Real-world effectiveness of pembrolizumab as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma : the ARON-2 study

© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature..

BACKGROUND: The advent of immune-checkpoint inhibitors has challenged previous treatment paradigms for advanced urothelial carcinoma (UC) in the post-platinum setting as well as in the first-line setting for cisplatin-ineligible patients. In this study, we investigated the effectiveness of pembrolizumab as first-line treatment for cisplatin-ineligible UC.

METHODS: Data from patients aged ≥ 18 years with cisplatin-ineligible UC and receiving first-line pembrolizumab from January 1st 2017 to September 1st 2022 were collected. Cisplatin ineligibility was defined according to the Galsky criteria. Thirty-three Institutions from 18 countries were involved in the ARON-2 study.

RESULTS: Our analysis included 162 patients. The median follow-up time was 18.9 months (95%CI 15.3-76.9). In the overall study population, the median OS was 15.8 months (95%CI 11.3-32.4). The median OS was significantly longer in males versus females while no statistically significant differences were observed between patients aged < 65y versus ≥ 65y and between smokers and non-smokers. According to Recist 1.1 criteria, 26 patients (16%) experienced CR, 32 (20%) PR, 39 (24%) SD and 55 (34%) PD.

CONCLUSIONS: Our data confirm the role of pembrolizumab as first-line therapy for cisplatin-unfit patients. Further studies investigating the biological and immunological characteristics of UC patients are warranted in order to optimize the outcome of patients receiving immunotherapy in this setting.

Medienart:

E-Artikel

Erscheinungsjahr:

2023

Erschienen:

2023

Enthalten in:

Zur Gesamtaufnahme - volume:72

Enthalten in:

Cancer immunology, immunotherapy : CII - 72(2023), 9 vom: 16. Sept., Seite 2961-2970

Sprache:

Englisch

Beteiligte Personen:

Santoni, Matteo [VerfasserIn]
Myint, Zin W [VerfasserIn]
Büttner, Thomas [VerfasserIn]
Takeshita, Hideki [VerfasserIn]
Okada, Yohei [VerfasserIn]
Lam, Elaine T [VerfasserIn]
Gilbert, Danielle [VerfasserIn]
Küronya, Zsófia [VerfasserIn]
Tural, Deniz [VerfasserIn]
Pichler, Renate [VerfasserIn]
Grande, Enrique [VerfasserIn]
Crabb, Simon J [VerfasserIn]
Kemp, Robert [VerfasserIn]
Massari, Francesco [VerfasserIn]
Scagliarini, Sarah [VerfasserIn]
Iacovelli, Roberto [VerfasserIn]
Vau, Nuno [VerfasserIn]
Basso, Umberto [VerfasserIn]
Maruzzo, Marco [VerfasserIn]
Molina-Cerrillo, Javier [VerfasserIn]
Galli, Luca [VerfasserIn]
Bamias, Aristotelis [VerfasserIn]
De Giorgi, Ugo [VerfasserIn]
Zucali, Paolo Andrea [VerfasserIn]
Rizzo, Mimma [VerfasserIn]
Seront, Emmanuel [VerfasserIn]
Popovic, Lazar [VerfasserIn]
Caffo, Orazio [VerfasserIn]
Buti, Sebastiano [VerfasserIn]
Kanesvaran, Ravindran [VerfasserIn]
Kopecky, Jindrich [VerfasserIn]
Kucharz, Jakub [VerfasserIn]
Zeppellini, Annalisa [VerfasserIn]
Fiala, Ondřej [VerfasserIn]
Landmesser, Johannes [VerfasserIn]
Ansari, Jawaher [VerfasserIn]
Giannatempo, Patrizia [VerfasserIn]
Rizzo, Alessandro [VerfasserIn]
Zabalza, Ignacio Ortego [VerfasserIn]
Monteiro, Fernando Sabino M [VerfasserIn]
Battelli, Nicola [VerfasserIn]
Calabrò, Fabio [VerfasserIn]
Porta, Camillo [VerfasserIn]

Links:

Volltext

Themen:

ARON-2 study
Antibodies, Monoclonal, Humanized
Cisplatin
DPT0O3T46P
Immunotherapy
Journal Article
NCT05290038
Pembrolizumab
Q20Q21Q62J
Real-world data
Urothelial cancer

Anmerkungen:

Date Completed 11.08.2023

Date Revised 26.04.2024

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1007/s00262-023-03469-5

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM357505972