Background Multigene assays (MGAs) are central to adjuvant chemotherapy (CT) decision making in hormone receptor (HR)-positive-positive/human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC). Clinical validity has been established in pivotal trials; however, implementation in routine practice remains incompletely characterized. In France, adoption occurred within specific temporary funding, contributing to heterogeneous access. Design Targeted narrative literature review of French observational studies from 2012 to 2025. Studies evaluating Oncotype DX®, MammaPrint®, EndoPredict®, or Prosigna® tests in HR-positive/HER2-negative eBC were eligible if they reported treatment decision and/or survival outcomes. Results Thirteen French observational studies were identified, including >9000 patients. CT de-escalation was the predominant clinical effect of MGA testing. Absolute changes in CT recommendations ranged from 17.5% to >70%, depending on assay, population, and study design, and de-escalation was highest in low genomic risk groups. Across assays, absolute changes in CT rate at the population level ranged from 17.5% to 45.4%, although denominators varied across studies. When reported, concordance between post-test recommendations and administered treatments exceeded 90%, supporting implementation of MGA-informed decisions in routine practice. FREDO-ODX, the main French observational study reporting survival endpoints, showed a 4-year invasive disease-free survival rate of 89.7%, consistent with benchmark trial data. French findings were aligned with international datasets. Conclusions French real-world data support the clinical relevance of MGAs in routine care, through CT de-escalation in clinically uncertain situations, with high implementation of post-test recommendations. These data are consistent with randomized trials and international real-world evidence and highlight the importance of equitable, sustainable access to testing in France.
Background Tropomyosin receptor kinase (TRK) inhibitors are highly active in neurotrophic tyrosine receptor kinase (NTRK) gene fusion cancers. The registrational datasets of the three approved TRK inhibitors are well described in the literature but real-world data remain limited. To address this gap, we conducted the Real wOrld treAtment anD outcoMes Among Patients with TRK fusion cancer study. Patients and methods This pooled analysis of five large, international clinicogenomic databases assessed patient characteristics, biomarker testing patterns, co-occurring genomic alterations, and clinical outcomes of patients with TRK fusion cancers. Results A total of 451 patients with advanced/metastatic TRK fusion cancer were identified. NTRK gene fusions were mainly identified by next-generation sequencing [363 (81%) patients]. The median time from diagnosis of advanced/metastatic cancer to the date of the first NTRK gene fusion test was 25 days [interquartile range (IQR) 0-459]. Of the 172 (38%) patients who received a TRK inhibitor, the median time from NTRK gene fusion testing to first TRK inhibitor administration was 118 days (IQR 31-335). The median real-world overall survival was 28 months [95% confidence interval (CI) 21-32] for any first-line systemic therapy and it varied widely across tumor types, from 11 months (95% CI 8-17) for pancreatic cancer to 41 months (95% CI 25-50) for breast cancer. Conclusions This is the largest integrated real-world cohort describing patients with TRK fusion cancer to date, providing a comprehensive picture of TRK fusion cancer treatment in the age of TRK-targeted therapy.
Background Cancer registries do not have resources to follow-up disease statuses of all patients actively. To get information on metachronous metastatic breast cancer (mMBC), we developed an algorithm based on hospital data from, among other, inpatient admissions, outpatient treatments, diagnoses, and medication use to identify patients with a high probability of having developed mMBC, with the aim of reducing registration burden. Materials and methods Nationwide hospital data from 2019 to 2020 were linked to data of patients with a primary breast cancer diagnosis between 1989 and 2020 in the Netherlands Cancer Registry (NCR). For 4395 patients, data on mMBC status (M1/M0) was available in the NCR and used as gold standard to develop a prediction algorithm. After validation its performance was evaluated with a pilot on 1056 patients with unknown M1/M0 status and an estimated prediction score of having metastasis in the range 0% to 100% which were manually checked by registrars. These results were used to retrain the algorithm and patients with a prediction score for mMBC of ≥0.6 were checked manually. Results Predictive variables of the algorithm included specific imaging procedures and medication use, counselling, diagnosis for MBC, and the number of hospital visits. Manual review confirmed that higher predicted probabilities corresponded with higher proportions of mMBC found. Of 3379 patients with prediction score of ≥0.6, 3029 patients (90%) were indeed diagnosed with mMBC. Conclusions We developed an algorithm based on hospital data to identify patients with a high probability of having developed mMBC. The algorithm will be updated continuously and implemented in cancer registry practice.
Background Cancer outcomes are shaped not only by tumor biology but also by the performance of health systems, the patients they fail to reach and how late they respond. In Brazil, race intersects with deep regional and socioeconomic inequalities yet nationwide analyses integrating incidence, hospital-based care, and mortality remain limited. We evaluated racial disparities in the cancer burden among women in Brazil using three complementary national real-world data sources. Materials and methods This retrospective observational study was based on three independent national secondary data: the population-based cancer registries (PBCRs), the national hospital-based cancer registries (HBCRs), and the mortality information system (MIS). Women with malignant neoplasms (International Classification of Diseases, 10th edition, C00-C97), excluding nonmelanoma skin cancer (C44), were included. Women classified as white and black were compared, with the black category including black and mixed race/brown women. Crude incidence rates were estimated from 2010 to 2015. Hospital-based analyses assessed demographic, clinical, and care-pathway characteristics from 2000 to 2023. Mortality trends from 2000 to 2024 were evaluated using age-adjusted rates and Joinpoint regression. Results Among 221 661 women included in the incidence analysis, crude incidence was higher in white than in black women (309.4 versus 196.7 per 100 000), with stable trends in both groups. In the hospital-based cohort (n = 1 601 829), Black women were younger at presentation and more frequently had markers of social vulnerability, advanced-stage disease, delays from symptoms to diagnosis and from diagnosis to treatment, lower treatment rates, and higher early death. Age-adjusted mortality increased in both groups, more sharply among black women (annual percentage change 1.26% versus 0.17%). Conclusions Black women with cancer in Brazil experienced less favorable care-related characteristics and a faster increase in age-adjusted mortality over time. These findings are consistent with persistent racial inequities in cancer care and highlight the need for more comprehensive race-disaggregated cancer surveillance.
Background Abemaciclib plus endocrine therapy (ET) is an established adjuvant treatment for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, high-risk early breast cancer (EBC), based on monarchE trial. Prospective real-world data on persistence, adherence, dose management, and patient-reported outcomes (PROs) remain lacking. IT-PATH was designed to address these gaps. Methods IT-PATH is a prospective, multicenter, noninterventional study enrolling patients with HR-positive, HER2-negative high-risk EBC treated with adjuvant abemaciclib + ET at 18 Italian sites. This preplanned interim analysis reports data from the first 100 patients reaching 6-month follow-up. Primary outcome: 6-month treatment persistence and discontinuation rate. Secondary outcomes: adherence [modified medication possession ratio (mMPR)], dose management, safety. Exploratory endpoints (PROs): health-related quality of life (HRQoL), sexual health, and work productivity. Results Patients were 100% female, with a mean age of 55.4 years; 89.6% had Eastern Cooperative Oncology Group Performance Status 0. Treatment persistence at 3 months was 100% and at 6 months was 98% (median follow-up, 5.6 months). Discontinuation occurred in 2% due to adverse events (AEs). Reductions occurred in 52%; high adherence (mMPR ≥0.8 in 89.8%). AEs ≥ grade 3 were reported in 29% (no grade 4/5). Diarrhea (85%), asthenia (38%), and neutropenia (34%) were the most frequent AEs (any grade). No clinically meaningful changes from baseline were observed across all PROs. Conclusions This interim analysis provides prospective real-world evidence that, in routine clinical practice, adjuvant abemaciclib + ET demonstrates feasibility and manageable tolerability with high treatment persistence and no clinically meaningful changes in HRQoL during the first 6 months of therapy. These findings support the value of proactive and personalized dose management to sustain treatment exposure and patient well-being.
