Clinical and economic value of oral nutrition supplements in patients with cancer: a position paper from the Survivorship Care and Nutritional Support Working Group of Alliance Against Cancer.

Malnutrition is a common clinical and public health problem that can frequently affect patients in hospital and community settings. In particular, cancer-related malnutrition results from a combination of metabolic dysregulation and anorexia, caused both by the tumor itself and by its treatment. Patients with head-neck cancer, or with gastroesophageal, pancreatic, lung, and colorectal cancer, are particularly at risk of developing malnutrition, with a prevalence varying between 30 and 50% depending on tumor location and anti-cancer treatment complications. Prevention and adequate management of malnutrition is now considered an essential key point of therapeutic pathways of patients with cancer, with the aim to enhance their quality of life, reduce complications, and improve clinical outcomes. Oral nutritional supplements (ONS) are part of the nutritional therapy and represent an effective tool to address cancer-related malnutrition, as supported by growing literature data. However, patients' access to ONS - which is regulated by different national and regional policies in terms of reimbursement - is quite heterogeneous. This narrative review aims to summarize the current knowledge about the role of ONS in terms of cost-effectiveness in the management of actively treated patients with cancer, following surgery and/or radiotherapy/chemotherapy treatment and to present the position on this issue of the Alliance Against Cancer, the Italian National Oncology Network, coming up from a focused virtual roundtable of the Survivorship Care and Nutritional Support Working Group.

Cost-effectiveness analysis of oral nutritional supplements with nutritional counselling in head and neck cancer patients undergoing radiotherapy.

OBJECTIVE: There is limited evidence regarding the economic effects of nutrition support in cancer patients. This study aims at investigating the cost-effectiveness profile of systematic oral nutritional supplementation (ONS) in head and neck cancer (HNC) patients undergoing radiotherapy (RT) and receiving nutritional counseling. METHODS: A cost-effectiveness analysis based on a RCT was performed to estimate direct medical costs, life years gained (LYG) and Quality-Adjusted Life Years (QALY) for nutritional counseling with or without ONS at 5-month and 6-year follow up time. Value of information analysis was performed to value the expected gain from reducing uncertainty through further data collection. RESULTS: ONS with nutritional counseling produced higher QALY than nutritional counseling alone (0.291 ± 0.087 vs 0.288 ± 0.087), however the difference was not significant (0.0027, P = 0.84). Mean costs were €987.60 vs €996.09, respectively in the treatment and control group (-€8.96, P = 0.98). The Incremental Cost Effectiveness Ratio (ICER) was -€3,277/QALY, with 55.4% probabilities of being cost-effective at a cost-effectiveness threshold of €30,000/QALY. The Expected Incremental Benefit was €95.16 and the Population Expected Value of Perfect Information was €8.6 million, implying that additional research is likely to be worthwhile. At a median 6-year follow up, the treatment group had a significantly better survival rate when adjusting for late effect (P = 0.039). CONCLUSION: Our findings provide the first evidence to inform decisions about funding and reimbursement of ONS in combination with nutritional counseling in HNC patients undergoing RT. ONS may improve quality of cancer care at no additional costs, however further research on the cost-effectiveness of nutritional supplementation is recommended. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02055833. Registered 5th February 2014 https://clinicaltrials.gov/ct2/show/NCT02055833.

Comprehensive nutritional assessment in short bowel syndrome with chronic renal failure on teduglutide therapy: A case report.

We report the case of a 62-y-old woman with short bowel syndrome (SBS) and chronic renal failure, successfully treated with teduglutide, who underwent comprehensive systematic nutritional assessment including bioelectrical impedance vectorial analysis (BIVA). The patient did not tolerate the attempt of gradual suspension of parenteral nutrition (PN), bumping into the worsening of nutritional status and renal function. She was declared eligible for teduglutide, a glucagonlike peptide 2 analog that stimulates structural and functional intestinal adaptation and increases nutrient and fluid absorption. To date, there is no standardized nutritional management protocol for PN-dependent SBS patients treated with teduglutide. We here report our first 1-y follow-up data. The patient underwent comprehensive systematic nutritional assessment initially every 2 wk, then monthly. It included handgrip strength (HGS), blood tests (particularly serum creatinine, estimated glomerular filtration rate, urea, electrolytes, micronutrients, serum albumin), fluid intake, urine output, quality-of-life (QoL) evaluation, and BIVA, which estimates fat-free mass (FFM) and measures phase angle (PhA) and hydration status. At treatment initiation, the patient was on PN 3 d/wk. After 3 mo, she was weaned off PN. At 1 y, weight and serum albumin were reduced (-7.5 kg and -0.6 g/dL, respectively); FFM, PhA, and HGS slightly decreased; hydration status and renal function were preserved; and QoL subtly improved. No relevant clinical complications or metabolic imbalances occurred. The inclusion of BIVA in the comprehensive systematic nutritional assessment of SBS patients treated with teduglutide could be proposed for appropriate and safe management, particularly in the presence of renal impairment.

Lung Cancer App (LuCApp) study protocol: a randomised controlled trial to evaluate a mobile supportive care app for patients with metastatic lung cancer.

INTRODUCTION: Mobile health technologies may enhance patient empowerment and data integration along the whole care continuum. However, these interventions pose relatively new regulatory, organisational and technological challenges that limit appropriate evaluation. Lung Cancer App (LuCApp) is a mobile application developed by researchers and clinicians to promote real-time monitoring and management of patients' symptoms. This protocol illustrates a clinical trial designed to evaluate the usability, effectiveness and cost-effectiveness of LuCApp versus standard of care. METHODS AND ANALYSIS: This is a 24-week two-arm non-blinded multicentre parallel randomised controlled trial. A total of 120 adult patients diagnosed with small or non-small cell lung cancer and eligible for pharmaceutical treatments will be allocated 1:1 to receiving either standard care or LuCApp in addition to standard care at three oncology sites in Northern Italy. During the treatment period, LuCApp allows daily monitoring and grading of a list of symptoms, which trigger alerts to the physicians in case predefined severity thresholds are met. Patients will complete a baseline assessment and a set of valid and reliable patient-reported outcome measures every 3±1 weeks, and up to 24 weeks. The primary outcome is the change in the score of the Trial Outcome Index in the Functional Assessment of Cancer Therapy (Lung) questionnaire from baseline to 12 weeks. Secondary outcomes are the Lung Cancer Subscale, the EuroQoL 5D-5L questionnaire, the Hospital Anxiety and Depression Scale, the Supportive Care Needs Survey Short Form, the app usability questionnaire and the Zarit Burden Interview for the main caregiver. ETHICS AND DISSEMINATION: The trial received ethical approval from the three clinical sites. Trial results will be disseminated through peer-reviewed publications and conference presentations. CONCLUSIONS: This trial makes a timely contribution to test a mobile application designed to improve the quality of life and delivery of care for patients with lung cancer. TRIAL REGISTRATION NUMBER: NCT03512015; Pre-results.

Position paper on management of iron deficiency in adult cancer patients.

INTRODUCTION: Disorders of iron metabolism are commonly seen in onco-hematological clinical practice. Iron-deficiency anemia and cancer-associated anemia are usually treated with supportive therapies. Optimal management of these conditions are discussed in this perspective paper. Areas covered: A position paper discussing a number of hot topics on anemia in cancer patients is presented. The main areas covered by experts in the field are: definitions, prevalence and consequences of anemia and iron deficiency, incidence of anemia resulting from targeted therapies, importance of anemia diagnosis and monitoring, evaluation of iron status before and during treatment, role of transfusions and erythropoiesis-stimulating agents, management of iron deficiency with or without anemia, parenteral iron supplementation, role of new oral iron formulations, safety and cost issues regarding different iron compounds and administration routes. Expert commentary: Despite the availability of newer therapeutic options for its management, anemia still represents a major complication of treatment in cancer patients (surgery, chemotherapy, radiotherapy, targeted therapies), aggravating physical impairment, and negatively affecting general outcome. The view expressed by the panelists, attendees of the 4th Mediterranean Course on Iron Anemia, summarizes what they consider optimal clinical practice for screening, diagnosis, treatment and monitoring of iron deficiency and anemia in cancer patients.