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;Büttner, Thomas;Takeshita, Hideki;Porta, Camillo;et.al.
(2023) Cancer Immunology, Immunotherapy — Vol. 72, n° 9, p. 2961-2970 (2023)

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Authors
  • Santoni, Matteo
    Author
  • Myint, Zin
    Author
  • Büttner, Thomas
    Author
  • Takeshita, Hideki
    Author
  • Seront, EmmanuelUCLouvain
    Author
  • Porta, Camillo
    Author
  • et. al.
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Abstract
Background The advent of immune-checkpoint inhibitors has challenged previous treatment paradigms for advanced urothe-lial 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.
Affiliations
  • Macerata Hospital, Via Santa Lucia 2, 62100 Macerata, ItalyOncology Unit
  • Centre Hospitalier de Jolimont, Haine Saint Paul, BelgiumDepartment of Medical Oncology
  • A.O.U. Consorziale Policlinico di Bari, Piazza G. Cesare 11, 70124 Bari, ItalyDivision of Medical Oncology
  • University of Bari “Aldo Moro”, Bari, ItalyInterdisciplinary Department of Medicine

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Santoni, M., Myint, Z., Büttner, T., Takeshita, H., Okada, Y., Lam, E., Gilbert, D., Küronya, Z., Tural, D., Pichler, R., Grande, E., Crabb, S., Kemp, R., Massari, F., Scagliarini, S., Iacovelli, R., Vau, N., Basso, U., Maruzzo, M., et al. (2023). Real-world effectiveness of pembrolizumab as first-line therapy for cisplatin-ineligible patients with advanced urothelial carcinoma: the ARON-2 study. Cancer Immunology, Immunotherapy, 72(9), 2961-2970. https://doi.org/10.1007/s00262-023-03469-5 (Original work published 2023)