Cost-effectiveness of a melanoma screening programme using whole disease modelling

OBJECTIVE: To assess the potential impact of a melanoma screening programme, compared with usual care, on direct costs and life expectancy in the era of targeted drugs and cancer immunotherapy. METHODS: Using a Whole Disease Model approach, a Markov simulation model with a time horizon of 25 years was devised to analyse the cost-effectiveness of a one-time, general practitioner-based melanoma screening strategy in the population aged over 20, compared with no screening. The study considered the most up-to-date drug therapy and was conducted from the perspective of the Veneto regional healthcare system within the Italian National Health Service. Only direct costs were considered. Sensitivity analyses, both one-way and probabilistic, were performed to identify the parameters with the greatest impact on cost-effectiveness, and to assess the robustness of our model. RESULTS: Over a 25-year time horizon, the screening intervention dominated usual care. The probabilistic sensitivity analyses confirmed the robustness of these findings. The key drivers of the model were the proportion of melanomas detected by the screening procedure and the adherence of the target population to the screening programme. CONCLUSIONS: The screening programme proved to be a dominant option compared with usual care. These findings should prompt serious consideration of the design and implementation of a regional or national melanoma screening strategy within a National Health Service

Clinical experience with ipilimumab 3 mg/kg: real-world efficacy and safety data from an expanded access programme cohort.

Ipilimumab improves survival in patients with advanced melanoma. The activity and safety of ipilimumab outside of a clinical trial was assessed in an expanded access programme (EAP).Ipilimumab was available upon physician request for patients aged 16 or over with pretreated stage III (unresectable)/IV melanoma, for whom no other therapeutic option was available. Patients received ipilimumab 3 mg/kg every 3 weeks for four doses. Patients with stable disease or an objective response to ipilimumab were eligible for retreatment upon disease progression. Tumour assessments were conducted at baseline and week 12. Patients were monitored for adverse events (AEs) within 3 to 4 days of each scheduled visit.Of 855 patients participating in the EAP in Italy, 833 were evaluable for response. Of these, 13\% had an objective immune response, and the immune-related disease control rate was 34\%. Median progression-free survival and overall survival were 3.7 and 7.2 months, respectively. Efficacy was independent of BRAF and NRAS mutational status. Overall, 33\% of patients reported an immune-related AE (irAE). The frequency of irAEs was not associated with response to ipilimumab.Outside of a clinical trial setting, ipilimumab is a feasible treatment option in patients with pretreated metastatic melanoma, regardless of BRAF and NRAS mutational status. Data from this large cohort of patients support clinical trial evidence that ipilimumab can induce durable disease control and long-term survival in patients who have failed to respond to prior treatment

18F-fluorodeoxyglucose PET/computed tomography and risk stratification after neoadjuvant treatment in esophageal cancer patients

OBJECTIVES: The aim of the study was to evaluate the prognostic value of 18F-fluorodeoxyglucose PET/computed tomography (CT) after neoadjuvant therapy (NAT) in locally advanced esophageal cancer (EC) patients. MATERIALS AND METHODS: We recruited 79 EC patients from a sample of 210 who underwent 18F-fluorodeoxyglucose PET/CT after NAT and who did not have evidence or suspicion of distant metastases. All patients were followed up for a median period of 18 months (range: 2-53 months) from nuclear imaging. PET/CT findings were correlated with surgical management and long-term prognosis. The \u3c7-test was used for categorical variables and the Student t-test for continuous data. Survival curves were computed using the Kaplan-Meier method. A P value less than 0.05 was considered statistically significant. RESULTS: Twenty patients (25.3%) had negative PET/CT and 59 (74.7%) had positive PET/CT results after NAT. Of the 20 patients with negative PET/CT results, eight underwent radical-intent surgery and 12 did not, whereas of the 59 patients with positive PET/CT 44 were scheduled for surgery and 15 were not (P<0.05). On follow-up, 38 patients were seen to be disease free, whereas 23 had relapsed and 15 had died. The overall survival was different between patients with negative PET/CT and those with positive PET/CT scans (98 vs. 40%; P=0.019). Event-free survival was higher in patients with negative PET/CT than in those with positive PET/CT after NAT (78 vs. 0%; P=0.003). Considering patients with positive PET/CT, in the nonsurgical group only three patients were alive without evidence of disease, whereas in the surgical group 19 patients were disease free (20 vs. 46%; P<0.001). CONCLUSION: PET/CT is able to stratify the recurrence risk of EC patients. After a median follow-up period of 18 months, 91% of patients with negative PET/CT scans who did not undergo surgery were seen to be disease free. A positive PET/CT after NAT should be followed by surgery for improving event-free survival

Positron emission tomography/computed tomography and esophageal cancer in the clinical practice: How does it affect the prognosis?

Aims: The aim of this study was to assess the diagnostic value of positron emission tomography/computed tomography (PET/CT) in staging of esophageal cancer and to evaluate the prognostic role of metabolic parameters before and after neo-adjuvant treatment. Settings and Design: Mono-institutional retrospective study. Materials and Methods: We retrospectively evaluated 29 patients who underwent PET/CT at initial staging and after neo-adjuvant therapy. Metabolic parameters were calculated: mean, average, maximum standardized uptake value (SUVmax), and total lesion glycolysis (TLG). Diagnostic advantages of PET/CT over conventional imaging (CI) were determined. The relationships between baseline and after-therapy SUVmax and TLG, change in SUV and TLG (reported as \uf044) for the primary tumor and prognosis were assessed. Statistical Analysis Used: Non-parametric statistic (e.g. Wilcoxon test and chi-square test). Results: Twenty-nine patients were eligible for the initial staging. Thirteen patients were incorrectly staged based on CI; PET/CT was able to identify distant lymph nodes in seven patients (59%) and distant metastases in four (31%). The median SUVmax before and after neoadjuvant therapy was 10.38 and 3.53 (P = 0.0005), respectively. Only few semi-quantitative parameters obtained by PET/CT after neoadjuvant therapy seemed to have a prognostic value. TLG and \uf044TLG were significantly different between disease-free and died patients (0.49 versus 15.51 and 100% versus 94%, respectively; all P = <0.05). Conclusions: PET/CT is confirmed as being able to detect distant metastases and to avoid unnecessary surgery. Although not routinely reported, post-neoadjuvant TLG and \uf044TLG might be considered as useful prognostic parameters and should be further evaluated prospectively

Results of esophagectomy for esophageal cancer in elderly patients: Age has little influence on outcome and survival

I.F. ISI 2009: 3.063 Categoria Q1, ultimo autore: punti 1