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Meal timings and daily night-time fasting periods can synchronise the circadian system, which regulates the cardiovascular system. The present study aims to evaluate the prospective associations between circadian nutritional behaviours, defined by meal timing and frequency, and the risk of cardiovascular diseases. We used data from 103,389 adults (79% females) in the French NutriNet-Santé study, 2009-2021. Circadian nutritional behaviours were assessed using repeated 24h food records during the first two years of follow-up. We examined the associations between circadian eating behaviours and risk of cardiovascular, coronary heart and cerebrovascular diseases by multivariable Cox proportional hazard models. During a median follow-up of 7.2 years, 2036 incident cardiovascular diseases were diagnosed. A later first meal of the day was associated with a higher risk of cardiovascular diseases (HR per hour increase = 1.06, 95% CI 1.01 - 1.12). A later last meal of the day was associated with a higher risk of cerebrovascular diseases (HR per hour increase = 1.08, 95% CI 1.01 - 1.15). Among women, a later last meal was also associated with a higher risk of cardiovascular disease (HR per hour increase = 1.08, 95% CI 1.01 - 1.15). We found no evidence for an association between night-time fasting duration nor meal frequency, with risk of cardiovascular diseases. This study suggests that the habit of eating a later first meal, and a later last meal (in women) could be associated with a higher risk of developing circulatory diseases. These results need to be confirmed in other largescale studies before they can be transferable to clinical practice. Key messages • Beyond nutritional quality of meals, meal timing could also be a risk factor for cardiovascular disease. • If confirmed in other largescale studies, early breakfast and dinner could be considered in preventive strategies of cardiovascular diseases.

Front-of-pack nutrition labellings (FoPL) have gained traction in the European Union as tools to tackle the burden of nutrition-related chronic diseases. Multiple FoPL have been implemented by both governments and private actors. Under the European food labelling regulation, any FoPL is optional to display, although the legal framework is being revised for a harmonized FoPL to emerge. Since the implementation of the Nutri-Score in France in 2017, little data is available to understand the motivations and strategies underlying the adoption of the FoPL from a food business’ perspective. A cross-sectional study was conducted in March 2021 on food businesses having adopted the Nutri-Score in France through an online questionnaire. In total, 121 businesses completed the questionnaire, representing 32% of companies adopting the scheme and covering a variety of company types. Engaged businesses had a rather healthier portfolio of products according to the Nutri-Score (on average, 69% of engaged products were A or B and 12% were D or E), with disparities between retailers and national brands. Businesses mostly reported their engagement was motivated by a will to be transparent (76%) and to simplify nutritional information (67%) but still 19% reported that they engaged following external pressures. External pressures were more likely to play a role in the engagement if the company engaged in 2020 compared to those engaged before 2018 (P = 0.032), if the company was larger (P = 0.044) and if the scope of engagement included D or E products (poorer nutritional quality) (P = 0.033). Our study showed that the Nutri-Score, as an optional measure, is mainly used by businesses, especially national brands, as a tool to promote rather healthier products, while companies with products of lower nutritional quality are more likely to engage following external pressure. This highlights the relevance of enforcing a mandatory FoPL system, in line with the Farm to Fork strategy. Key messages

Skipping breakfast and late-night-eating have been associated with risk factors for type 2 diabetes (T2D). However, less is known about the link between daily timing and frequency of food intake and risk of developing T2D. The objective of the present study is to investigate the associations between circadian nutritional behaviours, defined by meal timings and frequency, and risk of T2D. 103,312 adults (79% females, mean age at baseline=42.7) from the French NutriNet-Santé cohort were included. Participants’ circadian nutritional behaviours were assessed using repeated 24 h dietary records. Associations of time of first and last meal of the day, meal frequency and of nighttime fasting duration with risk of T2D were assessed by multivariable Cox proportional hazard models adjusted for known risk factors. During a median follow-up of 7.3 years, 963 new cases of T2D were ascertained. Compared with subjects reporting on average a first meal before 8AM, those having a first meal after 9AM had a higher risk of developing T2D, HR = 1.59 (1.30 to 1.94). A late time of last meal (after 9PM) was associated with a higher risk of T2D, HR = 1.28 (1.06 to 1.54), but this association was no longer significant after adjusting for time of first meal. Each additional eating episode was associated with a reduction of the risk of T2D, HR = 0.95 (0.90 to 0.99), p-value=0.01. Overall, nighttime fasting duration was not associated with risk of T2D, except in participants having breakfast before 8AM after a nighttime fasting duration of more than 13 hours (HR = 0.47, 0.27 to 0.82). In this large prospective study, circadian nutritional behaviours were associated with risk of T2D. Daytime nutritional behaviours and specifically an early first meal was associated with a lower risk of type 2 diabetes. If confirmed in other largescale studies, an early breakfast should be considered in preventive strategies for type 2 diabetes. Key messages • If confirmed in other largescale studies, an early breakfast could be considered in preventive strategies for type 2 diabetes. • Beyond nutritional quality of meals, meal timing could also be a risk factor for type-2 diabetes.

Background Interpretive Front-of-Pack Labels (FoPLs) are supported by WHO as a key policy tool to promote healthy diets. At present, various FoPLs formats co-exist in the European Union (EU). However, as part of the Farm to Fork strategy, the European Commission stated it would adopt a single mandatory FoPL in 2022. The aim of this study was to analyze Spanish consumers reactions to Nutri-Score and NutrInform, two FoPLs that are currently the subject of debate in EU, testing preference through subjective understanding and perception but also performance through objective understanding of the FoPLs. Methods The experimental study was conducted in 2021 on a representative sample of 1026 Spanish adults (50% women, mean age±SD = 46±14 years), through an online randomized questionnaire where participants were exposed to Nutri-Score or NutrInform. Performance of and preference for these two FoPLs were assessed in three food categories (Breakfast Products, Breakfast Cereals and Added Fats). Performance was tested using multivariate logistic regression while preference using principal component analysis and t-tests. Results In terms of objective understanding, Nutri-Score was significantly associated with an increase in consumers’ ability to identify healthier food products across all food categories compared to NutrInform (OR = 19.1 [14.2-25.7], p < 0.0001). On the preference dimension, Nutri-Score was perceived as significantly easier to use and was more liked than NutrInform (standardized PCA dimension resp. 0.32±1.58 vs. -0.29±1.66, p < 0.0001 and 0.080±1.18 vs. -0.072±1.17, p = 0.039) and participants found Nutri-Score more helpful to discriminate the nutritional quality of Breakfast Products and Breakfast Cereals (resp. 1.32±1.00 vs. 1.14±1.02, p < 0.01 and 1.33±1.00 vs. 1.00±1.03, p < 0.0001). Conclusions Results of this study provide new evidence to support Nutri-Score in comparison with the NutrInform battery, on both performance and preference aspects. Key messages • Nutri-Score better helps participants identify healthier food products than NutrInform. • European Commission should consider results of this study in its decision on a harmonized Front-of-Pack Label.

Background Nutrition is a well-established risk factor for cardiovascular diseases (CVD) that can be leveraged by public health prevention strategies. In addition to dietary guidelines, front-of-pack nutrition labels (FoPNL) can help consumers make healthier food choices. Nutri-Score, a scientifically validated 5-color FopNL based on the nutrient profile FSAm-NPS has been adopted by several European countries but remains optional under current EU labeling regulation, which is to be revised end of 2022. Scientific evidence is therefore needed on the relevance of the Nutri-Score at the European level. Our objective was to study the association between the consumption of food as graded by the FSAm-NPS and CVD risk in a large European population. Methods This prospective analysis was conducted on a case-cohort comprising 13,308 participants without CVD risk factors at baseline, among which 5,326 first incident cases of CVD from the EPIC-CVD study (8 European countries). Food intakes were assessed using country-specific dietary questionnaires. The FSAm-NPS was calculated for each food based on its 100g content in energy, sugar, saturated fatty acid, sodium, fibre, protein, and fruits/vegetables/legumes/nuts. Multi-adjusted Cox models were computed. Results Overall, associations were observed between the consumption of foods with a higher FSAm-NPS score (lower nutritional value) and a higher risk of myocardial infarction (MI; HR1-SD=1.12 [1.05,1.21]; HRQ5/Q1=1.23 [1.00,1.52]). Associations with stroke were not significant. Overall, associations were more particularly observed in men. Conclusions In this large European population, a higher risk of MI was observed in individuals consuming on average a diet with higher FSAm-NPS foods (reflecting consumption of foods with a lower nutritional value/less favourable Nutri-Score). This adds to the evidence on the relevance of Nutri-Score as a public health tool to help consumers choose healthier food products. Key messages • The consumption of foods with a lower nutritional quality as graded by the Nutri-Score was associated with a higher risk of myocardial infarction in the large European EPIC-CVD case-cohort study. • This adds to the evidence supporting the relevance of the Nutri-Score as a complementary tool to dietary guidelines to help consumers make healthier food choices.

Self-management of irritable bowel syndrome (IBS) is increasingly focusing on exclusion diets. In particular, patients are showing a significant interest in the gluten-free diet for the treatment of IBS. However, the lack of scientific evidence prevents the establishment of clear dietary guidelines and attention is needed as dietary restriction can lead to potentially adverse effects. This cross-sectional study aims to explore the practice of gluten avoidance in participants identified with IBS in a large cohort of non-celiac French adults. The population included 15,103 participants of the NutriNet-Santé study who completed a functional gastrointestinal disorder questionnaire based on the Rome III criteria to identify IBS in 2013 and a food avoidance questionnaire in 2016. Data on diet and anthropometric and sociodemographic characteristics were collected. Multivariate logistic regression models were used to compare the avoidance of gluten between IBS and non-IBS participants. Participants were mainly women (73.4%) and the mean age in this population was 55.8 ± 13.2 years. Among these individuals, 804 (5.4%) participants were identified as IBS cases. Among them, the prevalence of gluten avoidance was estimated at 14.8%, of which 3.0% reported total avoidance, versus 8.8% and 1.6% in non-IBS participants. After adjustments, gluten avoidance was higher in IBS participants compared to their non-IBS counterparts: (OR = 1.86, 95%CI = 1.21, 2.85) for total and (OR = 1.71, 95%CI = 1.36, 2.14) for partial avoidance. Participants identified with IBS were more associated with gluten avoidance than non-IBS participants. Further studies are needed to explore the long-term consequences of dietary interventions and to provide consistent dietary guidance connected to patient perception.

Background Added sugars' deleterious effects have been established for several chronic diseases, leading food industries to turn towards high-intensity sweeteners. Their safety is debated and findings remain contrasted regarding their role in the etiology of various diseases. In particular, their carcinogenicity has been suggested by several experimental studies but epidemiological data are lacking. Thus, our objective was to investigate the associations between sweetener intakes (total from all dietary sources, and most frequently consumed: acesulfame-K e950, aspartame e951 and sucralose e955) and cancer risk (overall and by sites). Methods Overall, 102,046 adults from the French NutriNet-Santé prospective cohort (2009-2021) were included. Consumption of sweeteners was obtained by repeated 24h-dietary records including brands and commercial names of industrial products. Associations between sweeteners and cancer incidence were assessed by multi-adjusted Cox hazard models. Results Compared to non-consumers, high-consumers had higher risk of overall cancer (n = 2527, hazard ratio=1.12, 95% confidence interval=1.00-1.25, P-trend=0.005). In particular, acesulfame-K (HR = 1.18 [1.04-1.34] P = 0.003) and aspartame (HR = 1.20 [1.05-1.38] P = 0.001) were associated with increased cancer risk. Similarly, higher risks were observed for breast (n = 723, HR = 1.25 [1.02-1.53] P = 0.01, HR = 1.39 [1.11-1.74] P = 0.003 and HR = 1.33 [1.05-1.69] P = 0.007 for total sweeteners, e950 and e951, respectively) and obesity-related cancers (n = 1509, HR = 1.16 [1.00-1.33] P = 0.02, HR = 1.23 [1.04-1.45] P = 0.01 and HR = 1.22 [1.02-1.45] P = 0.01 for total sweeteners, e950 and e951, respectively). Conclusions These results suggest that artificial sweeteners (especially e950 and e951), which are found in > 12,000 foods and beverage references worldwide, may be associated with increased cancer risk. These findings provide important and novel insights for the ongoing re-evaluation of sweeteners by the European Food Safety Authority. Key messages In this large-scale prospective cohort of French adults, intake of high-intensity artificial sweetener intake (especially acesulfame-K and aspartame) was associated with higher risk of cancer. These results provide novel insights to feed EFSA’s expertise for the ongoing risk assessment of artificial sweeteners.

Background Fermentable Oligosaccharides, Disaccharides and Monosaccharides And Polyols (FODMAPs), which are found in a variety of foods (dairy products, fruit, legumes, refined grains, sugary beverages, etc.) have been involved in risk for gastrointestinal disorders. In view of their pro-inflammatory potential and their interactions with the gut microbiota, their contribution to the etiology of other chronic diseases such as cancer has been postulated. However, no epidemiological study has investigated this hypothesis so far. Our objective was to investigate the associations between FODMAP intake (total and by type) and cancer risk (overall, breast, prostate and colorectal). Methods 104,909 French adults from the NutriNet-Santé prospective cohort (2009-2020) were included (median follow-up time=7.7y). FODMAP intakes were obtained from repeated 24h-dietary records linked to a detailed food composition table. Associations between FODMAPs and cancer risks were assessed by Cox proportional hazard models adjusted for a large range of lifestyle, sociodemographic and anthropometric variables. Results Total FODMAP intake was associated with increased overall cancer risk (n = 3,374 incident cases, Hazard Ratio for quintile 5 vs quintile 1=1.21, 95% confidence interval 1.02-1.44, P-trend=0.04). Oligosaccharides seemed to be the FODMAP type particularly associated with cancer risk: a trend was observed for overall cancer (HR = 1.10 (0.97-1.25) P-trend=0.04) and colorectal cancer (n = 272, HR = 1.78 (1.13-2.79) P-trend=0.02). Associations remained stable across a series of sensitivity analyses. Conclusions Our findings suggest a potential role of FODMAPs in cancer onset. Further epidemiological and experimental studies are needed to confirm these results and provide data on the potential underlying mechanisms. Key messages In this large-scale prospective cohort of French adults, FODMAP intake was associated with increased cancer risk. These associations need to be studied in other prospective cohorts, in order to clarify FODMAPs role in cancer development.

Las enfermedades cardiovasculares (ECV), constituyen un problema de salud pública a nivel mundial; en EsSalud, se ubica en séptimo puesto de las patologías con mayor carga de enfermedad. Los programas de rehabilitación cardiaca basados en ejercicios equipan un conjunto de intervenciones diseñadas para mejorar la recuperación del paciente con problemas cardiovasculares agudos o crónicos, los cuales mejoran la capacidad funcional, calidad de vida y ayudan al control de los factores de riesgo. OBJETIVO: Evaluar el efecto de un Programa de Rehabilitación Cardiaca (PRC) en pacientes con enfermedad coronaria. MATERIALES Y MÉTODOS: El estudio fue de tipo observacional, analítico, retrospectivo y longitudinal. La población estuvo constituida por pacientes que ingresaron al Programa de Rehabilitación Cardiaca del INCOR-ESSALUD entre los meses de setiembre a diciembre del 2017 con diagnóstico de enfermedad coronaria y que completaron las evaluaciones pertinentes. RESULTADOS: Se analizaron 109 historias clínicas de pacientes con enfermedad coronaria la mayoría de sexo masculino y con hipertensión arterial como el principal factor de riesgo cardiovascular. Se encontró que luego de completar la PRC, los participantes disminuyeron la circunferencia abdominal (p = 0.000), la presión arterial (p = 0.000) y mejoraron su consumo de oxígeno estimado en METS (p = 0.000); asimismo hubo una reducción de la obesidad abdominal (p = 0.008) y mejoría de la clase funcional (p = 0.000); además existe una mejoría significativa en la calidad de vida de los pacientes (p = 0.000). CONCLUSIONES: El PRC tiene efectos significativos sobre la obesidad abdominal, mejoría del consumo de oxígeno estimado, capacidad funcional y calidad de vida de los pacientes con enfermedad coronaria.

Objectives: Front-of-package nutrition labels are intended to easily convey to consumers comprehensible information about the nutritional composition of pre-packaged food and are thus a tool in the combat against the growing prevalence of nutrition-related disorders, such as obesity, type 2 diabetes, cardiovascular disease, and some types of cancer. The objective of the present narrative review was first to describe Nutri-Score and then to synthesize some of the international scientific evidence for its effectiveness. Guided by scientific data and collective expertise, France formally adopted labelling of pre-packaged food with the 5-colour Nutri-Score label in October 2017 and that move was later followed by Belgium, Spain, Germany, Switzerland, the Netherlands, and Luxembourg. Methods: This article synthesizes evidence from several countries regarding the effectiveness of Nutri-Score and the associated individual-level diet quality index in terms of attitude/behaviour- and health-related outcomes. It also addresses criticism levied at the label. Results: The effectiveness of Nutri-Score has been demonstrated in terms of consumer ability to correctly classify food according to its nutritional quality, the nutritional quality of actual and intended food purchases, and portion size choices. In addition, consumption of foods that are less favourably rated on the Nutri-Score scale has been prospectively associated with chronic disease risk (cancer, cardiovascular disease, metabolic syndrome, etc.). Conclusion: The adoption and implementation of a uniform front-of-package label such as the scientifically validated Nutri-Score on pre-packaged foods/beverages across Europe could be beneficial to consumers at the point of purchase and could help reduce the incidence of diet-related chronic diseases by means of improvement in diet quality.

Background Excessive sugar is now recognized as a key risk factor for several cardiometabolic diseases. In contrast, the associations between sugars and cancer risk in cohort studies have been less investigated, and data is lacking regarding differential effect of sugar types and sources. Experimental data suggest that sugars could play a role in cancer etiology, through obesity but also through inflammatory and oxidative mechanisms and insulin resistance. Our objective was to study the associations between total and added sugar intake and cancer risk, accounting for sugar types and sources. Methods 101,279 French adults from the NutriNet-Santé prospective cohort study (2009-2019) were included. Sugar intake was assessed using repeated 24h-dietary records, designed to register participants' usual consumption for more than 3,500 food and beverage items. Associations with cancer risk were assessed by multi-adjusted Cox proportional hazard models. Results Sugar intake was associated with increased cancer risk (2,503 cases, Hazard Ratio Quartile 4 vs 1=1.17, 95% Confidence Interval 1.00-2.37, P trend=0.02). This association was mainly driven by breast cancer (783 cases, HR Q4 vs Q1=1.51 (1.14-2.00); P trend=0.0007) and remained significant even when weight-gain during follow-up was accounted for. Associations were more specifically observed for added sugars (P trend=0.02), free sugars (P trend=0.007), sucrose (P trend=0.01), and sugars from milk-based desserts (P trend=0.02), from sugary drinks (P trend=0.002), and from dairy products (P trend=0.01). Conclusions These results suggest that sugar (especially added sugar), of which intake is increasing in Western countries, may represent a modifiable risk factor for cancer prevention, adding to its well-established effect on dental and cardiometabolic health. These findings provide important and novel insights to the current debate on the implementation of sugar taxation, marketing regulation, and other sugar-related policies. Key messages In this large-scale prospective cohort of French adults, sugar intake (especially added sugar) was associated with higher cancer risk. These results suggest that (added) sugar may represent a modifiable risk factor for cancer prevention, adding novel insights to current debates on implementing sugar-related public health policies.

Background Age-related hearing loss is prevalent yet insufficiently addressed by public health research. Subjective hearing loss has been highlighted as a key determinant of reduced quality of life, while chronic low-grade inflammation is an established determinant of adverse age-related outcomes. To our knowledge, this study was the first to investigate the link between the inflammatory potential of the diet and hearing loss. Methods We prospectively studied 3,435 French adults enrolled in the SU.VI.MAX (1994-2002) and SU.VI.MAX 2 (2007-2009) cohorts. The inflammatory potential of the diet was estimated by the Dietary Inflammatory Index (DII) using established methodology and repeated, baseline 24-h dietary records. Subjective hearing impairment was assessed after a median of 12 years by 3 Yes/No items and by a composite score, dichotomized for analyses. We fit multivariable logistic regression models adjusted for pertinent covariates. Results Compared to men, women exhibited higher DII (more pro-inflammatory diet) and less hearing impairment (both p Conclusions The findings among men support the hypothesis that a pro-inflammatory diet could increase risk of age-related hearing loss, whereas the findings among women were unexpected and merit further investigation. Key messages Given rapid population aging worldwide, there is an urgent need for public health research on modifiable risk factors of hearing impairment. The role of diet in hearing impairment is complex and likely sex-specific; a pro-inflammatory diet might be a risk factor for hearing impairment, especially among men.

Background Cancer remains one of the leading causes of death worldwide. In 2018, following its summary report, the World Cancer Research Fund (WCRF) issued its recommendations for cancer prevention based on the nutritional risk factors with a sufficient level of evidence. Our objective was to study whether adherence to these new recommendations leads to a reduced risk of cancer. Methods This study included 80,604 participants from the NutriNet-Santé population-based cohort study (2009-2019). Adherence to the 2018 WCRF recommendations was assessed using the operationalized score on a 7-point scale, proposed by Shams-White et al (Nutrients 2019), including: weight, physical activity, fruit and vegetables, dietary fibers, ultra-processed foods, red and processed meat, sugary drinks and alcohol. Usual dietary intakes were assessed using repeated 24h-dietary records and physical activity level using the IPAQ questionnaire. Multi-adjusted Cox proportional hazard models were used for the analyses. Results A total of 2,438 incident cancer cases were diagnosed during follow-up (median: 7.4 years). The median WCRF 2018 adherence score was 3.75 (IQR: 3.25-4.50). An increase of 1-point increment in the score was associated with a decreased risk of cancer overall (HR = 0.90; 95%CI 0.86-0.90; P Conclusions Our results suggest that a higher adherence to the WCRF 2018 recommendations for cancer prevention is associated to a decreased risk of cancer. Given the consistency between overall food-based dietary guidelines and the WCRF cancer recommendations, our result support their general promotion to the general public and transposition as public health actions. Key messages Following the recommendations for cancer prevention issued by the WCRF in 2018 can contribute to decrease the burden of cancer. The WCRF cancer recommendations are consistent with overall food-based dietary guidelines and should be promoted to the general public and transposed as public health actions.

The Nutri-Score is a summary graded front-of-pack nutritional label, providing a synthetic information to consumers on the overall nutritional quality of a food product, based on its composition in several key unfavourable (energy, saturates, sugars, salt) and favourable (proteins, fibers, fruit, vegetables, nuts, legumes and certain vegetable oils (olive, rapeseed and nuts)). The Nutri-Score was developed by a team of independent scientists, and initially proposed in France in 2014. Following intense opposition by industry and considerable arguments, a 2-yearlong debate, the Nutri-Score was selected to be the official French front-of-pack nutrition label. In parallel, more than 40 publications in peer-reviewed journals investigated its validity on multiple dimensions, further supporting its implementation. Following the implementation of the Nutri-Score, consumer groups' pressure and a growing interest from the public pushed manufacturers to adopt the label, with more than 300 pledges of adoption from industry in 2020. After France, neighbouring countries (Belgium, Spain, Switzerland, Germany and the Netherlands) have now also adopted the scheme, prompting new challenges for development at a larger scale. The implementation of the system in France was made possible by strong public support for such a measure - relayed by consumer groups and disseminated in the media and a strong political will from the Health ministry to put together a validated and helpful system, which finally prevailed upon economic interests. Sustained support from consumers in particular helped turn the tide from a relatively low engagement of stakeholders towards the acknowledgement of the Nutri-Score as a standard for front-of-pack labelling in France and several EU countries. The Nutri-Score is an example of a public health measure informed by scientific evidence that may have a clear impact on the nutritional quality of diets in the population.

BACKGROUND (OR PURPOSE): Nivolumab has been shown to be effective for the treatment of second-line mRCC. The present study has investigated the effectiveness and safety of nivolumab in real-world Eastern Spanish patients with advanced mRCC at TKI progression. PATIENTS AND METHODS: A retrospective review of mRCC patients treated with nivolumab as a second-line treatment was performed. Analyzed variables included age, sex, ECOG (quality of life scale designed by the Eastern Cooperative Oncology Group), histology, nephrectomy, location of metastases, number of metastasis locations, previous treatments, analytical data from the standard blood count and biochemistry, and response to treatment. RESULTS: 98 patients from 18 sites in Spain were retrospectively reviewed. The majority of patients were male (75%), had ECOG 0-1 (90.6%), had no brain metastasis (91.4%), had undergone one prior systemic regimen (94.3%), and were current/former smokers (97.1%). Fourteen patients (13.1%) had non-clear cell histology, seven (7.1%) had poor-IMDC prognostic group characteristics, 13 patients (13.1%) had liver metastasis and 35 (35.7%) had bone lesions. All patients received prior systemic therapy (63.3% sunitinib, 34.7% pazopanib). During the study, a median of eight doses of nivolumab was given (range 2-62) and 11 patients received more than 12 doses. Eleven patients (11.2%) received nivolumab as a third or fourth line of treatment. Median duration of therapy was 3.6months (range 0.5-29.3). Confirmed response rate was 25%. Median progression free survival was 7.8months (range 1.2-12.1). Median overall survival was 16.3months (range 1.7-29.3). After discontinuation of treatment, 27.58% of the patients received subsequent systemic cancer therapy. Side effects were mostly grade 1-2 (7.2% had hypothyroidism and 6.2% liver toxicity, 4% had nephritis and 2% hypophysitis). Two cases of grade 3-4 adverse events (2%) were reported. CONCLUSION: Benefit/risk profile of nivolumab in Eastern-Spanish real-world population with mRCC after tyrosine-kinase inhibitors was consistent with prior real-life studies reported as well as pivotal study.

Objective The consumption of ultra-processed foods has been increasing during the last decades, and has been previously associated with increased risks of mortality and several chronic diseases. The objective of this study is to assess for the first time the prospective associations between consumption of ultra-processed foods and the risk of type 2 diabetes (T2D). Methods 104707 participants aged at least 18 years (median age 41.5 years) from the French NutriNet-Santé cohort (2009-2019). Dietary intakes were collected using repeated 24 hour dietary records, designed to register participants’ usual consumption for 3300 different food items, categorized according to their degree of processing by the NOVA classification. Associations between ultra-processed food intake and risk of T2D were assessed using multi-adjusted Cox proportional hazard models. Results Ultra-processed sugary products, fruits and vegetables, and beverages were the highest contributors of the ultra-processed category (respectively 27.9, 18.5 and 15.6%). Ultra-processed food intake was associated with a higher risk of T2D (n = 821 incident cases; hazard ratio for an absolute increment of 10 in the percentage of ultra-processed foods in the diet = 1.15 (1.06-1.25); P = 0.0009, 582252 person-years). These results remained statistically significant after adjustment for other metabolic comorbidities, for several markers of the nutritional quality of the diet (red meat and sugary drinks consumption, intakes of saturated fatty acids, sodium, sugar, dietary fiber or Healthy/Western patterns derived by principal component analysis) and after a large range of sensitivity analyses. Conclusions In this large observational prospective study, higher consumption of ultra-processed foods in the diet was associated with a higher risk of T2D. Public health authorities in several countries recently started to recommend privileging unprocessed/minimally processed foods and limiting ultra-processed food consumption. Key messages The consumption of ultra-processed food is associated with an increased risk of type 2 diabetes. As the French Public Helath agency recommends, their consumption should be limited. Nutritional composition, food additives, contact materials, or neoformed contaminants might play a role in these associations and further studies are needed to understand their relative contribution.