How many Italian cancer patients are eligible for, and may respond to, Italian Medicines Agency-approved immune checkpoint inhibitors? - Original Research Article

Sep 21, 2026

Cross-sectional research estimates the number of Italian incident cancer patients in 2020 who were eligible for, and likely to respond to, immune checkpoint inhibitors (ICI) authorized by the Italian Medicines Agency (AIFA) up to August 2022. Using publicly available data on AIFA indications, observed responses, cancer incidence and deaths, and published frequency estimates, the study reports total ICI eligibility and potential responders across cancer types. Findings quantify eligible patients and the share who may benefit from ICI therapy.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages7

Reading Time18 min

AccessFree to download

Abstract

Introduction

Materials and methods

Results

Conclusions

Original Research Article Tj Tumori journal How many Italian cancer patients are eligible for, and may respond to, Italian Medicines Agency-approved immune checkpoint inhibitors? Emanuele Crocetti 1, Alessandra Ravaioli 1, Fabio Falcini 1,2, Rosa Vattiato 1, Silvia Mancini 1, Flavia Baldacchini 1, Federica Zamagni 1, Benedetta Vitali 1, Chiara Balducci 1, Lauro Bucchi 1 and Orietta Giuliani 1 Tumori Journal 2024, Vol. 110(2) 109–115 © Fondazione IRCCS Istituto Nazionale dei Tumori 2024 Article reuse guidelines: [sagepub.com/journals-permissions](sagepub.com/journals-permissions)[ ](sagepub.com/journals-permissions)[DOI: 10.1177/03008916241229649](DOI: 10.1177/03008916241229649)[ ](DOI: 10.1177/03008916241229649)[journals.sagepub.com/home/tmj](journals.sagepub.com/home/tmj) Abstract Introduction: This cross-sectional study was aimed at estimating the number of Italian incident cancer patients in 2020 eligible for, and respondent to, immune checkpoint inhibitors (ICI). Methods: The study is based on publicly available data: the ICI approved until August 2022 by the Italian Medicines Agency (AIFA) with their specific indications and overall observed responses, rther details can be found in the Online Supplementary Materi cancer incidence estimates at 2020 and observed cancer deaths, and published papers with estimates on the frequency of different cancer stage/histology/markers etc. corresponding to AIFA authorizations. Results: In the analyzed period, a total of seven ICI were authorized in Italy for 20 cancer types. The estimated number of ICI-eligible patients in 2020 was 48,400, 14.3% of those tumors (including skin epitheliomas) that may fit AIFAindications, and 10.5% of all the incident malignant tumors, including skin epitheliomas. The number of patients who may benefit from ICI therapy was 24,052, 49.7% of the ICI-eligible ones, or 5.2% of the overall estimated incident cancers in 2020. Conclusions: In conclusion, although the number of ICI-eligible patients is a relatively small proportion of the yearly burden of cancers, about half of them may respond to ICI-treatment. Keywords burden, cancer, estimate, immune checkpoint inhibitors, therapy Date received: 18 September 2023; revised: 11 December 2023; accepted: 11 January 2024 Introduction The immune checkpoint inhibitors (ICI) are immunotherapy drugs acting on the Programmed Cell Death Protein 1 (PD-1) and Cytotoxic T-Lymphocyte Antigen (CTLA) pathways repressing negative immune regulation and reactivating T-cell functions. Therefore, they allow more effective cancer cell elimination.1 The use of these drugs has improved outcomes for patients affected by several advanced solid tumors.2 In Italy, seven ICI have been approved by the Italian Medicines Agency (AIFA) until August 2022: ipilimumab (YERVOY),3 nivolumab (OPDIVO),4 pembrolizumab (KEYTRUDA),5 atezolizumab (TECENTRIQ),6 avelumab (BAVENCIO),7 durvalumab (IMFINZI),8 and cemiplimab (LIBTAYO) .9 Overall, these drugs were approved for the following indications: head and 1 Emilia-Romagna Cancer Registry, Romagna Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Forlì, Italy 2Local Health Authority, Cancer Prevention Unit, Forlì, Italy Corresponding author: Alessandra Ravaioli, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Via Maroncelli 40/42, Meldola, 47014, Italy. Email: [alessandra.ravaioli@irst.emr.it](alessandra.ravaioli@irst.emr.it) neck squamous cell carcinoma (SCCHN), squamous cell esophageal cancer, adenocarcinoma esophagus, junction and stomach HER2-PD-L1 cps ⩾5, stomach microsatellite instability–high (MSI-H)/mismatch repair deficient (dMMr) gastric cancer, MSI-H/dMMr colorectal cancer, MSI-H/ dMMr small bowel cancer, hepatocellular carcinoma, MSI-H/dMMr biliary tract cancer, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), skin squamous cell carcinoma, skin basal cell carcinoma, melanoma, Merke

FAQs

What was the purpose of this cross-sectional study?

To estimate how many Italian incident cancer patients diagnosed in 2020 were eligible for, and responsive to, AIFA-approved immune checkpoint inhibitors (ICI).

How did the study estimate eligible and responding patients?

It combined publicly available AIFA authorization and indication information (up to August 2022), cancer incidence estimates for 2020, observed cancer deaths, and published estimates of cancer stage/histology/biomarker frequencies, with further assumptions provided in the online supplementary materials.

What proportion of ICI-eligible patients may benefit from ICI therapy?

About half of the ICI-eligible patients may respond to ICI treatment, with the study estimating 24,052 patients as potential beneficiaries (49.7% of those eligible).

Sep 21, 2026

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