 0.0001). No significant differences in 3-year PFS and OS were found between patients with and without dose reductions. Conclusion: In real-world settings, and away from the stringency of controlled clinical trials, endocrine therapy in combination with ribociclib in patients with HR-positive/HER2-negative MBC is an effective and well-tolerated therapy with a manageable toxicity profile and a low drug discontinuation rate. Dose reduction due to toxicity did not worsen the outcome.

Background: Data sharing is now a mandatory prerequisite for several major funders and journals, where researchers are obligated to deposit the data resulting from their studies in an openly accessible repository. Biomedical open data are now widely available in almost all disciplines, where researchers can freely access and reuse these data in new studies. We aim to assess the impact of open data in terms of publications generated using open data and citations received by these publications, where we will analyze publications that used the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) as an example. Methods: As of July 2019, there was a total of 194 datasets stored in BioLINCC repository and accessable through their portal. We requested the full list of publications that used these datasets from BioLINCC, and we also performed a supplementary PubMed search for other publications. We used Web of Science (WoS) to analyze the characteristics of publications and the citations they received. Results: 1,086 published articles used data from BioLINCC repository, but only 987 (90.88%) articles were WoS indexed. The number of publications has steadily increased since 2002 and peaked in 2018 with a total number of 138 publications on that year. The 987 open data publications received a total of 34,181 citations up to 1st October 2019. The average citation per item for the open data publications was 34.63. The total number of citations received by open data publications per year has increased from only 2 citations in 2002, peaking in 2018 with 2361 citations. Conclusion: The vast majority of studies that used BioLINCC open data were published in WoS indexed journals and are receiving an increasing number of citations.

Background: Data sharing is now a mandatory prerequisite for several major funders and journals, where researchers are obligated to deposit the data resulting from their studies in an openly accessible repository. Biomedical open data are now widely available in almost all disciplines, where researchers can freely access and reuse these data in new studies. We aim to study the BioLINCC datasets, number of publications that used BioLINCC open access data, and the citations received by these publications. Methods: As of July 2019, there was a total of 194 datasets stored in BioLINCC repository and accessible through their portal. We requested the full list of publications that used these datasets from BioLINCC, and we also performed a supplementary PubMed search for other publications. We used Web of Science (WoS) to analyze the characteristics of publications and the citations they received, where WoS database index high quality articles. Results: 1,086 published articles used data from BioLINCC repository for 79 (40.72%) datasets, where 115 (59.28%) datasets did not have any publications associated with it. Of the total publications, 987 (90.88%) articles were WoS indexed. The number of publications has steadily increased since 2002 and peaked in 2018 with a total number of 138 publications on that year. The 987 open data publications (i.e., secondary publications) received a total of 34,181 citations up to 1 st October 2019. The average citation per item for the open data publications was 34.63. The total number of citations received by open data publications per year has increased from only 2 citations in 2002, peaking in 2018 with 2361 citations. Conclusion: Majority of BioLINCC datasets were not used in secondary publications. Despite that, the datasets used for secondary publications yielded publications in WoS indexed journals and are receiving an increasing number of citations.

Purpose: Adjuvant CDK4/6 inhibitors have demonstrated significant disease-free survival (DFS) benefits in high-risk early-stage hormone receptor (HR)-positive /HER2-negative breast cancer. However, real-world outcome data describing patients who would meet contemporary eligibility criteria remain limited. This study evaluates treatment outcomes in patients retrospectively classified as eligible for adjuvant ribociclib treatment. Patients and Methods: A retrospective cohort analysis was conducted using clinical data from patients with early-stage HR-positive/HER2-negative breast cancer. Eligibility for adjuvant ribociclib was assigned using the NATALEE trial-based criteria. Differences in treatment outcomes in those eligible versus ineligible patients are reported. Results: Among the 2730 patients included, 1,955 (71.6%) were high risk and would have met NATALEE eligibility, including 1,679 (85.9%) with node-positive disease, 602 (30.8%) with cT3-4 tumors, and 686 (35.1%) with grade 3 disease; 775 (28.4%) were ineligible due to lower-risk features. Across the cohort, the 5-year DFS rate was significantly worse in CDK4/6i-eligible patients compared to those deemed ineligible: 78.4% versus 91.5% (HR=2.51; 95% CI: 2.01– 3.14; p< 0.0001). Though median OS was not reached, survival curve separation became evident by 36 months and widened progressively. Multivariable Cox regression identified low/intermediate ER expression (< 50%), node-positive disease, larger tumors (cT3-4), and grade 3 histology as independent predictors of worse overall survival. Low/intermediate ER expression was associated with significantly poorer OS (HR 1.85, 95% CI 1.27– 2.70; p=0.001), while lower-grade and smaller tumors were associated with improved survival. Conclusion: A significant proportion of patients in this real-world cohort would have met criteria for adjuvant CDK4/6 inhibition. These patients experienced worse survival outcomes compared to their ineligible counterparts. These findings provide real-world historical outcome data for patients who would now be considered candidates for adjuvant ribociclib and may serve as a benchmark for evaluating outcomes following adoption of adjuvant ribociclib.