JCO oncology practice最新文献

Purpose: This study aimed to determine complete toxicity reporting (CTR), and the use of subjective toxicity-minimizing language (TML) among phase III oncology trials.

Methods: Two-arm superiority-design phase III oncology trials published from 2002 to 2020 were reviewed for toxicity data. CTR was defined as reporting total adverse events (TAEs), total serious adverse events (SAEs), total deaths, and study therapy discontinuations because of toxicity. Guideline concordance was defined according to guidelines published in the BMJ (defined as reporting total SAEs, total deaths, and study therapy discontinuations because of toxicity). TML was defined as a set of terms that subjectively downplay the harm of therapies.

Results: A total of 407 trials enrolling 322,645 patients were included. Most (51%, n = 207) reported SAEs, 88% (n = 358) reported total deaths, and 84% (n = 340) reported study therapy discontinuation because of toxicity. Although 55% of trials (n = 223) reported TAEs, only 32% (n = 131; 95% credible interval, 28 to 37) fit the criteria for CTR. CTR was more common in trials with industry sponsorship (37%) than with cooperative group sponsorship (4%). All 131 trials where CTR was observed were industry-sponsored, and only 3% (4/131) were cooperative group-sponsored trials. TML was used in 46% of trials (n = 186; 95% credible interval, 41 to 51), with no trial-related factors (including sponsorship source) associated with the odds of TML use.

Conclusion: Toxicity in phase III oncology clinical trials is often incompletely reported and is frequently minimized in its interpretation. Industry-sponsored trials more comprehensively report toxicity than do cooperative group-sponsored trials. CTR may improve patients' and oncologists' understanding of new treatments; thus, a more standardized approach to reporting toxicity data is needed.

Purpose: The prognostic significance of concomitant statin use in cancer treatment with immune checkpoint inhibitors (ICIs) remains a subject of ongoing investigation. This study aims to clarify the prognostic value of statin use in this patient population and to provide a robust, evidence-based foundation to guide therapeutic decisions.

Methods: A systematic search strategy was used across a multitude of digital archives to exhaustively identify all relevant academic literature published up until June 20, 2024. Studies published in English that reported hazard ratios (HRs) for overall survival (OS) and/or progression-free survival (PFS), along with corresponding 95% CIs, were considered eligible for inclusion. Meta-analyses were conducted to calculate combined HRs with 95% CIs.

Results: A total of 25 studies, involving 46,154 patients with cancer, were included in the meta-analysis. The pooled results indicated that concomitant statin use was linked to better OS (HR, 0.80 [95% CI, 0.71 to 0.92]) and PFS (HR, 0.80 [95% CI, 0.69 to 0.92]) in patients with cancer under ICI therapy. Sensitivity analyses further validated the consistency and robustness of the combined results.

Conclusion: On the basis of the available clinical evidence, the concomitant use of statin is linked to an improved prognosis in oncology patients on ICI-based therapy. These observations underscore the potential of statin as an important adjunctive therapy in the treatment paradigm for ICI-treated patients with cancer, thereby establishing their significance as a key consideration in clinical management strategies. Further randomized controlled trials are imperative to validate the effect of statin use within the realm of ICI therapy.

Multiple myeloma (MM), the second most common hematologic malignancy in the United States, is characterized by repeated cycles of remission and relapse, with increasing resistance to treatment after each line of therapy. Despite the virtually incurable nature of MM, recent therapeutic breakthroughs have fundamentally reshaped its treatment landscape. This review explores evolving care paradigms, spanning from newly diagnosed MM to relapsed or refractory disease. In the frontline setting, treatment strategies have shifted beyond their traditional emphasis on autologous stem-cell transplant eligibility to a broader categorization of patients on the basis of their suitability for quadruplet therapy. In the relapsed/refractory setting, novel immunotherapies, including chimeric antigen receptor T-cell (CAR-T) therapies and bispecific antibodies, have revolutionized treatment, offering new hope for patients with previously limited options. Precision medicine is playing a growing role in MM treatment, with venetoclax showing significant efficacy in patients with t(11;14) translocation, advancing targeted therapy for this subgroup. On the horizon, investigational CAR-T products and cereblon E3 ligase modulators, such as mezigdomide and iberdomide, may provide faster, more durable responses compared with current therapies. In addition, belantamab mafodotin, an antibody-drug conjugate withdrawn from the US market in 2022, is on the verge of reapproval after positive results from recent randomized trials. While these therapies offer significant potential, challenges remain in managing toxicity, ensuring treatment accessibility, and optimizing sequencing strategies. As the therapeutic arsenal expands, the need for personalized MM treatment plans that balance efficacy with quality of life becomes even more essential.

Purpose: Cancer-related financial toxicity occurs frequently and is a key driver of inequities in access to care and disparities in treatment outcomes. Current practices to screen for financial toxicity are inconsistent because of the lack of a validated and clinically integrated screening tool. This analysis aimed to create and assess an abbreviated version of the validated Comprehensive Score for Financial Toxicity (COST) tool, a measure of financial toxicity used for research purposes, which could easily be added into often-lengthy clinical screening workflows.

Methods: At an urban comprehensive cancer center with suburban satellite locations, a financial toxicity screening quality improvement project was conducted from June 2022 to August 2023 as part of routine clinical care: 57,526 longitudinal COST surveys were completed by 38,249 patients with cancer. An iterative algorithm selected the items with highest correlation with the total score. Using a separate validation data set, positive and negative predictive values (PPV and NPV, respectively) of the abbreviated tool (two-item) were assessed against the full COST score, with varying risk thresholds.

Results: Inclusion of two COST questions (Q3: "I worry about the financial problems I will have in the future as a result of my illness or treatment"; Q6: "I am satisfied with my current financial situation") yielded a score that had a correlation of 0.922 with the full instrument score. For the two-item scale, PPV ranged from 74% to 91%, and NPV ranged from 91% to 98% when compared with the full COST tool.

Conclusion: This analysis of a large data set finds that a simplified COST tool has high predictive value when compared with the full validated measure. An abbreviated COST measure of two questions is suitable for implementation into clinical screening workflows.

Adverse financial burden and its effect on patients resulting from the costs associated with cancer care, both direct and indirect, is known as financial toxicity. This review explores the interplay between financial toxicity and key social and legal needs in cancer care. Drawing from the WHO's framework and the ASCO's policy statement on social determinants of health, we propose a conceptual model that discusses five key needs-housing insecurity, food insecurity, transportation and access barriers, employment disruptions, and psychosocial needs-which interact with, and are affected by financial toxicity, and adversely influence patients' well-being and adherence to treatment. We review literature addressing the scope of each of these key needs, their effect on patients with cancer, and how each increases the overall burden of cancer treatment. There is an emphasis on both the patient and the caregiver as one unit navigating through cancer treatment together. The aim is to guide interventions at the patient-provider, institutional, and policy levels that alleviate financial toxicity and improve overall care delivery for patients and caregivers by addressing underappreciated social and legal needs.

Purpose: Financial hardship is common among cancer survivors and has been associated with worse physical and mental health in selected subpopulations. We comprehensively examined associations of financial hardship with multiple measures of health status, social functioning, and mental health in a large, nationally representative sample of cancer survivors.

Materials and methods: We identified adults with a cancer history (18-64 years: n = 3,157 and ≥65 years: n = 5,991) from the 2019 to 2021 National Health Interview Survey. Associations of financial hardship and health status, social functioning (eg, difficulty doing errands alone), and mental health (eg, feeling worried, nervous, or anxious) were evaluated with separate multivariable logistic regressions stratified by age group (18-64 and ≥65 years) to reflect differences in employment, health insurance coverage, and underlying health, and adjusted percentages were calculated.

Results: Cancer survivors with financial hardship were more likely to report fair/poor health (18-64 years: 34.7% v 23.2% and ≥65 years: 40.7% v 27.3%), social functioning limitations (18-64 years: 10.5% v 5.3% and ≥65 years: 18.1% v 11.1%), and work limitations (18-64 years: 36.0% v 26.2% and ≥65 years: 47.3% v 33.6%) than their counterparts without financial hardship in adjusted analyses (all P < .001). Survivors with financial hardship were also more likely to report frequent anxiety (18-64 years: 47.2% v 27.8% and ≥65 years: 36.2% v 16.3%) and depression (18-64 years: 21.7% v 10.8% and ≥65 years: 19.4% v 7.3%) than survivors without hardship (all P < .001).

Conclusion: In this large nationally representative sample, cancer survivors with financial hardship were more likely to report poorer health, social functioning limitations, and worse mental health across multiple measures than their counterparts without hardship. Interventions to screen and connect survivors with relevant services are warranted.