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PURPOSE: The present work aimed at conducting a real-world data analysis on the management costs and survival analysis comparing data from non–small-cell lung cancer (NSCLC) cases diagnosed in the Veneto region before (2015) and after (2017) the implementation of a regional diagnostic and therapeutic pathway including all new diagnostic and therapeutic strategies. METHOD: This study considered 254 incidental cases of NSCLC in 2015 and 228 in 2017 within the territory of the Padua province (Italy), as recorded by the Veneto Cancer Registry. Tobit regression analysis was performed to verify if total and each item costs (2 years after NSCLC diagnosis) are associated with index year, adjusting by year of diagnosis, sex, age, and stage at diagnosis. Logistic regression models were run to study overall mortality at 2 years, adjusting by the same covariates. RESULTS: The 2017 cohort had a lower mortality odd (odds ratio, 0.93; P = .02) and a significant increase in the average overall costs ( P = .009) than the 2015 cohort. The Tobit regression analysis by cost item showed a very significant increase in the average cost of drugs (coefficient = 5,953, P = .008) for the 2017 cohort, as well as a decrease in the average cost of hospice care (coefficient = –1,822.6, P = .022). CONCLUSION: Our study showed a survival improvement for patients with NSCLC as well as an economic burden growth. Physicians should therefore be encouraged to follow new clinical care pathways, while the steadily rising related costs underscore the need for policymakers and health professionals to pursue.

Background Non‐small cell lung cancer (NSCLC) is the first cause of cancer‐related death among men and the second among women worldwide. It also poses an economic threat to the sustainability of healthcare services. This study estimated the direct costs of care for patients with NSCLC by stage at diagnosis, and management phase of pathway recommended in local and international guidelines. Methods Based on the most up‐to‐date guidelines, we developed a very detailed “whole‐disease” model listing the probabilities of all potentially necessary diagnostic and therapeutic actions involved in the management of each stage of NSCLC. We assigned a cost to each procedure, and obtained an estimate of the total and average per‐patient costs of each stage of the disease and phase of its management. Results The mean expected cost of a patient with NSCLC is 21,328 € (95% C.I. −20 897−22 322). This cost is 16 291 € in stage I, 19530 € in stage II, 21938 € in stage III, 22175 € in stage IV, and 28 711 € for a Pancoast tumor. In the early stages of the disease, the main cost is incurred by surgery, whereas in the more advanced stages radiotherapy, medical therapy, treatment for progressions, and supportive care become variously more important. Conclusions An estimation of the direct costs of care for NSCLC is fundamental in order to predict the burden of new oncological therapies and treatments on healthcare services, and thus orient the decisions of policy‐makers regarding the allocation of resources. Key points Significant findings of the study The high costs of surgery make the early stages of the disease no less expensive than the advanced stages. What this study adds An estimation of the direct costs of care is fundamental in order to orient the decisions of policy‐makers regarding the allocation of resources., The high costs of surgery make the early stages of the disease no less expensive than the advanced stages. An estimation of the direct costs of care is fundamental in order to orient the decisions of policy‐makers regarding the allocation of resources.

Background Non-small-cell lung cancer (NSCLC) is the first cause of cancer-related death among men and the second among women worldwide. It also poses an economic threat to the sustainability of healthcare services. This study estimates the direct costs of care for patients with NSCLC by stage at diagnosis and management phase of pathway recommended in local and international guidelines. Methods Based on the most up-to-date guidelines we developed a detailed “whole-disease” model that lists the probabilities of all potentially necessary diagnostic and therapeutic actions involved in the management of each stage of NSCLC. Then we assigned the cost sustained by the public authorities to each procedure, obtaining an estimate of the total and average per-patient costs of each stage of the disease and management phase in Veneto Region, Italy. Results The mean expected cost of a patient with NSCLC is 22,968 € in the first year: 20,222 € in stage I, 23,935 € in stage II, 23,027 € in stage III, 22,915 € in stage IV and 31,749 € for Pancoast's tumors. In the second year the mean per patient-costs patient ranged from 2,722 €, for a patient with stage I disease, to 13,396 € for a patient with stage IV, with an overall average cost of 8,307 €. In the early stages, the main cost was due to surgery, whereas in the more advanced stages radiotherapy, medical therapy, treatment for progressions and supportive care become variously more important. Conclusions Our study enabled a prediction of the direct costs and outcomes for patients diagnosed with NSCLC on a two-year timeline after the diagnosis. An estimation of the direct costs of NSCLC, and in general for cancer, appears fundamental to predict the burden of new oncological therapies and treatments on healthcare services, and, in our opinion, our model could represent a useful tool for policy-makers in the optimization of resources allocation. Key messages Whole disease model allows an economic evaluation of a clinical pathway. The model is able to estimate direct costs of NSCLC by disease stage and management phase within a time horizon of two years. High cost-surgery makes the early stages no less expensive than advanced stages during the first year. In the second year, an advanced stage case costs almost five times more than an early stage case.

PURPOSE: Assuring quality of care, while maintaining sustainability, in complex conditions such as breast cancer (BC) is an important challenge for health systems. Here, we describe a methodology to define a set of quality indicators, assess their computability from administrative data, and apply them to a large cohort of BC cases. MATERIALS AND METHODS: Clinical professionals from the Italian Regional Oncology Networks identified 46 clinically relevant indicators of BC care; 22 were potentially computable using administrative data. Incident cases of BC diagnosed in 2016 in five Italian regions were identified using administrative databases from regional repositories. Each indicator was calculated through record linkage of anonymized individual data. RESULTS: A total of 15,342 incident BC cases were identified. Nine indicators were actually computable from administrative data (two structure and seven process indicators). Although most indicators were consistent with guidelines, for one indicator (blood tumor markers in the year after surgery, 44.2% to 64.5%; benchmark ≤ 20%), deviation was evident throughout the five regions, highlighting systematic overlooking of clinical recommendations. Two indicators (radiotherapy within 4 months after surgery if no adjuvant chemotherapy; 42% to 83.8%; benchmark ≥ 90%; and mammography 6 to 18 months after surgery, 55.1% to 72.6%; benchmark ≥ 90%) showed great regional variability and were lower than expected, possibly as result of an underestimation in indicator calculation by administrative data. CONCLUSION: Despite highlighting some limitations in the use of administrative data to measure health care performance, this study shows that evaluating the quality of BC care at a population level is possible and potentially useful for guiding quality improvement interventions.

e18734 Background: The COVID-19 outbreak has had a huge impact on health care services worldwide. Previous studies projected delays in cancer diagnoses and excess mortality for cancer patients as a result of the pandemic. Little is known, however, on the impact of the pandemic on the functioning of cancer services. We aimed to fill this gap by using a region-wide, population-based administrative health care data repository. Methods: We obtained data for patients initiating a targeted molecular therapy during 2017-2020 (January-September, by quarter) in Veneto. Eligible treatments were those with lapatinib, pertuzumab, TDM-1 and trastuzumab for breast cancer; with afatinib, alectinib, crizotinib, erlotinib, gefitinib and osimertinib for lung cancer; with cobimetinib, dabrafenib, trametinib and vemurafenib for melanoma; and with niraparib, olaparib and rucaparib for ovarian cancer. Patients starting more than one targeted molecular therapy in a given calendar year were included only once. We estimated the normalised difference between the number of patients for a given quarter in 2020 and the mean number of patients for the corresponding quarter during 2017-2019. Statistical significance was calculated assuming a type I error probability of 5%. Results: The study included 3,180 patients. In 2020, patients starting a targeted molecular therapy were 361 in the first quarter, 260 in the second quarter and 268 in the third quarter. The normalised difference between the number of treatments in 2020 and the mean number of treatments during 2017-2019 for all cancer types combined was statistically significant only for the first quarter, with more therapies in 2020 than in 2017-2019. In a breakdown by cancer type, differences were unremarkable for breast, lung or ovarian cancer, while there were significantly more treatments for melanoma for all the three quarters in 2020 compared to 2017-2019. Conclusions: We chose to use the rate of initiation of targeted molecular therapies as a proxy for the effectiveness of oncology services in managing cancer patients, because these therapies require that at least pathology and diagnostic facilities are fully operational. The study covered a population of nearly five million people, in a region where universal health coverage is available and where cancer care has been prioritised, by law, over non-cancer related health care services during the COVID-19 outbreak. Our findings suggest that provision of oncology care has not been substantially impacted by the pandemic in Veneto. Of note, label indications were unchanged for these drugs in 2020. The findings are also in line with the priority-based, adapted European Society for Medical Oncology recommendations. Further research is needed to assess whether delays at earlier stages of the route to cancer diagnosis (e.g. GP referrals for specialist care) may have occurred.

290 Background: Second (2L) or third-line (3L) treatment options for mRCC have dramatically changed in the last years. The standard of care as per Italian Regulatory Agencies approvals is N or C. To date, there are no criteria for the choice between N and C, which both demonstrated OS gain in the pivotal trials. Methods: We planned a retrospective, real world analysis of the use of N and C as 2L and 3L treatment in 17 Oncology Units of Veneto Region. All consecutive patients (pts) with mRCC treated in advanced setting in 2017-2018 were included. Results: We identified 170 pts, 73% males, median age 68.4 years. All pts started a 2L treatment while only 59% received a 3L treatment. In our cohort, patients with NLR > 3 at treatment start had a shorter OS (43 vs 90 months (mos), p < 0.0001); IMDC classification maintained its prognostic role. In 2L, N was administrated in 108 pts (63%), C in 29 pts (17%); in 3L N was administrated in 42 pts (25%), C in 49 pts (29%). Reported oncologists’ reasons for 2L choice were: change of mechanism of action compared to first line (28%), response to previous TKI (21.2%), intolerance to TKI (17.6%), previous toxicity (12.9%), tumor burden (11.2%), age of the patient (4.1%). Median OS and PFS in 2L were 28.4 and 6.6 mos for N, 16.8 and 6.6 mos for 2L C. Median OS and PFS in 3L were 27 and 5.2 mos for N, 16.6 and 7.5 mos for C. 46 pts received the sequence of drugs N > C, 12 the opposite sequence C > N. Median OS for N > C vs C > N were 96.6 vs 36 mos (p > 0.0001); median PFS for both the sequences were similar at 5.7 mos (p = ns). The cost per patient of the sequence N > C is 51.606 € while for the sequence C > N is 31.480,00 €. Between the two sequences a cost effectiveness per month of survival analysis was performed: the cost per month of OS for the sequence N > C was 534,18 € while for the sequence C > N was 874,46 €, heavily higher. Conclusions: In our real-world setting cohort, most of the pts received N as 2L treatment and a minority received C. Outcome of single drug are superimposable to published literature. With the limits of the retrospective nature of the study, with a cost per month of OS lower a much longer OS, the sequence N > C appear to be a better treatment strategy.

The diagnostic-therapeutic pathways (DTPs) are emerging as useful instruments for clinical management of complex diseases as gastric cancer, whose treatment is challenging and requires a multidisciplinary approach. However, the DPTs of patients with gastric cancer are still not defined yet. The aim of this study was to define the optimal DPT to be applied for patients with gastric cancer in the Veneto region. Rather than defining the ideal DTPs a priori, we conducted a preliminary research by analyzing the differences in the actual DPTs for patients with gastric cancer among different hospitals (hub and spokes) in Veneto. Then, the final DPT was elaborated based on the current available best clinical evidences; however, also the areas of homogeneity among the actual DPTs of the included centers as well as the critical issues that had emerged by our preliminary analysis were taken into account for pathway design. High heterogeneity in actual DTPs of patients with gastric cancer was observed among the analyzed centres. Moreover, some of the major criticisms have been found at crucial points of the current pathways. Based on these data, a reference path that is applicable to the whole-regional health network was constructed. The reference DTP is focused on multidisciplinary team management of patients with gastric cancer. Clinical pathways are essential tools to properly manage complex diseases such as gastric cancer. As such, more efforts should be done to implement their use.

The increasing number of elderly people in the world population has led to a parallel increase in the number of older cancer patients, with over 45% of all cancers in Europe occurring in patients >70 years of age. The increasing tendency to use oral chemotherapy is thus of interest in the elderly, given that both elderly patients and their physicians prefer to use less complex and toxic regimens when such treatments have equivalent efficacy to more complex regimens. However, data from studies designed to evaluate these therapies in the elderly are currently limited. Factors that must be considered before prescribing oral agents to this subset of patients include age-related physiological changes affecting clinical pharmacology, adherence, the patient's capability to self-administer medications, and safety issues concerning the older patient and his or her caregivers. The idea that elderly patients may benefit from the introduction of oral chemotherapy is very fashionable, but to date there is no proof that this approach is as effective as intravenous therapy in this age group, particularly since randomised trials are lacking. This review discusses these issues and reviews current information about the use of specific oral chemotherapeutic drugs for major neoplastic diseases in the elderly.

e12028 Background: The NHS in Italy is a public system of universal nature that guarantees health care to all citizens. Few Italian studies relate the therapy received by a cancer patients with their socio-economic status, so we decided to analyze the situation of the IOV. Methods: It is an observational monoinstitutional study conducted on 886 patients (pts) treated at the IOV from May 2006 to December 2011. They were selected from the Onco-AIFA registry which is a national tool used to monitor anticancer high-cost therapies. The socio-demographic data were obtained from medical records.We verified if there are differences in access to treatments (number of diagnostic tests, chemotherapy treatments, specialist and follow visits) in association with the socioeconomic determinants. We analyzed the survival differences in connection with demographic and clinical characteristics.The statistical analysis was performed using the Kruskal-Wallis test and the Cox model. Results: There are 520 pts evaluable of the 886 pts selected: 42% suffering from colorectal cancer, 28% lung cancer and 30% breast cancer. The median age is 63 years (41% male). With regard to the profession the sample is divided as follows: 34% traders/artisans/workers, 25% technical professions/office workers, 14% highly specialized occupations, 25% retired/housewives. The statistical analysis shows no significant differences in the number of exams and medical services in relation to the profession, except one that regards the mean number of chemotherapy infusions (25 manual professions vs. 20 other professions, p = 0.007). The socioeconomic variables do not affect survival, unlike the age (hazard ratio [HR], 1.42, p

11517 Background: We analyses a mono institutional series of patients treated with metastatic breast cancer (MBC). Methods: From 2000 to 2006 forty consecutive patients affected by MBC were evaluated. The average age was 50 years (range: 30–79). All patients had HER2+ tumors (IHC 3+ or FISH+) and LVEF > 50%. Metastatic sites were: liver 18, lymph nodes 10, bone 9, skin 7, lung 5 pts. In 11 cases the sites of metastases were multiple (1–3). All patients were treated with Trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly thereafter with weekly Paclitaxel 80 mg/m2 or weekly Vinorelbine 25 mg/m2; specifically, Paclitaxel was used in 26 patients and Vinorelbine in 14 patients. The endpoints were time to progression (TTP), duration of response, toxicity (including cardiologic) and overall survival. Results: A total of 1271 courses of weekly Trastuzumab were administered (average 28 courses per patient: range 8–72). There were 22 complete and partial responses (CR+PR=55%). In the association of Trastuzumab and Paclitaxel were seen :11 CR, 6 PR, 3 SD and 6 PD, (RR 65.3%). In the combination of Trastuzumab and Vinorelbine: 2 CR, 3 PR, 4 SD and 5 PD (RR 35.7%) . The most responsive sites were: liver 15 CR+PR (37.5%), lung 11 CR+PR (27.5%), lymph nodes 8 CR+PR (20%), and skin 6 CR+PR (15%). TTP was 7 months (2–27 months) and response duration 6.7 months (2–26 months). Overall survival at 5 years was estimated at 26.4 months. Toxicity rates were: hematological grade 4 in 2 pts, grade 3 in 3 pts, neurological grade 3 in 19 pts. No important cardiologic toxicity was observed: LVEF was reduced to 40% in 4 pts. Seven patients developed brain metastasis during therapy. The patients in PD continued Trastuzumab with other chemotherapy, no responses were observed. The median cost of treatment with Trastuzumab for patient was 16.147 € (range 3.987–39.959 €. Conclusions: Treatment with Trastuzumab plus chemotherapy has been shown to be effective and well-tolerated providing a good quality of life. The economic impact is important and is to define. The cost/benefit in this cohort of the patients is ongoing. No significant financial relationships to disclose.