Outpatient chemotherapy drug costs and expensive chemotherapy drug use in 340B and Non-340B hospitals: an observational study

BACKGROUND: The 340B Drug Pricing Program has been controversial since its inception in 1992, a major criticism being that 340B hospitals use more outpatient drugs, and more expensive drugs, because of financial incentives to make money through the program. The goal of this study was to determine whether characteristics of patients treated at 340B hospitals, and affiliation of hospitals with NCI-designated cancer centers, would explain higher Part B drug costs and use of more expensive chemotherapy drugs. METHODS: This is an observational study using data from SEER-Medicare and 340B entity database. Fee-for-service Medicare beneficiaries who were first diagnosed with cancer between 1/1/2013 and 12/31/2015 were included. Hospital, patient, and cancer/clinical characteristics were used as predictors of both overall Part B drug costs and use of expensive chemotherapy drugs. Patient characteristics and cancer conditions were compared between those who were treated at 340B and non-340B hospitals, and between those who used and who did not use any expensive chemotherapy treatment. Independent relationships between overall Part B drug costs and patients\u27 340B status, and between patients\u27 use of expensive chemotherapy drug and patients\u27 340B status were evaluated in multivariate analyses, using a stepwise generalized estimating equation modeling approach. RESULTS: We found that patients at 340B hospitals had a somewhat higher chance of using one of the ten expensive chemotherapy drugs, and somewhat higher overall drug costs, but these relationships became non-significant when patient, cancer/clinical factors, and cancer center status were considered. Compared to the reference patients, patients who were treated in an NCI-designated cancer center or a hospital affiliated with such center, who had certain types of cancers (e.g., B-cell), or had advanced-stage disease had a higher chance to use expensive chemotherapy treatment; patients who were older, survived the first 12 months upon diagnosis, had advanced-stage disease, or had more drug claims had higher drug costs. CONCLUSIONS: Hospital 340B status was not significantly associated with use of more expensive cancer drugs or drug costs once other relevant factors (e.g., cancer center status, advanced-stage disease) were taken into account

Transforming Transplantation Access: A Federal Directive for Comprehensive Pre-Waitlisting Data Collection

There is substantial variation in access to transplantation across the United States that is not entirely explained by the availability of donor organs. Barriers to transplantation and variation in care among patients with end-stage organ disease exist prior to patients\u27 placement on a transplant waiting list as well as following waitlist placement. However, there are currently no national data available to examine rates and variations in key care processes related to pre-listing, including transplant referral, evaluation, or candidate selection. In February of 2024, the Health Resources and Services Administration (HRSA) released a directive and, in November 2024, released for public comment the proposed expansion of the Organ Procurement and Transplantation Network (OPTN) data collection to include pre-waitlist data for all solid organ transplant patients to promote transparency across the transplant continuum. While data elements and details have not been finalized, the purpose of this article is to detail the rationale and anticipated details for pre-waitlisting data collection to inform the transplant community. These data aim to examine care processes and barriers to care for patients with end-stage organ disease in the United States

A prospective study of a whole blood metal mixture and depressive symptoms among Black women from Detroit, Michigan

Exposure to metals has been previously associated with depressive symptoms, but few studies have considered potential effects of metal mixtures. In addition, few previous studies have been conducted among Black women, who are disproportionately at risk for exposure to some metals and greater depression incidence and severity. We analyzed data from the Study of Environment, Lifestyle, and Fibroids (SELF), a prospective cohort study of reproductive-aged Black women from Detroit, to examine associations between a mixture of metals, metalloids, and trace elements ( metals ) and depressive symptoms (n = 1450). SELF participants self-identified as Black or African American and were 23-34 years of age at enrollment. We collected covariate information on structured questionnaires and whole blood samples at baseline. We quantified 17 metals in whole blood using inductively coupled plasma mass spectrometer triple quadruple or Direct Mercury Analyzer-80. Participants reported depressive symptoms on the Center for Epidemiologic Studies Depression Scale (CES-D) at the 20-month follow-up visit, where higher CES-D scores reflected greater depressive symptoms. We used quantile-based g-computation to estimate the cumulative association of the metal mixture with CES-D scores, adjusting for age, household income, educational attainment, body mass index, smoking status, alcohol intake, and parity. We estimated beta coefficients (with 95 % confidence intervals [CI]) as the percent difference in CES-D scores per quartile increase in all metals. A one-quartile increase in the metal mixture was associated with 14.8 % lower (95 % CI=-26.7 %, -1.1 %) CES-D scores, reflecting lower depressive symptoms. The mixture association was driven by nickel, copper, cesium, molybdenum, and lead. Other neurotoxic metals (cadmium, arsenic, mercury, chromium) were associated with greater depressive symptoms. Findings from this study suggest that exposure to a mixture of metals may affect depressive symptoms in Black women, with individual metals acting in opposing directions

S2303: phase II/III trial of paclitaxel + ramucirumab ± nivolumab in gastric and esophageal adenocarcinoma (PARAMUNE)

Cancer of the stomach and esophagus is aggressive with poor patient outcomes. Historically, the treatment for such patients has involved the use of combined chemotherapy. In recent years, the addition of immunotherapy to the treatment of patients with advanced cancers of the stomach and esophagus has led to patients living longer with a longer period without tumor growth. However, whether continuing the immunotherapy after the tumor has grown while on treatment is beneficial or not is a question that has not been answered. The standard treatment after patients’ tumor has grown on their initial treatment involves a drug called ramucirumab, which blocks the ability of cancer cells to create abnormal blood vessels around itself to support its own growth. Recent research suggests that drugs like ramucirumab make immunotherapy more effective. To test whether continuing immunotherapy in combination with this “second-line” treatment that includes ramucirumab, we have designed a study to compare whether one group who will receive immunotherapy will live longer versus another group who will not receive immunotherapy

Open Treatment of Mandible Angle Fractures and the Role for Maxillomandibular Fixation

BACKGROUND: Maxillomandibular fixation (MMF) remains a mainstay in the treatment algorithm of bony injuries involving the lower facial skeleton to help restore premorbid occlusion. PURPOSE: To compare postoperative open reduction and internal fixation outcomes in dentate patients with noncomminuted, isolated angle fractures of the mandible between patients that underwent postoperative MMF and those who did not. METHODS: Retrospective review of 224 patients treated for isolated, noncomminuted mandible angle fractures between January 1997 and December 2023. Patients were either kept in occlusion with intraoperative maxillomandibular (MMF) or with bimanual reduction. Patients either remained in MMF or not postoperatively. RESULTS: There was not a significant overall association of surgery group on complications (P=0.44). The odds of complications were lower for the intraoperative bimanual reduction group without MMF compared with patients that underwent intraoperative and postoperative MMF (odds ratio=0.48, P=0.26). CONCLUSION: This study describes similar surgical outcomes after open reduction and internal fixation of isolated, noncomminuted mandible angle fractures with or without postoperative MMF. This study helps show that in appropriately selected cases, postoperative MMF may not be necessary in this specific mandible fracture pattern

The Safety Profile of Inclisiran in Patients with Dyslipidemia: A Systematic Review and Meta-Analysis

INTRODUCTION: Inclisiran is a novel drug that employs ribonucleic acid (RNA) interference to lower the levels of the proprotein convertase subtilisin/kexin type 9 (PCSK9) protein. It has demonstrated a significant reduction in LDL cholesterol levels compared to a placebo. We aim to comprehensively evaluate the safety of using Inclisiran in patients with dyslipidemia and ASCVD or an ASCVD risk equivalent. METHODS: Four electronic databases, namely, Pubmed/MEDLINE, Web of Science, Embase, and ClinicalTrials.gov, were searched from inception to June 2024 to identify relevant randomized controlled trials (RCTs) comparing safety profiles of Inclisiran and the control group. The outcomes investigated were all-cause mortality, major adverse cardiovascular events (MACEs), injection-site adverse events, new-onset or worsening type 2 diabetes mellitus (T2DM), and nasopharyngitis. The effect estimates of outcomes were assessed using the risk ratio (RR) with a 95% confidence interval (CI). Random-effects meta-analysis was conducted using the restricted maximum likelihood method. Subgroup analysis was performed based on different dosing regimens. RESULTS: The study included 7 RCTs, enrolling 4790 patients (age 63.8 ± 9.7 years, 33.2% females) who received Inclisiran. Compared to the control group, Inclisiran use did not yield a significant effect on all-cause mortality (RR, 0.92; 95% CI, 0.54 to 1.54; I(2) = 0%), MACEs (RR, 0.98; 95% CI, 0.82 to 1.17; I(2) = 0%), nasopharyngitis (RR, 1.10; 95% CI, 0.83 to 1.45; I(2) = 0%), and T2DM (RR, 1.02; 95% CI, 0.85 to 1.21; I(2) = 0%). However, Inclisiran use demonstrated a significant increase in injection-site adverse events (RR, 6.50; 95% CI, 3.20 to 13.20; I(2) = 29%). CONCLUSIONS: Inclisiran use significantly increased injection-site reactions, with no increase in mortality, T2DM, or nasopharyngitis. It demonstrates a generally favorable safety profile, making it a promising option for lipid management in individuals at high cardiovascular risk, such as those with ASCVD or equivalent conditions. While it effectively improves dyslipidemia, decision-makers should be aware of an increased incidence of injection-site reactions, which, though typically mild, warrant consideration in clinical practice. Further trials are required to assess the safety of Inclisiran, particularly the association of the severity of injection-site adverse events over longer treatment durations

TP53-Mutated Acute Myeloid Leukemia: Review of Treatment and Challenges

Patients with acute myeloid leukemia (AML) harboring mutations in TP53 (TP53-MT) have poor responses to current therapies and unfavorable prognoses. Despite the recognition of variant TP53 as an adverse feature of AML, an optimal treatment regimen has not yet been established, underlining a critical need for new, more effective therapeutic combinations and novel treatments. We present the case of a patient with TP53-MT AML and marked myelodysplasia who developed primary refractory disease after induction therapy with the intensive chemotherapy regimen of liposomal daunorubicin and cytarabine. Our patient\u27s optimal response to second induction chemotherapy with FLAG-Ida prompted an exploration of established and investigational treatment regimens for this specific high-risk AML subtype. Therefore, we performed a comprehensive literature review of findings from studies exploring AML therapies, focusing on outcomes for patients with TP53-MT AML. The summary provided here reveals the complexity of defining the therapeutic responses of patients with the heterogeneous TP53-MT genetic background and the challenges in treating this high-risk form of AML. Future work must continue to investigate novel therapies and combinations to improve patient outcomes in this vulnerable population

Development of Patient-Specific Nomogram to Assist in Clinical Decision-Making for Single Port Versus Multi-Port Robotic Partial Nephrectomy: A Report from the Single Port Advanced Robotic Consortium

Objective: To develop a patient-specific algorithm to better guide clinical decision-making when considering between single port (SP) and multi-port (MP) robotic partial nephrectomy (RPN). Materials and Methods: A retrospective review was performed on the institutional review board-approved, prospectively maintained multi-institutional database of the Single Port Advanced Research Consortium to identify all consecutive patients who underwent SP and MP-RPN between 2019 and 2023. Baseline clinicodemographic variables were used to identify the significant predictors of SP-RPN. The significant variables were used to construct a nomogram to predict the likelihood of SP vs MP-RPN. Results: Of the 1021 patients included in our analysis, 189 (18.5%) and 832 (81.5%) underwent SP and MP-RPN, respectively. Statistically significant predictors of SP-RPN included a lower comorbidity profile, a significant abdominal surgical history as characterized by a higher Hostile Abdomen Index, as well as tumors of lower complexity. The nomogram generated using the aforementioned variables demonstrated a reasonable performance with an area under the curve of 0.79. An optimal cutoff point was determined, with likelihood ratios above 0.12 indicating a preference for SP-RPN. Of note, all SP-RPN cases that scored above the 0.12 cutoff exhibited improved perioperative outcomes, including shorter ischemia time and less intraoperative blood loss. Conclusions: In this study, we have devised a novel patient selection nomogram aimed at enhancing clinical decision-making within the expanding repertoire of RPN approaches. The findings highlighted in this study offer valuable guidance to facilitate appropriate patient selection and thereby ensuring favorable perioperative outcomes associated with RPN procedures

Outcomes of Deceased Donor Kidneys Turned Down for Biopsy Results That Were Transplanted Elsewhere

Background: The number of kidney transplants performed in the US remains insufficient for the number of patients awaiting one. To meet these demands, transplant centers should review their kidney utilization, especially for kidneys that were not accepted. Previous review of kidney offers turned down at our institution revealed a common refusal reason to be unacceptable biopsy results. Some of these organs were subsequently transplanted elsewhere. We analyzed accepted versus turned down biopsied kidneys for Henry Ford Hospital (HFH) to assess our acceptance practices and the need for modifying our acceptance criteria. Methods: Retrospective analysis of OPTN data on deceased donor kidneys offered by Gift of Life Michigan to HFH between 8/2/2022 and 7/19/2024. Only kidneys that were biopsied and ultimately transplanted were included. Biopsied kidneys were classified as either “kidney transplanted by center (KTC)” if accepted and transplanted by HFH and “kidney transplanted elsewhere (KTE)” if turned down by HFH and transplanted elsewhere. Only kidneys turned down for biopsy- specific reasons were included in the analysis. Kidney characteristics and recipient outcomes were compared between the groups. Outcomes of interest were rate of delayed graft function (DGF), recipient 6-month and 1-year serum creatinine (Se Cr), and 6-month and 1-year graft (GS) and patient survival (PS). Results: 103 offers with kidney biopsies were included in the analysis, with 46 in the KTC group and 57 in the KTE group. Selected analysis results are shown in Figure 1. KTE kidneys had a significantly higher percentage of glomerulosclerosis and longer cold ischemia time. Donor characteristics and other biopsy features did not differ significantly between the groups. Recipient outcomes did not differ significantly between the two groups in terms of DGF rate, 6-month and 1-year Se Cr, and 6-month and 1-year GS or PS. Conclusions: While kidney characteristics differed between accepted and passed biopsy kidneys, no significant differences in renal allograft outcomes were noted. Findings of comparable outcomes with KTE kidneys can help reframe a center’s understanding of acceptable organ quality metrics and motivate centers to rethink and expand their acceptance criteria. [Formula presented] DISCLOSURES: Z.Y. Lu: None. A. Yoshida: None. A. Patel: None