Outcome of immune checkpoint inhibitors in metastatic renal cell carcinoma across different treatment lines.

Background: Immune checkpoint inhibitors (ICIs) have led to a paradigm change in the management of metastatic renal cell carcinoma (mRCC). Prospective trials have focused on ICI treatment in the first or second line. The aim of this analysis is to evaluate the benefit of ICI across different treatment lines.
Patients and Methods: This is a single-center retrospective study that included mRCC patients who received ICIs in various treatment lines. Objective response rates (ORR), progression-free survival (PFS) and overall survival (OS) were evaluated.
Results: Ninety-four patients were eligible for full evaluation. Patients were classified as International mRCC Database Consortium (IMDC) risk group categorization as good, intermediate and poor risk in 26.8%, 61.6% and 14.8% of cases, respectively. They were treated with ICI monotherapy, dual ICI therapy and ICI + tyrosine kinase inhibitor in 59%, 20% and 21% of cases, respectively. ORR, median PFS and OS for the entire cohort was 39.4%, 9.67 months [95% confidence interval (CI) 6.9-12.4 months] and 23.6 months (95% CI 13.3-33.9 months), respectively. The ORR by treatment line was 33% in first, 40.4% in the second, 35% in the third and 43.5% in the fourth line and beyond. Median PFS by treatment line was 8.6, 10.3, 7.9 and 7.23 months, respectively. The median OS was not reached in first-line treatment and was 26.2, 18.1 and 20.7 months in the second, third and fourth line and beyond, respectively.
Conclusions: ICIs or ICI combinations are active in all treatment lines and should also be offered in heavily pretreated patients. Patient selection based on tumor and patient factors allows for maximal benefit from ICI-based therapies.
Competing Interests: Disclosure AB has received travel grants from Roche, Ipsen, Pfizer and EUSA and a research grant from Pfizer; MS has received honoraria for advisory boards or lectures from Pfizer, Ipsen, Exelixis, EUSA, EISAI, BMS, MSD, Merck, Alkermes; SFS has received honoraria from Astellas, AstraZeneca, Bayer, BMS, Cepheid, Ferring, Ipsen, Janssen, Lilly, MSD, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, SANOCHEMIA, Sanofi, Takeda, UroGen; had/having consulting or advisory roles in Astellas, AstraZeneca, Bayer, BMS, Cepheid, Ferring, Ipsen, Janssen, Lilly, MSD, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, SANOCHEMIA, Sanofi, Takeda, UroGen; member of speakers' bureau in Astellas, AstraZeneca, Bayer, BMS, Cepheid, Ferring, Ipsen, Janssen, Lilly, MSD, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, SANOCHEMIA, Sanofi, Takeda, UroGen, Movember Foundation; and has filed the following patents: method to determine prognosis after therapy for prostate cancer (granted 6 September 2002); methods to determine prognosis after therapy for bladder cancer (granted 19 June 2003); prognostic methods for patients with prostatic disease (granted 5 August 2004); soluble Fas urinary marker for the detection of bladder transitional cell carcinoma (granted 20 July 2010). All other authors have declared no conflicts of interest.
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