Contrast-enhanced intra-operative ultrasound as a clinical decision making tool during surgery for colorectal liver metastases: The ULIIS study.

BACKGROUND: Detecting more colorectal liver metastases (CRLMs) during surgery may help optimise strategy and improve outcomes. Our objective was to determine clinical utility (CU) of contrast-enhanced intra-operative ultrasound (CE-IOUS) using sulphur hexafluoride microbubbles during CRLM surgery. METHOD: A prospective phase II trial performed at two comprehensive cancer research centres. Patients operated for CRLMs were eligible and assessable if intra-operative ultrasound (IOUS) and CE-IOUS had been performed and pathological results were available and/or 3-month imaging. CU was defined as the justified change in planned surgical strategy or procedure using CE-IOUS. RESULTS: Out of the 68 patients enrolled, 54 were eligible and assessable. 43 patients underwent pre-operative chemotherapy. The median number of CRLMs was 2 (range, 1-11). Pre-operative staging was performed using MRI. IOUS allowed identification of 45 new CRLMs in 13 (24.7%) patients. Compared to IOUS, CE-IOUS allowed identification of 10 additional CRLMs in 9 (16.7%) patients. Surgery was altered and justified in 4 patients only, leading to a CU rate of 7.70% (95 CI, [3.2, 18.6]). No missing CRLMs were identified by CE-IOUS. CONCLUSIONS: Although the primary endpoint was not met for one protocol violation, secondary endpoints indicate that CE-IOUS has an intermediate added-value for surgeons treating CRLMs. TRIAL REGISTRATION: NCT01880554 (https://clinicaltrials.gov/).

Evidence-based data and rare cancers: The need for a new methodological approach in research and investigation.

Rare cancers are not so rare, their incidence is increasing and, as a group, they have worse survival than the common cancers. These factors emphasise the societal need to ensure sufficient focus on research into their biological basis, aetiological factors, new more effective therapies and organisation of healthcare to improve access to best practice and innovation. Accuracy of diagnosis is one of the first hurdles to be overcome, with around one third of tumours being reclassified - by type or risk group - when subject to a centralised pathology review process. Timely access to appropriate expert knowledge is a second challenge for patients - in Europe this is being addressed by the establishment of European Reference Networks (ERNs) as part of the EU cross border healthcare initiative. There are ERNs for adult solid and haematological cancers and childhood cancers, all of which are individually rare. These ERNs will facilitate creation of large databases of rare tumours that will incorporate knowledge of their molecular features and build an evidence base for the effectiveness of innovative, biology-directed therapies. With an increasing focus on 'real world' outcome data, research methodologies are evolving, to include randomised registry trials and data linkage approaches that exploit the ever-richer information held on patients in routine health care data. The inclusion of genomic analysis into cancer diagnosis, treatment and risk prediction raises many issues for the conduct of clinical research and cohort studies and personal data sharing. Sophisticated means of pseudonymisation, together with full involvement of affected and 'at risk' patients, are supporting novel research designs and access to data that will continue to build the evidence base to improve outcomes for patients with rare cancers.

Multidisciplinary development of the Geriatric Core Dataset for clinical research in older patients with cancer: A French initiative with international survey.

BACKGROUND: To define a core set of geriatric data to be methodically collected in clinical cancer trials of older adults, enabling comparison across trials. PATIENTS AND METHODS: Following a consensus approach, a panel of 14 geriatricians from oncology clinics identified seven domains of importance in geriatric assessment. Based on the international recommendations, geriatricians selected the mostly commonly used tools/items for geriatric assessment by domain (January-October 2015). The Geriatric Core Dataset (G-CODE) was progressively developed according to RAND appropriateness ratings and feedback during three successive Delphi rounds (July-September 2016). The face validity of the G-CODE was assessed with two large panels of health professionals (55 national and 42 international experts) involved both in clinical practice and cancer trials (March-September 2017). RESULTS AND DISCUSSION: After the last Delphi round, the tools/items proposed for the G-CODE were the following: (1) social assessment: living alone or support requested to stay at home; (2) functional autonomy: Activities of Daily Living (ADL) questionnaire and short instrumental ADL questionnaire; (3) mobility: Timed Up and Go test; (4) nutrition: weight loss during the past 6 months and body mass index; (5) cognition: Mini-Cog test; (6) mood: mini-Geriatric Depression Scale and (7) comorbidity: updated Charlson Comorbidity Index. More than 70% of national experts (42 from 20 cities) and international experts (31 from 13 countries) participated. National and international surveys showed good acceptability of the G-CODE. Specific points discussed included age-year cut-off, threshold of each tool/item and information about social support, but no additional item was proposed. CONCLUSION: We achieved formal consensus on a set of geriatric data to be collected in cancer trials of older patients. The dissemination and prospective use of the G-CODE is needed to assess its utility.

Radiofrequency ablation of stage IA non-small cell lung cancer in patients ineligible for surgery: results of a prospective multicenter phase II trial.

BACKGROUND: A prospective multicenter phase II trial to evaluate the survival outcomes of percutaneous radiofrequency ablation (RFA) for patients with stage IA non-small cell lung cancer (NSCLC), ineligible for surgery. METHODS: Patients with a biopsy-proven stage IA NSCLC, staging established by a positron emission tomography-computed tomography (PET-CT), were eligible. The primary objective was to evaluate the local control of RFA at 1-year. Secondary objectives were 1- and 3-year overall survival (OS), 3-year local control, lung function (prior to and 3 months after RFA) and quality of life (prior to and 1 month after RFA). RESULTS: Of the 42 patients (mean age 71.7 y) that were enrolled at six French cancer centers, 32 were eligible and assessable. Twenty-seven patients did not recur at 1 year corresponding to a local control rate of 84.38% (95% CI, [67.21-95.72]). The local control rate at 3 years was 81.25% (95% CI, [54.35-95.95]). The OS rate was 91.67% (95% CI, [77.53-98.25]) at 1 year and 58.33% (95% CI, [40.76-74.49]) at 3 years. The forced expiratory volume was stable in most patients apart from two, in whom we observed a 10% decrease. There was no significant change in the global health status or in the quality of life following RFA. CONCLUSION: RFA is an efficient treatment for medically inoperable stage IA NSCLC patients. RFA is well tolerated, does not adversely affect pulmonary function and the 3-year OS rate is comparable to that of stereotactic body radiotherapy, in similar patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01841060 registered in November 2008.

Alterations in comprehensive geriatric assessment decrease survival of elderly patients with cancer.

INTRODUCTION: A comprehensive geriatric assessment (CGA) evaluating several domains of health is recommended for elderly patients with cancer. Effects of altered domains on the risk of death in this population need to be clarified. The aim of this study was to estimate the independent association of each CGA domain to overall survival (OS). METHOD: Patients included in the ONCODAGE cohort completed a CGA at baseline. Cox models (one per domain) estimated the hazard ratio (HR) of death for each CGA domain. Directed Acyclic Graphs (DAGs) selected specific sets of adjustment factors for each model. RESULTS: The analysis included 1264 patients (mean age: 78 years, women: 70%). Median follow-up was 5.2 years, and 446 patients died. Each altered domain had a detrimental effect on survival, sometimes dependent on gender, age, education or time from inclusion. Nutritional status had a time-varying effect, with higher mortality rates if altered only within the first 3 years of follow-up. In case of altered mobility, the risk of death was higher only for the youngest patients and, in case of altered autonomy, only for the youngest women. An altered neurological state led to higher mortality rates; this effect increased with the level of education. Patients with altered psychological status or more than four comorbidities at baseline had also higher mortality rates. CONCLUSIONS: Patients with an altered CGA domain have a higher risk of death than those without any alteration. The effect of some alterations is different in some subgroups or at a given time of the treatments.

Modeling individual and relative accuracy of screening tools in geriatric oncology.

BACKGROUND: Classification probabilities reflect to what degree a screening test represents the true disease state and include true positive (TPF) and false positive fractions (FPF). With two tests, one can compare TPF and FPF using relative probabilities which offer advantages in terms of interpretation and statistical modeling. Our objective was to highlight how individual and relative TPF and FPF can be easily estimated and compared within a regression modeling framework. This allows the modeling of tests' accuracy while adjusting for multiple covariates, and thus provides valuable information in addition to the crude TPF and FPF. We illustrate our purpose with the G8 and VES-13 screening tests aimed at identifying elderly cancer patients in need for a comprehensive geriatric assessment (CGA). METHODS: Prospective cohort with a paired design. TPF and FPF of each test, as well as relative TPF and FPF were modeled using log-linear models. RESULTS: G8 detected patients in need for CGA better than VES-13 at the expense of misclassifying a large number of normal patients. Both tests had better TPF with older age and poorer performance status (PS), and for all cancer subtypes compared with prostate cancer. Effect of age and PS on TPF was more pronounced with VES-13. Age affected FPF, but not differentially. CONCLUSIONS: Regression modeling helps provide a thorough assessment of the accuracy of diagnostic tests and should be used more frequently. In the context of screening, we encourage the use of G8 as failing to identify patients in need of a CGA might be more problematic than over-detection. Moreover, although we identified variables associated with the sensitivity of these tests, this association was less pronounced for the G8.

Predictive factors of depressive symptoms of elderly patients with cancer receiving first-line chemotherapy.

BACKGROUND: Depression is the most common psychiatric disorder in geriatrics and oncology. For elderly cancer patients, it has a significant impact on quality of life, morbidity, and mortality. Nevertheless, depression is under-diagnosed and under-treated. Cancer management is key in improving the quality of care in this population. We aim to identify sociodemographic, clinical, and treatment-related factors of depression in elderly patients during chemotherapy, thus allowing early detection of patients in need of specific treatment. Further, we investigate whether chemotherapy efficacy and safety are associated with depression. PATIENTS AND METHODS: A prospective multicenter cohort composed of incident cases of cancer diagnosed in patients 70 years and older, receiving first-line chemotherapy. Depressive symptoms were measured by the Geriatric Depression Scale at baseline and after four chemotherapy cycles. Associations between depressive symptoms during chemotherapy and patients' clinical and treatment characteristics were identified by logistic regression. RESULTS: Among 344 patients measured for depression before chemotherapy, 260 had a second assessment at the fourth treatment cycle. At baseline, 45.4% were depressed, and 44.6% were depressed after the fourth cycle. Independent factors of depression were depressive symptoms at baseline (odds ratio (OR) = 6.7, p < 0.001), malnutrition (OR = 5.1, p = 0.014), and risk of malnutrition (OR = 1.6, p = 0.014). After controlling for missing data, effective chemotherapy was associated with a lower risk of depression (OR = 0.4, p = 0.018). CONCLUSION: We highlight the role of depressive symptoms and nutritional status at baseline, on the occurrence of depressive symptoms during chemotherapy. These factors should be taken into account in any pre-treatment consultation and appropriate nutritional and psychiatric preventative measures established. Copyright © 2016 John Wiley & Sons, Ltd.

Estimating attributable fraction of lung cancer linked to smoking in Morocco.

The objective of this research was to estimate the attributable fraction (AF) of lung cancer linked to smoking in Morocco. The estimation was based on the SAMMEC (Adult Smoking-Attributable Mortality, Morbidity and Economic Costs) method based on the Levin formula to calculate AF linked to tobacco. Data about frequencies, association measures and relative risks were taken from available sources. The AF of lung cancer linked to smoking was about 87%, and around 3049 cases of this cancer in men could be avoided if tobacco use could be prevented. About a 10% reduction in smoking prevalence would result in a reduction of 346 lung cancer cases. Our study provides additional important elements for further advocacy to policy-makers to implement a tobacco control strategy based on a prevention policy in line with the epidemiological situation which could avoid a huge burden on the country.

Using surveillance data to understand cancer trends: an overview in Morocco.

BACKGROUND: The aim was to use the existing surveillance data sources of cancer in Morocco that could be used to better describe cancer mortality and incidence trends in Morocco. METHODS: National incidence data were derived from population-based cancer registries. Mortality data were collected from the international GLOBOCAN database. RESULTS: An overview of the main results was presented. In general, the most commonly diagnosed cancers in men are lung and prostates whereas in women, breast and cervical cancers are the pre-dominant cancers. Fifty nine percent and of breast and 65.7 % of cervical cancers in women are diagnosed at stages II and III. Cancer remains the second highest cause of mortality in Morocco. CONCLUSION: The data provides a description of the cancer incidence and trends in the Moroccan population. The Moroccan national cancer program should aim for more coherent, consistent and comparable incidence data between different cancer registries in the country, and develop uniform datasets with respect to quality.

INTRODUCTION: L'objectif était d'utiliser les sources de données existantes de surveillance du cancer qui pourraient être utiles pour décrire les tendances d'incidence et de mortalité du cancer au Maroc. MÉTHODES: Les données de morbidité et mortalité nationales et internationales disponibles ont été explorées. Les registres populationnels de cancer couvrent les données d'incidence régionale. Les données de mortalité sont disponibles par les données internationales de Globocan. RÉSULTATS: Un aperçu des principaux résultats a été présenté. Globalement, les cancers les plus fréquents sont le poumon et la prostate chez les hommes; le sein et le col utérin chez les femmes; ces deux cancers représentant 56,3 % de cancers féminins. Les cancers de sein et du col sont diagnostiqués dans 59 % et 65,7 % aux stades II et III. Le cancer est la deuxième cause de mortalité au Maroc. CONCLUSION: Les données fournissent une description de l'incidence des cancers et leurs tendances dans la population marocaine. Le programme national du cancer marocaine devrait viser pour les données d'incidence cohérents et comparables entre les différents registres du cancer dans le pays, et de développer des ensembles de données uniformes par rapport à la qualité.