Osimertinib in Patients With Treatment-Naive EGFR-Mutant Non-small Cell Lung Cancer: Overall Survival, Post-progression Management and Budget Impact Analysis in Real-World.

Introduction: The observational multicenter prospective FLOWER study (NCT04965701) confirmed effectiveness and safety of osimertinib in the real-world (RW) management of untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) patients.

Methods: Herein, we report updated survival data, post-progression management, cost/effectiveness and budget impact (BI) of osimertinib compared with a RW population receiving gefitinib or erlotinib.

Results: Overall, 189 Caucasian patients receiving first-line osimertinib were included.

Indicators of clinical performance in monitoring soft tissue sarcoma management: a population-based perspective.

Background: Soft tissue sarcomas (STS) are rare malignancies which prognosis varies significantly by primary site, histological subtype, and tumor stage. Their low incidence, and the complexity of their clinico-pathological characteristics demand standardized, cancer-tailored diagnostics and therapies managed at high-volume, multidisciplinary care centers. This study evaluates the quality of STS management in north-east Italy (Veneto Region) through a list of defined clinical indicators.

Estimated Direct Costs of Renal Cancer by Stage of Disease at Diagnosis and Phase of Its Management: A Whole-Disease Model.

Background: Renal cell carcinoma (RCC) is the seventh most common neoplasm in high-income countries. New clinical pathways have been developed to deal with this tumor, which includes costly drugs that pose an economic threat to the sustainability of healthcare services. This study provides an estimate of the direct costs of care for patients with RCC by stage of disease (early vs.

Cost-effectiveness analysis of the new oncological drug durvalumab in Italian patients with stage III non-small cell lung cancer.

Background: The monoclonal antibody durvalumab, an immune-checkpoint inhibitor (ICI) antiprogrammed death ligand 1 (PD-L1), is available for unresectable stage III NSCLC patients as consolidation therapy following induction chemoradiotherapy, with very promising overall survival (OS) and progression-free survial (PFS) results in registration trials. The purpose of this study was to provide policymakers with an estimate of the cost-effectiveness of durvalumab in the treatment of non-small cell lung cancer (NSCLC).

Methods: The study developed a Markov model covering a 5-year period to compare costs and outcomes of treating PD-L1 positive patients with or without durvalumab.

Clinical performance indicators for monitoring the management of cutaneous melanoma: a population-based perspective.

The prognosis of cutaneous malignant melanoma (CMM) is based on disease progression. The highly heterogeneous clinical-pathological characteristics of CMM necessitate standardized diagnostic and therapeutic interventions tailored to cancer's stage. This study utilizes clinical performance indicators to assess the quality of CMM care in Veneto (Northeast Italy).

Real-World Treatment with Nivolumab or Cabozantinib for Metastatic Renal Cell Carcinoma (mRCC) in the Veneto Region of Italy: Results of AMOUR Study.

Background: Second- or third-line treatment options for metastatic renal cell carcinoma (mRCC) have dramatically changed in the last few years. There are no criteria for the choice between nivolumab and cabozantinib, which both demonstrated overall survival (OS) gain in pivotal trials.

Objective: We conducted an analysis of oncological outcomes in patients treated in the Veneto Region (Italy), studying different sequences of TKI-nivolumab-cabozantinib or TKI-cabozantinib-nivolumab in a publicly funded healthcare system.

Multicenter Real-World Study on Effectiveness and Early Discontinuation Predictors in Patients With Non-small Cell Lung Cancer Receiving Nivolumab.

Background: Real-world (RW) evidence on nivolumab in pretreated patients with non-small cell lung cancer (NSCLC) by matching data from administrative health flows (AHFs) and clinical records (CRs) may close the gap between pivotal trials and clinical practice.

Methods: This multicenter RW study aims at investigating median time to treatment discontinuation (mTTD), overall survival (mOS) of nivolumab in pretreated patients with NSCLC both from AHF and CR; clinical-pathological features predictive of early treatment discontinuation (etd), budget impact (BI), and cost-effectiveness analysis were investigated; mOS in patients receiving nivolumab and docetaxel was assessed.

Results: Overall, 237 patients with NSCLC treated with nivolumab were identified from AHFs; mTTD and mOS were 4.

Quality management of cutaneous melanoma: impact on short-term outcomes and costs.

Promoting standardization and quality assurance (QA) may guarantee better outcomes for patients and ensure a better allocation of healthcare system resources. The present study tested the association between process quality indicators of the clinical pathway for melanoma and both patient short-term mortality and budget utilization. Specific indicators were selected to assess quality of processes in different phases of the pathway as well as the pathway as a whole.

Non-Small-Cell Lung Cancer: Real-World Cost Consequence Analysis.

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.

Estimated direct costs of non-small cell lung cancer by stage at diagnosis and disease management phase: A whole-disease model.

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.

Real world data in the era of Immune Checkpoint Inhibitors (ICIs): Increasing evidence and future applications in lung cancer.

Immune checkpoint inhibitors (ICIs) targeting programmed death 1 (PD-1) and PD-ligand 1 (PD-L1) quickly subverted the standard of treatment in Non-Small Cell Lung Cancer (NSCLC), where they were first introduced in all comers previously treated advanced/metastatic NSCLC patients and subsequently in the first line of PD-L1 selected cases of metastatic and locally advanced disease. Treatment algorithm is an evolving landscape, where the introduction of front-line ICIs, with or without chemotherapy, unavoidably influences the following treatment lines. In this context, medical oncologists are currently facing many unclear issues, which have been not clarified so far by available data.

Use of Electronic Administrative Databases to Measure Quality Indicators of Breast Cancer Care: Experience of Five Regional Oncology Networks in Italy.

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.

From Diagnostic-Therapeutic Pathways to Real-World Data: A Multicenter Prospective Study on Upfront Treatment for -Positive Non-Small Cell Lung Cancer (MOST Study).

Introduction: Gefitinib, erlotinib, and afatinib represent the approved first-line options for epidermal growth factor receptor ()-mutant non-small cell lung cancer (NSCLC). Because pivotal trials frequently lack external validity, real-world data may help to depict the diagnostic-therapeutic pathway and treatment outcome in clinical practice.

Methods: MOST is a multicenter observational study promoted by the Veneto Oncology Network, aiming at monitoring the diagnostic-therapeutic pathway of patients with nonsquamous -mutant NSCLC.

Clinical pathways in gastric cancer care.

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.

OECI accreditation at Veneto Institute of Oncology IOV -- IRCCS, general framework and multidisciplinary approach.

The aim of this article is to describe the accreditation process of the Veneto Institute of Oncology (IOV-IRCCS) according to the Organisation of European Cancer Institutes (OECI) model, with particular reference to the standards for the multidisciplinary approach. Through the analysis of the process and the activities of each multidisciplinary team (MDT) and the development, at a regional level, of diagnostic, therapeutic, and care pathways (PDTA), all the necessary steps to meet the OECI standards have been determined. Adjustment is ongoing.

Oral anticancer drugs in the elderly: an overview.

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.

Recent progress in target therapy in colorectal cancer.

Monoclonal antibodies are a new class of agents targeting at specific receptors on cancer cells. In addition to having direct cellular effects, antibodies can cany substances, such as radioactive isotopes, toxins and antineoplastic agents, to the targeted cells. Two of them, cetuximab (Erbitux) and bevacizumab (Avastin), seem to have acquired a significant role in the management of patients with radically resected and advanced colorectal carcinoma.

Rectal cancer neoadjuvant treatment in elderly patients.

Background: The aim of the study was to evaluate the differences in terms of toxicity and feasibility of neoadjuvant 5-fluorouracil (5FU) continuous infusion (c.i.) or bolus in combination with pelvic radiotherapy (RT) in locally advanced rectal cancer "fit" or "vulnerable" elderly patients.