Κατεύθυνση Ανάπτυξη Νέων Φαρμάκων: Έρευνα, Κυκλοφορία και Πρόσβαση
Library of the School of Health Sciences

2023-05-26

2023

Koui Eirini-Maria

Χαρά Κανή, Εξωτερική Συνεργάτης, Ιατρική Σχολή, ΕΚΠΑ
Κωνσταντίνος Συρίγος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Κυριάκος Σουλιώτης, Καθηγητής, Τμήμα Κοινωνικών και Πολιτικών Επιστημών, Πανεπιστήμιο Πελοποννήσου

Συστηματική ανασκόπηση ασφάλειας νεότερων θεραπειών πρώτης γραμμής που χρησιμοποιούνται στο μικροκυτταρικό καρκίνο του πνεύμονα

English

Systematic review of safety of new first-line drugs for small cell lung cancer

Background: Clinical practice guidelines for the treatment of Extensive-Stage Small Cell Lung Cancer (SCLC) currently recommend immunotherapy drugs, ipilimumab, pembrolizumab, atezolizumab, durvalumab και bevacizumab. Collection and analysis of scientific clinical evidence is essential to use these new therapeutic modalities for the improvement of oncologic health care. Moreover, diffusion of new health technologies requires management of health care budgets. Budget Impact Analysis (BIA) is often used for resource allocation purposes.
Objectives: To perform a Systematic Review and Meta-analysis to evaluate the clinical safety of immunotherapy with immune checkpoint inhibitors and anti-VEGF drugs, in patients with SCLC and to conduct a Budget Impact Analysis of these approved interventions, as First-Line Treatment.
Methods: A search strategy was developed in order to conduct a comprehensive literature search in Cochrane Central Register of Controlled Trials (CENTRAL) και PUMBED. Additional electronic sources (ClinicalTrials.gov, Eudra-CT, eof.gr) were also searched. Eligible studies were phase II and III RCTs. Quality assessment and risk of bias analysis was performed according to Cochrane standards. Study selection, data extraction and quality assessment were made by two independent authors. Direct estimates were calculated using RevMan5.4. Primary outcomes of study were G3 to G5 adverse events while secondary outcome included Discontinuations due to adverse events. Evidence standards framework by The National Institute for Health and Care Excellence (NICE), UK and the updated price list of the Greek Ministry of Health were used for the BIA.
Results: Meta-analysis of two (2) randomized controlled trials (RCTs) comparing efficacy and safety of chemotherapy (carboplatin,etoposide) versus immunotherapy (bevacizumab,atezolizumab) in previously untreated patients with Extensive-Stage SCLC. Meta-analysis reported results for Grade 3 to Grade 5 (G3 to G5) Adverse Events OR=1,15 [95%, 0.80-1.65] and Discontinuations due to Adverse Events OR=3.21 [95%, 1.53-6.71]. Cost for durvalumab first-line therapy for the 2-yeat time horizon of the analysis equals to 24.652.782 €. Cost for atezolizumab first-line therapy for the 2-yeat time horizon of the analysis equals to 17.574.791,08 €, for the eligible population.
Conclusions: It was not demonstrated statistically important difference between chemotherapy and immunotherapy , with regards to safety profile (ΑΕs G3-G5), however, with immunotherapy, more Discontinuations due to Adverse Events were observed. First -Line therapy with durvalumab revealed higher cost compared to atezolizumab and numbers 24.652.782 €.

Health Sciences

Small cell lung cancer, immunotherapy, Meta-analysis, Clinical safety, Budget impact

No

0

Yes

49

72

File access is restricted only to the intranet of UoA.

https://pergamos.lib.uoa.gr/uoa/dl/object/3329177