Abstract 1897P
Background
The upfront treatment of metastatic renal cell carcinoma (mRCC) has been revolutionized by the introduction of immune-based combinations. The role of cytoreductive nephrectomy (CN) in these patients is still debated. The ARON-1 study (NCT05287464) was designed to globally analyze real-world data of mRCC patients receiving first-line immuno-oncology combinations. This sub-analysis is focused on the role of upfront or delayed partial or radical CN in three geographical areas (Western Europe, Eastern Europe, America/Asia).
Methods
We conducted a multicenter retrospective observational study in mRCC patients treated with first-line immune combinations from 55 centers in 19 countries. From 1152 patients in the ARON-1 dataset, we selected 651 patients with de novo mRCC. 255 patients (39%) had undergone CN, partial in 14% and radical in 86% of cases; 396 patients (61%) received first-line immune-combinations without previous nephrectomy. Primary endpoint was overall survival (OS) while progression-free survival (PFS) and tumor response rate were secondary endpoints.
Results
Median OS from the diagnosis of de novo mRCC was 41.6 months and not reached (NR) in the CN subgroup and 24.0 months in the no CN subgroup, respectively (p<0.001). Median OS from the start of first-line therapy was NR in patients who underwent CN and 22.4 months in the no CN subgroup (p<0.001). Patients who underwent CN reported longer OS compared to no CN in all the three geographical areas (Western Europe: NR vs 23.7 months, p<0.001; Eastern Europe: NR vs 29.8 months, p=0.005; America/Asia: 57.3 months vs 25.5 months, p<0.001).
Conclusions
No significant differences in terms of patients’ outcome seem to clearly emerge in our analysis, even if the rate CN and the choice of the type of first-line immune-based combination varies across the different Cancer Centers participating in the ARON-1 project.
Clinical trial identification
NCT05287464.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
F. Massari: Other, Personal, Research Funding: Astellas, BMS, Ipsen, MSD, Pfizer. E. Grande Pulido: Other, Personal, Research Funding: Pfizer, AstraZeneca, Astellas, Lexicon Pharmaceuticals. A. Bamias: Financial Interests, Personal, Advisory Role: BMS. R. Iacovelli: Other, Personal, Advisory Board: Astellas, BMS, Eisai, Ipsen, Janssen, MSD, Novartis, Pfizer, Sanofi. O. Fiala: Financial Interests, Personal, Invited Speaker: Roche, Janssen, GSK, Pfizer. F.S.M. Monteiro: Financial Interests, Personal, Research Funding: Janssen, Merck Sharp Dome, Ipsen. S. Buti: Financial Interests, Personal, Advisory Role: BMS, Pfizer, MSD, Ipsen, AstraZeneca, Merck. C.G. Porta: Financial Interests, Personal, Other: Angelini Pharma, AstraZeneca, BMS, Eisai, Ipsen, MSD. M. Santoni: Financial Interests, Personal, Research Funding: Janssen, BMS, Ipsen, MSD, Astellas, Bayer. All other authors have declared no conflicts of interest.
Resources from the same session
1706P - Time to full approval of novel anticancer medicines granted accelerated approval and implications for reform of the accelerated approval pathway
Presenter: Thomas Hwang
Session: Poster session 23
1707P - Cancer drug prices in the US: Efficacy, innovation, clinical trial evidence, and epidemiology
Presenter: Christoph Michaeli
Session: Poster session 23
1708P - The registration pathways in China for globally developed novel anticancer drugs
Presenter: Da-wei Wu
Session: Poster session 23
1709P - Influence of censoring on conclusions of FDA-approved cancer drugs using the modified time to treatment failure
Presenter: Jonathan Ofer
Session: Poster session 23
1710P - Protocol waivers and consequences on treatment safety and efficacy in the Drug Rediscovery Protocol (DRUP)
Presenter: Laurien Zeverijn
Session: Poster session 23
1711P - The DRUP-like clinical trials family: A distributed European trial network for equitable access to precision medicine
Presenter: Hans Gelderblom
Session: Poster session 23
1712P - Implementation of a molecular pre-screening program (MPP) in a network of public cancer centres for phase I clinical trial (Ph1-CT) candidates: The PREICO program
Presenter: Juan José Soto Castillo
Session: Poster session 23
1713P - Non-inferiority oncology clinical trials in major journals: Purposes, methods and results
Presenter: Rafael Barreto
Session: Poster session 23
1714P - Geographical disparities in access to cancer clinical trials in Korea
Presenter: Sokbom Kang
Session: Poster session 23
1715P - Analysis of the adequacy of control arms in oncology randomized clinical trials published between 2017 and 2021: A meta-research study
Presenter: Alessandro Rossi
Session: Poster session 23