Analysis of economic impact of laparoscopic liver resection according to surgical difficulty.

INTRODUCTION: The advantages of laparoscopic liver resection (LLR) are well known, but their financial costs are poorly evaluated. The aim of this study was to analyze the economic impact of surgical difficulty on LLR costs, and to identify clinical factors that most affect global charges. METHODS: All patients who underwent LLR from 2014 to 2018 in a single French center were included. The IMM classification was used to stratify surgical difficulty, from group I through group III. The costing method was done combining top-down and bottom-up approaches. A multivariate analysis was performed in order to identify clinical factors that most affect global charges. RESULTS: Two hundred seventy patients were included (Group I: n = 136 (50%), Group II: n = 60 (22%), Group III: n = 74 (28%)). Total expenses significantly increased (p < 0.001) from Group I to Group III, but there was no difference regarding financial income (p = 0.133). Technical platform expenses significantly increased (p < 0.001) from Group I to Group III and represented the main expense among all costs with a total of 4 930 ± 2 601€. Among technical platform expenses, the anesthesia platform represented the main expense. In multivariate analysis, the four clinical factors that affected global charges in the whole study population were operating time (p < 0.001), length of stay (p < 0.001), admission in ICU (p < 0.001) and the occurrence of major complication (p < 0.05). An admission in ICU was the clinical factor that affected most global charges, as an ICU stay had a 39.1% increase effect on global charges in the whole study population. CONCLUSION: LLR is a cost-effective procedure. The more complex is the LLR, the higher is the hospital cost. An admission in ICU was the clinical factor that most affected global charges.

Enhanced recovery protocols in colonic surgery: retrospective cohort analysis of economic impact from an institutional point of view.

BACKGROUND: Despite increasing evidence supporting the beneficial effects of enhanced recovery protocols (ERPs), their accurate economic impact on institutions remains lacking. The aim of this study was to analyze ERP economic impact in a French center in order to further encourage implementation. METHODS: All patients who underwent elective laparoscopic right or left colectomy for benign or malignant pathology from 2014 to 2017 in a single center were retrospectively reviewed. ERP according to national recommendations was effective starting November 2015. Perioperative data and all direct costs borne by the institution were collected for each patient. Patients who underwent colectomy before and after ERP implementation were compared. RESULTS: Overall, 288 patients were included of which 144 received conventional perioperative care (CC) and 144 received ERP. There were 161 (56%) men, median age was 71 (28-92) years, and 242 (84%) patients underwent surgery for malignant disease. Operative time, intraoperative blood loss, and severe postoperative complications were similar between both groups. ERP was associated with reduced Clavien-Dindo I-II postoperative complications (15% vs. 28%, p = 0.010) and overall in-hospital stay (6 vs. 7 days, p = 0.003). Overall institutional costs were lower in the ERP group although difference was not statistically significant (7022 vs. 7501 euros, p = 0.098). Estimated savings per patient reached a mean of 480 euros. CONCLUSIONS: In a tertiary French center, ERP was associated with reduced postoperative morbidity and in-hospital stay resulting in considerable cost savings. Although not significant, ERP resulted in positive economic impact even in an early implementation phase.

Comparative transplacental transfer of taxanes using the human perfused cotyledon placental model.

OBJECTIVES: The use of taxanes (paclitaxel and docetaxel) in pregnant cancer patients is increasing. We aimed to compare their transplacental transfer using the gold standard human placental perfusion model, to guide drug selection. STUDY DESIGN: Term placentas were perfused with paclitaxel or docetaxel and 2 different albumin concentrations. Main transfer parameters such as fetal transfer rate (FTR), clearance index, and placental uptake of taxanes were assessed. RESULTS: Twelve placentas were perfused, 6 with paclitaxel and 6 with docetaxel. Mean FTR of paclitaxel decreased significantly from 5.67 ± 0.02% in low albumin conditions to 1.72 ± 0.09% in physiological albumin conditions. Similarly, mean clearance index decreased significantly from 0.22 ± 0.02 to 0.09 ± 0.01. Regarding docetaxel, mean FTR were similar in low albumin and physiological conditions (5.03 ± 0.60% and 4.04 ± 0.22%, respectively) while mean clearance index decreased significantly from 0.18 ± 0.02 to 0.13 ± 0.01. Taxanes accumulation in cotyledon was similar for docetaxel and paclitaxel: 4.54 ± 1.84% vs 3.31 ± 1.88%, respectively. CONCLUSION: Transplacental transfer and placental accumulation of paclitaxel and docetaxel were low and similar, especially in physiological conditions of albumin. Further studies are warranted to optimize the selection of a taxane in pregnant cancer patients.

Treatment of bevacizumab-induced hypertension by amlodipine.

BACKGROUND: Hypertension is a common toxicity of anti-VEGF agents, but its optimal treatment remains to define. This study aimed to describe the efficacy and tolerability of amlodipine, a calcium channel blocker, in patients with metastatic malignancies treated with bevacizumab, a humanized monoclonal antibody to VEGF. PATIENTS AND METHODS: One hundred and eighty-seven patients with advanced or metastatic NSCLC, colorectal or ovarian cancer receiving bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) and chemotherapy were eligible for this analysis. Blood pressure was measured at home twice daily according to international guidelines. Patients received amlodipine 5 mg daily for grade ≥ 2 bevacizumab-induced hypertension. RESULTS: Twenty-six patients received amlodipine 5 mg daily for de novo hypertension (group A), and another 10 patients received amlodipine for exacerbation of previously existing hypertension (group B). Hypertension was controlled within 7 days under amlodipine in 23/26 (88.5%, 95%CI: 76.2-100) patients in group A, and 8/10 (80%, 95%CI: 55.2-100) patients in group B, with a favourable toxicity profile. CONCLUSIONS: Amlodipine 5 mg daily appears safe and efficient for the treatment of hypertension in patients receiving bevacizumab at a dose-intensity of 2.5 mg/kg/week. Further prospective studies are warranted to confirm these results.

Rituximab maintenance therapy for granulomatosis with polyangiitis and microscopic polyangiitis.

OBJECTIVE: To evaluate the efficacy compared to the relapse risk and tolerance of systematic rituximab (RTX) infusions as maintenance therapy for patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), who entered remission taking conventional immunosuppressants or RTX. METHODS: A retrospective study of the main clinical characteristics, outcomes, and RTX tolerance of patients who had received ≥ 2 RTX maintenance infusions in our center, regardless of induction regimen, between 2003 and 2010. RESULTS: We identified 28 patients [4 MPA and 24 GPA; median age 55.5 yrs (range 18-78); 17 (60%) males] who received a median of 4 (range 2-10) RTX maintenance infusions, with median followup of 38 months (range 21-97) since diagnosis or last flare. None experienced a RTX infusion-related adverse event; 15 patients (among the 21 with available data) had hypogammaglobulinemia (predominantly IgM) prior to their last RTX maintenance infusion; 3 had infectious events (1 cutaneous abscess, 1 otitis, 1 fatal H1N1 flu). Two patients suffered pulmonary relapses shortly before a planned RTX maintenance infusion (both had increased antineutrophil cytoplasmic antibody levels and 1 had CD19+ lymphocyte reconstitution). CONCLUSION: Rituximab maintenance therapy was well tolerated but did not completely prevent relapses and persistent "grumbling" disease. These preliminary results remain to be confirmed by a randomized controlled trial currently in progress.

Ambulatory administration of 5-day infusion ifosfamide+mesna: a pilot study in sarcoma patients.

PURPOSE: Ifosfamide is a cornerstone of chemotherapy in bone and soft-tissue sarcoma. Results of pharmacokinetic studies indicate that the optimal schedule of ifosfamide should be repeated doses over several days. With the development of 5-day infusion devices, we developed and evaluated a 5-day infusion regimen of ifosfamide in sarcoma patients in the outpatient setting. METHODS: Sarcoma patients requiring chemotherapy after at least one doxorubicin-based line were enrolled in this study. Ifosfamide+mesna was administered as 1:1 concentration for a total of 6 g/m2 of each over 5 days (i.e. 1.2 g/m2 per day as continuous infusion) every 3 weeks. Patients were treated until progression or limiting toxicity, and salvage surgery was attempted when possible. An economic study was run comparing ifosfamide plus mesna as a 5-day infusion regimen and conventional Ifosfamide regimen. RESULTS: Thirteen sarcoma patients were evaluable. The median number of cycles per patient was 6 (range, 1-8), for a total of 69 cycles. No acute encephalopathy or aggravation of renal function was noted. Acute grade 3 and 4 haematological toxicities were observed in 11.6 and 1.4% of patients, respectively without febrile neutropenia. Median time to progression survival and overall survival were 8.7 and 21.5 months, respectively. Total cost per cycle for a 2-m2 patient body surface area was ambulatory infusion=1,891 euros and conventional ifosfamide=6,256 euros. CONCLUSION: The combination of ifosfamide and mesna as a continuous infusion over 5 days is feasible and well tolerated in the outpatient setting using infusion device. Its very favourable cost-effectiveness invites to further develop this approach.

How to use clinical vignettes in hematology--a pilot survey in the context of chronic lymphocytic leukemia.

RATIONALE: Case vignettes have been validated as an efficient tool for assessing the quality of clinical practices, and have been used in a variety of medical settings. However, their use in the field of hematology has not been tested. OBJECTIVES: We undertook a study to pre-test seven case vignettes, and thereby to assess practice patterns and, when possible, guideline adherence in the treatment of chronic lymphocytic leukemia (CLL) by French hematologists. FINDINGS: Of the 64 hematologists who agreed to participate, 26 (41%) completed the vignettes. We found significant differences in the physicians' patterns of ordering further investigations among young and old patients in the same clinical context. This is not consistent with published guidelines. Moreover, the most striking differences concerned the physicians' interpretations of prognostic factors and the use of radiological testing before treatment. Modalities of treatment were variable across clinical situations, especially with regard to second-line treatments. Clinicians understood the vignettes well, except for those that dealt with stem cell transplantation. CONCLUSIONS: This pilot study showed the feasibility of the use of case vignettes to assess the quality of clinical practice in CLL. The initial results identified deviations from the published guidelines. A large-scale European survey will commence in a few months.

[Medico economic analysis in first line chemotherapy in advanced lung cancer]. / Analyse economique de deux chimiothérapies en première ligne du cancer pulmonaire a un stade avancé.

Our objective was to analyse economic consequences modifying first line chemotherapy in treatment non small cell lung cancer IIIB-IV. Therefore a cost minimisation has been performed. Resources consumption were collected in a Pneumology department for 21 patients receiving previously mitomycine-ifosfamide-platin and for the 21 first patients receiving vinorelbine-platin, new patients diagnosed during year 2001. Costs were derived from hospital accounting system, economic analysis performed from the hospital and from the health French system points of view. Activity Synthetic Index point decrease of 2.9% per patient in vinorelbine-platin versus mitomycine-ifosfamide-platin, as an increase of 64.6% of hospital drug spending is registered (1,893 Euro versus 1,150 Euro) and an over cost of 15.7% for health French system (14179 Euro versus 12,257 Euro). Whatever the perspective of economic analysis, vinorelbine-platin arm is dominated by the mitomycine-ifosfamide-platin arm.