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result(s) for
"Faron, M"
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Prognostic value of total, free and lipoprotein fraction-bound plasma mitotane levels in advanced adrenocortical carcinoma: a prospective study of the ENDOCAN-COMETE-Cancer network
by
Leboulleux, S.
,
Al-Ghuzlan, A.
,
Delahousse, J.
in
Adrenal Cortex Neoplasms - blood
,
Adrenal Cortex Neoplasms - drug therapy
,
Adrenal Cortex Neoplasms - mortality
2025
Purpose
Mitotane is the only approved treatment for metastatic adrenocortical carcinoma (ACC). Monitoring plasma levels is recommended, but its predictive value is insufficient.
Methods
This prospective study of the French ENDOCAN-COMETE network aimed to investigate the prognostic role of plasma mitotane levels pharmacokinetics and free or bound to lipoprotein fraction measurements during six consecutive months. Lipoprotein fractions were isolated by ultracentrifugation, and mitotane level was determined by HPLC–UV. Total, free, and lipoprotein fraction bound plasma mitotane were monitored every two months for six months with morphological assessment. The primary endpoint was overall survival (OS).
Results
21 patients with metastatic ACC were included. Median overall survival was 23 months. The median free mitotane level per patient was 12% (± 7%), and the majority (88%) was bound to lipoprotein fractions. Several pharmacokinetics measures of total mitotane were related to OS: first level at one month (
p
= 0.026), mean level (
p
= 0.055), and area under the curve (AUC) (
p
= 0.048), with higher exposure associated to longer OS. Free mitotane (not bounded) and mitotane bounded to lipoprotein subfraction added no prognostic values. The relationship between the mitotane level and OS suggested a minimum “effective” threshold of 10–15 mg/L or an area under the curve above 100 mg/L/month with no individualized maximum value.
Conclusion
This prospective study did not identify any added prognostic value of free mitotane level over the total level. Early total mitotane level measurements (before 3–6 months) were related to OS with a higher and faster exposure related to more prolonged survival.
Journal Article
Long-Term Outcome After Surgery for a Localized Retroperitoneal Soft Tissue Sarcoma in Elderly Patients: Results from a Retrospective, Single-Center Study
2018
BackgroundTo evaluate short- and long-term results after curative surgery for a retroperitoneal sarcoma (RPS) in elderly patients.MethodsWe retrospectively analyzed data of all patients operated in our single, tertiary care center for a nonmetastatic RPS and identified patients aged 70 years and older.ResultsAmong 296 patients with an RPS treated between 1994 and 2015, 60 (20%) were aged 70 years and older (median age 74 years; range 70–85). The median tumor size was 24 cm (range 6–46). Forty-six patients (77%) had mass-related symptoms at the time of diagnosis. The most frequent histological subtypes were de-differentiated liposarcoma (53%, n = 32) and well-differentiated liposarcoma (35%, n = 21). Twenty-two patients (37%) had perioperative radiotherapy and/or chemotherapy. Fifty-eight patients (97%) had macroscopically complete resection. The postoperative mortality was 8% and severe morbidity (Dindo/Clavien ≥ 3) was 32%. A reoperation was required for ten patients (17%). After a median follow-up of 20 months (range 1–121), the 5-year overall survival (OS) rate was 90% (95% confidence interval [CI] 79–100%), and median OS was not reached. The cancer-specific death rate was 88%. No prognostic factor for disease-specific survival was detected. The 5-year disease-free survival (DFS) rate was 52% (95% CI 33–84%) and 5-year locoregional recurrence-free survival rate was 52% (95% CI 33–84%). Median DFS was 94 months (95% CI 35–NA). Reoperation after inappropriate surgery and postoperative morbidity were independent predictive factors of locoregional relapse. No predictive factors of distant metastasis were found.ConclusionsCurative surgery is feasible in selected elderly patients but with higher mortality and morbidity rates than in younger patients. It enables a prolonged survival. Future studies should focus on selection process to minimize postoperative mortality and morbidity.
Journal Article
946 Long term follow-up of a large series od stage II/III serous ovarian borderline tumors
2021
Introduction/Background*The aim of this study was to assess prognostic factors and implications on further management in a large series of stage-II or III Serous Borderline Ovarian Tumors (SBOTs) with a long-term follow-up.MethodologyPatients with SBOTs and peritoneal implants treated in, or referred to, our institution were retrospectively reviewed. Prognostic factors on invasive recurrence, disease-free (DFS) and overall survival (OS) were analyzed.Result(s)*Between 1971 and 2017, 212 patients were identified and followed (33 having invasive implants). After a median follow-up of 115 months, 70 recurrences were observed, 28 of them under the form of invasive disease. DFS at 5 years and 10 years was 73% and 62% respectively. The use of a conservative treatment (HR=5.5[3.33-9.08], p<.0001), the presence of ≥ 3 peritoneal sites with implants (HR=1.65[1.01-2.72], p=.045) were unfavorable prognostic factors for DFS. The presence of ≥ 3 peritoneal sites with implants (HR=3.02[0.96-9.53], p=.049) and the presence of stromal microinvasion (HR=3.19[1.12-9.1], p=.022) were unfavorable prognostic factors for OS. Non-conservative surgery (HR=7[2.35-20.87], p=0.0002), invasive implants (HR=5.37[1.29-22.26], p=0.013), and ≥ 3 peritoneal sites with implants (HR=3.56 [1.11-11.39], p=0.024) were identified as predictors of recurrence in the form of an invasive disease. Invasive implants were not associated with DFS (HR=1.39[0.77-2.51], p=0.27), nor OS (HR=1.76[0.57-5.47], p=0.32).Conclusion*After a long-term follow-up, type of peritoneal implants is no longer a prognostic factor for OS. Implants ≥ 3 peritoneal sites seem to impact significantly OS and then require a specific follow-up in this subgroup of patients.
Journal Article
947 Results after conservative surgery of stage II/III serous borderline ovarian tumors
2021
Introduction/Background*The aim of this study was to assess the outcomes of a large series of patients treated conservatively for a stage II or III serous borderline tumors of the ovary (SBOTs) with a long-term follow-up.MethodologyPatients with SBOTs and peritoneal implants, treated in or referred to our institution, were retrospectively reviewed. Outcomes of patients treated conservatively (preservation of the uterus and at least a part of one ovary) to promote subsequent fertility were specifically analyzed.Result(s)*Between 1971 and 2017, 212 patients were identified and followed-up. Among them, 65 underwent a conservative treatment. Eight patients had invasive implants. Among patients treated conservatively, 38 (58%) patients recurred. Twenty-eight recurrences were observed under the form of borderline tumor on spared ovary and/or noninvasive implants, but 8 patients had a recurrence under the form of invasive disease. Compared to radical surgery, the use of a conservative treatment (p<.0001) was a prognostic factors on disease free survival (DFS), but without impact on overall survival (OS). Nevertheless, 3 deaths occurred. Twenty-four pregnancies (13 spontaneous) were observed in 20 patients (29 patients wishing to be pregnant).Conclusion*In this series collecting the largest number of patients undergoing conservative surgery for stage II/III SBOTs, spontaneous pregnancies can be achieved after conservative treatment of advanced-stage disease, but the recurrence rate is high, and 3 deaths were observed. These patients spared their fertility but with a high rate of recurrence. Uncertainties about safety of conservative treatment should be exposed to them.
Journal Article
1015 Linear relationship of peritoneal cancer index and survival in patients with epithelial ovarian cancer in carcinomatosis
2021
Introduction/Background*The aim of this study was to investigate the relation between the PCI and overall survival (OS) and recurrence-free survival (RFS). The peritoneal cancer index (PCI) is one of the main prognostic factor for the evaluation of ovarian peritoneal carcinosis. Different thresholds have been reported in terms of prognosis and to help in the decision between chemotherapy or primary surgery, but no consensus was found.MethodologyPatients treated at Gustave Roussy between 2004 and 2017 for advanced epitoneal ovarian cancer in complete resection were included. The correlation between PCI and survival was studied using statistical modeling. Multivariate analysis was performed by a logistic regression model.Result(s)*Of the 351 patients included, 27% had initial surgery, 73% had interval surgery. The median follow-up was 52.7 months. The mean PCI was 10.8 (0-32). The linear model best represented the relationship between PCI and OS. Patients with neoadjuvant chemotherapy had a greater instantaneous risk of baseline death than those with initial surgery, as well as a more rapid increase in this risk as PCI increased. OS and PFS were better in the initial surgery group (103.4 months [79.1-NA] vs. 66.5 months [59.1-95.3] and 31.8 months [23.7-48.7] vs. 25.9 months [23.2-29] respectively). Risk factors for death were BMI, PCI and performance of neoadjuvant chemotherapy.Conclusion*PCI is a major prognostic element but its linear relationship with survival does not allow us to establish a cut-off. Moreover, the prognostic impact of PCI is even stronger in the case of primary chemotherapy.
Journal Article
Effectiveness of NELSON versus PLCOm2012 lung cancer screening eligibility criteria in Germany (HANSE): a prospective cohort study
by
Vogel-Claussen, Jens
,
Stiebeler, Susanne
,
Schmid-Bindert, Gerald
in
Aged
,
Cancer screening
,
Cohort analysis
2025
Low-dose chest CT screening can reduce lung cancer mortality through early diagnosis. Several studies suggest that risk prediction models are more efficient than categorical age and smoking criteria for participant selection, but there are still reservations from policy makers about their implementation. We aimed to compare the effectiveness of a predefined PLCOm2012 model threshold with the categorical NELSON risk criteria.
In this ongoing prospective cohort study, current or former smokers aged 55–79 years who met either NELSON risk criteria or had a PLCOm2012 6-year risk of at least 1·58% were recruited from three certified German lung cancer centres in Großhansdorf, Hannover, and Lübeck, and received low-dose CT at baseline and 1-year follow-up screening rounds, including all downstream follow-up procedures. The PLCOm2012 cutoff point of at least 1·58% was predefined and estimated to result in an equal group size as with the NELSON inclusion criteria. The primary outcome was the comparison of the positive predictive values for lung cancers detected in PLCOm2012-selected versus NELSON-selected groups. Here, we report the final results of the primary analysis. This study is registered with ClinicalTrials.gov, NCT04913155.
Between July 23, 2021, and Aug 19, 2022 (end of recruitment), 5191 participants (2208 [43·5%] female, 2983 [57·5%] male, and 5076 [97·8%] of European White ethnicity) who met either one or both high-risk criteria were enrolled (4167 PLCOm2012-selected vs 3916 NELSON-selected participants) and underwent the baseline low-dose CT scan. In the observation period between the two low-dose CT screening rounds (mean volume CT dose index 1·15 mGy [SD 0·15]) with a median time interval of 1·05 years (IQR 0·95–1·08), 111 lung cancers were detected. The positive predictive value (lung cancer detection rate) in the PLCOm2012-selected group was 108 of 4167 participants (2·59% [95% CI 2·13–3·12]) compared with 85 of 3916 participants (2·17% [1·74–2·68]) in the NELSON-selected group (p=0·0016), resulting in a lower number needed to screen (38·6 [32·1–46·9] vs 46·1 [37·3–57·5]).
Participant selection using the PLCOm2012 risk prediction model with a 6-year risk of at least 1·58% cutoff is more efficient and effective in detecting lung cancer than the NELSON criteria and should therefore be implemented in lung cancer screening programmes.
Federal Ministry of Education and Research (German Center for Lung Research) and AstraZeneca.
Journal Article
The Pitfalls of Introducing Electronic Medical Records
by
Faron, Mark
,
Hale, Thomas
,
Jesberg, Linda
in
Consumer Behavior
,
Data entry
,
Electronic health records
2006
The perspective expressed by Dr. Baron and his partners (1) demonstrated the pitfalls associated with the difficult task of implementing an electronic medical record (EMR) system. Mercy Medical Group, owned by the Sisters of Mercy Health System, comprises 160 physicians and includes internists, family practitioners, pediatricians, and women's health practitioners. With the financial backing of the health system, we researched several EMR vendors and chose Misys EMR (Misys Healthcare Systems, Raleigh, North Carolina) because we had been using their practice management system, which interfaced with their EMR system.
Journal Article
Induction of labour versus expectant management for large-for-date fetuses: a randomised controlled trial
by
Perrotin, Franck
,
Faron, Gilles
,
Senat, Marie-Victoire
in
Adult
,
Belgium
,
Cesarean Section - statistics & numerical data
2015
Macrosomic fetuses are at increased risk of shoulder dystocia. We aimed to compare induction of labour with expectant management for large-for-date fetuses for prevention of shoulder dystocia and other neonatal and maternal morbidity associated with macrosomia.
We did this pragmatic, randomised controlled trial between Oct 1, 2002, and Jan 1, 2009, in 19 tertiary-care centres in France, Switzerland, and Belgium. Women with singleton fetuses whose estimated weight exceeded the 95th percentile, were randomly assigned (1:1), via computer-generated permuted-block randomisation (block size of four to eight) to receive induction of labour within 3 days between 37+0 weeks and 38+6 weeks of gestation, or expectant management. Randomisation was stratified by centre. Participants and caregivers were not masked to group assignment. Our primary outcome was a composite of clinically significant shoulder dystocia, fracture of the clavicle, brachial plexus injury, intracranial haemorrhage, or death. We did analyses by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00190320.
We randomly assigned 409 women to the induction group and 413 women to the expectant management group, of whom 407 women and 411 women, respectively, were included in the final analysis. Mean birthweight was 3831 g (SD 324) in the induction group and 4118 g (392) in the expectant group. Induction of labour significantly reduced the risk of shoulder dystocia or associated morbidity (n=8) compared with expectant management (n=25; relative risk [RR] 0·32, 95% CI 0·15–0·71; p=0·004). We recorded no brachial plexus injuries, intracranial haemorrhages, or perinatal deaths. The likelihood of spontaneous vaginal delivery was higher in women in the induction group than in those in the expectant management group (RR 1·14, 95% CI 1·01–1·29). Caesarean delivery and neonatal morbidity did not differ significantly between the groups.
Induction of labour for suspected large-for-date fetuses is associated with a reduced risk of shoulder dystocia and associated morbidity compared with expectant management. Induction of labour does not increase the risk of caesarean delivery and improves the likelihood of spontaneous vaginal delivery. These benefits should be balanced with the effects of early-term induction of labour.
Assistance Publique–Hôpitaux de Paris and the University of Geneva.
Journal Article
Weight Gain in FTT Population Post RD Intervention
Three months of outcome data on failure to thrive patients demonstrated the positive effects of intervention by an RD via improved weight status. All patients included in the study had to meet the criteria: 1) have a primary diagnosis of FTT, and 2) must be free from other diseases that have an impact on weight Within the data collection period 8/13/98-11/17/98,12 subjects met this criteria, to include 4 females and 8 males. Subjects ranged in age from 14 months to 9 years of age. The primary interventions provided to the subjects during the visit were nutritional counseling and medical intervention to rule out any organic causes for FTT. Weight information prior to the visit was obtained from the patient's medical record. Each patient's care giver was counseled for a 20-30minute period of time using an individualized education approach appropriate for the age of the patient The mam outcome, growth, was measured by weighing the child and converting to a percentage of expected weight gain based on Foman's expected weight gain for age data. Descriptive statistics to include percent of net change in weight were derived from this data. The z score was calculated to assess discrete changes in growth. Comparing baseline to post RD intervention data the percentage of children exhibiting > 100% of expected growth (catch up growth) improved from 16.7% (2/12) to 58.3% (7/12). The patients exhibiting weight gain of 50-100% of expected growth changed from 41.7% (5/12) to 16.7% (2/12). The patients exhibiting weight gain of 50% or less of expected growth changed from 33.3% (4/12) to 25% (3/12). The z score statistical analysis demonstrated that 75% (9/12) of patients experienced an improvement in weight status (z score increased post intervention.) The results illustrate a marked increase in the number of patients experiencing catch up growth (>100% of expected), as well as an increase in z score, a sensitive monitor of discrete weight changes. The integral role of RD intervention in the FTT population can be defined not only as improvement in patient care, but also as a significant cost savings per case. The ADA has derived that upwards of $13,758 can be saved when the complications of Pediatric FTT ( hospitalizations, and resulting mental and physical retardation) are treated.
Journal Article
Body composition analysis using CT and MRI: intra-individual intermodal comparison of muscle mass and myosteatosis
by
Endler, Christoph
,
Isaak, Alexander
,
Attenberger, Ulrike
in
692/53
,
692/698/1671/1668
,
Adipose Tissue - diagnostic imaging
2020
Computed tomography (CT) and magnetic resonance imaging (MRI) can quantify muscle mass and quality. However, it is still unclear if CT and MRI derived measurements can be used interchangeable. In this prospective study, fifty consecutive participants of a cancer screening program underwent same day low-dose chest CT and MRI. Cross-sectional areas (CSA) of the paraspinal skeletal muscles were obtained. CT and MRI muscle fat infiltration (MFI) were assessed by mean radiodensity in Hounsfield units (HU) and proton density fat fraction (MRI
PDFF
), respectively. CSA and MFI were highly correlated between CT and MRI (CSA: r = 0.93, P < 0.001; MFI: r = − 0.90, P < 0.001). Mean CSA was higher in CT compared to MRI (46.6cm
2
versus 43.0cm
2
; P = 0.05) without significance. Based on MRI
PDFF
, a linear regression model was established to directly estimate skeletal muscle fat content from CT. Bland–Altman plots showed a difference between measurements of − 0.5 cm
2
to 7.6 cm
2
and − 4.2% to 2.4% regarding measurements of CSA and MFI, respectively. In conclusion, the provided results indicate interchangeability of CT and MRI derived imaging biomarkers of skeletal muscle quantity and quality. Comparable to MRI
PDFF
, skeletal muscle fat content can be quantified from CT, which might have an impact of analyses in larger cohort studies, particularly in sarcopenia patients.
Journal Article