Skip pattern approach toward the early access of innovative anticancer drugs.

BACKGROUND: With the rapid development of innovative anticancer treatments, the optimization of tools able to accelerate the access of new drugs to the market by the regulatory authority is a major issue. The aim of the project was to propose a reliable methodological pathway for the assessment of clinical value of new therapeutic innovative options, to objectively identify drugs which deserve early access (EA) priority for solid and possibly in other cancer scenarios, such as the hematological ones. MATERIALS AND METHODS: After a comprehensive review of the European Public Assessment Report of 21 drugs, to which innovation had previously been attributed by the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA), an expert panel formulated an algorithm for the balanced use of three parameters: Unmet Medical Need (UMN) according to AIFA criteria, Added Benefit (AB) according to the European Society for Medical Oncology's Magnitude of Clinical Benefit Scale (ESMO-MCBS) criteria and Quality of Evidence (QE) assessed by the Grades of Recommendation Assessment, Development and Evaluation (GRADE) method. By sequentially combining the above indicators, a final priority status (i.e. EA or not) was obtained using the skip pattern approach (SPA). RESULTS: By applying the SPA to the non-curative setting in solid cancers, the EA status was obtained by 5 out of 14 investigated drugs (36%); by enhancing the role of some categories of the UMN, additional 4 drugs, for a total of 9 (64%), reached the EA status: 2 and 3 drugs were excluded for not achieving an adequate score according to AB and QE criteria, respectively. For hematology cancer, only the UMN criteria were found to be adequate. CONCLUSIONS: The use of this model may represent a reliable tool for assessment available to the various stakeholders involved in the EA process and may help regulatory agencies in a more comprehensive and objective definition of new treatments' value in these contexts. Its generalizability in other national contexts needs further evaluation.

Prostate cancer as a chronic disease: cost-effectiveness and proper follow-up.

In western countries, prostate cancer (PCa) is the most common non-dermatological malignant disease in men. Bone metastases more often develop in patients with advanced PCa; the associated complications present a substantial disease and economic burden. Although the introduction of new therapeutic strategies have provided some advantages in terms of overall survival and quality of life in patients with metastatic PCa, the skeletal related events and side effects due to the therapies are associated with an important impact on the healthcare costs. In particular, the number of hospital admission, clinical consultation and the introduction of new expensive diagnostic modalities have changed the management of metastatic patients. However, the National and International guidelines suggest to follow patients with metastatic PCa by using clinical assessment, biochemical evaluation and, when necessary, diagnostic imaging. The aims of the present review were: 1) to summarize the information regarding the clinical and economic burden of metastasis; 2) to evaluate the quality of life; and 3) to suggest a proper follow-up in advanced PCa patients.

Evaluation of the udder health status in subclinical mastitis affected dairy cows through bacteriological culture, somatic cell count and thermographic imaging.

Subclinical mastitis in dairy cows is a big economic loss for farmers. The monitoring of subclinical mastitis is usually performed through Somatic Cell Count (SCC) in farm but there is the need of new diagnostic systems able to quickly identify cows affected by subclinical infections of the udder. The aim of this study was to evaluate the potential application of thermographic imaging compared to SCC and bacteriological culture for infection detection in cow affected by subclinical mastitis and possibly to discriminate between different pathogens. In this study we evaluated the udder health status of 98 Holstein Friesian dairy cows with high SCC in 4 farms. From each cow a sample of milk was collected from all the functional quarters and submitted to bacteriological culture, SCC and Mycoplasma spp. culture. A thermographic image was taken from each functional udder quarter and nipple. Pearson's correlations and Analysis of Variance were performed in order to evaluate the different diagnostic techniques. The most frequent pathogen isolated was Staphylococcus aureus followed by Coagulase Negative Staphylococci (CNS), Streptococcus uberis, Streptococcus agalactiae and others. The Somatic Cell Score (SCS) was able to discriminate (p<0.05) cows positive for a pathogen from cows negative at the bacteriological culture except for cows with infection caused by CNS. Infrared thermography was correlated to SCS (p<0.05) but was not able to discriminate between positive and negative cows. Thermographic imaging seems to be promising in evaluating the inflammation status of cows affected by subclinical mastitis but seems to have a poor diagnostic value.

[Percutaneous neurolysis of the celiac plexus. Description of a new CT-guided technique and preliminary results]. / Neurolisi percutanea del plesso celiaco. Descrizione di una nuova metodica TC-guidata e risultati preliminari.

June 1991 to June 1992, twelve CT-guided percutaneous celiac plexus neurolyses were performed by a new simplified technique with the patient in left-hand side decubitus and a single right lumbar needle access. CT guidance allows the interventional radiologist to locate the best access point on the skin, to give the needle the appropriate depth and inclination to avoid passing through pleura, parenchyma and vessels, and finally to check the correct position of the needle tip and the spread of neurolytic solution. In left-hand side decubitus, fat and loose connective tissue around ganglia and vessels expands much more, thus allowing the alcohol-contrast medium solution to spread easily and evenly getting to both celiac ganglia by gravity. The analgesic value of celiac plexus neurolysis has been proved complete and lasting. The technique is quick and safe (apart from inevitable hypotension due to splanchnic vasodilatation).