Building Efficiency and Scaling With a Remote Genetic Counseling Program.

Purpose A third-party telemedicine (TM) genetic counseling program was initiated at a large community oncology practice spanning 35 clinical sites with 110 clinicians and 97 advanced practice providers throughout Tennessee and Georgia. Patients and Methods Appropriate patients were referred through the electronic health record (EHR) based on current National Comprehensive Cancer Network guidelines. A combination of TM and genetic counseling assistants enhanced convenience, broadened access, and decreased no-show rates. Physician education for mutation-positive screening recommendations was provided through deep integration of dedicated genetic counseling notes in the EHR. Results From 2019 to 2022, the program expanded from 1 to 20 clinics with referrals growing from 195 to 885. An average of 82% of patients completed genetic counseling consultations over TM with more than 70% completing genetic testing. The average was 4 to 6 days from referral to consultation. The no-show rate was maintained at less than 7%. In 2023, this model supported all 35 clinics across the state. Conclusion Our program illustrates how remote genetic counseling programs are an effective choice for scaling genetics care across a large community oncology practice. Deep integration of TM genetic counseling within the EHR helps identify patients who are high risk and improves test adoption, patient keep rate, and turnaround time, helping to achieve better patient outcomes.

Progressing From Disparity to Equity: Untangling the Complexities of Timely Care and the Rural Cancer Experience.

Richard L. Martin III, MD, MPH, and Stephen Schleicher, MD, MBA, share a perspective on rural cancer care.

Medication overuse in oncology: current trends and future implications for patients and society.

The high cost of cancer care worldwide is largely attributable to rising drugs prices. Despite their high costs and potential toxic effects, anticancer treatments could be subject to overuse, which is defined as the provision of medical services that are more likely to harm than to benefit a patient. We found 30 studies documenting medication overuse in cancer, which included 16 examples of supportive medication overuse and 17 examples of antineoplastic medication overuse in oncology. Few specific agents have been assessed, and no studies investigated overuse of the most toxic or expensive medications currently used in cancer treatment. Although financial, psychological, or physical harms of medication overuse in cancer could be substantial, there is little published evidence addressing these harms, so their magnitude is unclear. Further research is needed to better quantify medication overuse, understand its implications, and help protect patients and the health-care system from overuse.

Alternative payment and care-delivery models in oncology: A systematic review.

Rising US health care costs have led to the creation of alternative payment and care-delivery models designed to maximize outcomes and/or minimize costs through changes in reimbursement and care delivery. The impact of these interventions in cancer care is unclear. This review was undertaken to describe the landscape of new alternative payment and care-delivery models in cancer care. In this systematic review, 22 alternative payment and/or care-delivery models in cancer care were identified. These included 6 bundled payments, 4 accountable care organizations, 9 patient-centered medical homes, and 3 other interventions. Only 12 interventions reported outcomes; the majority (n = 7; 58%) improved value, 4 had no impact, and 1 reduced value, but only initially. Heterogeneity of outcomes precluded a meta-analysis. Despite the growth in alternative payment and delivery models in cancer, there is limited evidence to evaluate their efficacy. Cancer 2018. © 2018 American Cancer Society.

Comparative effectiveness of less commonly used systemic monotherapies and common combination therapies for moderate to severe psoriasis in the clinical setting.

BACKGROUND: The effectiveness of psoriasis therapies in real-world settings remains relatively unknown. OBJECTIVE: We sought to compare the effectiveness of less commonly used systemic therapies and commonly used combination therapies for psoriasis. METHODS: This was a multicenter cross-sectional study of 203 patients with plaque psoriasis receiving less common systemic monotherapy (acitretin, cyclosporine, or infliximab) or common combination therapies (adalimumab, etanercept, or infliximab and methotrexate) compared with 168 patients receiving methotrexate evaluated at 1 of 10 US outpatient dermatology sites participating in the Dermatology Clinical Effectiveness Research Network. RESULTS: In adjusted analyses, patients on acitretin (relative response rate 2.01; 95% confidence interval [CI] 1.18-3.41), infliximab (relative response rate 1.93; 95% CI 1.26-2.98), adalimumab and methotrexate (relative response rate 3.04; 95% CI 2.12-4.36), etanercept and methotrexate (relative response rate 2.22; 95% CI 1.25-3.94), and infliximab and methotrexate (relative response rate 1.72; 95% CI 1.10-2.70) were more likely to have clear or almost clear skin compared with patients on methotrexate. There were no differences among treatments when response rate was defined by health-related quality of life. LIMITATIONS: Single time point assessment may result in overestimation of effectiveness. CONCLUSIONS: The efficacy of therapies in clinical trials may overestimate their effectiveness as used in clinical practice. Although physician-reported relative response rates were different among therapies, absolute differences were small and did not correspond to differences in patient-reported outcomes.

New Federal Guidance Makes It Harder for Patients With Cancer to Access Drugs.

A recent interpretation of the Stark Law limits cancer practices from delivering drugs to their patients by mail or courier-a perverse interpretation of a law meant to curb physician self-referrals and one that has led to patient harm.

Practice Consolidation Among US Medical Oncologists, 2015-2022.

PURPOSE: Health care consolidation has significantly affected cancer care delivery, with oncology practices undergoing substantial consolidation over the past two decades. This study investigates practice consolidation trends among medical oncologists (MOs), factors associated with consolidation, and changes in MO geographic distribution. METHODS: Medicare data from 2015 to 2022 were used to assess MO practice consolidation in hospital referral regions (HRRs), linked with regional health care market data and physician demographics. The Herfindahl-Hirschman Index (HHI) was used to measure consolidation, and the Gini coefficient was used to measure MO distribution across counties. Multivariable linear regression explored factors associated with MO practice consolidation. RESULTS: Between 2015 and 2022, the number of MOs increased by 14.5% (11,727-13,433), whereas the number of MO practices decreased by 18.0% (2,774-2,276). The mean number of MOs per practice increased by 40% (4.26-5.95; P < .001). The percentage of MOs in small practices decreased, whereas larger practices saw an increase. MO consolidation, as indicated by the HHI, increased by 9% (median HHI, 0.3204-0.3480). HRRs with higher baseline hospital consolidation and more hospital beds per capita were more likely to have MO practice consolidation. Despite MO practice consolidation, the county-level distribution of MOs did not change substantially. CONCLUSION: On the basis of Federal Trade Commission classifications, MO practices were highly concentrated in 2015 and consolidated even further by 2022. While distribution of MOs at the county level remained stable, further research is needed to assess the effects of rapid consolidation on cancer care cost, quality, and access. These data have important implications for policymakers and payers as they design programs that ensure high-quality, affordable cancer care.

Patient-reported reasons for the discontinuation of commonly used treatments for moderate to severe psoriasis.

BACKGROUND: Despite widespread dissatisfaction and low treatment persistence in moderate to severe psoriasis, patients' reasons behind treatment discontinuation remain poorly understood. OBJECTIVES: We sought to characterize patient-reported reasons for discontinuing commonly used treatments for moderate to severe psoriasis in real-world clinical practice. METHODS: A total of 1095 patients with moderate to severe plaque psoriasis from 10 dermatology practices who received systemic treatments completed a structured interview. Eleven reasons for treatment discontinuation were assessed for all past treatments. RESULTS: A total of 2231 past treatments were reported. Median treatment duration varied by treatment, ranging from 6.0 to 20.5 months (P < .001). The frequency of each cited discontinuation reasons differed by treatment (all P < .01). Patients who received etanercept (odds ratio [OR] 5.19; 95% confidence interval [CI] 3.23-8.33) and adalimumab (OR 2.10; 95% CI 1.20-3.67) were more likely to cite a loss of efficacy than those who received methotrexate. Patients who received etanercept (OR 0.34; 95% CI 0.23-0.49), adalimumab (OR 0.48; 95% CI 0.30-0.75), and ultraviolet B phototherapy (OR 0.21; 95% CI 0.14-0.31) were less likely to cite side effects than those who received methotrexate, whereas those who received acitretin (OR 1.56; 95% CI 1.08-2.25) were more likely to do so. Patients who underwent ultraviolet B phototherapy were more likely to cite an inability to afford treatment (OR 7.03; 95% CI 3.14-15.72). LIMITATIONS: The study is limited by its reliance on patient recall. CONCLUSIONS: Different patterns of treatment discontinuation reasons are important to consider when developing public policy and evidence-based treatment approaches to improve successful long-term psoriasis control.

Trifarotene Reduces Risk for Atrophic Acne Scars: Results from A Phase 4 Controlled Study.

BACKGROUND: Atrophic acne scarring often accompanies acne vulgaris. The efficacy of topical retinoids for treatment of acne is well documented; however, evidence for use in atrophic acne scars is limited. METHODS: In this randomized, split-face, double-blind study, subjects (age: 17-34 years, N = 121) with moderate-to-severe facial acne, with acne scars present, were treated with either trifarotene 50 µg/g or vehicle once daily for 24 weeks. Efficacy was assessed by absolute and percent change from baseline in atrophic acne scar counts, Scar Global assessment (SGA), and IGA success rates as well as acne lesion counts. RESULTS: At week 24, a statistically significantly greater reduction in the mean absolute change from baseline in the total atrophic scar count was noted in the trifarotene- vs vehicle-treated area (- 5.9 vs - 2.7; p < 0.0001) with differences between sides noted as early as week 2 (- 1.5 vs - 0.7; p = 0.0072). The SGA success rate was higher in the trifarotene side at week 12 (14.9% vs 5.0%, P < 0.05) and improved through week 24 (31.3% vs 8.1%, P < 0.001). Similarly, at week 24, the IGA success rate was higher with trifarotene (63.6% vs 31.3%, P < 0.0001) along with reductions in total (70% vs 45%) and inflammatory (76% vs 48%) lesion counts. The incidence of treatment-emergent adverse events was 5.8% (trifarotene) and 2.5% (vehicle); most common (> 1%) was skin tightness (1.7% vs 0.8%), and all events were mild to moderate in severity. CONCLUSIONS: Trifarotene was effective and well tolerated in treating moderate-to-severe facial acne and reducing atrophic acne scars, with reduction of total atrophic scar count as early as week 2. TRIAL REGISTRATION: Clinicaltrials.gov NCT04856904.

GSK-3ß inhibition promotes cell death, apoptosis, and in vivo tumor growth delay in neuroblastoma Neuro-2A cell line.

Neuroblastoma is the most common extracranial solid tumor of childhood. While survival rates are high for localized disease, treatment response remains poor for a subset of patients with large tumors or disseminated disease. Thus, there remains much room for improvement in treatment strategies for this disease. Using in vitro and in vivo systems, we present glycogen synthase kinase-3ß (GSK-3ß) inhibition as a potential mechanism to treat neuroblastoma. Using the specific GSK-3ß inhibitor SB415286, we demonstrate that GSK-3ß inhibition decreases the viability of Neuro-2A cells, as determined by cell proliferation assay and clonogenic survival. Moreover, we show that GSK-3ß inhibition induces apoptosis in neuroblastoma cells, as determined by Annexin V staining and confirmed with DAPI staining. Using flow cytometry, we are able to demonstrate that SB415286 induces the accumulation of cells in the G2/M phase of the cell cycle. Finally, we show that these in vitro results translate into delayed tumor growth in vivo using a heterotopic tumor model in nude mice treated with SB415286. These findings suggest that GSK-3ß is a potential molecular target for the treatment of neuroblastoma.

Progress in the unraveling of the endoplasmic reticulum stress/autophagy pathway and cancer: implications for future therapeutic approaches.

Given the inherent resistance to apoptosis that characterizes cancer, the targeting of alternative pathways is an attractive strategy to improve anti-tumor therapy. Endoplasmic reticulum (ER) stress, which is basally activated in many cancers, and the subsequent activation of autophagy represent novel cancer treatment targets. While these associated pathways are often protective and promote cell survival, when excessive, ER stress results in autophagic cell death. Therefore, depending on the circumstances, either inhibition or activation of ER stress and autophagy can improve cancer therapy. This review provides an update on how ER stress relates to autophagy, and how these associated pathways can serve dual functions to promote survival or cell death in cancer. Furthermore, it lays out a spectrum of potential pharmacological agents and combinatorial approaches that target these pathways to enhance tumor cell kill.

The EGFR polymorphism rs884419 is associated with freedom from recurrence in patients with resected prostate cancer.

PURPOSE: Prognostic biomarkers are needed to optimize treatment decisions for prostate cancer. Single nucleotide polymorphisms participate in the individual genetic background modulating risk and clinical outcomes of cancer. We tested whether EGFR polymorphisms are associated with prostate cancer clinical outcomes. MATERIALS AND METHODS: The study population consisted of 212 patients with clinically localized prostate cancer treated with radical prostatectomy from 1997 to 1999. Resected prostatic tissues were genotyped with allele specific probes for 9 haplotype tagging single nucleotide polymorphisms, which were located in intronic, exonic and flanking regions of linkage disequilibrium in the EGFR gene. Correlations between alleles, and recurrence and survival data were investigated using univariate and multivariate genetic analysis models. RESULTS: There was a statistically significant association between the single nucleotide polymorphism rs884419 and prostate cancer recurrence, as defined in the study by at least prostate specific antigen biochemical recurrence (log rank test p <0.001). The incidence of the recurrence risk enhancing genotype A/A was 3.1% vs 17.4% and 80% for the risk decreasing genotypes A/G G/G, respectively. Based on Cox proportional hazard regression modeling patients carrying G/G and A/G genotypes were associated with a decreased risk of prostate cancer recurrence compared to those with the A/A genotype (HR 0.10, 95% CI 0.02-0.41 and 0.13, 95% CI 0.04-0.46, respectively, p <0.002). CONCLUSIONS: These data suggest that a polymorphism flanking the EGFR gene is an independent prognostic genetic biomarker that predicts prostate cancer biochemical recurrence after radical prostatectomy.

Genomic Alteration in Metastatic Breast Cancer and Its Treatment.

Metastatic breast cancer (mBC) remains responsible for the majority of breast cancer deaths. Whereas clinical outcomes have improved with the development of novel therapies, resistance almost inevitably develops, indicating the need for novel therapeutic approaches for the treatment of mBC. Recent investigations into mBC genomic alterations have revealed novel and potential therapeutic targets. Most notably, therapies against PIK3CA mutation and germline BRCA1/2 mutations have solidified the role of targeted therapy in mBC, with treatments against these alterations now approved by the U.S. Food and Drug Administration (FDA) on the basis of clinical benefit for patients with mBC. Familiarity with relevant genomic alterations in mBC, technologies for mutation detection, methods of interpreting genomic alterations, and an understanding of their clinical impact will aid practicing clinicians in the treatment of mBC as the field of breast oncology moves toward the era of precision medicine.

Cutaneous Metastasis from Renal Cell Carcinoma.

A 73-year-old man presented with a red papule on the posterior aspect of his neck (Figure 1). The growth had first been noted approximately 1 month before his visit. The patient complained of irritation from his collar but had no other symptoms. He had hypertension controlled by medication and denied recent weight loss, malaise, or swollen glands. Examination of the lesion revealed a firm, bright red papule 4 mm in diameter on a slightly indurated flesh-color base. (SKINmed. 2019;17:65-66).

Practice Patterns for Older Adult Patients With Advanced Cancer: Physician Office Versus Hospital Outpatient Setting.

PURPOSE: A shift in outpatient oncology care from the physician's office to hospital outpatient settings has generated interest in the effect of practice setting on outcomes. Our objective was to examine whether medical oncologists' prescribing of drugs and services for older adult patients with advanced cancer is used more in physicians' offices compared with hospital outpatient departments. METHODS: This was a retrospective comparative study. SEER-Medicare data (2004 to 2011) were used to identify Medicare beneficiaries diagnosed with advanced breast, colon, esophagus, non-small-cell lung, pancreatic, or stomach cancer. Between physicians' offices and hospital outpatient departments, we compared use of selected likely low-value supportive drugs, low-value therapeutic drugs, chemotherapy-related hospitalizations, and hospice. We used hierarchical modeling to assess differences between settings to account for correlation within physicians. RESULTS: Compared with patients treated in a hospital outpatient department, those treated in a physician's office setting were more likely to receive erythropoiesis-stimulating agents (odds ratio, 1.72; 95% CI, 1.53 to 1.94) and granulocyte colony-stimulating factors (odds ratio, 1.28; 95% CI, 1.18 to 1.38). For combination chemotherapy and nanoparticle albumin-bound-paclitaxel in patients with breast cancer, there was a trend toward higher use in physicians' offices, although this was not statistically significant. Chemotherapy-related hospitalizations and hospice did not vary by setting. CONCLUSION: We found somewhat higher use of several drugs for patients with advanced cancer in physicians' office settings compared with hospital outpatient departments. Findings support research to dissect the mechanisms through which setting might influence physicians' behavior.

Next-Generation Alternative Payment Models in Oncology-Will Precision Preclude Participation?

This Viewpoint proposes 3 changes to the Enhancing Oncology Model of the US Centers for Medicare & Medicaid Services.