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What can be done to promote the academic success of learners? More than a question, it is a major challenge of our time. In this perspective, metacognition seems to be a way to empower learners to take ownership of their academic success. Considering the recommendations established in the literature, we co-constructed with teachers a metacognitive educational program, called Cogni'Scol, based on brain functioning in learning. Its benefits were determined through a longitudinal study focusing on the academic success of French students. We followed sixth grade students over a two-year period who either benefited or not from a weekly session of the Cogni'Scol program. Results showed a significant effect on students' knowledge and representations of brain functioning but not on the students' academic performances mediated by improvements in their metacognition. We conclude with pragmatic reflections for researchers and educational professionals interested in the implementation of educational programs based on brain functioning in learning.

Introduction: Stereotactic radiotherapy (SBRT) potentially has a role in the management of oligometastatic melanoma. However, literature with data specific to this management is very limited. The objectives of this study were to evaluate the time to local control (LC) of extra-cranial melanoma metastases after SBRT treatment and to help establish if SBRT is a useful therapy for oligometastatic melanoma. Methods: A retrospective study was conducted with data collected from two referral centers in France between 2007 and 2020. The oligometastatic status of patients was reported based on the latest recommendations with a maximum of three lesions prior to treatment. Results: A total of 69 patients receiving SBRT for 88 oligometastatic melanoma metastases were included. The median follow-up time was 42.6 months. Most patients were treated for metachronous oligometastatic lesions. Occurrence of oligoprogression, oligorecurrence, and oligopersistence was reported in 42.0%, 39.1%, and 17.4% of cases, respectively. Treated lesions were mostly pulmonary (40.6%), followed by lymph node (34.8%) and hepatic sites (24.6%). Progressionfree survival at 1, 2, and 3 years were 47.0% (35-59), 27.0% (16-39), and 25.0% (15.0-37.0), respectively. Time to LC rates at 1, 2, and 3 years were 94.2% (87.0-98.1), 90.3% (81.3-96.1), and 90.3% (81.3-96.1), respectively. Overall survival at 1, 2, and 3 years were 87% (76.0-93.0), 74.0% (76.0-93.0), and 61.0% (47.0-73.0), respectively. Only 17.4% of patients experienced acute, grade 1 or grade 2 toxicities with no reports of grade 3 or higher toxicities. Conclusion: SBRT demonstrated efficacy in managing melanoma patients with extracranial oligometastases and showed an overall low toxicity profile. Future randomized studies are needed to establish the role of SBRT in therapeutic approaches for patients with oligometastatic melanoma. [ABSTRACT FROM AUTHOR]

Simple Summary: Elderly cancer patients over the age of 80 years represent a growing population; these are notably melanoma patients since 25% of cases are diagnosed after 75 years of age. Establishing the best therapeutic strategies for older patients with melanoma is a challenge since this subpopulation has poor disease-specific outcomes, partly due to age-related variations in therapeutic management. Regarding mono-immunotherapy, either with anti-CTLA-4 or anti-PD-1, several studies have shown similar tolerability outcomes in older and younger patients. However, there are limited data in very elderly patients, especially those treated with immunotherapy combinations. The aim of this multicenter retrospective study is to analyze the prescribing patterns and the safety profile of nivolumab combined with ipilimumab in a cohort of octogenarian and nonagenarian melanoma patients in a real-life setting. The results indicate that the prescribing patterns are very heterogeneous in patients aged over 80 years old, highlighting the lack of clear therapeutic guidelines in the elderly population. In this cohort, the toxicity data did not show a high frequency of severe immune-related adverse events. Data regarding elderly melanoma patients treated with anti-PD-1 or anti-CTLA-4 antibodies are in favor of tolerability outcomes that are similar to those of younger counterparts. However, there are very few studies focusing on elderly patients receiving nivolumab combined with ipilimumab (NIVO + IPI). Here, we ask what are the current prescribing patterns of NIVO + IPI in the very elderly population and analyze the tolerance profile. This French multicenter retrospective study was conducted on 60 melanoma patients aged 80 years and older treated with NIVO + IPI between January 2011 and June 2022. The mean age at first NIVO + IPI administration was 83.7 years (range: 79.3–93.3 years). Fifty-five patients (92%) were in good general condition and lived at home. Two dosing regimens were used: NIVO 1 mg/kg + IPI 3 mg/kg Q3W (NIVO1 + IPI3) in 27 patients (45%) and NIVO 3 mg/kg + IPI 1 mg/kg Q3W (NIVO3 + IPI1) in 33 patients (55%). NIVO + IPI was a first-line treatment in 39 patients (65%). The global prevalence of immune-related adverse events was 63% (38/60), with 27% (16/60) being of grade 3 or higher. Grade ≥ 3 adverse events were less frequent in patients treated with NIVO3 + IPI1 compared with those treated with NIVO1 + IPI3 (12% versus 44%, p = 0.04). In conclusion, the prescribing patterns of NIVO + IPI in very elderly patients are heterogeneous in terms of the dosing regimen and line of treatment. The safety profile of NIVO + IPI is reassuring; whether or not the low-dose regimen NIVO3 + IPI1 should be preferred over NIVO1 + IPI3 in patients aged 80 years or older remains an open question. [ABSTRACT FROM AUTHOR]

Background: With more than 15,000 new cases /year in France and 2,000 deaths, cutaneous melanoma represents approximately 4% of incidental cancers and 1.2% of cancer related deaths. In locally advanced (stage III) or resectable metastatic (stage IV) melanomas, medical adjuvant treatment is proposed and recent advances had shown the benefit of anti-PD1/PDL1 and anti-CTLA4 immunotherapy as well as anti-BRAF and anti-MEK targeted therapy in BRAF V600 mutated tumors. However, the recurence rate at one year is approximately 30% and justify extensive research of predictive biomarkers. If in metastatic disease, the follow-up of circulating tumor DNA (ctDNA) has been demonstrated, its interest in adjuvant setting remains to be precised, especially because of a lower detection rate. Further, the definition of a molecular response could prove useful to personalized treatment. Methods: PERCIMEL is an open prospective multicentric study executed through collaboration of the Institut de Cancérologie de Lorraine (non-profit comprehensive cancer center) and 6 French university and community hospitals. A total of 165 patients with resected stage III and IV melanoma, eligible to adjuvant imunotherapy or anti-BRAF/MEK kinase inhibitors will be included. The primary endpoint is the presence of ctDNA, 2 to 3 weeks after surgery, defined as mutated ctDNA copy number calculated as the allelic fraction of a clonal mutation relative to total ctDNA. Secondary endpoints are recurrence-free survival, distant metastasis-free survival and specific survival. We will follow ctDNA along treatment, quantitatively through ctDNA mutated copy number variation, qualitatively through the presence of cfDNA and its clonal evolution. Relative and absolute variations of ctDNA during follow-up will be also analyzed. PERCIMEL study aims at provide scientific evidence that ctDNA quantitative and qualitative variations can be used to predict the recurrence of patients with melanoma treated with adjuvant immunotherapy or kinase inhibitors, thus defining the notion of molecular recurrence. [ABSTRACT FROM AUTHOR]

This research aimed to test the moderating effect of people's initial position to blood donation on the actual acceptance to donate blood in a door-in-the-face situation. This position (attitude, self-importance, normative beliefs) was measured one month prior to the request (Study 1, N = 99) or immediately before (Study 2, N = 80). The results revealed that the door-in-the-face effect is moderated by the importance of blood donation to the self, all the more so when the position is made salient. This highlights the specific character of blood donation in France and the centrality of the importance of donating for the self at the heart of the DITF technique. These results offer new insights into the conditions that must be met to achieve acceptance to donate blood after an initial refusal. [ABSTRACT FROM AUTHOR]

Nine drugs have been marketed for 10 years for the treatment of advanced melanoma (AM). With half of patients reaching a second line, the optimal sequence of treatments remains unclear. To inform policy-makers about their efficiency, we performed a cost-effectiveness analysis of sequential strategies in clinical practice in France, for BRAF-mutated and wild-type patients. A multistate model was developed to describe treatment sequences, associated costs, and health outcomes over 10 years. Sequences, clinical outcomes, utility scores, and economic data were extracted from the prospective Melbase cohort, collecting individual data in 1518 patients since 2013, from their AM diagnosis until their death. To adjust the differences in patients' characteristics among sequences, weighting by inverse probability was used. In the BRAF-mutated population, the MONO-targeted therapies (TT)-anti-PD1 sequence was the less expensive, whereas the anti-PD1-BI-TT sequence had an incremental cost-effectiveness ratio (ICER) of 180,441 EUR/QALY. Regarding the BRAF wild-type population, the three sequences constituted the cost-effective frontier, with ICERs ranging from 116 to 806,000 EUR/QALY. For BRAF-mutated patients, the sequence anti-PD1-BI-TT appeared to be the most efficient one in BRAF-mutated AM patients until 2018. Regarding the BRAF wild-type population until 2018, the sequence starting with IPI+NIVO appeared inefficient compared to anti-PD1, considering the extra cost for the QALY gained. [ABSTRACT FROM AUTHOR]

Avelumab has been approved worldwide for treatment of metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. This study evaluated outcomes in patients with mMCC in France who received avelumab as second-line or later (2L+) treatment in routine clinical practice. This retrospective, noninterventional study evaluated all patients diagnosed with mMCC using two databases: CARADERM (French national database of rare dermatological cancers) and SNDS (national healthcare database), identified via probabilistic linkage. Eligible patients initiated avelumab as 2L+ treatment between August 2016 and December 2019 and were followed for 24 months. The primary endpoint was overall survival (OS) at 24 months. Overall, 180 patients who received 2L+ avelumab were identified (112 from CARADERM, 68 after SNDS linkage). Median age at diagnosis was 74.0 years and 177 (98.3 %) had received chemotherapy alone as first-line treatment. Median follow-up was 13.1 months. Median OS from start of avelumab was 14.6 months (95 % CI, 9.9–21.3) in the overall population, 15.9 months (95 % CI, 8.6–28.3) in CARADERM patients, and 13.3 months (95 % CI, 6.7–19.1) in non-CARADERM patients. OS rates at 12 and 24 months were 53.8 % (95 % CI, 46.2 %−60.8 %) and 40.5 % (95 % CI, 33.2 %−47.6 %), respectively. In evaluable patients (CARADERM database), median progression-free survival was 3.6 months (95 % CI, 2.7–7.5) and the objective response rate was 55.3 % (95 % CI, 45.3–65.4), including complete response in 31.9 %. Real-world outcomes with 2L+ avelumab treatment for mMCC are consistent with clinical trial findings, supporting the recommendation of avelumab as a standard of care. • This study examined patients with metastatic Merkel cell carcinoma in France. • 180 patients who received second-line or later avelumab treatment were identified. • Median overall survival was 14.6 months and 24-month overall survival was 40.5 %. • Objective response rate was 55.3 % including complete response in 31.9 %. • Findings support the use of avelumab treatment for patients with this disease. [ABSTRACT FROM AUTHOR]

This retrospective observational study aimed to determine the effectiveness, safety and patterns of the use of nivolumab in patients with advanced melanoma in real‐world clinical practice in France using data from a Temporary Authorization for Use Program (ATU). Data were collected from patients with unresectable or metastatic melanoma enrolled in a French national database (Réseau pour la Recherche et l'Investigation Clinique sur le Mélanome: Ric‐Mel) and treated with nivolumab during the ATU program (12 September 2014 to 31 August 2015). The primary objectives of the study were to evaluate the effect of patient characteristics on clinical response and overall survival (OS). Among 400 included patients (median age 66 years), the majority (83%) received nivolumab as second‐ or subsequent‐line therapy. The median durations of progression‐free survival and OS were 3.3 and 14.1 months, respectively, and 31.6% of patients achieved an objective response with a median duration of 20.1 months (range: 0‐34.7). The safety profile of nivolumab was manageable and consistent with those of previous clinical trials, with an incidence of grade 3‐5 adverse events of 13.8%. The safety and effectiveness of nivolumab in patients with advanced melanoma in real‐world clinical practice in France were in line with the data reported in the Phase 3 trials CheckMate 066 and 037 of nivolumab in this patient population. What's new? Clinical trial data support the use of nivolumab in melanoma patients, and the drug received a Temporary Authorization for Use in France. Here, the authors present real‐world clinical data on the safety and efficacy of nivolumab collected from 400 patients with unresectable or metastatic melanoma. They found that the safety and efficacy in the real world context was consistent with the profile reported in phase 3 trials. The study also includes data from some sub‐populations that may have been underrepresented in the clinical trials. [ABSTRACT FROM AUTHOR]

Background: Significant progress was recently observed in the treatment of metastatic melanoma (MM). With >50% of patients now reaching a second line of treatment and a significant improvement in the survival rate, an assessment of quality of life (QoL) during the whole course of the disease becomes necessary. The objective of this study was to describe the QoL of patients with MM in France, from their diagnosis of advanced disease to their death, in real life.Methods: QoL data were collected through MelBase, a prospective, French, multicentric cohort dedicated to the follow-up of adults with MM. QoL was assessed using the EuroQoL-5D questionnaire and the Functional Assessment of Cancer Treatment (FACT)-Melanoma questionnaire at the time of study inclusion, every 3 months, and at the time of each treatment change until death. To assess longitudinal changes from baseline to death, mixed-effect models for repeated-measures analyses were used to control for baseline covariates.Results: QoL was assessed in 1435 patients who were included in the study between 2013 and 2018. The median follow-up was 9.4 months, and 47% of patients died during follow-up. During first-line treatment, the model-based, mean utility score was 0.830 (95% CI, 0.818-0.843), the mean FACT-General score was 77.22 (95% CI, 76.23-78.22), and the mean FACT-Melanoma score was 129.46 (95% CI, 128.02-130.90). At the time of a change in treatment line, there was a decrease of -0.027 (95% CI, -0.03, -0.02) in the utility score, -1.82 (95% CI, -1.88, -1.76) in the FACT-General score, and -2.98 (95% CI, -3.05, -2.91) in the FACT-Melanoma score compared with first-line treatment.Conclusions: In the MelBase cohort, the QoL among patients with MM seems to be fairly stable over the whole disease course, although a small but significant decrease at time therapy is changed is observed. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to describe the proportion of liver-related diseases ( LRDs) as a cause of death in HIV-infected patients in France and to compare the results with data from our five previous surveys. Methods In 2010, 24 clinical wards prospectively recorded all deaths occurring in around 26 000 HIV-infected patients who were regularly followed up. Results were compared with those of previous cross-sectional surveys conducted since 1995 using the same design. Results Among 230 reported deaths, 46 (20%) were related to AIDS and 30 (13%) to chronic liver diseases. Eighty per cent of patients who died from LRDs had chronic hepatitis C, 16.7% of them being coinfected with hepatitis B virus ( HBV). Among patients who died from an LRD, excessive alcohol consumption was reported in 41%. At death, 80% of patients had undetectable HIV viral load and the median CD4 cell count was 349 cells/μL. The proportion of deaths and the mortality rate attributable to LRDs significantly increased between 1995 and 2005 from 1.5% to 16.7% and from 1.2‰ to 2.0‰, respectively, whereas they tended to decrease in 2010 to 13% and 1.1‰, respectively. Among liver-related causes of death, the proportion represented by hepatocellular carcinoma ( HCC) dramatically increased from 5% in 1995 to 40% in 2010 (p = 0.019). Conclusions The proportion of LRDs among causes of death in HIV-infected patients seems recently to have reached a plateau after a rapid increase during the decade 1995−2005. LRDs remain a leading cause of death in this population, mainly as a result of hepatitis C virus ( HCV) coinfection, HCC representing almost half of liver-related causes of death. [ABSTRACT FROM AUTHOR]

Background Routine sun protection is recommended to prevent skin cancer. The aims of the present analysis were to assess and compare modalities of sun protection in parents and their children. Methods EDIFICE Melanoma is a French nationwide observational survey. It was conducted through phone interviews among a representative sample of 1502 individuals aged ≥18 years, using the method of quotas. The survey took place shortly after the summer, from 28 September to 20 October 2011. Results Of the 1502 subjects interviewed, 1067 reported sun exposure (SE) at least 10 days per year, 748 were parents and 319 had no children. Sun protection measures seemed adequate in both the 'parents' and 'non-parents' groups: 74% used clothing and 43% used sunscreen, which was reapplied regularly in 57% of cases. Sun protection measures used by SE parents for SE children were superior, both qualitatively and quantitatively, to those used for themselves, i.e., 50% of parents reported using clothing, sunglasses and hats for their children vs. 23% for themselves. In 87% of cases, parents reported regular re-application of sunscreen for their children vs. 44% for themselves. The sunscreen SPF (Sun Protection Factor) was significantly lower for parents than for their children. Conclusions Sun protection awareness appears to be globally satisfactory in the French population, with no difference between adults who are parents and those who are not. From both qualitative and quantitative standpoints, French parents use sun protective measures more efficiently for their children than for themselves. [ABSTRACT FROM AUTHOR]

Objectives The incidence of skin cancers, melanoma in particular, is increasing rapidly. Consequently, specific recommendations for sun-protection measures now exist. This survey set out to assess the compliance of the general population with these guidelines. Methods The French nationwide observational survey, EDIFICE Melanoma, was conducted (28 September to 20 October 2011) through phone interviews of a representative sample of 1502 subjects aged ≥ 18 years, using the quota method. Sun-protection was defined as frequent or systematic use of clothes or sunscreen. The group of individuals who declared exposure to the sun (N = 1172) was subdivided: risk-takers (N = 442), and those who used sun protection (N = 730). Results Risk-takers were significantly more often male (62% vs. 44%, P < 0.01), had a lower level of education (40% vs. 26%, P < 0.01), lower incomes (2587 euros vs. 2948 euros/month) and were more often smokers (42% vs. 31%, P < 0.01). In contrast, age, marital status and use of sunbeds were not significantly different between the two groups. Interestingly, risk-takers had less risk factors for melanoma. However, they were less well-informed about high-risk exposure and optimal use of sunscreen. Sun-protection measures for their children were less stringent than those of the group who used sun protection: systematic/frequent use of sunglasses (42% vs. 59%, P < 0.01), systematic use of sunscreen (77% vs. 86%, P < 0.01), and frequent renewal (69% vs. 82%, P < 0.01), high sun protection factors (SPF) (46% vs. 56%, P < 0.01), use of clothing (84% vs. 92%, P < 0.01) and hats (88% vs. 94%, P < 0.01). Conclusions Risk-takers are characterized by a lesser understanding of sun-protection measures and behaviours. Their children benefit less from protective measures than those of people who use sun protection themselves. Improved understanding may well improve behaviours; one can therefore legitimately predict a considerable impact on parents' attitude to their own protection and that of their children. [ABSTRACT FROM AUTHOR]

An innovative way to take the large-scale circulation influence into account in coastal primitive-equation models is explored by an inverse modelling approach. Restricted to barotropic external forcing, this work is a first step in the development of a four-dimensional variational (4DVAR) data-assimilation approach to estimate the best initial and open-boundary conditions that force a coastal model according to interior observations. This development is founded on the OPA modelling system which representation of barotropic coastal dynamics is restricted to motions of long time scales (∼ a day) due to its “rigid lid” approximation. Twin experiments are performed in an academic configuration of the Gulf of Lions (located in the northwestern Mediterranean Sea) to study the sensitivity of a remote barotropic forcing to different observational networks measuring surface currents deployed in this area. Three monitoring designs are tested for a large-scale barotropic perturbation in the hindcast mode. It is shown that the space and time distribution of observations acts on the efficiency of the 4DVAR method and then allows coarser datasets. [ABSTRACT FROM AUTHOR]

In France, the entire population theoretically has access to health coverage, but in fact a section of the poorest population does not. Institutions have therefore been set up to provide medical care for the destitute. The objectives of this study were to describe the social characteristics of the HIV-positive destitute population attending an out-patient clinic providing free health care for the destitute in a Paris University Hospital, to compare their clinical-epidemiological characteristics with those of non-destitute HIV-positive patients, and to evaluate the quality of their care. We performed a historical prospective study wherein a cohort of 115 HIV-positive destitute patients (defined as having no health coverage at their first consultation) was compared with a control cohort of 183 HIV-positive non-destitute patients attending the same clinic. Ninety-five per cent of the destitute patients had no stable employment, 32% had no source of income, 75% had no permanent residence and 27% were IV drug abusers. Fifty-nine per cent were foreigners, most of whom had legal residence papers and had been in France for more than 3 years. When comparing the control and the destitute groups, the latter had a three times greater risk of developing tuberculosis (RH = 3.2, CI 95% = \[1.1-9.4]). Medical compliance, access to antiretroviral treatment and hospitalization were identical in both groups. No difference was observed in terms of occurrence of a new AIDS-related disease during follow-up when full-blown AIDS before entry, CD4 count at entry and transmission group were taken into account in multivariate analysis. From the moment that destitute patients attended this adapted medico-social facility, their access to care was the same as, if not better than, that of the other patients. The development of out-patient medico-social facilities for HIV-positive destitute patients must be a public health priority even for those countries theoretically providing generalized health coverage. [ABSTRACT FROM AUTHOR]

Despite significant progress in melanoma survival, therapeutic options are still needed in case of progression under immune checkpoint inhibitors (ICI), and resistance to targeted therapies (TT) in BRAF-mutated melanomas. This study aimed to assess the safety of combined ICI and TT as a rescue line in real-life clinical practice. We conducted a study within the prospective French multicentric MelBase cohort, including patients treated with a combination of anti-PD1 (pembrolizumab/nivolumab) and BRAF inhibitor (BRAFi: dabrafenib/vemurafenib) and/or MEK inhibitors (MEKi: trametinib/cobimetinib) for BRAF mutated or wild-type advanced melanoma. Fifty-nine patients were included: 30% received the triple combination, 34% an anti-PD1 and BRAFi, and 36% an anti-PD1 and MEKi. Grade 3–4 adverse events occurred in 12% of patients. Permanent discontinuation or dose reduction of one of the treatments for toxicity was reported in 14% and 7% of patients, respectively. In the BRAF wild-type subgroup, treatment with MEKi and anti-PD1 induced a tumor control rate of 83% and median progression-free survival of 7.1 months. The combination of anti-PD1 and BRAFi and/or MEKi was a safe rescue line for advanced melanoma patients previously treated with ICI/TT. The benefit of these combinations, specifically anti-PD1 and MEKi in BRAF wild-type melanoma patients, needs to be prospectively studied. [ABSTRACT FROM AUTHOR]

Summary: An actinic keratosis (AK) is an area (lesion) of sun‐damaged skin, mainly found on sun‐exposed parts of the body, particularly the forearms, backs of the hands, face, ears, bald scalp and the lower legs. Left untreated, there is a small risk that an AK could progress into a form of skin cancer called squamous cell carcinoma. One way of treating AK is called photodynamic therapy (PDT). The usual, or conventional, protocol for using PDT to treat AK is called C‐PDT. It involves applying a light‐sensitising cream to the skin which is activated by a high‐intensity red light about 2.5 hours later. This causes intense inflammation in the skin which destroys abnormal, but not normal, skin tissue. The main drawback of C‐PDT is the pain experienced by patients during the treatment. Due to this pain, many patients cannot complete the treatment. The authors of this study, based in France and Germany, proposed a new protocol for PDT of AK, called P‐PDT. P‐PDT involves a revised red light activation: the light intensity has been considerably reduced and the activation begins only 30 minutes after the molecule (cream) application. This revision was expected to increase the patient's tolerance. The primary aim of the study was to assess whether P‐PDT is at least as effective as C‐PDT in destroying AK. One of the secondary aims was to compare pain levels between P‐PDT and C‐PDT. Forty‐six patients with AKs of the head were included. These patients were treated with P‐PDT on one side of the head and with C‐PDT on the other side. With 94.2% disappearance of AKs six months after the treatment, P‐PDT was found to be at least as effective as C‐PDT, which had a disappearance rate of 94.9%. Moreover, from the pain levels reported by the patients for each protocol, P‐PDT is much less painful, or even painless, compared to C‐PDT. This summary relates to the study: The conventional protocol vs. a protocol including illumination with a fabric‐based biophotonic device (the Phosistos protocol) in photodynamic therapy for actinic keratosis: a randomized, controlled, noninferiority clinical study Linked Article: Mordon et al. Br J Dermatol 2020; 182:76–84 [ABSTRACT FROM AUTHOR]

Background: France is the European country with the lowest level of confidence in vaccines. Measurement of patients' acceptability towards a future therapeutic HIV vaccine is critically important. Thus, the aim of this study was to evaluate patients' acceptability of a future therapeutic HIV vaccine in a representative cohort of French patients living with HIV-AIDS (PLWHs).Methods: This multicentre study used quantitative and qualitative methods to assess PLWHs' opinions and their potential acceptance of a future therapeutic HIV vaccine. Cross-sectional study on 220 HIV-1 infected outpatients, aged 18-75 years.Results: The participants' characteristics were similar to those of the overall French PLWH population. Responses from the questionnaires showed high indices of acceptance: the mean score for acceptability on the Visual Analog Scale VAS was 8.4 of 10, and 92% of patients agreed to be vaccinated if a therapeutic vaccine became available. Acceptability depended on the expected characteristics of the vaccine, notably the duration of its effectiveness: 44% of participants expected it to be effective for life. This acceptance was not associated with socio-demographic, clinical (mode of contamination, duration of disease), quality of life, or illness-perception parameters. Acceptability was also strongly correlated with confidence in the treating physician.Conclusion: The PLWHs within our cohort had high indices of acceptance to a future therapeutic HIV vaccine.Trial Registration: This study was retroactively registered on ClinicalTrials.gov with ID: NCT02077101 in February 21, 2014. [ABSTRACT FROM AUTHOR]

Summary: Actinic keratoses (AKs) are areas of sun‐damaged skin found mainly on sun‐exposed parts of the body, particularly the backs of the hands and forearms, the face and ears, and the scalp in balding men. They are usually harmless although they can be unsightly or inconvenient, and there is a very small risk of some actinic keratoses progressing to a form of skin cancer called squamous cell carcinoma. There are several possible treatments, including photodynamic therapy (PDT), in which a special light activates a cream called a photosensitiser, which has been applied to the affected area of skin. This treatment kills the abnormal cells in the skin. The photosensitisers approved in Europe for PDT of AKs require either activation by red light three hours after application of the photosensitiser (referred to as C‐PDT) or activation by daylight within 30 minutes following application of the photosensitiser (referred to as D‐PDT). The major drawback of C‐PDT is pain during treatment, whereas D‐PDT is nearly pain‐free due to the short time between photosensitiser application and daylight activation. Unfortunately, D‐PDT requires favourable weather conditions. The authors of this study, who belong to the ONCO‐THAI research unit based in France, therefore tested a way to activate the photosensitiser 30 minutes after application, by red light using a flexible, light‐emitting, fabric‐based device (hereinafter referred to as FLEXI‐PDT). This study aimed to assess whether FLEXI‐PDT is at least as effective as C‐PDT in destroying AK. The authors were also interested in whether pain scores differ between FLEXI‐PDT and C‐PDT. For these purposes, 35 patients with AKs on the scalp were treated with FLEXI‐PDT on one side of the scalp and with C‐PDT on the other side. Patients rated their pain during FLEXI‐PDT and during C‐PDT separately. The response of each AK (complete or incomplete disappearance) was assessed by a dermatologist at three months after treatment. From the analyses of the data collected, the authors showed that FLEXI‐PDT, which can be performed in all weather conditions, is at least as effective as and less painful than C‐PDT in destroying AK. Linked Article: Vicentini et al. Br J Dermatol 2019; 180:765–773 [ABSTRACT FROM AUTHOR]

Despite the poor prognosis associated with melanoma brain metastases (BM), data concerning these patients and their inclusion in clinical trials remains scarce. We report here the efficacy results of a subgroup analysis in patients with BRAFV600-mutant melanoma and BM treated with BRAF and MEK inhibitors dabrafenib (D) and trametinib (T). This phase IIIb single-arm, open-label, multicenter, French study included patients with unresectable stage IIIc or IV BRAFV600-mutant melanoma with or without BM. The present analysis focuses on patients with BM. Response rates were determined clinically and/or radiologically as per standard clinical practice. Progression-free survival (PFS) was estimated using the Kaplan Meier analysis and modelled with multivariate Cox regression model. Risk subgroups were identified using an exponential regression tree analysis. Significance was set at p < 0.05. Between March 2015 and November 2016, 856 patients were included and 275 (32%) patients had BM. Median PFS was 5.68 months (95% confidence interval [CI], 5.29–6.87). Significant independent factors associated with shorter PFS were ECOG ≥1, elevated serum lactate dehydrogenase (LDH), ≥3 metastatic sites, and non-naïve status. The binary-split classification and regression tree modelling identified baseline LDH and ECOG status as major prognostic factors. This is to date the largest, close to real-world, study in advanced BRAFV600-mutant melanoma patients with BM treated with D+T. ECOG >1, ≥3 metastatic sites and elevated LDH were associated with shorter PFS, a finding previously demonstrated only in patients without BM. Further studies are warranted to determine the optimal treatment sequence in this population. • This is the largest cohort of patients with BRAF V600-mutant melanoma and with brain metastases. • The results confirm the clinical activity of trametinib + dabrafenib in these patients. • LDH, Eastern Cooperative Oncology Group, number of metastatic sites and naïve/non-naïve status were associated with progression-free survival. [ABSTRACT FROM AUTHOR]

BRAF and MEK inhibitors combination, including dabrafenib (D) and trametinib (T) have transformed the treatment of BRAF V600 -mutant advanced melanoma patients, including patients with brain metastasis (BM). In a large phase IIIb, single-arm, open-label, multicenter French study, we assessed safety, response to treatment, progression-free survival (PFS) and factors associated with progression, and stratified the population into risk groups. Patients with unresectable, advanced, BRAF V600 -mutant melanoma were included, including those with the presence of BM, Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2, elevated lactate dehydrogenase (LDH) or previous melanoma treatments. Responses were determined locally, without central review. PFS was estimated using the Kaplan–Meier analysis and modelled with multivariate Cox model. Risk subgroups were identified using a regression tree analysis. Between March 2015 and November 2016, 856 patients received at least one D + T dose. Overall, 92% had stage IV melanoma, 38% ECOG PS ≥1, 32% BM and 37.5% elevated LDH. Median PFS was 8.02 months (95% confidence interval [CI] 7.33–8.77). Significant factors associated with lower PFS were ECOG PS ≥1, elevated LDH, ≥3 metastatic sites and presence of BM. Patients with <3 metastatic sites, ECOG = 0 and no BM had the highest probability of PFS at 6 months (83%, 95% CI 76–87) and 12 months (56%, 95% CI 47–64), respectively. This is the largest prospective study in advanced BRAF V600 -mutant melanoma patients treated with D + T, conducted in conditions close to 'real-world practice'. We confirm previous findings that LDH, ECOG PS and ≥3 metastatic sites are associated with shorter PFS, but the real-world setting introduces BM as a major prognostic factor. • This is the largest close to real-word study on BRAF V600-mutant melanoma patients. • The study included the largest population of melanoma patients with brain metastases. • The results confirm the clinical activity of trametinib associated to dabrafenib. • LDH, ECOG, number of metastatic sites and presence of brain metastases associated with PFS. [ABSTRACT FROM AUTHOR]

Abstract Purpose Since 2011, significant progress was observed in metastatic melanoma (MM), with the commercialisation of seven immunotherapies or targeted therapies, which showed significant improvement in survival. In France, in 2004, the cost of MM was estimated at €1634 per patient; this cost has not been re-estimated since. This study provided an update on survival and cost in real-life clinical practice. Methods Clinical and economic data (treatments, hospitalisations, radiotherapy sessions, visits, imaging and biological exams) were extracted from the prospective MelBase cohort, collecting individual data in 955 patients in 26 hospitals, from diagnosis of metastatic disease until death. Survival was estimated by the Kaplan-Meier method. Costs were calculated from the health insurance perspective using French tariffs. For live patients, survival and costs were extrapolated using a multistate model, describing the 5-year course of the disease according to patient prognostic factors and number of treatment lines. Results Since the availability of new drugs, the mean survival time of MM patients has increased to 23.6 months (95% confidence interval [CI] :21.2;26.6), with 58% of patients receiving a second line of treatment. Mean management costs increased to €269,682 (95% CI:244,196;304,916) per patient. Drugs accounted for 80% of the total cost. Conclusion This study is the first that evaluated the impact of immunotherapies and targeted therapies both on survival and cost in real-life conditions. Alongside the introduction of breakthrough therapies in the first and subsequent lines, MM has been associated with a significant increase in survival but also in costs, raising the question of financial sustainability. Highlights • This study updates the survival and cost of advanced melanoma since the arrival of targeted therapies and immunotherapies. • Costs were calculated using individual data prospectively collected from the MelBase cohort in real-life conditions. • Mean survival time of patients with MM was estimated at 23.6 months, for a mean cost estimated at €269,682 per patient. [ABSTRACT FROM AUTHOR]

KIR3DL2 is a killer immunoglobulin-like receptor, expressed in >90% of Sézary syndrome (SS) pts and 50% in pts with MF. Lacutamab is a humanized first-in-class monoclonal antibody designed to deplete KIR3DL2-expressing cells via antibody-dependent cell-cytotoxicity and phagocytosis. In a previous phase 1 trial, lacutamab showed adequate safety profile with no dose limiting toxicities and a global response rate of 42.9% in pts with SS, with a median time to response of 4.9 months (m). TELLOMAK is an open-label, multi-cohort, international phase II trial. Up to 148 pts are planned to be enrolled. Pts are allocated to one of three cohorts: Cohort 1: SS, Cohort 2: KIR3DL2 expressing (≥1%) MF and Cohort 3: KIR3DL2 non-expressing MF, based on central KIR3DL2 testing. Eligible pts should have received at least 2 prior systemic therapies with no evidence of large cell transformation. Lacutamab 750 mg is administered as an intravenous (i.v.) infusion weekly × 5 weeks (w), every 2 w × 10 then every 4 w, until progression or unacceptable toxicity. The primary endpoint is global confirmed response, evaluated using the International Consensus Criteria. Secondary endpoints include safety, quality of life, other efficacy endpoints, and biomarker analysis. Evaluable pts should have at least one response assessment 5 w after treatment initiation. In each of the MF cohorts, the study follows a Simon 2-stage design in which 21 and 18 pts were required in stage 1 for Cohorts 2 and 3, respectively with early termination if <3 global confirmed responses per cohort were observed. Here we report early stage 1 data for the two MF cohorts. As of January 20 2021, recruitment in stage 1 for both cohorts 2 and 3 is ongoing, with 12 pts enrolled in each cohort. Median age for all 24 pts is 57 years (range: 19–81). At study entry, 42% (n=5) and 17% (n=2) had stage III/IV in cohorts 2 and 3, respectively. Median number of prior systemic therapies is 3.5 (range: 2–10). At a median follow-up of 2.8 m (range: 0.3–14.1 m), 7 and 6 pts in cohort 2 and 3, respectively, are ongoing treatment. Overall, 19 pts were evaluable for response in Cohort 2 (n=11) and Cohort 3 (n=8). In Cohort 2, 5 skin responses were observed, of whom 3 had global confirmed responses (1 complete response, 2 partial responses). 7 pts had global stable disease. No responses are reported yet in Cohort 3. Adverse events (AEs) of any grade were observed in 17/24 pts (71%), of which 10/24 (42%) were treatment-related [TR]. Grade ≥3 AEs were observed in 2/24 (8%) pts, of which 1/24 (4%) was TR. Most common AEs were asthenia (N=6, 25%; TR: 2), pruritus (N=3, 12%; TR: 0), and peripheral oedema (N=2, 8%; TR: 1). Lacutamab met the predefined threshold of activity in the KIR3DL2 expressing MF cohort required to expand recruitment to 50 pts. Safety profile is reassuring and consistent with previous phase 1 data. Updated results on all stage 1 pts from cohort 2 and 3 will be presented. [ABSTRACT FROM AUTHOR]

Since 2011 seven innovative drugs were commercialized for the treatment of metastatic melanoma (MM), significantly improving patient survival and management cost in 1st line of treatment. With 52% of patients now reaching a second line of treatment, the optimal sequence in patients with BRAF wild-type metastatic melanoma (MM) remains unclear. To inform policy makers about the value of these sequences, we performed a cost-effectiveness analysis comparing treatment sequences for BRAF wild-type MM in real life in France. [Extracted from the article]

Study was performed to understand the patient care pathway of these patients, stakeholders involved and identify improvement to be undertaken to optimize diagnostic and follow-up of these patients. Among 130 OD-HCPs contacted, 50 filled in the questionnaire (A) and filled in for 122 patients (B), i.e., an average of 2.4 patients per OD-HCP. Then, 18 OD-HCP accepted to provide the questionnaire to, overall, 45 MCC patients (C). 2/3 of patients were male, with an average age of 70.2 years, and a majority with a stage 3 or 4 MCC. [Extracted from the article]

Since 2011, seven innovative drugs were commercialized for the treatment of metastatic melanoma (MM), significantly improving patient survival and cost in 1st line of treatment. With 52% of patients reaching a second line of treatment, the optimal sequence in patients with BRAF-mutated MM remains unclear. [Extracted from the article]