JCO oncology practice最新文献

Purpose: Ovarian function suppression (OFS) with gonadotropin-releasing hormone agonists (GnRHas) is a standard of care for premenopausal patients with high-risk stage II/III hormone receptor-positive breast cancer (BC). Practical guidance on the optimal choice of GnRHa, timing, schedule, and monitoring is limited. Our aim was to determine how oncologists use OFS in routine care.

Methods: We designed a questionnaire to determine the choice of GnRHa, schedule, duration, initiation, use of bone modifiers, and monitoring of estradiol (E2). The questionnaire was sent to oncologists treating BC, in practice for >1 year and participating in the ASCO Research Survey Pool (RSP). It was also forwarded by investigators to oncologists meeting these criteria. The survey was open between November 14, 2023, and January 5, 2024.

Results: Of 996 oncologists participating in the ASCO RSP, 178 (18%) completed the survey. An additional 56 oncologists contacted by investigators responded. Respondents were from the United States (57%), Asia (15%), and Europe (14%). Goserelin (54%) and leuprolide (39%) were the most frequently used GnRHas and were administered once every month by 46%. Approaches to starting GnRHas were varied. Most continued them for the duration of aromatase inhibitor therapy (57%). Estradiol monitoring was performed regularly, sometimes, or never by 43%, 27%, and 27%, respectively. The E2 assays used were standard (65%), ultrasensitive (16%), and unknown (14%). Interpreting E2 assay results were considered difficult by 55%; however, 62% of oncologists changed treatment on the basis of them. A total of 92% of respondents would like ASCO guidance on the practical use of OFS.

Conclusion: Considerable practice variation exists for similar clinical scenarios in OFS administration. Respondents would welcome ASCO guidance on all aspects of OFS.

Purpose: Limited health literacy-ability to obtain, process, and understand health information-can hinder communication, access to medical treatment, and identification and management of comorbidities. Older adults have high rates of poor health literacy, but its role in aging-related outcomes among older adults with cancer is understudied.

Methods: We included 876 older adults age 60 years and older with cancer from the Cancer and Aging Resilience Evaluation Registry completing self-reported geriatric assessment, including health literacy, at first visit to medical oncology. The exposure was limited health literacy. Outcomes were frailty, physical/mental health-related quality of life (HRQOL), and health care utilization. We used modified Poisson regression to examine the association of exposure on outcomes adjusting for age, race-ethnicity, sex, and cancer type/stage.

Results: Median age at enrollment was 68; 57.8% were male; 20.2% were non-Hispanic Black. The most prevalent cancers were advanced-stage (46.8% stage IV) colorectal (26.9%) and pancreatic (19.0%). Those with limited health literacy were older (70 v 68 years; P < .001), male (63.0% v 55.1%; P = .026), non-Hispanic Black (28.8% v 16.1%; P < .001), ≤high school educated (62.3% v 28.1%; P < .001), and retired/disabled (86.3% v 71.2%; P < .001). In multivariable analysis, limited health literacy was associated with higher prevalence of frailty (prevalence ratio [PR], 2.64 [95% CI, 2.15 to 3.26]), impaired physical (PR, 1.90 [95% CI, 1.59 to 2.27]) and mental (PR, 2.08 [95% CI, 1.76 to 2.47]) HRQOL, and hospitalization in the last year (PR, 1.28 [95% CI, 1.10 to 1.48]) versus adequate health literacy.

Conclusion: Older adults with cancer and limited health literacy had higher adjusted prevalence of frailty, impaired physical and mental HRQOL, and recent hospitalization. Interventions to address limited health literacy should be explored in this vulnerable and growing cancer population.

Molecular prognostic and diagnostic tools allow for targeted cancer surveillance, prognostication, and treatment, and these assays have the potential to improve the lives of patients and their relatives. The impact of these advances, however, is not uniform across populations. Underserved communities frequently do not have the same level of access to novel assays, and the clinical application of these tools is often limited by disproportionate representation of White and European ancestry populations in foundational data, as well as limited diversity in clinical trials. In this review, we highlight major advances in clinical molecular assays, key areas of disparity, and contributing factors. We then list ongoing and future areas of intervention to improve access to and efficacy of molecular assays across populations, so that we as a community may work to improve equity at this critical area of cancer care.

Pharmacogenomic (PGx) testing is a growing area of personalized medicine with demonstrated clinical utility in improving patient outcomes in oncology. PGx testing of pharmacogenes affecting drug pharmacokinetics, pharmacodynamics, and response can help inform drug selection and dosing of several anticancer therapies and supportive care medications. Several PGx testing techniques exist including polymerase chain reaction (PCR), MassARRAY, microarray, and sequencing. This review article provides a clinician-friendly guide of these techniques. Understanding the advantages, limitations, ideal use, and potential clinical applications of each platform can help clinicians choose the appropriate PGx testing platform for specific use cases.

Circulating tumor DNA (ctDNA) refers to DNA fragments released from cancer cells into the bloodstream. Clinical utility of ctDNA in breast cancer has been explored in both metastatic breast cancer (MBC) and early-stage breast cancer (EBC) settings. In MBC, ctDNA can detect therapeutically targetable genomic alterations and has shown great potential in predicting treatment response or resistance. Accumulating data suggest that ctDNA might also have prognostic value in MBC. In EBC, emerging data have shown ctDNA's predictive and/or prognostic value in both neoadjuvant and adjuvant settings. Minimal residual disease (MRD) detection via ctDNA to detect clinical recurrence after curative therapy is a rapidly advancing field. In this review, we discuss the existing and emerging data regarding ctDNA utility in both MBC and EBC settings.

Purpose: Precision therapies and immunotherapies have revolutionized cancer care, with novel genomic biomarker-associated therapies being introduced into clinical practice rapidly, resulting in notable gains in patient survival. Despite this, there is significant variability in the utilization of tumor molecular profiling that spans the timing of test ordering, comprehensiveness of gene panels, and clinical decision support through therapy and trial recommendations.

Methods: To standardize testing, we designed a pathologist-directed test ordering system at the time of diagnosis using a 523-gene DNA/RNA hybrid comprehensive genomic profiling (CGP) panel and extensive clinical decision support tools. To comprehensively characterize the clinical impact of this protocol, we developed a novel natural language processing (NLP)-based approach to extract clinical features from physician chart notes. We assessed test actionability rates, therapy choice, and outcomes across a set of 3,216 patients with advanced cancer.

Results: We observed 49% of patients had at least one actionable genomic biomarker-driven-approved and/or guideline-recommended targeted or immunotherapy (IO) and 53% of patients would have been eligible for a precision therapy clinical trial from three large basket trials. When assessing CGP versus an in silico 50-gene panel, 67% of tumors compared with 33% harbored actionable alterations including clinical trials. Among patients with 6 months or more of follow-up, over 52% received a targeted therapy (TT) or IO, versus 32% who received conventional chemotherapy alone. Furthermore, patients receiving TT had significantly improved overall survival compared with patients receiving chemotherapy alone (P < .001).

Conclusion: Overall, these data represent a major shift in standard clinical practice toward molecularly guided treatments (targeted and immunotherapies) over conventional systemic chemotherapy. As guidelines continue to evolve and more precision therapeutics gain approval, we expect this gap to continue to widen.

This paper discusses the administrative aspects of molecular diagnostics in oncology, including US Food and Drug Administration (FDA) oversight, the regulatory approval process, clinical, and operational workflows, and payment models. Comprehensive molecular testing is important to deliver optimal oncology care and improve patient outcomes. Despite the potential benefits of testing, utilization remains low. The FDA regulatory approval process is reviewed for in vitro diagnostic products, which includes classification into three regulatory classes on the basis of risk. Companion diagnostic devices are used to guide treatment decisions. The clinical and operational challenges associated with molecular testing in oncology are also discussed, including the rapidly evolving landscape of precision oncology, the wide range of biomarker testing options, and complexities of test ordering, interpretation, and result delivery. There is a need for a multifaceted support approach involving education, technology enhancements, and workflow support to overcome these challenges. In terms of payment models, coverage policies between Medicare and commercial payers are compared with differences in coverage criteria, with Medicare focusing on FDA approval or clearance, whereas commercial payers consider additional factors such as National Comprehensive Cancer Network and ASCO guidelines. Commercial payers tend to cover smaller panels on the basis of guideline-recommended biomarkers, whereas coverage for broad tumor profiling is limited. Several strategies can increase the utilization of molecular testing, including integrating test results into electronic medical record platforms, standardizing billing practices, increasing clinical trials, and primary literature supporting the use of molecular testing, educating physicians, and using tumor boards for result interpretation and treatment discussions.

Over the next few years, the analysis of circulating tumor DNA (ctDNA) through liquid biopsy is expected to enter clinical practice and revolutionize the approach to biomarker testing and treatment selection in GI cancers. In fact, growing evidence support the use of ctDNA testing as a noninvasive, effective, and highly specific tool for molecular profiling in GI cancers. Analysis of blood ctDNA has been investigated in multiple settings including early tumor detection, minimal residual disease evaluation, tumor diagnosis and evaluation of prognostic/predictive biomarkers for targeted treatment selection, longitudinal monitoring of treatment response, and identification of resistance mechanisms. Here, we review the clinical applications, advantages, and limitations of ctDNA profiling for precision oncology in GI cancers.