Rationale: The Global Leadership Initiative on Malnutrition (GLIM) recommends nutritional risk screening to be done before the assessment, diagnosis and grading of malnutrition severity. Malnutrition Universal Screening Tool (MUST) and Patient Generated-Subjective Global Assessment (PG-SGA) Short Form are two validated screening tools commonly performed in oncology settings. However, the agreement between GLIM criteria and the above mentioned screening tools is yet to be fully established. Methods: A total of 110 cancer patients were enrolled and assessed for malnutrition according to the GLIM criteria. For all patients MUST and PG-SGA Short Form nutritional screening, and PG-SGA assessment were performed as well. The concordance of the considered nutritional screening and assessment tools with the GLIM criteria for malnutrition diagnosis (score ≥1) were evaluated by calculating the sensibility, specificity, positive and negative predictive values, the concordance through Cohen’s Kappa, and the exact Fisher test. Results: Compared to PG-SGA SF and PG-SGA, MUST with a threshold ≥1, has the best combination of Sensitivity and Specificity, expressed by an AUC = 0.912 (K = 0.819). Conclusion: MUST with a threshold ≥1 has shown a higher agreement with GLIM criteria than PG-SGA SF and PG-SGA. Disclosure of Interest: None declared

Background and Purpose: Data on immunoresponse after SARS-CoV-2 vaccines for patients treated with exclusive radiotherapy (RT) are scarce. Since RT may affect the immune system, we conducted the MORA trial (Antibody response and cell-mediated immunity of MOderna mRNA-1273 vaccine in patients treated with RAdiotherapy). Materials and Methods: Data regarding humoral and cellular immune response of patients treated with RT were prospectively collected after the second and third dose of mRNA vaccines. Results: Ninety-two patients were enrolled. With a median of 147 days after the second dose, the median SARS-CoV-2 IgG titer was 300 BAU/mL: six patients were seronegative (Spike IgG titer & LE; 40 BAU/mL), whereas 24, 46 and 16 were poor responders (Spike IgG titer:41-200 BAU/mL), responders (Spike IgG titer:201-800 BAU/mL) and ultraresponders (Spike IgG titer > 800 BAU/mL), respectively. Among seronegative patients, two patients were negative also for cell mediated response, as tested with IFN-& gamma; release Assay (IGRA) test. With a median of 85 days after the third dose, the median SARS-CoV-2 IgG titer was 1632 BAU/mL in 81 patients: only two pa-tients were seronegative, whereas 16 and 63 patients were responders and ultraresponders, respectively. Among the 2 persistently seronegative patients, IGRA test was negative in one who had previously received anti-CD20 therapy. Documented paucisymptomatic (n = 3) or asymptomatic (n = 4) infection occurred after the third dose, during the Omicron wave. Conclusion: In patients treated with exclusive RT, even during the Omicron breakthrough, robust humoral response and clinical protection from severe SARS-CoV-2 disease were achievable with three doses of mRNA vaccine.

Rationale: Nutrition disorders are common in cancer patients and are frequently associated with degenerative loss of skeletal muscle (cachexia). Therefore, skeletal muscle mass assessment in sarcopenia and cachexia has a relevant clinical impact for risk stratification. Skeletal muscle mass can be precisely quantified through computed tomography (CT) images. The aim of this study is to compare CT scans to traditional malnutrition screening/assessment tools (Patient Generated-Subjective Global Assessment (PG-SGA), Malnutrition Universal Screening Tool (MUST) and GLIM criteria) for the detection of myopenia in cancer patients. Methods: A total of 67 cancer patients were enrolled. Skeletal muscle index (SMI) was calculated through semi-automatic segmentation of the muscle area at the L3 level on abdominal CT scan and defined by cut-off values associated with sarcopenia and increased mortality. MUST and PG-SGA Short Form nutritional screening, and PG-SGA assessment were performed and related scoring were obtained. GLIM criteria were also applied. The diagnostic value for the considered nutritional screening and assessment tools and criteria were evaluated considering multiple thresholds for the obtained scores. For each tool and criteria, sensibility, specificity, positive and negative predictive values, the concordance through Cohen’s Kappa and the exact Fisher test were applied. Results: None of the considered tests and criteria have shown to be a myopenia reliable predictor in cancer patients, excepting the Nutrition focused Physical Exam performed as part of the PG-SGA assessment (K = 0.379). Conclusion: CT measurements have proven to be an irreplaceable tool to effectively detect myopenia in cancer patients since neither MUST nor PG-SGA, nor the application of the GLIM criteria, have shown a sufficiently accurate predictive value. Disclosure of Interest: None declared

Background SAFE trial (NCT2236806) is a phase 3 study comparing the effect on subclinical heart damage of bisoprolol (B), ramipril (R), or both drugs (R+B), as compared to placebo (P), in breast cancer treated with (neo)adjuvant anthracyclines +/- trastuzumab. Methods Primary endpoint is subclinical cardiotoxicity measured with echocardiography and global linear strain (GLS). This interim analysis was pre-specified on the first 120 patients who had completed cardiological assessments at 12-mos. Stopping rules per arm were: dose reduction >15%, study withdraw rate >5%, and no significant impact on 3D-left ventricular ejection fraction (3D-LVEF) as compared to T0 at 12-mos assessment. Results A total of 191 out of 480 patients have been enrolled; overall 123 patients were available for the analysis (P = 34; R = 28; B = 31; R+B=30). 3D-LVEF decreased at 3-mos (-3.3%; p Conclusions Following the stopping rules, the closure of the R arm is required and the study will continue with 3 arms. At the interim analysis, a cardioprevention strategy significantly impact on subclinical heart damage. Clinical trial identification NCT2236806. Legal entity responsible for the study University of Florence. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

Because of the novel mechanism of action of immunotherapies like nivolumab, response patterns may differ from other therapies and may provide a rationale for considering treatment beyond progression. Immunotherapy protocols generally allow patients (pts) to continue treatment beyond investigator-assessed progressive disease (PD) as long as there is ongoing clinical benefit. Here we report the analysis of pts treated beyond PD in the Italian nivolumab EAP for pts with non-squamous non-small cell lung cancer (Non-Sq-NSCLC).

Background: Different multimodality approaches including chemotherapy (CT) or chemo-radiotherapy (CRT) prior to surgery have been investigated for locally advanced oesophageal squamous cell cancer (OESCC), but direct comparisons are lacking. We performed a systematic review and mixed meta-analysis to assess the best strategy. Methods: Pubmed, EMBASE and abstracts presented at ASCO meetings, ASCO Gastrointestinal Cancers Symposium and ESMO congresses were searched for randomised controlled trials. Primary endpoint was overall survival. A mixed meta analysis of the network obtained was performed in a Bayesian framework using hazard ratios (HRs) and standard errors extracted from the publications. Risk of bias was addressed as suggested by the Cochrane Collaboration. Node-split models were built to assess inconsistency. Results: 25 trials including a total of 3866 patients were included. Most studies compared surgery with neoadjuvant CRT (n= 942) or CT (n = 997); 2 trials compared surgery with adjuvant CT (n= 447); 1 trial compared adjuvant with neoadjuvant CT (n = 330); 2 trials investigated definitive CRT vs. surgery (n = 81) or neoadjuvant CRT (n = 172); 3 studies compared surgery with either neoadjuvant RT, CT and CRT (n = 186), neoadjuvant CT and CRT (n = 473) or neoadjuvant CRT and adjuvant CRT (n = 238). Despite marked differences in study procedures, we found no evidence of significant heterogeneity or inconsistency: 10 studies were deemed at high risk of bias, 6 at low risk and 8 at unclear risk. Our results suggest that neoadjuvant CRT provides the most consistent survival advantage among the different multimodality treatment options (Table 1). Definitive and adjuvant CRT may represent effective alternatives to surgical resection, but the small number of studies prevents definitive conclusions. Neoadjuvant CT is associated to a lesser benefit. Conclusions: our analysis confirms that neoadjuvant CRT seems to be the best strategy in locally advanced OSCC, with definitive and adjuvant CRT as a reasonable alternative in selected cases.

An increasing amount of scientific evidence has confirmed the utility for cancer patients, in terms of quality and quantity of life, performance of therapeutic results, and gradual transition of care, of a simultaneous care approach. In a period of human and financial resource constraints innovative forms of cooperation between oncologists and palliative care providers are needed. The Oncology Department in the Florence Health District with the support of the Tuscany Tumors Association, a non-profit organization, has conducted, from March to December 2015, a pilot project to test the feasibility of a Supportive Home Care Service, a dedicated home-based service for the prevention and treatment of severe cancer symptoms, and of the side effects and toxicities secondary to palliative cancer therapies. Home care was guaranteed by a highly qualified staff, and was available 24 hours a day, every day of the year. A total of 28 patients, median age 75 years (range 46-85), affected by advanced solid tumors were enrolled. The majority of patients had metastatic disease (82%), and they all received palliative and supportive care in the home setting and active anticancer treatment as outpatient. A total of 153 (range 1-27) medical and 146 (range 1-37) nursing visits were perfomed, respectively. The average number of medical and nursing visits per patient was 6.95 and 9.73, respectively. Infusional therapy was administered in 28% of the patients for a total of 105 days of treatment. The average duration of care as of January 2016 was 122.67 days (range 13-311). The average number of intervening hospital admissions due to severe toxicity was 0.14 (calculated as the ratio between the number of admissions and the number of patients). Thirteen patients (46% of the total) have died at the time of this analysis, with an average duration of care of 76.92 days. The place of death was home in 92% of the cases. A pharmacoeconomic analysis of this intervention is currently ongoing. In our experience early integration of simultaneous care and active cancer treatments is effective. A home-based intervention guarantees personalization and humanization of cancer treatments, and reduces hospitalization, potentially leading to a more wise use of human and financial resources.

Background: Fatigue is one of the most common and distressing side effects of cancer and its treatment. The National Comprehensive Cancer Network defines Cancer-Related Fatigue (CRF) as a persistent, subjective sense of physical, emotional and/or cognitive exhaustion that is not proportional to recent activity. It can range from mild to severe, and may be either temporary or a long-term effect. Percentages of patients who experience CRF vary across studies from 25% to 100% according to the type of cancer, treatments, and method of assessment. Screening for fatigue before, during and after cancer treatment is today a core part of clinical evaluation and quality of life assessments. Material and methods: The aim of this study was to report the preliminary validation results of an Italian version of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF-I), one of the most used and validate CRF-assessing tool. A total of 121 cancer patients (44 men and 77 women) were recruited to this study from the outpatient oncology clinic at the Santa Maria Annunziata Hospital in Florence. The Italian version of the MFSI-SF was developed through a forward-backward translation procedure, according to the EORTC Quality of Life Group Translation Procedure. We estimated internal consistency using Cronbach's &agr; and split-half technique. Test-criterion validity was evaluated through ANOVA. The convergent validity was evaluated by estimating the Pearson's r correlation with the Italian version of the Brief Fatigue Inventory (BFI-I). Results: This Italian version of MFSI-SF revealed adequate internal consistency (&agr; = .919) and convergent validity (r = .683; p < .01) and confirmed the original unidimensional structure (explained variance = 51%). More than the 50% of participants showed a significant CRF. Patients in the adjuvant and first line setting showed a lower level of fatigue as compared to more advanced lines of treatment (p < .05), although with a significant higher score (F = 3.844; p < .05) at the item 17 (“I feel sluggish”). Moreover, patients with low scholarization rate (primary and secondary school degree) showed a significant higher score (F = 3.829; p < .05) at the item 19 (“I ache all over”). Conclusions: While further studies are needed in order to extend the sample size (n ≈ 300) and verify the validity and the sensitivity of this Italian version of MFSI-SF, it seems a reliable tool to detect clinically significant fatigue in cancer patients.

Background: Health-Related Quality of Life (HRQOL), a ubiquitous construct, has proven difficult to define. It covers the subjective perceptions of the positive and negative aspects of patients' symptoms, including physical, emotional, social, and cognitive functions and, specifically, disease symptoms and side effects of treatment. Despite the difficulty in defining such a construct, it has been recognized as a basis for approval of new anticancer drugs and a common indicator of research. As the EORTC Quality of Life Group pointed out, collecting HRQOL data in a clinical trial can be complicated. It requires resources and surveys through the patients' own language and meanings. At the same time it requires to confront such meanings with the ones professionals use and agree on. Methods: The aims of this study were:-to explore the personal narratives of patients and professionals about HRQOL, cancer illness and therapy;- to analyze differences in the narratives between patients and professionals;-to explore the correlations between such differences and the distress and social support of patients. All the subjects (51 patients and 21 professionals) were recruited at the Oncological Department of Florence. They all completed a written survey. The patients fulfilled two questionnaires about distress (Distress Thermometer, DT) and social support (Norbeck Social Support Questionnaire, NSSQ). All the narratives were analyzed through a Computer Aided Qualitative Data Analysis Software (CAQDAS). We explored occurrences and co-occurrences of words and themes and performed correspondence and cluster analysis. CAQDAS results were finally confronted, through Pearson's r correlation and Student's t test, with patients' scores at the DT and NSSQ. Results: Patients described HRQOL in terms of psychological and social effects of cancer, whereas professionals usually talked about side effects and physiological response to treatment. Both the subgroups find difficult to hypothesize the narratives of the other subgroup. Patients who showed different themes in describing HRQOL from those of professionals, exhibited a significant higher distress(t= 2.06; dof = 51; p < .05) as compared to the other patients. Conclusions: For both patients and professionals it was difficult to define how the others perceive HRQOL: Differences in narratives seem to affect the distress of patients. Further studies are needed in order to confirm the results and estimate possible effects of confounding variables.

Aim: In the last decade an increasing number of scientific evidence has confirmed that an early integration of palliative medicine into routine oncological care, or simultaneous care approach, ensures the best results in terms of quantity and quality of life, and performance of antitumor therapy for advanced cancer patients. To determine the outcome of an integrated oncology and palliative care approach in a real-world clinical practice setting in Italy.

The European Medicines Agency strongly recommends administration of trabectedin through a central venous catheter (CVC) to minimize the risk of extravasation. However, CVCs place patients at risk of catheter-related complications and have a significant budgetary impact for oncology departments. The most frequently used CVCs are subcutaneously implanted PORT-chamber catheters (PORTs); peripherally inserted central venous catheters (PICCs) are relatively new. We reviewed data of trabectedin-treated patients to evaluate the relative cost-effectiveness of the use of PORTs and PICCs in six Italian centres. Data on 102 trabectedin-treated patients (20 with sarcoma, 80 with ovarian cancer and two with cervical cancer) were evaluated. Forty-five patients received trabectedin by a PICC, inserted by trained nurses using an ultrasound-guided technique at the bedside, whereas 57 patients received trabectedin infusion by a PORT, requiring a day surgery procedure in the hospital by a surgeon. Device dislocation and infections were reported in four patients, equally distributed between PORT or PICC users. Thrombosis occurred in a single patient with a PORT. Complications requiring devices removal were not reported during any of the 509 cycles of therapy (median 5; range 1–20). PICC misplacement or early malfunctions were not reported during trabectedin infusion. The cost-efficiency ratio favours PORT over PICC only when the device is used for more than 1 year. Our data suggest that trabectedin infusion by PICC is safe and well accepted, with a preferable cost-efficiency ratio compared with PORT in patients requiring short-term use of the device (⩽1 year).