No abstract

La necessità di ottimizzare i processi di erogazione di servizio del SSN (sistema sanitario nazionale) italiano è cresciuta velocemente con la diffusione del SARS-CoV-2. In particolar modo, i processi di gestione dei centri tamponi hanno richiesto interventi di miglioramento al fine di ottimizzate i tempi e le modalità di esecuzione della procedura.Mediante la metodologia del caso studio, il presente lavoro descrive l'esperienza di un centro per tamponi antigenici e molecolari della Regione Veneto in cui sono stati utilizzati alcuni strumenti del toolbox della metodologia Lean per mappare i processi, raccogliere i dati e definire azioni efficaci di miglioramento dei flussi degli utenti. A seguito di questo intervento il tempo medio di transito utente nel centro tamponi è stato ridotto del 73% per i test molecolari e del 42% per i test rapidi antigenici. Ulteriori risultati ottenuti sono stati l'azzeramento degli errori in fase di accettazione e un contestuale aumento del livello di soddisfazione del personale.L'importanza di saper rispondere alle sfide con agilità, l'efficacia di un approccio iterativo e della collaborazione trasversale rappresentano i principali insegnamenti emersi.

Objectives: A previous analysis showed the economic sustainability of adding liquid biopsy, whenever possible, to tissue biopsy for the assessment of epidermal growth factor receptor-positive (EGFR+) mutation in patients with advanced non-small cell lung cancer (mNSCLC). The following analysis evaluated the clinical outcome (progression free survival, PFS) when adopting two different diagnostic strategies in the first-line treatment of patients with EGFR+ mNSCLC. Methods: A previous decisionanalytic model was adopted to compare the two diagnostic strategies: i) tissue strategy and ii) combined strategy (tissue biopsy and, were its outcome unknown, liquid biopsy). We only evaluated the PFS variation between the two diagnostic strategies considered. We assumed that mNSCLC EGFR+ patients were treated with 3 rd generation EGFR-TKI (PFS: 18.9 months), while mNSCLC EGFR Wilde Type (WT) patients were treated with chemotherapy (PFS: 5.7 months). Key variables were tested in the sensitivity analysis. Results: A total of 13,030 patients eligible for tissue biopsy in Italy were considered, of whom 2,463 were assumed to be EGFR+. The combined strategy showed an increase of the number of correctly identified EGFR+ patients (2,293 patients) compared to the tissue strategy (1,691 patients). When considering mNSCLC EGFR+ patients treated with 3 rd generation EGFR-TKI, the PFS would increase from 14.8 months per patient with the tissue strategy to 18.5 months per patient with the combined strategy. When considering mNSCLC EGFR+ patients treated with other 1 st /2 nd generation EGFR-TKI, the PFS would increase from 8.8 months per patient with the tissue strategy to 10.1 months per patient with the combined strategy. Conclusions: The choice of a correct diagnostic strategy is crucial in order to optimize cancer therapies in the first-line treatment of mNSCLC EGFR+. The addition to the diagnostic pathway of the liquid biopsy would correctly identify a greater number of cases, supporting the prescription of a more effective oncological therapy.

BACKGROUND: A histopathological and mutational diagnosis has become a priority in the correct choice of the most appropriate cancer therapy for NSCLC. In the absence of a molecular analysis, the therapeutic choice will be directed towards platinum-based chemotherapy, thus preventing, in the presence of a specific mutation, the benefits deriving from the administration of a target therapies (TT).AIM: the present analysis was carried out with the aim of estimating the clinical impact, expressed in terms of progression free survival (PFS), associated with the use of the combined strategy (tissue biopsy and liquid biopsy) or the tissue strategy in the EGFR+ mNSCLC population.METHODS: A pre-existing cost-consequence model was adapted to estimate the annual number of mNSCLC patients with or without the EGFR mutation in order to decide the oncological treatment to be administered in first (1L) or second line (2L). In 1L, against the presence of the EGFR mutation, the administration of a Tyrosine Kinase Inhibitor (TKI), such as osimertinib, gefitinib, erlotinib or afatinib, was considered; in the absence of the EGFR mutation, the administration ofstandard platinum-based chemotherapy was instead considered. With reference to 2L, in the presence of the EGFR T790M mutation, only osimertinib was considered. In the absence of the EGFR T790M mutation, the administration of the standard platinum-based chemotherapy was also considered. The PFS data associated with each of the drugs considered were extrapolated from the respective clinical studies. Key variables were tested in the sensitivity analysis.RESULTS: The adoption of the combined strategy (tissue biopsy and liquid biopsy), by virtue of a greater number of patients treated with TKIs, would make it possible to increase the average PFS in the range of 1.1-3,7 months in the 1L and by 1.4 months in the 2L.CONCLUSION: These results show how the adoption of a correct diagnostic strategy is critical in order to optimize the choice of the therapeutic path in the 1L and 2L of mNSCLC. The addition of the liquid biopsy to the classic diagnostic path (tissue biopsy) would in fact allow to obtain an increase in therapeutic efficacy (average PFS).