Explore the vast range of titles available.

Background The Centers for Medicare and Medicaid Services (CMS) price transparency rule tries to facilitate cost-conscious decision-making. For surgical services, such as pancreaticoduodenectomy (PD), factors mediating transparency and real-world reimbursement are not well described. Methods The Leapfrog Survey was used to identify United States hospitals performing PD. Financial and operational data were obtained from Turquoise Health and CMS Cost Reports. Chi-square tests and modified Poisson regression evaluated associations with reimbursement disclosure. Two-part logistic and gamma regression models estimated effects of hospital factors on commercial, Medicare, and self-pay reimbursements for PD. Results Of 452 Leapfrog hospitals, 295 (65%) disclosed PD hospital or procedure reimbursements. Disclosing hospitals were larger (beds > 200: 81.0% vs. 71.3%, p = 0.04), reported higher net margins (0.7% vs. − 2.1%, p = 0.04), more likely for-profit (26.1% vs. 6.4%, p < 0.001), and teaching-affiliated (82.0% vs. 65.6%, p < 0.001). Nonprofit status conferred hospitalization reimbursement increases of $8683–$12,329, while moderate market concentration predicted savings up to $5066. Teaching affiliation conferred reimbursement increases of $4589–$16,393 for hospitalizations and $644 for procedures. Top Leapfrog volume ratings predicted an increase of up to $7795 for only Medicare hospitalization reimbursement. Conclusions Nondisclosure of hospital and procedural reimbursements for PD remains a major issue. Transparency was noted in hospitals with higher margins, size, and academic affiliation. Factors associated with higher reimbursement were non-profit status, academic affiliation, and more equitable market share. Reimbursement inconsistently tracked with PD quality or volume measures. Policy changes may be required to incentivize reimbursement disclosure and translate transparency into increased value for patients.

•The novel TLPLDC technology creates a patient-specific dendritic cell vaccine.•Vaccine production requires just 120 ml blood, 1 mg tumor, and 48 h to produce.•The vaccine is well tolerated, with primarily grade 0/1 toxicities.•Nearly 40% of patients with a wide variety of advanced cancers demonstrated clinical benefit. Tumor vaccines use various strategies to generate immune responses, commonly targeting generic tumor-associated antigens. The tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is produced from DC loaded with autologous tumor antigens, creating a patient-specific vaccine. Here, we describe initial phase I/IIa trial results. This trial includes patients with any stage solid tumors, ECOG ≤1, and >4 months life-expectancy. A personalized vaccine is created using 1 mg of tumor and 120 ml blood (to isolate DC). Primary vaccination series (PVS) is four monthly inoculations. Patients are followed per standard of care (SOC). Endpoints include safety and tumor response (RECIST v1.1). 44 patients were enrolled and vaccinated consisting of 31 late stage patients with residual/measurable disease, and 13 disease-free patients after SOC therapies. While 4 patients progressed before completing the PVS, 12/31 (39%) demonstrated clinical benefit (2 complete responses, 4 partial responses, 6 stable disease). In the adjuvant setting, 46% of late stage patients remain disease free at a median of 22.5 months. The TLPLDC vaccine is scalable, generates a personalized DC vaccine, and requires little autologous tumor tissue and few DC. The vaccine is safe, with primarily grade 0–2 toxicities, and nearly 40% clinical benefit rate in varied tumors, warranting further study. Trial Registration: ISRCTN81339386, Registered 2/17/2016.

Background E39, an HLA‐A2‐restricted, immunogenic peptide derived from the folate‐binding protein (FBP), is overexpressed in multiple malignancies. We conducted a phase I/IIa trial of the E39 + GM‐CSF vaccine with booster inoculations of either E39 or E39′ (an attenuated version of E39) to prevent recurrences in disease‐free endometrial and ovarian cancer patients(pts). Here, we present the final 24‐month landmark analysis. Patients and methods HLA‐A2 + patients receiving E39 + GM‐CSF were included in the vaccine group (VG), and HLA‐A2‐ pts (or HLA‐A2 + patients refusing vaccine) were followed as the control group (CG). VG group received 6 monthly inoculations as the primary vaccine series (PVS) and were randomized to receive either E39 or E39′ booster inoculations. Demographic, safety, immunologic, and disease‐free survival (DFS) data were collected and evaluated. Results Fifty‐one patients were enrolled; 29 in the VG and 22 in the CG. Fourteen patients received <1000 μg and 15 received 1000 μg of E39. There were no clinicopathologic differences between VG and CG or between dose groups. E39 was well tolerated. At the 24 months landmark, DFS was 55.5% (VG) vs 40.0% (CG), P = 0.339. Patients receiving 1000 μg and boosted patients also showed improved DFS (P < 0.03). DFS was improved in the 1000 μg group after treatment of primary disease (90.0% vs CG:42.9%, P = 0.007), but not in recurrent patients. In low‐FBP expressing patients, DFS was 100.0% (1000 μg), 50.0% (<1000 μg), and 25.0% (CG), P = 0.029. Conclusions This phase I/IIa trial reveals that E39 + GM‐CSF is safe and may be effective in preventing recurrence in high‐risk ovarian and endometrial cancer when optimally dosed (1000 μg) to FBP low patients being treated for primary disease. The folate binding protein derived E39 peptide vaccine is safe, and may improve disease‐free survival in clinically disease‐free ovarian and endometrial cancer patients, especially in those with primary disease and low FBP expression. These results will help determine the population of further studies of E39, and subgroup analyses have broader implications for peptide vaccines.

Ventral hernia is a common complication of open Roux-en-Y gastric bypass (RYGB). The aim of this study was to determine whether prophylactic mesh placement during RYGB would reduce the incidence of postoperative hernias. Obese patients undergoing RYGB by a single surgeon had prosthetic mesh placed in a subfascial location at the conclusion of the procedure. The incidences of recurrent hernia and morbidity associated with the placement of mesh were assessed. Sixteen patients underwent RYGB with prophylactic mesh placement over 6 months. The average preoperative body mass index was 46.6 kg/m 2. Half of the patients were diabetics. None were smokers. During mean follow-up of 6 months, 4 patients (25%) required mesh excision, 3 for infection and 1 for a persistently symptomatic seroma. One patient was explanted incidentally in the course of reexploration for intractable nausea and vomiting. Another developed an incisional hernia despite prophylactic mesh. In the investigators' experience, the use of prophylactic new-generation mesh at the time of open RYGB led to an unacceptable rate of local complications. They caution against this technique in patients undergoing open RYGB.

Background Stage IV melanoma has high mortality, largely unaffected by traditional therapies. Immunotherapy including cytokine therapies and checkpoint inhibitors improves outcomes, but has significant toxicities. In this phase I/IIa trial, we investigated safety and efficacy of a dendritoma vaccine, an active, specific immunotherapy, in stage IV melanoma patients. Methods Autologous tumor lysate and dendritic cells were fused creating dendritoma vaccines for each patient. Phase I patients were vaccinated every 3 months with IL-2 given for 5 days after initial inoculation. Phase IIa patients were vaccinated every 6 weeks with IL-2 given on days 1, 3 and 5 after initial inoculation. Toxicity and clinical outcomes were assessed. Results Twenty-five patients were enrolled and inoculated. All dendritoma and IL-2 toxicities were

Journal Article

Share this book

Add to My Shelf