Cost-effectiveness of granulocyte colony-stimulating factors (G-CSFs) for the prevention of febrile neutropenia (FN) in patients with cancer.

PURPOSE: Clinical practice guidelines recommend the use of all approved granulocyte colony-stimulating factors (G-CSFs), including filgrastim and pegfilgrastim, as primary febrile neutropenia (FN) prophylaxis in patients receiving high- or intermediate-risk regimens (in those with additional patient risk factors). Previous studies have examined G-CSF cost-effectiveness by cancer type in patients with a high baseline risk of FN. This study evaluated patients with breast cancer (BC), non-small cell lung cancer (NSCLC), or non-Hodgkin's lymphoma (NHL) receiving therapy who were at intermediate risk for FN and compared primary prophylaxis (PP) and secondary prophylaxis (SP) using biosimilar filgrastim or biosimilar pegfilgrastim in Austria, France, and Germany. METHODS: A Markov cycle tree-based model was constructed to evaluate PP versus SP in patients with BC, NSCLC, or NHL receiving therapy over a lifetime horizon. Cost-effectiveness was evaluated over a range of willingness-to-pay (WTP) thresholds for incremental cost per quality-adjusted life year (QALY) gained. Sensitivity analyses evaluated uncertainty. RESULTS: Results demonstrated that using biosimilar filgrastim as PP compared to SP resulted in incremental cost-effectiveness ratios (ICERs) well below the most commonly accepted WTP threshold of €30,000. Across all three countries, PP in NSCLC had the lowest cost per QALY, and in France, PP was both cheaper and more effective than SP. Similar results were found using biosimilar pegfilgrastim, with ICERs generally higher than those for filgrastim. CONCLUSIONS: Biosimilar filgrastim and pegfilgrastim as primary prophylaxis are cost-effective approaches to avoid FN events in patients with BC, NSCLC, or NHL at intermediate risk for FN in Austria, France, and Germany.

Opportunities to improve the adoption of health-related quality of life evidence as part of the French Health Technology Assessment process.

OBJECTIVES: Patient's health-related quality of life (HRQoL) is an important outcome measure that is considered by many payers and health technology assessment (HTA) bodies in the evaluation of treatments. We aimed to identify opportunities for HRQoL to be further incorporated into the assessment of the French HTA by comparing three health systems. We put forward recommendations that could bring further innovations to French patients. METHODS: We reviewed methodologies by the French, German and British HTA, and conducted a systematic review of all French (n = 312) and German (n = 175) HTA appraisals from 01 January 2019 to 31 December 2021. We also setup an advisory board of 11 ex-HTA leaders, payers, methodologists, healthcare providers and patient advocates, from France, Britain and Germany, to discuss opportunities to improve acceptance and adoption of HRQoL evidence in France. RESULTS: Our systematic review of HTA appraisals showed a higher HRQoL data rejection rate in France: in > 75% of cases the HRQoL evidence submitted was not accepted for the assessment (usually for methodological reasons, for example, data being considered exploratory; 16-75% of the appraisals mentioned HRQoL evidence, varying by therapeutic area). Overall, we found the French HTA to be more restrictive in its approach than IQWiG. CONCLUSIONS: Based on these findings we articulate collaborative proposals for industry and the HAS to improve acceptance of HRQoL evidence and create a positive feedback loop between HAS and industry along four dimensions (1) patient perception, (2) testing hierarchy, (3) trial design and (4) data collection.

The prevalence of CT-defined low skeletal muscle mass in patients with metastatic cancer: a cross-sectional multicenter French study (the SCAN study).

BACKGROUND: Cachexia, characterized by involuntary muscle mass loss, negatively impacts survival outcomes, treatment tolerability, and functionality in cancer patients. However, there is a limited appreciation of the true prevalence of low muscle mass due to inconsistent diagnostic methods and limited oncologist awareness. METHODS: Twenty-nine French healthcare establishments participated in this cross-sectional study, recruiting patients with those metastatic cancers most frequently encountered in routine practice (colon, breast, kidney, lung, prostate). The primary outcome was low skeletal muscle mass prevalence, as diagnosed by estimating the skeletal mass index (SMI) in the middle of the third-lumbar vertebrae (L3) level via computed tomography (CT). Other objectives included an evaluation of nutritional management, physical activity, and toxicities related to ongoing treatment. RESULTS: Seven hundred sixty-six patients (49.9% males) were enrolled with a mean age of 65.0 years. Low muscle mass prevalence was 69.1%. Only one-third of patients with low skeletal muscle mass were receiving nutritional counselling and only 28.4% were under nutritional management (oral supplements, enteral or parenteral nutrition). Physicians highly underdiagnosed those patients identified with low skeletal muscle mass, as defined by the primary objective, by 74.3% and 44.9% in obese and non-obese patients, respectively. Multivariate analyses revealed a lower risk of low skeletal muscle mass for females (OR: 0.22, P < 0.01) and those without brain metastasis (OR: 0.34, P < 0.01). Low skeletal muscle mass patients were more likely to have delayed treatment administration due to toxicity (11.9% versus 6.8%, P = 0.04). CONCLUSIONS: There is a critical need to raise awareness of low skeletal muscle mass diagnosis among oncologists, and for improvements in nutritional management and physical therapies of cancer patients to curb potential cachexia. This calls for cross-disciplinary collaborations among oncologists, nutritionists, physiotherapists, and radiologists.

How to Design a Remote Patient Monitoring System? A French Case Study.

BACKGROUND: Remote Patient Monitoring Systems (RPMS) based on e-health, Nurse Navigators (NNs) and patient engagement can improve patient follow-up and have a positive impact on quality of care (by limiting adverse events) and costs (by reducing readmissions). However, the extent of this impact depends on effective implementation which is often restricted. This is partly due to the lack of attention paid to the RPMS design phase prior to implementation. The content of the RPMS can be carefully designed at this stage and various obstacles anticipated. Our aim was to report on an RPMS design case to provide insights into the methodology required in order to manage this phase. METHODS: This study was carried out at Gustave Roussy, a comprehensive cancer centre, in France. A multidisciplinary team coordinated the CAPRI RPMS design process (2013-2015) that later produced positive outcomes. Data were collected during eight studies conducted according to the Medical Research Council (MRC) framework. This project was approved by the French National Data Protection Authorities. RESULTS: Based on the study results, the multidisciplinary team defined strategies for resolving obstacles prior to the implementation of CAPRI. Consequently, the final CAPRI design includes a web app with two interfaces (patient and health care professionals) and two NNs. The NNs provide regular follow-up via telephone or email to manage patients' symptoms and toxicity, treatment compliance and care packages. Patients contact the NNs via a secure messaging system. Eighty clinical decision support tools enable NNs to prioritise and decide on the course of action to be taken. CONCLUSION: In our experience, the RPMS design process and, more generally, that of any complex intervention programme, is an important phase that requires a sound methodological basis. This study is also consistent with the notion that an RPMS is more than a technological innovation. This is indeed an organizational innovation, and principles identified during the design phase can help in the effective use of a RPMS (e.g. locating NNs if possible within the care organization; recruiting NNs with clinical and managerial skills; defining algorithms for clinical decision support tools for assessment, but also for patient decision and orientation).

[Self and hetero evaluation of cancer treatment side effects]. / Auto- et hétéro-évaluation des effets indésirables des traitements du cancer.

Self and hetero evaluation of cancer treatment side effects. The accurate and continuous assessment of the side effects of cancer treatments is a major factor in the quality of patient care. The combination of self-evaluation by the patient himself and hetero-evaluation by health professionals makes it possible to optimize the follow-up of the patients and to better adapt the therapeutics. The use of connected devices and modern communication tools fits in perfectly with the need for regular monitoring of patients, which also makes the best use of professional resources.

Auto- et hétéro-évaluation des effets indésirables des traitements du cancer. L'évaluation précise et continue des effets indésirables des traitements du cancer est un élément majeur de la qualité de la prise en charge des patients. La combinaison de l'autoévaluation par le patient lui-même et de l'hétéro-évaluation par les professionnels de santé permet d'optimiser le suivi des patients et d'adapter au mieux les thérapeutiques. L'utilisation de dispositifs connectés et d'outils modernes de communication s'intègre parfaitement dans la nécessité d'un suivi régulier des patients, permettant également d'utiliser au mieux les ressources professionnelles.

Analysis of nurse navigators' activities for hospital discharge coordination: a mixed method study for the case of cancer patients.

BACKGROUND: Modern cancer care requires the development of clinical pathways to enhance coordination, but there are few descriptive studies about the content of coordination activities. More specifically, little is known about hospital discharge coordination, although this is seen as a sensitive phase of clinical pathway. PURPOSE: The purpose of this study was to identify and quantify the categories of activities performed by nurse navigators for hospital discharge coordination. METHODS: Patients supported within the Coordinating Outpatient Care department (COC) at Gustave Roussy (Villejuif, France). Study conducted over two consecutive phases (Feb-September 2014): (1) a qualitative phase to identify the categories of coordination activities (interviews with patients plus, focus groups with nurse navigators-NNs); (2) a quantitative phase to quantify the relative share of each category. The calls received through the telephone platform of COC (made by both patients and primary care providers) were systematically reported (caller; reason for the call; procedure performed) and then analyzed. RESULTS: Qualitative phase: 17 interviews with patients, plus 2 focus groups with NNs. Quantitative phase: 543 calls analyzed. The callers were patients or their relatives (38 %), private nurses (35 %), medical device providers (20 %), and other primary care providers (e.g., pharmacists, family physicians) (7 %). Five categories of coordination activities identified: (F1) Patient monitoring (29 %); (F2) Helping to navigate (24 %); (F3) Managing technical problems (17 %); (F4) Explaining care protocols (16 %); (F5) Collecting and transmitting the patient medical record information (14 %). CONCLUSIONS: The majority of requirements are related to organizational issues (e.g., navigation, lack of information, appointments). Nurse navigators' training and qualification must therefore combine both clinical and managerial skills.

Efficacy and safety of Vinflunine for advanced or metastatic urothelial carcinoma in routine practice based on the French multi-centre CURVE study.

BACKGROUND: To retrospectively assess the efficacy and safety of Vinflunine (VFL) under routine conditions and identify overall survival (OS) prognostic factors. METHODS: Twenty centres participated in the retrospective study (minimum 4 patients undergoing VFL treatment for advanced/metastatic UC after platinum-based regimen progression. Primary endpoint was OS. Secondary endpoints: progression-free survival (PFS), radiological response rate (RR) RECIST criteria and toxicity (CTC NCI v3). RESULTS: These centres enrolled 134 patients. Prior chemotherapy (CT) lines (≥ 1 palliative): 1 and ≥ 2 in 69% and 26% of patients, respectively. Performance status (PS): 0, 1, 2 in 25%, 46% and 23% of patients. Median OS = 8.2 months [6.5-9.4], PFS = 4.2 months and RR 22%, median number of 5 cycles. In risk groups based on 0-3 presence of adverse prognostic factors (PS ≥ 1, haemoglobin ≤ 10 g/dl and liver metastasis), median OS: 13.2, 9.9, 3.6, and 2.4 months (P < .0001), respectively; 3.3 months (1.9-5.6) in PS ≥ 2 subgroup. CONCLUSION: This study reflects routine UC management and confirmed VFL patient efficacy. The drug is safe with gastro-intestinal and haematological prophylaxis. Analysis of prognostic factors for OS is consistent with pivotal trials.

Supportive Care Needs of Newly Diagnosed Cancer Patients in a Comprehensive Cancer Center: Identifying Care Profiles and Future Perspectives.

The prompt introduction of supportive care for patients with cancer leads to a better quality of life, potential survival benefits, and improvements in treatment safety. Considering that patients' needs vary, descriptive assessments could serve as a compass for an efficient and prompt healthcare response. The aim of this study was to identify supportive care needs in newly diagnosed patients according to cancer type. A retrospective study was conducted by collecting data from the case consultation and medical records of a comprehensive cancer center in France. Patients' needs were divided into twelve domains: nutrition, psychological support, psychiatric support, social care, physiotherapy, addictology, pain management, palliative care, pharmacology, complementary and alternative practice (CAM), sexual health, and speech therapy. Out of 6217 newly diagnosed patients of various cancer types who sought medical care at Gustave Roussy in 2021, 2541 (41%) required supportive cancer care (SCC), and of them, 1331 patients (52%) required two or more different SCC specialist interventions. The top five interventions were dietary (for 60% of patients), physiotherapy (33%), psychology (29%), social care (28%), and pain management (16%). Subgroup analysis according to cancer department highlighted additional specific needs: CAM for breast cancer patients (11%), speech specialist (27%) and addictologist (22%) interventions for ENT patients, psychiatry consultations for neurological patients (16%), and palliative care for dermatology patients (23%). The aforementioned data suggest that an early, multidisciplinary supportive care intervention should be required. Assembling human resources at the time of diagnosis within a dedicated day unit would be the next appropriate step in developing personalized care pathways related to the highlighted needs.

Skeletal muscle density predicts prognosis in patients with metastatic renal cell carcinoma treated with targeted therapies.

BACKGROUND: Studies have shown that skeletal muscle and adipose tissue are linked to overall survival (OS) and progression-free survival (PFS). Because targeted therapies have improved the outcome in patients with metastatic renal cell carcinoma (mRCC), new prognostic parameters are required. The objective of the current study was to analyze whether body composition parameters play a prognostic role in patients with mRCC. METHODS: Adipose tissue, skeletal muscle, and skeletal muscle density (SMD) were assessed with computed tomography imaging by measuring cross-sectional areas of the tissues and mean muscle Hounsfield units (HU). A high level of mean HU indicates a high SMD and high quality of muscle. OS and PFS were estimated using the Kaplan-Meier method and compared with the log-rank test. The multivariable Cox proportional hazards model was adjusted for Heng risk score and treatment. RESULTS: In the 149 patients studied, the median OS was 21.4 months and was strongly associated with SMD; the median OS in patients with low SMD was approximately one-half that of patients with high SMD (14 months vs 29 months; P = .001). After adjustment for Heng risk score and treatment, high SMD was associated with longer OS (hazards ratio, 1.85; P = .004) and longer PFS (hazards ratio, 1.81; P = .002). Adding SMD will separate the intermediate-risk and favorable-risk groups into 3 groups, with different median OS periods ranging from 8 months (95% confidence interval [95% CI], 6 months-12 months) for an intermediate-risk Heng score/low SMD to 22 months (95% CI, 14 months-27 months) for an intermediate-risk Heng score/high SMD and a favorable-risk Heng score/low SMD to 35 months (95% CI, 24 months-43 months) for a favorable-risk Heng score/high SMD. CONCLUSIONS: High muscle density appears to be independently associated with improved outcome and could be integrated into the prognostic scores thereby enhancing the management of patients with mRCC.

Systematic review of amifostine for the management of oral mucositis in cancer patients.

PURPOSE: The aim of this study was to review the available literature from 1966 until December 31, 2010 and define clinical practice guidelines for the use of amifostine for the prevention and treatment of oral mucositis in cancer patients. METHODS: A systematic review was conducted by the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology. The body of evidence for the use of amifostine, in each cancer treatment setting was assigned an evidence level. Based on the evidence level, one of the following three guideline determinations was possible: recommendation, suggestion, or no guideline possible. RESULTS: Thirty papers were reviewed for evidence on amifostine as an intervention for oral mucositis. No guideline was possible for amifostine in any cancer treatment setting due to inadequate and conflicting evidence. CONCLUSION: Review of the amifostine studies for the prevention and treatment of oral mucositis has found insufficient evidence to support its use in any cancer treatment setting for this purpose. Additional well-designed research is needed to clarify the role of amifostine as an intervention for oral mucositis.

Systematic review of anti-inflammatory agents for the management of oral mucositis in cancer patients.

PURPOSE: The aim of this project was to review the available literature and define clinical practice guidelines for the use of anti-inflammatory agents for the prevention and treatment of oral mucositis in cancer patients. MATERIALS AND METHODS: A systematic review was conducted by the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology. The body of evidence for use of each intervention, in each cancer treatment setting, was assigned an evidence level. Based on the evidence level, one of the following three guideline determinations was possible: recommendation, suggestion, and no guideline possible. RESULTS: Forty-one papers were reviewed. There was sufficient evidence to recommend the use of benzydamine mouthwash for the prevention of oral mucositis in head and neck cancer patients receiving moderate-dose radiation therapy (up to 50 Gy), without concomitant chemotherapy. A new suggestion was developed against the use of misoprostol mouthwash for the prevention of oral mucositis in head and neck cancer patients receiving radiation therapy. Positive results were reported for some other anti-inflammatory agents. However, no guidelines were able to be developed for any other agents due to insufficient and/or conflicting evidence. CONCLUSIONS: The use of anti-inflammatory agents continues to be a promising strategy for the prevention and treatment of oral mucositis. Additional well-designed studies are needed to examine the use of this class of agents for oral mucositis.

[The social responsibility report drafting in healthcare facilities. Experiences in Fatebenefratelli's Hospitals]. / La redazione del Bilancio Sociale nelle strutture sanitarie. Esperienza negli ospedali Fatebenefratelli.

Medical facilities have the duty to report, in a transparent, comprehensive and integrated manner, their performance, not only in relation to the services provided directly but also in relation to the interest of the various stakeholders and the economic and social benefits for the community. The Social Report is not only a communication tool related to corporate social responsibility but also the initial basis for acquiring social legitimacy, and serves the role of "social accounting" of the activities of an organization, with respect to its mission and institutional role. In healthcare, it can contribute to achieving the fundamental objectives of the healthcare system, in the financial area (fair financing), and also in the medical (outcomes) and ethical-social areas.

Psoas muscle index is not representative of skeletal muscle index for evaluating cancer sarcopenia.

BACKGROUND: A common method for diagnosing sarcopenia involves estimating the muscle mass by computed tomography (CT) via measurements of the cross-sectional muscle area (CSMA) of all muscles at the third lumbar vertebra (L3) level. Recently, single-muscle measurements of the psoas major muscle at L3 have emerged as a surrogate for sarcopenia detection, but its reliability and accuracy remain to be demonstrated. METHODS: This prospective cross-sectional study involved 29 healthcare establishments and recruited patients with metastatic cancers. The correlation between skeletal muscle index (SMI = CSMA of all muscles at L3/height2 , cm2 /m2 ) and psoas muscle index (PMI = CSMA of psoas at L3/height2 , cm2 /m2 ) was determined (Pearson's r). ROC curves were prepared based on SMI data from a development population (n = 488) to estimate suitable PMI thresholds. International low SMI cut-offs according to gender were studied for males (<55cm2 /m2 ) and for females (<39 cm2 /m2 ). Youden's index (J) and Cohen's kappa (κ) were calculated to estimate the test's accuracy and reliability. PMI cut-offs were validated in a validation population (n = 243) by estimating the percentage concordance of sarcopenia diagnoses with the SMI thresholds. RESULTS: Seven hundred and sixty-six patients were analysed (mean age 65.0 ± 11.8 years, 50.1% female). Low SMI prevalence was 69.1%. Correlation between the SMI and PMI for the entire population was 0.69 (n = 731, P < 0.01). PMI cut-offs for sarcopenia were estimated in the development population at <6.6cm2 /m2 in males and at <4.8 cm2 /m2 for females. The J and κ coefficients for PMI diagnostic tests were weak. The PMI cut-offs were tested in the validation population where 33.3% of the PMI measurements were dichotomously discordant. CONCLUSIONS: A diagnostic test employing single-muscle measurements of the psoas major muscle as a surrogate for sarcopenia detection was evaluated but found to be unreliable. The CSMA of all muscles must be considered for evaluating cancer sarcopenia at L3.

Implementing a PROACTive Care Pathway to Empower and Support Survivors of Breast Cancer.

PURPOSE: Optimal comprehensive survivorship care is insufficiently delivered. To increase patient empowerment and maximize the uptake of multidisciplinary supportive care strategies to serve all survivorship needs, we implemented a proactive survivorship care pathway for patients with early breast cancer at the end of primary treatment phase. METHODS: Pathway components included (1) a personalized survivorship care plan (SCP), (2) face-to-face survivorship education seminars and personalized consultation for supportive care referrals (Transition Day), (3) a mobile app delivering personalized education and self-management advice, and (4) decision aids for physicians focused on supportive care needs. A mixed-methods process evaluation was performed according to the Reach, Effectiveness, Adoption, Implementation and Maintenance framework including administrative data review, pathway experience survey (patient, physician, and organization), and focus group. The primary objective was patient-perceived satisfaction with the pathway (predefined progression criteria for pathway continuation ≥70%). RESULTS: Over 6 months, 321 patients were eligible for the pathway and received a SCP and 98 (30%) attended the Transition Day. Among 126 patients surveyed, 77 (66.1%) responded. 70.1% received the SCP, 51.9% attended the Transition Day, and 59.7% accessed the mobile app. 96.1% of patients were very or completely satisfied with the overall pathway, whereas perceived usefulness was 64.8% for the SCP, 90% for the Transition Day, and 65.2% for the mobile app. Pathway implementation seemed to be positively experienced by physicians and the organization. CONCLUSION: Patients were satisfied with a proactive survivorship care pathway, and the majority reported that its components were useful in supporting their needs. This study can inform the implementation of survivorship care pathways in other centers.

Relationship between the creatinine/cystatin C ratio and muscle mass measured by CT-scan in cancer patients.

BACKGROUND: Sarcopenia is observed in about 50% of cancer patients. Cancer-related sarcopenia negatively affects survival and is a predictive factor of anticancer drug toxicity. Sarcopenia diagnosis is challenging in routine care. We investigated whether plasma creatinine and cystatin C predict sarcopenia diagnosis in the specific population of cancer patients. METHODS: Two common diagnostic criteria of cancer-related sarcopenia based on skeletal muscle mass ± handgrip strength were separately applied as the "gold standard" sarcopenia definition. Four sarcopenia indexes based on creatinine and cystatin C values were evaluated: Creatinine/Cystatin C, Glomerular Filter rate (GFR) Cockroft-Gault/GFR CKD-EPI, GFR Cockroft-Gault/GFR Grubb and GFR Cockroft-Gault/GFR simple. The receiver operating characteristic (ROC) curves and the area under the ROC curves were applied to evaluate the sarcopenia diagnostic accuracy of the four different sarcopenia indexes. RESULTS: A total of 99 patients were included. Among them, 47.5% were overweight or obese. The ratio creatinine/cystatin C (ratio value at 0.8) more accurately predicts the diagnosis of sarcopenia in the entire population based on low skeletal muscle mass and low handgrip strength (sensitivity, specificity, accuracy and Youden index at 0.77, 0.57, 0.90, 0.34 respectively). The other evaluated ratios predict sarcopenia with a lower specificity in all conditions. In the overweight/obese group, the results are similar. The ratio creatinine/cystatin C (ratio value at 1) accurately predicts sarcopenia with a sensitivity, a specificity, an accuracy and a Youden index at 0.50, 0.86, 0.95, 0.36 respectively in overweight/obese population. CONCLUSIONS: The creatinine/cystatin C ratio is a useful and simple biomarker to predict sarcopenia in cancer patients. Moreover, this sarcopenia index also seems to be a strong sarcopenia diagnosis biomarker in overweight and obese cancer patients. Our results must be confirmed in a larger cohort.

PARP Inhibition, a New Therapeutic Avenue in Patients with Prostate Cancer.

Up to 25% of patients with metastatic prostate cancer present with germline or somatic DNA damage repair alterations, some of which are associated with aggressive disease and poor outcomes. New data have brought poly(ADP-ribose) polymerase (PARP) inhibitors into sharp focus in the treatment of metastatic castrate-resistant prostate cancer (mCRPC). Olaparib improved survival after at least one new hormonal therapy (NHT) in a cohort of patients harboring BRCA1, BRCA2 or ATM mutations in the PROfound trial, while rucaparib, talazoparib and niraparib demonstrated compelling activity in phase II trials. While patients with prostate cancer and BRCA1 or BRCA2 mutations may derive greatest benefit of PARP inhibition, the magnitude of benefit seems much lower in the context of most other homologous recombination gene mutations. Several PARP inhibitors are currently developed in combination with conventional therapy, including chemotherapy, NHT, and alpha-particle emitters, at different disease stages. Herein, we review the rationale for PARP inhibition in patients with prostate cancer, discuss the impact of PARP inhibitors on outcomes, and explore underlying challenges for future developments.

Is sarcopenia a missed factor in the management of patients with metastatic breast cancer?

BACKGROUND: Sarcopenia has emerged as an important parameter to predict outcomes and treatment toxicity. However, limited data are available to assess sarcopenia prevalence in metastatic breast cancer and to evaluate its management. METHODS: The SCAN study was a cross-sectional multicenter French study that aimed to estimate sarcopenia prevalence in a real-life sample of metastatic cancer patients. Sarcopenia was identified by low muscle mass (estimated from the skeletal muscle index at the third lumbar, via computed tomography) and low muscle strength (defined by handgrip strength). Three populations were distinguished based on EWGSOP criteria: a sarcopenic group with low muscle mass AND strength, a pre-sarcopenic group with low muscle mass OR strength and a normal group with high muscle mass AND strength. RESULTS: Among 766 included patients, 139 patients with breast cancer and median age of 61.2 years (29.9-97.8 years) were evaluable; 29.5% were sarcopenic and 41.0% were pre-sarcopenic. Sarcopenic patients were older (P < 0.01), had a worse PS-score (P < 0.05), and a higher number of metastatic sites (P < 0.01), the majority being hepatic and bone. A moderate agreement between the oncologist's diagnosis and sarcopenia evaluation by muscle mass and strength was recognized (Cohen's kappa = 0.45). No associations were found between sarcopenia and adverse event occurrence in the 12 patients for whom these were reported. Sarcopenic patients were underdiagnosed and nutritional care and physical activity were less proposed. CONCLUSION: It is necessary to evaluate sarcopenia due to its impact on patient prognosis, and its utility in guiding patient management in metastatic breast cancer.

Digital remote monitoring plus usual care versus usual care in patients treated with oral anticancer agents: the randomized phase 3 CAPRI trial.

Strategies that individualize the care of cancer patients receiving oral anticancer agents offer opportunities to improve treatment adherence and patient care. However, the impact of digital remote monitoring systems in this setting has not been evaluated. Here, we report the results of a phase 3 trial (CAPRI, NCT02828462) to assess the impact of a nurse navigator-led program on treatment delivery for patients with metastatic cancer. Patients receiving approved oral anticancer agents were randomized (1:1) to an intervention combining a nurse navigator-led follow-up system and a web portal-smartphone application on top of usual care, or to usual symptom monitoring at the discretion of the treating oncologist, for a duration of 6 months. The primary objective included optimization of the treatment dose. Secondary objectives were grade ≥3 toxicities, patient experience, rates and duration of hospitalization, response and survival, and quality of life. In 559 evaluable patients the relative dose intensity was higher in the experimental arm (93.4% versus 89.4%, P = 0.04). The intervention improved the patient experience (Patient Assessment of Chronic Illness Care score, 2.94 versus 2.67, P = 0.01), reduced the days of hospitalization (2.82 versus 4.44 days, P = 0.02), and decreased treatment-related grade ≥3 toxicities (27.6% versus 36.9%, P = 0.02). These findings show that patient-centered care through remote monitoring of symptoms and treatment may improve patient outcomes and experience.

[Management of toxicities of BRAF inhibitors and MEK inhibitors in advanced melanoma]. / Gestion des toxicités des inhibiteurs BRAF et MEK dans le mélanome métastatique.

Major therapeutic advances have been made recently in the treatment of metastatic melanoma, due to the development of targeted therapies, namely BRAF and MEK inhibitors, in patients with BRAF V600 mutation. Combinations of vemurafenib+cobimetinib, dabrafenib+trametinib, et encorafenib+binimetinib, evaluated in coBRIM, COMBI-d/COMBI-v and COLUMBUS trials respectively have been approved in this indication. Toxicities induced by combination therapies are different from those reported with monotherapies, in terms of frequency and intensity. Physicians who treat melanoma patients thus face news issues relating to prevention, detection and treatment of these adverse events. This paper summarizes tolerance data from the three pivotal trials (coBRIM, COMBI-v and COLUMBUS) and issues recommendations for the specific management of main toxicities, based on experts' opinion. We discuss dermatological, ophthalmological, cardiovascular, digestive, musculoskeletal, renal and general toxicities and propose a timetable for examinations to be performed before and during treatment.