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Purpose: Early palliative care (EPC) has shown a positive impact on quality of life (QoL), quality of care, and healthcare costs. We evaluated such effects in patients with advanced gastric cancer. Methods: In this prospective, multicenter study, 186 advanced gastric cancer patients were randomized 1:1 to receive standard cancer care (SCC) plus on-demand EPC (standard arm) or SCC plus systematic EPC (interventional arm). Primary outcome was a change in QoL between randomization (T0) and T1 (12weeks after T0) in the Trial Outcome Index (TOI) scores evaluated through the Functional Assessment of Cancer Therapy-Gastric questionnaire. Secondary outcomes were patient mood, overall survival, and family satisfaction with healthcare and care aggressiveness. Results: The mean change in TOI scores from T0 to T1 was − 1.30 (standard deviation (SD) 20.01) for standard arm patients and 1.65 (SD 22.38) for the interventional group, with a difference of 2.95 (95% CI − 4.43 to 10.32) (p= 0.430). The change in mean Gastric Cancer Subscale values for the standard arm was 0.91 (SD 14.14) and 3.19 (SD 15.25) for the interventional group, with a difference of 2.29 (95% CI − 2.80 to 7.38) (p= 0.375). Forty-three percent of patients in the standard arm received EPC. Conclusions: Our results indicated a slight, albeit not significant, benefit from EPC. Findings on EPC studies may be underestimated in the event of suboptimally managed issues: type of intervention, shared decision-making process between oncologists and PC physicians, risk of standard arm contamination, study duration, timeliness of assessment of primary outcomes, timeliness of cohort inception, and recruitment of patients with a significant symptom burden. Clinical trial registration: ClinicalTrials.gov (NCT01996540).

Background Pain is a common symptom among patients with cancer, yet pain prevalence and management in older cancer pts. are poorly known. Methods Patients aged ≥70 years referred to Istituto Oncologico Veneto IRCCS from January 2011 to December 2013 were evaluated with Comprehensive Geriatric Assessment (CGA). Pain was assessed by means of short form of McGill Pain Questionnaire (MPQ-sf), Brief Pain Inventory (BPI-sf), and numerical rating scale (NRS). Pts with completed CGA, no severe cognitive impairment and completed pain assessment were enrolled. Results Enrolled patients were 745; 51% male, median age 76 years, median ECOG Performance Status (PS) 1. Frail patients at CGA were 45.2%. Patients with pain were 266 (35.7%). Mean Average Pain Intensity (API) was significantly higher among females, patients fit at CGA, with advanced disease, poorer PS and more comorbidity. Pain was detected by the oncologist in 20.4% of cases and deemed cancer-related in 54.8%. Gender, PS, status of disease, stage, function disability, mood, cognitive functioning and frailty were significantly associated with reporting of pain. At BPI, moderate-severe pain was found in 81 patients. The degree of agreement between API and pain intensity evaluated by physician was minimal. Patients on pain medications were 184, with 113 patients reporting rates of pain relief ≥50%. Conclusion About one third of older patients with cancer report pain, which is not cancer-related in about half of cases. Female gender, fitness at CGA, advanced stage, poorer PS, higher number of comorbidities and primary site were associated with significant differences in pain reporting.

The publisher regrets that the collaborators for this paper were not listed as such within the author details of the published paper. The collaborators were published in the Acknowledgements and are as follows: Alberto Farolfi, Silvia Ruscelli, Martina Valgiusti, Sara Pini, Marina Faedi, Department of Medical Oncology, IRST IRCCS, Meldola; Angela Ragazzini, Unit of Biostatistics and Clinical Trials, IRST IRCCS, Meldola; Cristina Pittureri and Elena Amaducci, Palliative Care and Hospice Unit, AUSL Romagna, Cesena; Irene Guglieri, Psychooncology Service, Veneto Institute of Oncology IOV – IRCCS, Padua; Francesca Bergamo, Sara Lonardi, Department of Clinical and Experimental Oncology, Medical Oncology 1, Veneto Institute of Oncology IOV – IRCCS, Padua; Camilla Di Nunzio, Medical Oncology Unit, Oncology–Hematology Department, Guglielmo da Saliceto Hospital, Piacenza; Monica Bosco, Palliative Care Unit, Oncology–Hematology Department, Guglielmo da Saliceto Hospital, Piacenza; Barbara Bocci, Medical Oncology Unit, San Paolo Hospital, Milan; Alfina Bramanti and Chiara Gandini, Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia; Angela Buonadonna, Medical Oncology Unit, Aviano National Cancer Institute, Aviano; Alessandro Comandone, Medical Oncology Unit, Presidio Humanitas Gradenigo, Turin; Sonia Zoccali, Coordinamento Cure Palliative (supported by F.I.L.E., Leniterapia Italian Foundatio), Florence; Maria Simona Pino, Medical Oncology Unit, Oncology Department, S. Maria Annunziata Hospital, Florence; Davide Dalu, Palliative Care Unit, Oncology Department, L. Sacco Hospital, Milan; Pietro Sozzi, Oncology Unit, Ospedale degli Infermi, Ponderano; Alberto Gozza, Medical Oncology, Department of Medicine, E.O. Galliera Hospitals, Genoa; Monica Giordano and Carla Longhi, Oncology Unit, Sant'Anna Hospital, Como; Cristina Autelitano, Palliative Care Unit, Arcispedale S. Maria Nuova – IRCCS, Reggio Emilia; Teresa Gamucci, Oncology Unit, SS Trinità Hospital Sora, ASL Frosinone, Frosinone; Cataldo Mastromauro, Oncology Unit, ULSS 12 Veneziana, Venice; Rodolfo Scognamiglio, Hospice Nazareth, Mestre; Daniela Degiovanni, Palliative Care Unit, Casale Monferrato, ASL Alessandria; Federica Negri, Medical Oncology Unit, Istituti Ospitalieri, Cremona; Augusto Caraceni, Palliative Care, Pain Therapy and Rehabilitation Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan; and Luigi Montanari, Palliative Care Unit Ravenna, AUSL Romagna, Italy. The publisher would like to apologise for any inconvenience caused.

Aim Early palliative care (EPC) in oncology has shown sparse evidence of a positive impact on patient outcomes, quality of care outcomesand costs. Patients and methods Data for this secondary analysis were taken from a trial of 207 outpatients with metastatic pancreatic cancer randomly assigned to receive standard cancer care plus on-demand EPC (standard arm) or standard cancer care plus systematic EPC (interventional arm). After 20 months’ follow-up, 149 (80%) had died. Outcome measures were frequency, type and timing of chemotherapy administration, use of resources, place of death and overall survival. Results Some indices of end-of-life (EoL) aggressiveness had a favourable impact from systematic EPC. Interventional arm patients showed higher use of hospice services: a significantly longer median and mean period of hospice care (P=0.025 for both indexes) and a significantly higher median and mean number of hospice admissions (both P&nbsp

OBJECTIVES Anti-tissue transglutaminase antibody (anti-tTG) determination using second-generation (human antigen) enzyme-linked immunoassays (ELISAs) is a very accurate test to diagnose celiac disease (CD). In this study, we compared 2 second-generation ELISAs (Celikey tTG; Pharmacia Diagnostics GmbH & Co, Freiburg, Germany, and QuantaLite; Inova Diagnostics, San Diego, CA) and antiendomysial antibodies (EMAs) with a new indirect chemiluminescence immunoassay (LIAISON tTG; DiaSorin S.p.A., Saluggia, Italy) in diagnosing and monitoring CD in children. PATIENTS AND METHODS Antiendomysial antibodies, anti-tTGs and total immunoglobulin A were measured in the sera of 103 control children, 101 children with histologically proven CD and 31 CD children on gluten-free diet (GFD). RESULTS Anti-tissue transglutaminase antibody mean levels were significantly higher in CD with respect to control or GFD children. The sensitivity value of EMAs, LIAISON tTG, Celikey tTG and QuantaLite in diagnosing CD was 97.7%, 97.0%, 94.1% and 98.0%, respectively, and the corresponding specificity values were 91.1%, 98.1%, 97.1% and 96.1%, respectively. The degree of mucosal destruction (Marsh criteria) was correlated with EMA semiquantification (P < 0.01) and with the circulating levels of anti-tTGs measured using LIAISON (P < 0.05) or QuantaLite (P < 0.01). Twenty-six CD children were followed up from 5 to 25 months after GFD. The circulating levels of anti-tTGs measured with any of the 3 assays significantly dropped after GFD. CONCLUSIONS Anti-tissue transglutaminase antibody determination with second-generation ELISAs is as effective as EMAs for CD diagnosis. The novel chemiluminescent method described in the present paper for the detection of anti-tTGs in the diagnosis of CD had the highest sensitivity and specificity values. The anti-tTG test correlates with the degree of mucosal destruction and is suitable for verifying patient compliance to dietary treatment.

In 1996, a gap between the literature evidence for the prevention of chemotherapy-induced emesis and the prescription pattern in clinical practice was demonstrated in a drug utilization study. This study, carried out in 103 Italian oncological centers (77 new; 26 old that participated in the previous study) evaluates three different intervention strategies to implement these guidelines. In cancer patients submitted to chemotherapy, prescriptions of antiemetics were prospectively monitored for 2 consecutive weeks in 1999. Simple diffusion of guidelines was evaluated in an observational study in the 77 new centers, while the double combination of simple diffusion and “audit and feedback” strategy was randomly compared in the old centers with the triple combination of the same two strategies plus an “educational outreach visit.” Simple diffusion of guidelines improved the prescription but only for acute and delayed emesis induced by high-moderate emetogenic chemotherapy. No significant difference was detected in the prescriptions against cisplatin-induced emesis. The inappropriate use of 5-HT3 antagonists for prophylaxis of low emetogenic chemotherapy was found most frequently. Similar poor results were achieved by the audit and feedback strategy, while the educational outreach visit significantly increased the prescription of the optimal prophylaxis for cisplatin-induced acute and delayed emesis. A combination of interventions, including an educational outreach visit, seems to be a good strategy for transferring the results of antiemetic research to oncological practice.

159 Background: Bone metastases are responsible for high morbidity in patients (pts) with a strong clinical impact. Recently, a new multidisciplinary approach called osteoncology has benn develped. No data on multidisciplinary management of large series of patients (pts) with bone cancer disease are available. Methods: We reviewed clinical data of all the consecutive pts evaluated from Apr 2013 to Dec 2016 in the multidisciplinary Osteoncology clinic of Istituto Oncologico Veneto. We collected clinical data on primary diasease, sites of disease, pain, bone clinical and radiological situation, assesment and medical decision taken in a multidisciplinary team. Results: 481 pts (303 F, 63%) have been evaluated by a multidisciplinary team composed by medical and clinical oncologist, pain specialist, endocrinologist, radiologist and ortopedic surgeon. Totally, 444 visits and 340 discussione have been performed. 422 pts (88%) had bone metastases, median age 65 years (range 34-89). 388 pts (92%) had vertebral metastases, 167 (39%) had pelvic bone disease, 201 (47%) had other site of bone disease including extremities. 186 (39%) pts had pain. We have prescribed a corset for 151 (31%) pts, radiation therapy for 202 (42%) pts with a median time from prescription to delivery of 15 days. Vertebroplastic has been prescribed in 66 (14%) pts with a median time for delivery of 7.5 days. 33 (7%) pts received indication to orthopedic surgery with a median waiting time of 15 days. For 115 pts data on pain at visit and 30 days later were available: 41 pts had no change in NRS, 11 pts had a worst paint (median NRS Δ = +2), 63 pts had a pain reduction (median NRS Δ = -3). 301 pts received a diagnosis of SRE. Median OS (mOS) was 80.9 months; at 2 yrs 91% of M0 pts vs 75.8% of M1 pts was alive (p = 0.0018); mOS for pts with a SRE was 70 vs 89.5 mos in pts without SRE (p = 0.033); among M1 pts, there was no significant difference from having or not a SRE. Conclusions: To our knowledge this is the first reported series of pts evalutated by an osteoncologic team. OS confirms that pts with SRE had a poorer outcome. Median time from prescrition to care delivery is shorter from data available in literature, conferming the positive impact for pts from multidisciplinary approach.

169 Background: Early palliative care has been shown to improve outcomes in pts with advanced cancer. In accordance with ASCO and AIOM recommendations of implementing palliative care early for pts with metastatic cancer along with active cancer treatment a SCC was set up at Istituto Oncologico Veneto (IOV) in Padova since 2014; Methods: Data of pts referred to the SCC from Mar 2014 to Nov 2016 were retrieved from a prospectively maintained database. Data collected included cancer type, status of disease, PS, ongoing oncological treatment, psychological evaluation, social evaluation, nutritional evaluation, activation of home territorial services and/or Palliative Care services, use of other health services after a first visit and place of death; Results: 533 pts were evaluated by a multidisciplinary team. Overall symptom burden was low with baseline symptom scores highest for fatigue, lack of appetite and depression. Nutritional evaluation revealed 224 pts (42%) with nutritional problems, the most frequent being weight loss (n = 121). Psychological distress was present in 185 pts (35%). Social issues were present in 26 pts (5%) and were dealt with activation of social services (n = 9) or volunteer territorial services (n = 8). Patients deemed in need of home care services after the first access to the SCC were 177 (33%) and for these a formal request for Home Care services activation was sent to the Local Health Territorial Unit. After the first visit 141 patients referred to Emergency Room for intervening problems with median time of 41 days. Globally 290 pts (54%) died with 53% of deaths occurring at home. For pts who were receiving active oncological treatment median time from first-visit in the SCC and death was 126 days. We are also evaluating a score for priority for access to SCC; Conclusions: Early integrated SC may be most effective if targeted to the specific needs of each patient population

150 Background: WHO defines palliative care as an approach that improves the quality of life of patients (pts) and their families facing problems associated with life threatening illnesses. This occurs by means of early identification, assessment and treatment of pain and other problems physical, psychosocial, and spiritual. Recently, palliative care has been incorporated into the treatment of oncology pts earlier in the course of their disease. We aimed to explore this approach at our institution. Methods: We established an interdisciplinary clinic at IOV with the goal of promoting pts’ comprehensive support by integrating palliative care into active oncology treatments. Our primary objectives were to: optimize the quality of life of pts at every stage of their disease, ensure continuity of care through proper coordination of available services and avoid a sense of abandonment at the end of life. Pts included were those with advanced disease who had a life expectancy of less than one year, pts who had symptomatic disease regardless of prognosis, and pts who were considered frail, because of clinical, social, psychological, spiritual, logistical, and economical criteria. The multidisciplinary team consisted of a medical oncologist, a palliative care physician, a psychologist, a nurse and a nutritionist. Results: Between March 2014 and March 2016, 337 pts were visited, with different types of cancer. Median age was 69 (range: 34-93), 44% were men, median PS (ECOG) was 1.5, 47% were undergoing anti-cancer treatment. Reasons for referral included: physical complaints (71%), psychosocial issues (30.3%), nutritional problems (38%) and social problems (7%). For the 46% of patients, domiciliary health care was activated directly by the Local Health Department or through the General Practitioner; specific action have been made in relations to the problems encountered. Conclusions: The Interdisciplinary Clinic of Simultaneous Care carried out at IOV represents a successful pilot experience that proposes an organizational model for early integration of palliative care as an integral part of treating the oncology patient.

Aim: A total of 371 patients under stable warfarin therapy were retrospectively selected to develop a pharmacogenetic algorithm to identify the individual maintenance dose. Materials & methods: The variables that were entered into the algorithm were: VKORC1, CYP2C9 and CYP4F2 polymorphisms, body surface area and age. Results: The percentage of cases whose predicted mean weekly warfarin dose was within 20% of the actual maintenance dose was 51.8% considering patients overall, and were 36.2, 66.2 and 55.4%, respectively, taking into account patients requiring low (≤25 mg/week), intermediate (25–45 mg/week) and high (≥45 mg/week) doses. The algorithm could correctly assign 73.8 and 63.2% of patients to the low- and high-dose regimens, respectively. We developed and validated a pharmacogenetic algorithm in a series of Italian patients, we then tested, in the same series of italian patients, the formulas of three published algorithms. These three algorithms were developed and validated by their authors in a series of patients different from our own. The performance of our algorithm in our patients series was slightly higher than that achieved when using the three other algorithms in our patients series. Conclusion: The high predictive accuracy of low and high warfarin requirements of our algorithm warrants its application in prospective studies for clinical validation.

Background: AGA IgA II and AGA IgG II have recently been suggested as reliable tools for celiac disease (CD) diagnosis. We compared their utility for diagnosis and monitoring CD in children with that of tTG IgA, an established CD marker.Methods: We studied a cohort of 161 CD and 129 control children in whom CD was histologically confirmed or ruled out. We followed 37 children with CD on a gluten-free diet for 12–84 months. In fasting sera, we measured AGA IgA II, AGA IgG II, and tTG IgA using ELISAs.Results: The best sensitivity (92.5%), specificity (97.6%), positive predictive value (98%), and negative predictive value (91.2%) were obtained using tTG IgA. AGA IgG II correctly identified 3 of 3 children with CD with total IgA deficiency who had negative AGA IgA II and tTG IgA results. In children Conclusions: The best available index for diagnosing CD in children was tTG IgA. In infants

Background The combined evaluation of serum pepsinogens A (PGA) and C (PGC), gastrin-17 (G17) and anti- H. pylori antibodies (anti- H. pylori )(GastroPanel) has recently been proposed as a useful aid for investigating H. pylori -associated gastric mucosal inflammation. Our aim was to evaluate whether GastroPanel can correctly classify children who need or not endoscopy (EGD). Methods GastroPanel was performed in 554 consecutive children subjected to EGD. Results PGC and anti- H. pylori were sensitive (82.5% and 73.1%) and specific (58.1% and 84.0%) indices of H. pylori infection. Antral H. pylori colonization density, inflammation and activity grades were correlated with PGC. PGC and G17 were significantly higher in children with celiac disease (14.9 ± 0.88 µg/L and 5.6 ± 0.79 pmol/L) than in controls (8.5 ± 0.38 µg/L and 2.4 ± 0.24 pmol/L). The best cut-offs to distinguish H. pylori infected children from controls were 7.45 µg/L for PGC, 4.2 pmol/L for G17, 18 U for anti- H. pylori and 25 µg/L for PGA. With these cut-offs, GastroPanel had a NPV of 89.6% and a PPV of 66.8%. Conclusions A negative GastroPanel result in children with upper abdominal non alarm symptoms, should allow the paediatrician to reasonably rule out the presence of major gastro-duodenal diseases and therefore avoid EGD.

Aim. GastroPanel combines the evaluation of pepsinogens A and C PGA, PGC), anti-H. pylori antibodies (Ab) and gastrin-17 (G17) to identify astric mucosal inflammation and atrophy. We analysed GastroPanel in H. ylori infected (Hp+) and coeliac disease (CD) children. Methods. Five hundred and forty-five children subjected to EGDS. In asting sera: PGA, PGC, G17, Ab (ELISAs) and total gastrin (tG) (RIA). In astric juice: pH. Histology for inflammation, Hp and CD diagnosis. Results. Eighty-nine Hp+, 45 CD and 411 Hp and CD negative (conrol children). PGC and Ab were higher in Hp+ than in controls (F= 12.2, < 0.001; F= 35.6, p< 0.001). PGA/PGC was reduced in Hp+ (6.8± 0.44, ean±S.E.M.) and in CD (6.7± 0.67) with respect to controls (10.1± 0.52) F= 6.25, p< 0.005). tG and G17 were higher in Hp+ (67.6± 3.2 ng/l and .0± 1.7 pmol/l) and CD (103.4± 23.6 and 8.6± 2.3) than in controls 61.2± 2.4 and 3.2± 0.4) (F= 9.23, p< 0.001; F= 9.48, p< 0.001). PGC, b and G17 correlated withHp density grade (F= 6.44, p< 0.005;F= 20.79, < 0.001; F= 7.43, p< 0.005). PGC correlated also with the degree of antral nflammation (F= 6.18, p< 0.005) and activity (F= 9.89, p< 0.001). In Hp+ direct correlation between PGA and tG was found (r= 0.396, p< 0.001); in D this association was opposite (r=−0.388, p< 0.05). In Hp+ intragastric H correlated directly with tG (r= 0.264, p< 0.05); in CD intragastric pH nversely correlated with PGA (r=−0.336, p= 0.06) and directly with tG r= 0.787, p< 0.001) and with G17 (r= 0.609, p< 0.01). In CD histology ailed to demonstrate frank gastric mucosal atrophy. Summary.Hp associated gastritis enhanced serum PGC, Ab and G17. In D the reduced levels of PGA/PGC suggest that atrophy might involve gasric body mucosa, probably with a patchy pattern escaping routine histology; he consequent reduced gastric acid secretion enhanced gastrin release. Conclusion. Hp associated gastritis enhances serum PGC and G17. In D, gastric mucosal atrophy, suggested by the combined PGA/PGC reduced nd G17 increased levels might be extended outside the duodenum affecting he stomach.