Comparison of baseline patient characteristics in Italian oncology drug monitoring registries and clinical trials: a real-world cross-sectional study DOI Creative Commons
Maria Lucia Iacovino, Simone Celant, Luca Tomassini

et al.

The Lancet Regional Health - Europe, Journal Year: 2024, Volume and Issue: 41, P. 100912 - 100912

Published: April 22, 2024

BackgroundGeneralizability of registrative clinical trials to real-world practice is influenced by comparability patients in the two settings. We compared characteristics cancer with Italy.MethodsData on age, sex and performance status (PS) were derived from web-based monitoring registries developed Italian Medicines Agency (AIFA) corresponding reported European Public Assessment Reports (EPAR) (EMA). Weighted means calculated differences described. Multivariate analysis was performed using Principal Component Analysis Cluster Analysis.FindingsFrom January, 2013 April, 2023, 419,461 unique pairs therapeutic indications recorded 129 AIFA registries. Within 140 related trials, 87,452 had been enrolled. Median age rate elderly (≥65 years old) higher than [mean difference median 5.3 years, p < 0.001; mean 17.17% (95% CI 1.06, 1.48)]. Overall, female not different between −0.55% –1.06, −0.05)]. Mean deteriorated PS low both (3.1%) (4.3%) a 1.27% 1.48). Two clusters identified multivariate analysis: one including more (higher rate, lower patients), other (lower patients).InterpretationThis study supports that enrolled do only partially represent those who have treated Italy practice. Inclusiveness should be increased ensure generalizability results population.FundingPartially supported Ministry Health.

Language: Английский

Immunotherapy for Elderly Patients with Advanced Non-Small Cell Lung Cancer: Challenges and Perspectives DOI Open Access
Anass Baladi,

Hassan Abdelilah Tafenzi,

Othmane Zouiten

et al.

International Journal of Molecular Sciences, Journal Year: 2025, Volume and Issue: 26(5), P. 2120 - 2120

Published: Feb. 27, 2025

Lung cancer, a leading cause of cancer-related mortality, disproportionately affects the elderly, who face unique challenges due to comorbidities and reduced organ function. Immune checkpoint inhibitors (ICIs) offer more tolerable alternative chemotherapy, but their efficacy safety in elderly non-small cell lung cancer (NSCLC) patients remain underexplored limited representation clinical trials. A narrative literature review was conducted using PubMed, Embase, Cochrane Library evaluate studies on NSCLC (≥65 years) treated with ICIs. Key outcomes assessed included overall survival, progression-free response rates, treatment-related adverse events, influence immunosenescence treatment efficacy. The highlighted evidence supporting ICIs patients, particularly those good performance status. Age-related may affect outcomes, emphasizing need for individualized treatment. Limited data suggest alone be preferable chemo-immunotherapy over 75 years. However, exclusion from trials methodological limitations reduces generalizability these findings. hold promise advanced older adults, tailored approaches greater inclusion are needed optimize outcomes.

Language: Английский

Citations

1
The role of geriatric oncology in the care of older people with cancer: some evidence from Brazil and the world DOI Open Access
Theodora Karnakis, Polianna Mara Rodrigues de Souza, Ana Lumi Kanaji

et al.

Revista da Associação Médica Brasileira, Journal Year: 2024, Volume and Issue: 70(suppl 1)

Published: Jan. 1, 2024

Language: Английский

Citations

3
Senotherapy, cancer, and aging DOI
Lodovico Balducci, Claire Falandry, S. Monfardini

et al.

Journal of Geriatric Oncology, Journal Year: 2023, Volume and Issue: 15(4), P. 101671 - 101671

Published: Nov. 17, 2023

Language: Английский

Citations

6
Comparison of baseline patient characteristics in Italian oncology drug monitoring registries and clinical trials: a real-world cross-sectional study DOI Creative Commons
Maria Lucia Iacovino, Simone Celant, Luca Tomassini

et al.

The Lancet Regional Health - Europe, Journal Year: 2024, Volume and Issue: 41, P. 100912 - 100912

Published: April 22, 2024

BackgroundGeneralizability of registrative clinical trials to real-world practice is influenced by comparability patients in the two settings. We compared characteristics cancer with Italy.MethodsData on age, sex and performance status (PS) were derived from web-based monitoring registries developed Italian Medicines Agency (AIFA) corresponding reported European Public Assessment Reports (EPAR) (EMA). Weighted means calculated differences described. Multivariate analysis was performed using Principal Component Analysis Cluster Analysis.FindingsFrom January, 2013 April, 2023, 419,461 unique pairs therapeutic indications recorded 129 AIFA registries. Within 140 related trials, 87,452 had been enrolled. Median age rate elderly (≥65 years old) higher than [mean difference median 5.3 years, p < 0.001; mean 17.17% (95% CI 1.06, 1.48)]. Overall, female not different between −0.55% –1.06, −0.05)]. Mean deteriorated PS low both (3.1%) (4.3%) a 1.27% 1.48). Two clusters identified multivariate analysis: one including more (higher rate, lower patients), other (lower patients).InterpretationThis study supports that enrolled do only partially represent those who have treated Italy practice. Inclusiveness should be increased ensure generalizability results population.FundingPartially supported Ministry Health.

Language: Английский

Citations

1