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A votive offering or ex-voto includes a variety of usually non-professional artworks offered to divinities and placed in religious sites to fulfill a vow or in gratitude for recovery from an illness or injury. Unfortunately, the ancient period lacks a scientifically verifiable understanding of the true nature of cancer and its natural history and, consequently, a lack of effective treatment. This paper discusses two ex-votos potentially related to breast cancer distant more than 2000 years, one from the other. The ex-votos convey the complex relationship of humans with illness through an art expression stemming from the heart and minds of ordinary people.

Background/Aim: Abemaciclib is a cyclin-dependent kinase 4/6 inhibitor approved in combination with endocrine therapy for treating hormone receptor-positive and human epidermal growth factor receptor 2-negative early and advanced breast cancer patients. The safety profile of abemaciclib is characterized by frequent gastrointestinal toxicity, especially diarrhea. Therefore, we performed an exploratory analysis of clinical factors that may be potentially associated with diarrhea in patients treated with abemaciclib plus endocrine therapy. Patients and Methods: Factors potentially predisposing to diarrhea were selected, such as age ≥70 years, concomitant medications and diseases, diet, and use of laxatives. These variables were correlated with the onset of grade 2/3 diarrhea in a cohort of patients treated with abemaciclib from advanced breast cancer. Univariate and multivariate analysis was performed. Sensitivity and specificity were tested using the ROC curve. Results: Eighty women with advanced breast cancer were included in the study. The univariate analysis found a statistically significant correlation between grade 2/3 diarrhea and age ≥70 years, polypharmacy, and concomitant gastrointestinal diseases (p

Many cancer patients use integrative therapies with a combination of natural products and diets. In the Western world, integrative medicine is often not shared with oncologists even during antineoplastic treatments. This behavior stems from the unmet needs of cancer patients who may feel oncologists’ underestimation of their symptoms and spiritual aspects. This case report demonstrates the potential harm of inadequate diet and nutraceutical intake in a 68-year-old woman with metastatic estrogen receptor-positive, human epidermal growth factor receptor-2-negative breast cancer. Her care team recommended hormone therapy with abemaciclib plus fulvestrant. Her diarrhea started after 10 days of therapy and did not disappear, despite the use of loperamide, causing a significant reduction in adherence and dose intensity of abemaciclib. The patient finally disclosed to her oncologist she was following a detoxifying diet and taking several nutraceuticals. Her diarrhea was correlated with abemaciclib but most probably exacerbated and prolonged by the diet. Evaluation of disease after 3 months showed progressive disease. Integrative medicine should be in the multidisciplinary management of cancer patients to avoid potentially harmful events and ameliorate patients’ quality of life in a holistic approach.

At present, multidisciplinary tumor boards (MDTB) are considered best practice in oncology. However, web-based virtualization of MDTB may increase participation in meetings, the number of cases discussed, and adherence to guidelines, deliver better treatment, and eventually improve outcomes for patients with prostate cancer.This is an observational study focused on exploring the structuring process and implementing a multi-institutional virtual MDTB in Sicily, Italy. Other endpoints included the analysis of cooperation between participants, adherence to guidelines, patient outcomes, and patient satisfaction.Overall, 126 patients were referred to the virtual MDTB for a total of 302 cases discussed in an 18-month period. Nearly 45% of cases were referred from general hospitals or tertiary centers, 38% from comprehensive cancer centers, and only 17% from academic ones. Most health professional participants (95%) reported eliminating geographical barriers and consequently reducing costs and saving time as key advantages of virtual meetings over face-to-face ones. Using a specifically designed platform for virtual MDTBs was another excellent point, especially to geolocate clinical trials and time-lapse data storage. The majority of referred patients had stage T 3-4 prostate cancer (79%). Overall, 71% of proposals discussed were approved unchanged, while 19% changed after the virtual MDTB discussion. Debated points were mostly radiologic, surgical, medical, or radiation treatment-related issues. In particular, the prescriptive appropriateness of positron emission tomography with 68Ga-prostatic specific membrane antigen, newer drugs, radiation versus surgical approach, stage T3-4 cases, and adjuvant therapy represented the most debated issues. The proposed diagnostic and/or therapeutic options were controlled for adherence to the guidelines and/or updated scientific evidence. Overall, 98% of approved proposals and changes were in line with the guidelines. Overall, most participants felt virtual MDTB was very useful and case discussions led to a major change of strategy in 19% of cases.Virtual MDTBs are a very useful way to achieve best management of prostate cancer while saving time and fostering cooperation.

To date, the virtual multidisciplinary tumor boards (vMTBs) are increasingly used to achieve high-quality treatment recommendations across health-care regions, which expands and develops the local MTB team to a regional or national expert network. This review describes the process of lung cancer-specific MTBs and the transition process from face-to-face tumor boards to virtual ones. The review also focuses on the project organization's description, advantages, and disadvantages. Semi-structured interviews identified five major themes for MTBs: current practice, attitudes, enablers, barriers, and benefits for the MTB. MTB teams exhibited positive responses to modeled data feedback. Virtualization reduces time spent for travel, allowing easier and timely patient discussions. This process requires a secure web platform to assure the respect of patients’ privacy and presents the same unanswered problems. The implementation of vMTB also permits the implementation of networks especially in areas with geographical barriers facilitating interaction between large referral cancer centers and tertiary or community hospitals as well as easier access to clinical trial opportunities. Studies aimed to improve preparations, structure, and conduct of MTBs, research methods to monitor their performance, teamwork, and outcomes are also outlined in this article. Analysis of literature shows that MTB participants discuss 5–8 cases per meeting and that the use of a vMTB for lung cancer and in particular stage III NSCLC and complex stage IV cases is widely accepted by most health professionals.Despite still-existing gaps, overall vMTB represents a unique opportunity to optimize patient management in apatient-centeredapproach.

Background Most oncology units underestimate the prevalence of cancer-related malnutrition (CRM) and its negative consequences even in western countries. Various studies have reported a prevalence of CRM ranging from 25% to over 70% based on nutritional assessments. This paper describes the feasibility of implementing an innovative, multi- disciplinary, multi-site nutrition-based oncology program among oncological centers in Sicily. Methods This project is a pre-post feasibility observation analysis to assess an oncology rehabilitation program’s viability based on Bowen’s Framework according to the Template for Intervention Description and Replication checklist. These feasibility guidelines describe eight domains to be addressed: acceptability, demand, implementation, practicality, adaptation, integration, expansion, and limited-ef cacy testing. Results Eighteen medical oncologists from twelve medical oncology units actively participated in the educational sessions. Other participants included eight radiation oncologists from seven radiotherapy units, eight surgeons, including one head/neck specialist, and six internal medicine/nutritionists for a total of thirty-nine health-professionals. Acceptability was high since the participation rate was 88%. During the two months interval between the web-based implementation events, there was a ten-fold increase in the number of oncology centers that started a nutritional screening program and the number of patients referred to a nutritionist. This increase showed a statistical signi cance (Fisher exact p< 0.00001). Patients’ satisfaction, evaluated with a simple 5-point Likert scale, was > 4 in 84% of interviewed patients. Conclusion This implementation program showed high acceptability among oncologists and a high degree of patients satisfaction. A further step is to implement this high-quality process in the large volume cancer centers and create an ef cient network with smaller institutions according to a cooperative hub and spoke model. This program also includes elaborating a multi-institutional, multidisciplinary tumor board to coordinate treatment decisions in the network.

Background Online cancer communities provide a space for cancer patients and their caregivers to discuss issues related to the disease itself. On their institutional website, the Italian Association of Cancer Patients offers visitors a forum pointing it out as a free space where it is possible to share one’s story, exchanging emotions, feelings, information, and thoughts through writing. This study aims to explore, within the AIMaC community and regarding prostate cancer, how member behavior is distributed and how message sentiment changes over time. Materials and methods We retrospectively analyzed all Prostate cancer-related discussion posts recorded within the AIMaC community forum from 2010 to 2019. We apply to the dataset a sentiment analysis using an unsupervised approach of Natural Language Processing Results Three thousand ve hundred forty-nine messages exchanged by 219 members belonging to the prostate cancer posts were extracted from 2010 to 2019 for 39,040 words. The authors explored the time series trend for each sentiment. By dividing the original dataset into two sub-datasets organized by the rst and second ve-year periods, this insight allowed us to apply the Student’s t-test to the differences between these two new time series for both negative and positive feelings. The results is t(9)=-7,664228406, p

Health professionals involved in oncology care should make more efforts in developing a holistic attitude by placing the person and their needs at the center of their attention. Such an integrative approach has been the subject of in-depth studies and is currently active in Italy in a very limited number of oncology centers. On the other hand in the USA, the Society for Integrative Oncology actively collaborates with the American Society of Clinical Oncology and has developed Integrative Medicine guidelines of great scienti c strength. The program of the “Setting an Integrative Medicine Oncology Network” project aims to implement the use of integrative medicine at oncology centers in assisting people with cancer at all stages of their path in our territory. The most salient aspects of this holistic integrative medicine project in oncology are represented by nutrition, the psychological aspect, mindfulness, phytotherapy, the use of natural substances, Qi-gong, acupuncture, music therapy, physiotherapy methods (kinesis, lymphatic drainage, respiratory gymnastics, etc.), motor activity and adapted physical activity and other methods, but also by the promotion of clinical research.

Italian legislation has included citizens’ active participation and voluntary associations in the phases of planning and evaluation of health-related services. Between September 2020 and February 2021, representatives of Serena a Palermo, a patients’ advocacy group, participated in 25 multidisciplinary meetings discussing nearly 200 female cancer-speci c clinical cases. The virtual MTB included 16 hospitals. Fifty-nine diverse specialists participated in the discussion, including medical oncologists, surgeons, gynecologists, urologists, pathologists, molecular biologists, radiation oncologists, nutritionists, and radiologists. A survey was launched and implemented to measure, among the specialists involved in the MTB meetings, their perception of the impact of this project concerning improving equity of care for cancer patients in terms of acceptability, appropriateness, and feasibility. The survey concluded by investigating what other health care personnel should be involved in tumor boards to meet the needs of currently unmet patients. Virtual MTD participant response rate was 100%. We feel mandatory an alliance between patients and health professionals and the patient advocacy front-of ce in most, if not all, oncological centers.

Dear Editor, We carefully read the interesting report of Australian researchers (Tan et al.)1 on the feasibility of implementing an innovative, multidisciplinary, multi-site exer- cise-based rehabilitation program for cancer patients in the community.2 The acronym (POWER) of this multidisciplinary Program for Oncology Wellness and Exercise Rehabilitation implies a significant emphatic value. The authors carried out this feasibility study based on a Bowen’ Framework system with a highly shareable, strict scientific method in a holistic approach to people surviving cancer.3 Any interventional program is “intended to ultimately influence or change peo- ple’s social, environmental, and organizational conditions as well as their choices, attitudes, beliefs, and behaviors”.3

The spread of instant messenger systems provides an excellent opportunity and a helpful tool to healthcare professionals. WhatsApp instant messenger use is widely prevalent among health professionals, cancer patients, caregivers and the general population. It is a quick and easy communication tool that may also be used on personal computers and business purposes. WhatsApp instant messenger and other similar tools may be a very useful complement for e-medicine. Instant messaging systems may be helpful, especially in rural areas, in medium- or low-income countries, or to avoid unnecessary travels, improve knowledge and awareness of cancer, monitor home care and support the delivery of home care. The unregulated use of WhatsApp instant messenger requires sound and shared guidelines to assure impeccable professional service. Although a significant number of papers have investigated the roles of social networks in connecting patients to health professionals, there is still a lack of information and scientific data about their uses, benefits and limitations in connecting health providers only for professional communication. The role of instant messenger systems in cancer practice and research needs to be clarified. In this paper, we report a focus on available data, pros and contras of the unregulated use of WhatsApp instant messaging, in the context of e-medicine, as an interprofessional and doctor/patient communication tool in oncology.

Background/aim Upper limb breast cancer-related lymphedema (BCRL) is a chronic and severe condition affecting a significant percentage of breast cancer survivors. Even though its physiopathology is well-known, there is no worldwide consensus on BCRL evaluation and a gold-standard treatment. This narrative review aims at providing a brief descriptive overview with regard to BCRL treatment modalities. Materials and methods We conducted a literature search within the PubMed database, and 33 articles out of 56 were selected, including reviews, systematic reviews, and meta-analyses aiming find the most updated evidence regarding BCRL treatment modalities. Results Physical exercise (aerobic exercise, resistance exercise, aquatic therapy), bandages, and intermittent pneumatic compression were shown to be most effective in BCRL patients, in terms of swelling reduction in the acute-intensive phase. Furthermore, physical exercise was beneficial also as a maintenance tool. Manual lymphatic drainage demonstrated efficacy in preventing secondary lymphedema if applied immediately after breast cancer surgery or in early phases of BCRL or as a maintenance tool. Complementary procedures such as acupuncture, reflexology, yoga and photo-biomodulation therapy did not show conclusive results in BCRL treatment. Surgery was shown effective in managing symptoms (liposuction), preventing (lymphaticovenular anastomosis) and treating BCRL (vascularized lymph node transfer). Conclusion BCRL is still a challenging condition either for breast cancer survivors and clinicians, deeply impacting patient functioning and quality of life. Due to the lack of globally accepted criteria in evaluating BCRL, to date a gold standard treatment for this widespread issue is still needed.

A retrospective analysis of 70 patients with triple-negative or hormone-resistant advanced breast carcinoma who had not previously received chemotherapy was carried out. Patients received oral vinorelbine 60 mg/m2 on day 1 and 8, plus capecitabine 1000 mg/m2 bid for 14 consecutive days every 3 weeks. Overall response rate was 53% with a 9% complete response rate. Stable disease was recorded in 27% of the cases. Median progression-free survival was 7.9 months and median overall survival was 29.2 months. Toxicity was generally mild and easily manageable. These data demonstrate that this combination is feasible, safe and active as first-line treatment of triple-negative fully hormone-resistant advanced breast carcinoma patients., Lay abstract The adoption of metronomic chemotherapy in the treatment of breast cancer is an important step forward in the management of this disease. The fluoropyrimidine capecitabine and the vinca alkaloid vinorelbine have been shown to be at least as active. Our data confirm the activity and safety of this all-oral regimen as first-line metronomic therapy being response rate.

BACKGROUND Multidisciplinary tumor boards play a pivotal role in the patient-centered clinical management and in the decision-making process to provide best evidence-based, diagnostic, and therapeutic care to patients with cancer. Among the barriers to achieve an efficient multidisciplinary tumor board, lack of time and geographical distance play a major role. Therefore, the elaboration of an efficient virtual multidisciplinary tumor board (VMTB) is a key point to successfully obtain an oncology team and implement a network among health professionals and institutions. This need is stronger than ever during the COVID-19 pandemic. OBJECTIVE This paper presents a research protocol for an observational study focused on exploring the structuring process and the implementation of a multi-institutional VMTB in Sicily, Italy. Other endpoints include analysis of cooperation between participants, adherence to guidelines, patients’ outcomes, and patient satisfaction. METHODS This protocol encompasses a pragmatic, observational, multicenter, noninterventional, prospective trial. The study’s programmed duration is 5 years, with a half-yearly analysis of the primary and secondary objectives’ measurements. Oncology care health professionals from various oncology subspecialties at oncology departments in multiple hospitals (academic and general hospitals as well as tertiary centers and community hospitals) are involved in a nonhierarchic manner. VMTB employs an innovative, virtual, cloud-based platform to share anonymized medical data that are discussed via a videoconferencing system both satisfying security criteria and compliance with the Health Insurance Portability and Accountability Act. RESULTS The protocol is part of a larger research project on communication and multidisciplinary collaboration in oncology units and departments spread in the Sicily region. The results of this study will particularly focus on the organization of VMTBs, involving oncology units present in different hospitals spread in the area, and creating a network to allow best patient care pathways and a hub-and-spoke relationship. The present results will also include data concerning organization skills and pitfalls, barriers, efficiency, number, and types with respect to clinical cases and customer satisfaction. CONCLUSIONS VMTB represents a unique opportunity to optimize patient management through a patient-centered approach. An efficient virtualization and data-banking system is potentially time-saving, a source for outcome data, and a detector of possible holes in the hull of clinical pathways. The observations and results from this VMTB study may hopefully be useful to design nonclinical and organizational interventions that enhance multidisciplinary decision-making in oncology. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/26220

Background Multidisciplinary tumor boards play a pivotal role in the patient-centered clinical management and in the decision-making process to provide best evidence-based, diagnostic, and therapeutic care to patients with cancer. Among the barriers to achieve an efficient multidisciplinary tumor board, lack of time and geographical distance play a major role. Therefore, the elaboration of an efficient virtual multidisciplinary tumor board (VMTB) is a key point to successfully obtain an oncology team and implement a network among health professionals and institutions. This need is stronger than ever during the COVID-19 pandemic. Objective This paper presents a research protocol for an observational study focused on exploring the structuring process and the implementation of a multi-institutional VMTB in Sicily, Italy. Other endpoints include analysis of cooperation between participants, adherence to guidelines, patients’ outcomes, and patient satisfaction. Methods This protocol encompasses a pragmatic, observational, multicenter, noninterventional, prospective trial. The study’s programmed duration is 5 years, with a half-yearly analysis of the primary and secondary objectives’ measurements. Oncology care health professionals from various oncology subspecialties at oncology departments in multiple hospitals (academic and general hospitals as well as tertiary centers and community hospitals) are involved in a nonhierarchic manner. VMTB employs an innovative, virtual, cloud-based platform to share anonymized medical data that are discussed via a videoconferencing system both satisfying security criteria and compliance with the Health Insurance Portability and Accountability Act. Results The protocol is part of a larger research project on communication and multidisciplinary collaboration in oncology units and departments spread in the Sicily region. The results of this study will particularly focus on the organization of VMTBs, involving oncology units present in different hospitals spread in the area, and creating a network to allow best patient care pathways and a hub-and-spoke relationship. The present results will also include data concerning organization skills and pitfalls, barriers, efficiency, number, and types with respect to clinical cases and customer satisfaction. Conclusions VMTB represents a unique opportunity to optimize patient management through a patient-centered approach. An efficient virtualization and data-banking system is potentially time-saving, a source for outcome data, and a detector of possible holes in the hull of clinical pathways. The observations and results from this VMTB study may hopefully be useful to design nonclinical and organizational interventions that enhance multidisciplinary decision-making in oncology. International Registered Report Identifier (IRRID) DERR1-10.2196/26220

Highlights • To contain COVID-19 spread, Italy is under a global lockdown except for health services and food supply. • In this scenario, growing apprehension concerning legal consequences is rising among health professionals. • Hospitals and health professionals are highly exposed to liability. • More articulated legal regulations are strongly needed., To contain COVID-19 spread, Italy is under a global lockdown since February 21, 2020, except for health services and food supply. In this scenario, growing apprehension concerning legal consequences is rising among health professionals due to several ethical and legal questions. Even if medical ethicists may approve patients’ prioritization protocols, hospitals and health professionals remain highly exposed to liability. The so-called smart-working may be very useful, but it may harbor potential legal harms for health personnel and patients and safety. Moreover, personal umbrella policies also often exclude liability arising out of the transmission of a communicable disease, especially a pandemic state, is declared. Under the pressure of medical associations, Italian Government political forces have very recently presented an amendment to the recently released ordinances for the COVID-19 emergency aimed to reduce medical liability. Presumably, similar epidemics or other wide-scale similar events may happen again in an unpredictable future. Therefore, more articulated legal regulations are strongly needed starting from lessons learned from this epidemic.

Aim This paper aims to analyze the usefulness of the G8 geriatric oncology questionnaire in patients with advanced/metastatic pancreatic adenocarcinoma (aPAC) and its possible association with different clinical outcomes. Methods Patients age > 70 years were screened with the G8 tool and treated with intravenous nab-paclitaxel 125 mg/m2 and gemcitabine 1000 mg/m2 for 3 consecutive weeks followed by one-week rest as prescribed after clinical evaluation by treating oncologists. Patient’s charts were evaluated for type and severity of toxicity, 2 cycle rate of completion, discontinuation rate, delays, dose reductions, and other outcomes response rates, progression-free, and overall survival. Sensitivity, specificity, and possible correlations were analyzed. Results Sensitivity and specificity of the G8 score for severe toxicity were respectively 55.9% and 50%. No association between all types of severe grade 3-4 toxicity, delays, or dose reductions, and the G8 score was present (p=0.622). ORR was 32.5% with no complete responses. Median PFS and OS were 4.5 months and 8.1 months, respectively. Correlation between G8 score and PFS was not statistically significant (p=0.0652). Correlation between G8 score and OS was statistically significant (p=0.0251). Although median survival of G8 fit patients was superior to that of G8 vulnerable patients (6.5 versus 4 months), the difference was not statistically different (p=0.1975). Conclusion Clinical results in terms of response rate, survival outcomes, and side-effects were in the range reported by others. However, the G8 questionnaire is not a reliable diagnostic tool to predict the risk of severe toxicity, and clinical outcomes in older patients with aPAC.

PURPOSE This descriptive investigation was undertaken at three oncology units to report queries, needs, and fears related to severe acute respiratory syndrome coronavirus 2 (COVID-19) of patients with cancer and to avoid uncontrolled treatment delays or withdrawal, behavioral mistakes, and panic. PATIENTS AND METHODS All queries spontaneously delivered through the WhatsApp instant messaging system commonly used by patients to communicate with oncology units were collected and grouped by homology in five categories. Responses to the queries were given according to recommendations by the Italian Association of Medical Oncology through WhatsApp and by subsequent phone calls. Patients were also classified according to the site of the primary tumor, stage of disease, and current treatments. Analysis of the association between these data and queries was carried out. RESULTS The social scenario in Italy is a nationwide lockdown except for hospitals, pharmacies, and food supplies. Overall, 446 different patients’ WhatsApp conversations were analyzed between March 1 and March 13 and comprised the following: requirement of visit delay by patients undergoing oral therapies or in follow-up, delays in chemotherapy or immunotherapy administration, queries about possible immunosuppression, and changes in lifestyle or daily activities. Delay requirements were statistically more frequent among patients with prostate or breast cancer compared with those with lung or pancreatic cancer. Actions taken by oncologists are also reported. CONCLUSION To our knowledge, the WhatsApp instant messaging system has been occasionally used in other medical settings with controversial results. In our experience, WhatsApp turned out to be adequate to give a rapid answer to most queries from patients with cancer in the COVID-19 pandemic scenario.

Background This descriptive, unplanned investigation has been undertaken to report reactions, attitudes and countermeasures which have been put in place and implemented by medical oncology units facing the COVID-19 outbreak in Southern Italy. Materials and methods Data have been retrospectively obtained from the time-related analysis of conversations via a WhatsApp messenger-based group chat between the medical directors belonging to the Italian College of Medical Oncology Directors. Overall number, intensity and time trend of conversations related to reactions during the 4 weeks of observation related to the crucial events which occurred between 24 February and 28 March, 2020 2020 are included. A sentiment analysis of conversations was also carried out. Results We report 956 conversations among 19 medical oncology units related to reactions to the crucial events, such as epidemic spread, Government ordinances and guidelines during the 4 weeks of observation. Data show significant awareness of problems linked to the COVID-19 spread among oncologists and rapid diffusion of countermeasures. Actions taken were correlated time wise to crucial events. A correlation between conversations and the volume of activity of oncology units was found. By analysing the sentiment analysis of raw data, positive emotions were reduced in percentage over the weeks. A significant increase in negative emotions was observed as the outbreak impacted on the healthcare system. Conclusion In our experience, the WhatsApp instant-messaging system seems to be a useful tool to share news and reactions between medical oncologists to rapidly implement necessary health measures and answers to most cancer patients’ needs and queries in the COVID-19 pandemic scenario.

Purpose The availability of immune checkpoint inhibitors has deeply changed the therapeutic scenario of patients with advanced non-small cell lung cancer (NSCLC). Up until now, chemotherapy still represents the first-line treatment for patients with advanced NSCLC not harbouring genetic mutations or lacking high expression of programmed death ligand even if the addition of immunotherapy to first-line chemotherapy has recently been shown to improve clinical outcome. We carried out a multi-institutional retrospective analysis on third-line chemotherapy with metronomic oral vinorelbine (VNR) in a series of patients with metastatic NSCLC pre-treated with first-line chemotherapy and second-line immunotherapy. Patients and methods Thirty patients with metastatic NSCLC with progressive disease after first-line chemotherapy and subsequent immunotherapy were treated with metronomic oral VNR continuously at the fixed dose of 30 mg three times per week. Results A partial response was achieved in 4 patients (13.3%), while 10 patients (33.3%) displayed disease stabilisation for an overall disease control rate of 46.7%. Median progression-free survival was 3.9 months (range 1-13 months) and median OS reached 8.1 months (range 4.0-24.0+ months) with a 12-month survival rate of 22%. Conclusion Oral metronomic VNR appears to be active and safe in patients with metastatic NSCLC in progression after first-line chemotherapy and second-line immunotherapy. The results reported, although from a limited sample, may suggest its use for long-term stabilisation of the disease with good patient compliance.

Aim This retrospective observational study evaluated the role of hypo-fractionated stereotactic radiotherapy (SRT) in patients with oligo-progressive metastatic renal cell carcinoma (mRCC) treated with first-line oral tyrosine kinase inhibitors (TKI). Data on local control, delay of further progression, and safety are reported. Patients and methods Between January 2010 and December 2016, 28 patients with mRCC who showed oligo-progressive disease while receiving first-line pazopanib were treated with hypofractionated SRT to progressive metastatic sites to delay the change of systemic therapy. First and second progression-free survival (PFS-1 and PFS-2) were recorded, as well as objective response and toxicity. Results After pazopanib therapy, nine partial remissions (32%), 12 stable disease (43%) and seven progressions (25%) were recorded. The median time to progression from first-line pazopanib until oligo-progression was 9.45 months (PFS-1 range=2-30 months). Seventeen patients (61%) showed progression at pre-existing tumor sites, and 11 patients (39%) showed the appearance of new metastases. Progression-free survival after radiation therapy was 4.55 months (PFS-2 range=1-11 months). PFS-1 plus PFS-2 was 14.0 months (range=3-41 months). Severe grade 3-4 toxicities were seen only occasionally. Conclusion Patients with oligo-progressive mRCC treated with first-line pazopanib may benefit from hypo-fractionated high-dose SRT at progressing sites achieving a further increase in median progression-free survival. Further studies and prospective validation are required to establish if this minimally invasive approach may have a positive impact on overall survival and reported outcomes.

Background/aim Local ablative treatments for oligo-progressive, EGFR mutated non-small cell lung cancer (mut-NCSLC) may improve long-term disease control and survival. We analyzed the efficacy of hypo-fractionated, high-dose radiation therapy (HDRT), in association with prolonged EGFR tyrosine kinase inhibitors (TKI) in oligo-progressive, EGFR mutant-NSCLC. Patients and methods Progression-free survival-1 (PFS-1, date from initiation of TKI therapy until oligo-progression or death), and progression-free survival-2 (PFS-2, date of focal progression until further progression or death) were evaluated. Results Thirty-six patients were analyzed. The median PFS 1 was 12.5 months. HDHRT consisted of intensity-modulated RT and stereotactic RT in 23 (64%) and 13 (36%) patients respectively. The median PFS 2 was 6.3 months. Overall survival was 38.7 months. Conclusion Hypo-fractionated HDRT plus TKI therapy, is associated with a significant prolongation of disease control (overall PFS: 18.8 months), with manageable side effects. These real-world data support the use of local ablative approaches in oligo-progressive EGFR mut-NSCLC.

Fighting cancer is an economically expensive challenge for both health care payers, and the patients and their families and the median costs for cancer care are rapidly increasing in the last decade. Although both direct and indirect costs of medical assistance have been a frequent source of distress and contention, however analysis of the non-medical expenses incurred directly by cancer patients has not received adequate attention. Developing a deeper understanding of so-called "out-of-pocket" costs may be necessary. Out-of-pocket costs for medical care range from 7 % to 11 % of medical costs for all payers. However, the range of out-of-pocket costs shows considerable variability in different studies. In this review, we reviewed available data concerning direct and indirect medical costs, including psychosocial ones.

e19389 Background: Financial toxicity (FT) among cancer patients (CP) is multifactorial, arising from both disease-related and non- disease related factors, including socio-cultural, environmental, and psychological attributes. It derives both from costs related to assistance and borne on the patients and its caregivers, and reduction of income capacity also in this case borne on the patients and on the caregivers. Stress levels may escalate to significant proportions in some patient, to present with symptoms of anxiety especially during therapy administration periods. Methods: In order to highlight financial toxicity related to the diagnosis of metastatic pancreatic and lung cancer and to measure its evolution over time and any correlation with the prognosis, we developed a questionnaire called FT16 and we conducted a validation study on a sample of 31 patients. The design of the study involved the development and the psychometric assessment of a scale to measure the perceived sources of FT among CP. Following extensive literature review, a table of specification with the initial items was created to guide item construction for developing the scale. The items related to these FT were converted into an 16-item, multipoint questionnaire, resulting in the FT16. We also monitored quality of life of the patients, using the QlQ C-30 questionnaire, in the aim to capture correlation between FT onset and quality of life deterioration; clinical characteristics of the patients, response to therapy and outcome parameters also have been recorded in the aim to evaluate eventual correlation with FT. Results: The questionnaire was administered to 31 adult patients with lung and pancreatic metastatic cancer, both men and women, who were newly diagnosed and will undergo cancer treatment. Each of them has been informed about the research and written informed consent has been obtained. The internal consistency reliability (Cronbach’s alpha) was 0.77 for the 16 items of the FT16. Analyses of variance (ANOVAs) indicated that there were no significant differences in the mean FT16 score, between sexes, and age groups in the severity score. Conclusions: FT16 questionnaire seems to be an useful tool to capture FT onset in this poor-prognosis subset of patients; the analysis of the data recorded will continue to assess the capability of the FT16 to capture correlations with clinical characteristics at diagnosis and correlations with the prognosis.

The aim of the study was to evaluate depressive symptomatology within the student population of the University of Palermo (Italy). An anonymous online questionnaire was provided to the students of the University of Palermo. The first section investigated demographic and social data, while in the second section the QIDSSR16 (Quick Inventory of Depressive Symptomatology Self-Report) test was administered. 539 students (68.3% female) gave informed consent and completed the questionnaire. Considering as a dependent variable: Depressive symptomatology moderate-severe-very severe, the statistically significant independent variables associated are I don't live with my family (aOR 1.63, 95% CI 1.01-2.63, P=0.043), I currently smoke (aOR 1.55, 95% CI 1.01-2.39, P=0.048) and Low perceived health status (aOR 4.14, 95% CI 2.73-6.28, P

Background: Adenosine triphosphate bioluminescence produced by the firefly luciferase has been successfullyintroduced to verify cleaning procedures in the food industry according to the Hazard Analysis Critical Control Pointprogram.Our aim was to evaluate the reliability of bioluminescence as a tool to monitor the effectiveness of sanitation in healthcaresettings, in comparison with the microbiological gold standard.Methods: 614 surfaces of various material were randomly sampled in Policlinico University Hospital units in Palermo,Italy, to detect adenosine triphosphate bioluminescence and aerobic colony count. Linear regression model andPearson correlation coefficient were used to estimate the relationship between the two variables of the study.Results: Aerobic colony count median was 1.71 colony forming units/cm2 (interquartile range = 3.8), whereasadenosine triphosphate median was 59.9 relative light units/cm2 (interquartile range = 128.3). Pearson coefficientR2 was 0.09. Sensitivity and specificity of bioluminescence test with respect to microbiology were 46% and 71%,whereas positive predictive value and negative predictive value were 53% and 65%, respectively.Conclusion: According to our results, there seemed to be no linear correlation between aerobic colony countand adenosine triphosphate values, suggesting that current bioluminescence technology has not any proportionalrelationships with culturable microbes contaminating environmental surfaces in health-care settings.

e14676 Background: HCC accounts for approximately 90% of all primary liver cancers, and is the fifth most common cancer in the world and prognosis is so far very poor,particularly in E patients.Between all tentative of treatment till know SFB seems to be the most promising drug in patients with advanced or metastatic HCC.Aim of the study is to investigate if SFB is efficient and safe also in E HCC patients despite the comorbidities and other problems. Objectives: To investigate if CgA and VEGF work as predicting factors of Sorafenib treatment outcomes. Methods: 51 patients, mean age 68,9 (65-85) with HCC were enrolled . Serum CgA, VEGF and αFP were evaluated at baseline and after end of treatment (SFB 400mg p.o. bid), until disease progression. Clinical response (RECIST), Comprehensive Geriatric Assessment and PFS were considered as well. Results: CgA mean value (baseline: 77.9 – after treatment: 26.25 UI/L) and VEGF levels (baseline: 67.3 – after treatment 47.2 pg/ml) seems to have a predictive role in clinical benefit. A correlation between lower values of CgA and VEGF was noted in pts with longer PFS. Furthermore 3-4 toxicity was not observed in these pts. OS median was 11 months. Conclusions: The most relevant data in this study refer to the role of serum CgA and VEGF levels, for prediction of tumor response. If these findings were confirmed in future largest studies, it could be sufficient to measure these markers levels for identification of those HCC patients who have more probability of obtaining clinical benefit from a sorafenib treatment.

Background: ACRC is one of most common neoplastic disease in very old pts. The administration of oral fluoropyrimidine (capecitabine-CAP) in a standard schedule of 1,200 mg/sqm twice a day for 14 d shows similar effects to 5-FU continuous infusion (C.I.). Furthermore, CAP- IRI showed super -additive antitumor activity. Recently many study show the safety and efficacy of a "flat dose" administration of CAP particularly in the treatment of elderly people with cancer. Also, the efficacy of BEV is well demonstrated in CRC pts. Aim of the study is to evaluate impact of bevacizumab (BEV) in combination with IRI and XEL in ACRC very old patients. Methods: 42 (20 f-22 m) elderly patients with advanced colorectal cancer (median age: 77; range: 73-91) were enrolled. Comprehensive Geriatric Assessment (CGA) was performed to assess eligibility for chemotherapy. All Patients were included into groups I, according to Balducci's classification of frailty. Primary endpoint: clinical response rates (RR) according to RECIST criteria and toxicity profile using NCI-CTC v2.0. Secondary endpoints: PFS, OS and QoL score measured through EORTC QLQ-C30 questionnaires. All patients were evaluated for common treatment-related adverse events with regard to haematological and liver toxicity, nausea and vomiting, stomatitis, diarrhea, hand/foot syndrome and sensory neuropathy, according to the ECOG Common Toxicity Criteria. Results: Patients were treated with IRI (180 mg/mq) + BEV (7.5 mg/Kg) on day 1q21, and XEL (fixed dose of 1,000 mg bid) assumed orally continuously for a maximum of 12 cycles. Medium value of cycles delivered was 9.7. Tumor response rates observed were 37.1% (CR+PR). Clinical benefit, including stable disease, was 77.8%. No grade 4 toxicity was experienced. QoL score improvement was noted in all pts after treatment. Median PFS was 12.3 months with a 6 months PFS rate of 82%. Median OS was 22 months with a 12 months survival probability of 77.8%. Conclusions: In elderly ACRC BEV plus IRI every 3 weeks with CAP continuously show a good toxicity and effectiveness profile and seem to be a valid terapeutical opportunity also for ACRC very old patients.

e16070 Background: Prostate cancer is one of the most frequent malignancy in men of the Western countries. The identification of new predictive factors of drug activity is crucial for elderly cancer patients, who need a particular selection according to prediction of efficacy and safety by pre-treatment parameters. Several prostate cancers show focal neuroendocrine (NE) spots and CgA seems to be associated to NE phenotype both in tissue and in circulation. VEGF expression in NE cells is corelated with clinical characteristics and disease-specific survival. Somatostatin analogues induce a decrease in plasma CgA and could have also anti-angiogenic activity by inhibition of VEGF, bFGF and GH/IGF-I axis. Methods: elderly patients, median age 75 (range: 65–83), were selected for hormone-refractory disease, previously treated with CAB. Serum PSA and plasmatic CgA and VEGF were evaluated in all pts at baseline (T0) and at 4 months (T4) and 8 months (T8) after therapy. Pts were treated with docetaxel 75 mg/m2 every 3 weeks for 6 cycles and octreotide acetate 20 mg administered intramuscularly every 4 weeks until progression. Clinical and biochemical response, progression- free survival and toxicity were also evaluated. A correlation of basal CgA and VEGF with biochemical response, clinical response and clinical benefit was also investigated. Results: Median duration of follow-up was 18 months (range: 8–32). Patients evaluable for response were 22. PSA response rate (RR) was observed in 10/22 (45%); clinical objective RR was 33% (7/22). Clinical benefit was observed in 19/22 pts (86%). Only mild toxicities was observed in both groups. CgA and VEGF were both strongly reduced after therapy. Lower CgA values correlated with clinical benefit, lower VEGF values also correlated with biochemical and clinical response. Conclusions: This combination treatment showed a good toxicity profile. The most relevant data in this study refer to the role of serum CgA and VEGF levels, for prediction of tumour response. If these findings were confirmed, it could be sufficient to measure these markers levels for identification of those HRPC patients who have more probability of obtaining clinical benefit from a docetaxel-based treatment in combination with a somatostatin analogue. No significant financial relationships to disclose.

12003 Background: Fulvestrant is the first of a new class of pure estrogen receptor antagonists. It was studied in comparison to anastrozole and tamoxifen in the 1st and 2nd line of hormonal treatm...

19586 Background: It was estimated that a quarter of all patients who have a diagnosis of NSCLC worldwide are more than 70 years old. This meta-analysis tries to shed light on the controversial results of phase III trials evaluating in NSCLC EP doublets against third generation S. Methods: We performed a literature search using MEDLINE and Cochrane Library. We selected only clinical trials responding to the question of our meta-analysis. Outcomes recorded were 1-year survival rate (1-y SR), overall response rate (ORR) and haematological toxicity (HT). Fixed-effects and random-effects models were used to calculate pooled odds ratios (OR). An OR greater than 1 indicates that doublet is more effective for 1-y SR and ORR and more toxic for HT. Results: Three published randomized controlled phase III trials (SICOG 9909; MILES; AISCAP-SICOG) were selected yielding a total of 1082 patients (G: 426; S: 655) clustered in seven comparisons. Drugs delivered to randomized patients included gemcitabine, vinorelbine and paclitaxel. EP treated with doublets showed respect to control patients a pooled estimate for 1-y SR advantage of 36%, not statistically significant (OR=1.356; 95% CI=0.925–1.990; p>0.05). The pooled estimate for ORR advantage was 57% and statistically significant (OR=1.559; 95% CI=1.220–2.015; p0.05). Conclusions: These data confirm in EP superior efficacy and equal tolerability of G in comparison with S previously demonstrated for adult patients. Anyway G seems to not change prognosis of NSCLC EP. It is worthy to note that all the trials analysed showed some biases: early closure of the study, second-line therapy or crossover, lower dosage of drugs in combination regimen, inclusion of unfit or strongly comorbid patients. This meta-analysis doesn’t solve troubles in decision-making of treatment for EP, but suggest to design a better phase III trial including more patients and improving accrual criteria for reducing biases. An indication of a potentially active combination regimen (gemcitabine + paclitaxel) is suggested in SICOG 9909 trial. No significant financial relationships to disclose.

1578 Background: Temozolomide (TMZ) is an oral alkylating agent known to cross the blood-brain barrier with efficacy against HGG and a favourable safety profile compared to conventional chemotherap...