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.
Real-world effectiveness of pembrolizumab as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma: the ARON-2 study / Santoni, Matteo; Myint, Zin W; Büttner, Thomas; Takeshita, Hideki; Okada, Yohei; Lam, Elaine T; Gilbert, Danielle; Küronya, Zsófia; Tural, Deniz; Pichler, Renate; Grande, Enrique; Crabb, Simon J; Kemp, Robert; Massari, Francesco; Scagliarini, Sarah; Iacovelli, Roberto; Vau, Nuno; Basso, Umberto; Maruzzo, Marco; Molina-Cerrillo, Javier; Galli, Luca; Bamias, Aristotelis; De Giorgi, Ugo; Zucali, Paolo Andrea; Rizzo, Mimma; Seront, Emmanuel; Popovic, Lazar; Caffo, Orazio; Buti, Sebastiano; Kanesvaran, Ravindran; Kopecky, Jindrich; Kucharz, Jakub; Zeppellini, Annalisa; Fiala, Ondřej; Landmesser, Johannes; Ansari, Jawaher; Giannatempo, Patrizia; Rizzo, Alessandro; Zabalza, Ignacio Ortego; Monteiro, Fernando Sabino M; Battelli, Nicola; Calabrò, Fabio; Porta, Camillo. - In: CANCER IMMUNOLOGY, IMMUNOTHERAPY. - ISSN 0340-7004. - (2023). [10.1007/s00262-023-03469-5]
Real-world effectiveness of pembrolizumab as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma: the ARON-2 study
Buti, SebastianoMembro del Collaboration Group
;
2023-01-01
Abstract
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.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
