For early-stage hormone receptor (HR)-positive and HER2-negative breast cancer, tools to estimate treatment benefit include free and publicly available algorithms (e.g., PREDICT 2.1) and expensive molecular assays (e.g., Oncotype DX). There remains a need to identify patients who de-rive the most benefit from molecular assays and where this test may be of poor value. In this multicenter prospective cohort study, we evaluated whether use of PREDICT 2.1 would impact physician decision making. For the first 6 months of the study, data on physician use of both PREDICT 2.1 and Oncotype DX ordering were collected on all newly diagnosed patients eligible for molecular testing. After 6 months, an educational intervention was undertaken to see if providing physicians with PREDICT 2.1 results affects the frequency of Oncotype DX requests. A total of 602 patients across six cancer centers in Ontario, Canada were recruited between March 2020 and November 2021. Providing PREDICT 2.1 results and an educational intervention did not alter the ordering of an Oncotype DX. For patients with low clinical risk, either by clinico-pathologic features or by PREDICT 2.1, the probability of obtaining a high Oncotype DX recurrence score was substantially lower compared to patients with high-clinical-risk disease. The introduction of an educational intervention had no impact on molecular assay requests. However, routine ordering of molecular assays for patients with low-clinical-risk disease is of poor value.
Cyclin-dependent kinase (CDK)4/6 inhibitors have become a key component of adjuvant treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) early breast cancer who are at high risk of recurrence. The addition of abemaciclib and ribociclib to standard endocrine therapy has demonstrated clinically meaningful improvements in invasive disease-free survival, supported by the monarchE and NATALEE trials, respectively. With expansion of patient eligibility for CDK4/6 inhibitors, multidisciplinary coordination among medical oncologists, surgeons, nurses, pharmacists, and other health care providers is critical to optimizing patient identification, monitoring, and management of adverse events. This expert guidance document provides practical recommendations for implementing adjuvant CDK4/6 inhibitor therapy in routine clinical practice, incorporating insights from multiple specialties and with patient advocacy representation. Key considerations include patient selection based on clinical trial data, treatment duration, dosing schedules, adverse event profiles, monitoring requirements, drug–drug interactions, and patient-specific factors such as tolerability, cost, and quality of life. This guidance aims to support Canadian clinicians in effectively integrating CDK4/6 inhibitors into clinical practice, ensuring optimal patient outcomes through a multidisciplinary and patient-centric approach.
(1) Background: To make recommendations on the most effective therapy options for Ductal Carcinoma of the Breast (DCIS) patients; (2) Methods: MEDLINE, EMBASE, Cochrane Library, PROSPERO databases, and main relevant guideline websites were searched. Draft versions of the guideline went through formal internal and external reviews, with a final approval by the Program in Evidence Based Care and the DCIS Expert Panel. The Grading of Recommendations, Assessment, Development, and Evaluation approach was followed; (3) Results: Based on the current evidence from the systematic review and this guideline authors’ clinical opinions, initial draft recommendations were developed to improve the management of patients with DCIS. After a comprehensive internal and external review process, ten recommendations and 27 qualifying statements were eventually made. This guideline includes recommendations for the primary treatment of DCIS with surgical treatment and/or radiation therapy and the management of DCIS after primary treatment for patients with DCIS, including DCIS with microinvasion (<1 mm through the duct); (4) Conclusions: The current guideline was created after a systematic review and a comprehensive internal and external review process. We believe this guideline provides valuable insights that will be useful in clinical decision making for health providers.