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Biosimilars; Oncologia; Prescriptors Biosimilares; Oncología; Prescriptores Biosimilars; Oncology; Prescribers Background: Biosimilars can potentially improve the sustainability of cancer care; however, uptake is sometimes limited by safety concerns and a lack of understanding of the concept of extrapolation. The European Society for Medical Oncology (ESMO) conducted a survey to assess the current level of knowledge, understanding and comfort of use of biosimilars among prescribers specialised in oncology. Methods: A 19-question survey was developed using the SurveyMonkey online platform (https://www.surveymonkey.com/). Data collection occurred between September and October 2017 and included paper and online responses. Results: Overall, 393 responses were received from prescribers. Overall, 49.0% of prescribers use biosimilars in clinical practice and most (79.2%) rate their general knowledge of biosimilars as average to very high. Potential increased risk of immunogenicity remains a significant concern of switching. Gaps in knowledge identified by the survey include biosimilar development, clinical trial design and endpoint selection, and requirements for extrapolation, which should form the focus of future educational initiatives. A substantial demand remains for further educational activities with equal preference for online and face-to-face initiatives. A higher rate of biosimilar use (56.3% vs 46.5%), knowledge of biosimilar development and trial design, and comfort with extrapolation, but a lower knowledge of European Medicines Agency definitions, was found among prescribers from Asia-Pacific versus those from Europe. Conclusion: Encouraging levels of prescriber use and general knowledge of biosimilars were found, but a substantial need for further education remains. Efforts should be made worldwide to align terms, definitions and guidelines for the development and approval of biosimilars.

A. Kawai43, K. Kopeckova44, D. A. Krakorova45, A. Le Cesne46, F. Le Grange1, E. Legius47, A. Leithner48, A. Lopez Pousa49, J. Martin-Broto36, O. Merimsky50, C. Messiou51, A. B. Miah52, O. Mir53, M. Montemurro54, B. Morland55, C. Morosi56, E. Palmerini57, M. A. Pantaleo58, R. Piana59, S. Piperno-Neumann60, P. Reichardt61, P. Rutkowski62, A. A. Safwat63, C. Sangalli64, M. Sbaraglia19, S. Scheipl48, P. Schoffski65, S. Sleijfer66, D. Strauss67, K. Sundby Hall13, A. Trama68, M. Unk69, M. A. J. van de Sande70, W. T. A. van der Graaf66,71, W. J. van Houdt72, T. Frebourg73x, R. Ladenstein41z, P. G. Casali2,74z &

Purpose: The increase in the prevalence "long-term cancer survivor” (LCS) patients is expected to increase the cost of LCS care. The aim of this study was to obtain information that would allow to optimise the current model of health management in Spain to adapt it to one of efficient LCS patient care. Methods: This qualitative study was carried out using Delphi methodology. An advisory committee defined the criteria for participation, select the panel of experts, prepare the questionnaire, interpret the results and draft the final report. Results: 232 people took part in the study (48 oncologists). Absolute consensus was reached in three of the proposed sections: oncological epidemiology, training of health professionals and ICT functions. Conclusion: The role of primary care in the clinical management of LCS patients needs to be upgraded, coordination with the oncologist and hospital care is essential. The funding model needs to be adapted to determine the funding conditions for new drugs and technologies, Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature. This project was funded by AZ. The funding party did not influence the opinion of the authors. All the authors have accepted the participation as advisers of the ASISTO group and give their consent for the publication of the document

The COVID-19 pandemic affected millions of people globally with lasting effects on society, patients, investigators and health institutions. Clinical trials, our best tool to improve cancer treatment for patients through testing the clinical value of a new treatment, have been affected by the pandemic. The pandemic footprint represents both a risk of compromising development of new therapies and an opportunity to elicit discussion over a portfolio of broader reforms, applicable irrespective of pandemics, in order to improve the design and implementation of clinical trials in oncology. The administrative load should be reduced, without affecting the quality of research and principles of good clinical practice. Cancer centres are encouraged to adapt their research/operational structures to the requirements of molecular oncology and embrace novel trial designs. Technological and methodological leaps in telemedicine can convert physical to virtual visits while routine examinations may be performed in local institutions (co-research centres), maintaining adherence to good clinical and research practices. The adoption of broader inclusion criteria and clinically significant endpoints (survival, quality of life) should be promoted, co-existing with pathways for fast-track “conditional” drug approvals in areas of unmet need, based on surrogate endpoints that are linked to strict post-approval validation requirements. The utility of Real World Data as part of these validation requirements should be actively investigated. Lessons learnt from the SARS Cov2 pandemic can be developed in order to expand equitable access to clinical trials of a real world population, in a simplified and methodologically robust modus operandi, for the benefit of all our patients.

International audience; PURPOSE:A substantial proportion of cancer survivors experience fatigue after diagnosis. Physical activity (PA) can impact fatigue after cancer. In this study, we evaluated the prevalence and association of fatigue and the practice of PA in a population with early cancer.METHODS:Using the national population-based French cross-sectional study Vie après le cancer 2, we included 1984 patients with early breast (61.1%), prostate (21.5%), and colorectal (17.4%) cancer. Severe fatigue at 2 years postdiagnosis was defined by a score ≥40 in the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ C30) fatigue subscale. PA was defined as (a) self-reported PA before diagnosis (active/inactive) and (b) change in PA since diagnosis (increased/maintained exposure vs decreased exposure/remaining inactive). Multivariate regression examined associations of severe fatigue with PA, adjusting for baseline clinical and treatment variables.RESULTS:Median age was 52 years. 51.5% of patients experienced severe fatigue 2 years post-diagnosis. 87.7% reported to be physically active before cancer diagnosis; 53.3% of patients either decreased PA or remained inactive at 2 years postdiagnosis. At 2 years postdiagnosis, severe fatigue was associated with a change in PA since diagnosis: patients with decreasing PA/remaining inactive from pre- to postdiagnosis had a higher risk of severe fatigue vs those with increasing/maintaining PA (adjusted odds ratio [95% confidence interval] 2.32 [1.85-2.90]).CONCLUSION:Fatigue continues to be a substantial problem for cancer survivors 2 years after cancer diagnosis and is associated with PA decreasing/remaining inactive since diagnosis. Interventions to maintain or increase PA for cancer survivors should be tested to mitigate long-term fatigue after cancer.

Presented in part at: 1. 2nd IMPAKT Breast Cancer Conference, European Society of Medical Oncology, 2010, Brussels, Belgium. 2. 46th Annual Meeting of the American Society of Clinical Oncology, 2010, Chicago, IL, USA.-- et al., [Introduction]: Anthracyclines have various mechanisms of action that in the end lead to DNA double-strand breaks. Single-nucleotide polymorphisms (SNPs) in DNA repair genes may alter the protein function, affecting DNA repair proficiency and, therefore, the efficiency of DNA damaging chemotherapy. We have analysed whether SNPs in DNA repair genes (XRCC1, XRCC3 and XPD) could be useful to predict the response to anthracyclines in patients with early-stage breast cancer (EBC). Methods: Peripheral blood samples from 150 patients with EBC were used for genotyping XRCC3Thr241Met, XRCC1Arg399Gln and XPDLys751Gln. Genotypes were correlated with survival outcomes. [Results]: Eighty-four patients received treatment with chemotherapy regimens containing anthracyclines. In this group, patients with XRCC1Arg399Arg had a significant improvement in 5-year Disease Free Survival (DFS) compared with those with the Arg/Gln and Gln/Gln variants (84 vs 46 %, p = 0.026). In the multivariate analysis, XRCC1Arg399Arg was reported as an independent prognostic factor for DFS (HR 0.4, CI-95 % 0.2-0.9, p = 0.035). Patients with the XRCC3 Met241Met genotype presented better 5-year OS than those carrying the Thr/Thr and Met/Thr variants (100 vs 70 %, p = 0.030). A multivariate analysis for OS confirmed the independent prognostic value of XRCC3 Met241Met (HR 0.15, CI-95 % 0.02-0.90, p = 0.048). These differences were not significant when patients receiving other chemotherapy treatments, different from anthracyclines, were also considered (n = 150). XPDLys751Lys was associated with older age at diagnosis than the Lys/Gln and Gln/Gln genotypes (65 vs 58 years, p < 0.0001). [Conclusions]: XRCC3Thr241Met and XRCC1Arg399Gln may be predictive of survival outcome in EBC patients treated with anthracycline-based chemotherapy regimens., ESMO Foundation awarded Elena Castro with an IMPAKT 2010 travel grant for the presentation of this work.

IF 9.269; International audience; Background: We prospectively detected circulating tumor DNA (ctDNA) and circulating tumor cells (CTC) levels in patients (pts) included in the PRODIGE14-ACCORD21-METHEP2 randomized phase II trial.Methods: The trial enrolled colorectal cancer pts with potentially resectable liver metastases & no prior treatment; the primary endpoint was the rate of R0/R1 liver metastases resection achieved by 1st line regimen (targeted therapies & bi- vs tri-chemotherapy; Ychou, ASCO 2016). Blood samples were collected at inclusion, after 1 month of therapy and before any liver metastases surgery. CTCs (CellSearch) & ctDNA (ddPCR, BioRad) were detected in an experienced laboratory (Inst. Curie).Results: 153 pts had at least one blood analysis. High CTC count (≥3 CTC/7.5ml) was detected in 25/132 pts (19%) at baseline and associated with synchronous...

Background: Gliomas are the most common primary brain tumors in adults. The heterogeneity of tumors, the lack of reliable criteria for identifying different subtypes make their histopathological diagnosis and their management complex. The molecular classification is one of the most promising approaches to better characterize gliomas. The aim of this study was to characterize molecular markers from the differential transcriptomic analysis of high and low-grade gliomas. Methods: Tumor samples were obtained from 81 patients diagnosed with gliomas between 1998 and 2013 at Limoges and Montpellier University Hospitals. Transcripts from brain tumor frozen samples were analyzed by Taqman Low Density Array. Cluster and principal component analyses were performed on a list of 96 selected genes belonging to glioma markers, genes coding for neurotrophins and their receptors or involved in different mechanisms such as glycosylation, autophagy, RTK signaling pathways, hypoxia and angiogenesis. Protein expressions from selected genes were achieved by immunohistochemical staining on Tissue MicroArray. Results: Firstly, variations in gene expression were noted between the primary tumor and its recurrence and between biopsy and resected surgical specimen for a same patient. To have homogeneous series, only 64 primary brain tumors obtained from resected surgical specimens and free from radiotherapy and/or chemotherapy were presented in this work. Brain tumors were diagnosed as grade II oligo-astrocytoma (n = 9), grade III oligo-astrocytoma (n = 10), grade III astrocytoma (n = 8), glioblastoma (n = 17), grade II oligodendroglioma (n = 9) and grade III oligodendroglioma (n = 11). Using the hierarchical cluster method, we identified gene expression patterns specific of low or high grades and a set of genes of interest appeared significantly overexpressed or under-expressed according to tumor grade (p

Aim: The goal of this study was to identify which patient characteristics had a significant impact on the patient-perceived usefulness of information technologies (IT) in health care and the current utilization by patients. Methods: A questionnaire-based survey was conducted in 2013, over seven non-consecutive days within seven outpatient departments of a comprehensive cancer center. We computed descriptive statistics based on survey responses and performed correlation analysis (Spearman test) to investigate characteristics of patients' IT usage and attitudes in relation to age, gender, socioeconomic status, social isolation, and place of living (urban/rural). We then performed multinomial logistic regression models for which likelihood ratio tests were used. Results: The participation level was 85% (n = 1371). 70% of respondents were females, and the median age was 53.4 years. 84% of patients reported feeling comfortable with the use of computers, tablets and smartphones. 71% of them used a mobile phone every day and 68% were daily Internet users. Age and socioeconomic status were negatively associated with the use of IT (p Study findings indicate that age and socioeconomic status were negatively associated with the perceived ease of use of IT (p IT applications useful/very useful neutral not useful/rather not useful n/a Schedule an appointment 71% 6% 22% 1% Communicate via emails with your physician 75% 5% 18% 2% Get help with medication monitoring (reminders, side effects) 61% 12% 26% 1% Get information about disease/support 69% 12% 18% 1% Get access to external contacts (psychologist, nurses,..) 66% 13% 20% 1% Conclusions: Most patients were connected to the Internet and used information technologies on a daily basis. Overall, they expressed an interest in using these tools in health care. Differences in perceived ease of use of IT according to age and socioeconomic status have to be addressed. Disclosure: All authors have declared no conflicts of interest.

International audience; Purpose: Image-based biomarkers play an increasing role in the assessment of response to therapy. The value of a biomarker comes, in part, from its ability to guarantee reproducibility in a varying context. This study aims at evaluating the impact of workflow normalization and automation on the reproducibility of volume-based response assessment. This impact is measured in terms of inter-reader agreement (IRA).Method: A retrospective study was performed on 10 patients with Non-Small Cell Lung Cancer (NSCLC) lesions followed over 7 time points (TP) on average with Computed Tomography. Five imaging scientists measured sequentially the volume of each lesion at each TP and the time required to perform segmentations. We relied on a software providing semi-automatic segmentation capabilities and follow-up (FU) display. After 6 months, a second reading session used no automation for segmentation. The response to treatment was assessed according to +/-30% thresholds as recommended by the Quantitative Imaging Biomarker Alliance (QIBA). The IRA was measured by using Kappa coefficient. From the initial reading, where the same reader reviewed consecutively all TPs from the same patient, additional IRA assessments where performed by random mixing of measurements from different readers. Different types of mixing patterns simulated several deviations from normalization, this corresponding to FUs involving more than one radiologist or method.Results: The IRA of a normalized and automated workflow yielded a significantly higher kappa = 0.69 [0.59; 0.79] compared to mixed manual segmentations where kappa was 0.24 [0.06; 0.42]. Analyzed separately, both single-reviewer assessment and semi-automated segmentation led to higher reproducibility. The recourse to semi-automated segmentation reduces the average segmentation time by a factor of 4. Conclusions: Normalization and automation of the measurements improved significantly the IRA. Both normalization and automation contribute to improved reproducibility. Even small deviations from a normalized review may impair the global reliability of FUs. Single-reviewer reading and automation must be considered for a highly reproducible assessment of response to therapy.