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. 2023 Jul;149(7):3249-3258.
doi: 10.1007/s00432-022-04173-0. Epub 2022 Jul 30.

Real world data on IO-based therapy for metastatic renal cell carcinoma

Viktoria Stühler  1 , Lisa Herrmann  1 , Steffen Rausch  1 , Arnulf Stenzl  1 , Jens Bedke  2
Affiliations

Real world data on IO-based therapy for metastatic renal cell carcinoma

Viktoria Stühler et al. J Cancer Res Clin Oncol. 2023 Jul.

Abstract

Purpose: Immune-based (IO)-combinations are the backbone in the systemic therapy of metastatic renal cell carcinoma (mRCC). Despite phase III clinical trial data, real world data are of special importance to reflect clinical practice.

Methods: This retrospective study included 201 mRCC patients receiving first-line systemic therapy from January 2006. Clinicopathological and treatment-related data were recorded. Progression-free (PFS) and overall survival (OS) were analyzed using descriptive statistics and Kaplan-Meier analysis.

Results: Over the years, IO-based therapies have increased significantly. The collective comprises 76 patients with first-line IO-based therapy (IO-IO:55, TKI-IO:21) and 125 patients with TKI-monotherapy. PFS was significantly improved with TKI-IO combinations if compared to both TKI-monotherapy (23.9 vs. 10.3 months, HR 0.48, p = 0.034) and IO-IO combination (23.9 vs. 6.1 months, HR 0.37, p = 0.012). OS for TKI-IO treated patients was longer compared to TKI-monotherapy (HR 0.37, p = 0.050) at median follow-up of 24.1 versus 29.9 months. In a subanalysis of nivolumab treated patients, starting from second-line (n = 40), PFS was 5.5 months. The addition of nivolumab either in second-or later lines improved OS compared to repeated TKI- or mTOR-therapies alone (6.13 vs. 2.61 years, HR 0.46, p = 0.003).

Conclusion: Both first-line IO-based combinations and nivolumab after first-line TKI-monotherapy prolong OS in a real-world setting.

Keywords: Immune checkpoint inhibitor; Immuno-oncology; Renal cell carcinoma; Tyrosine kinase inhibitor.

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Conflict of interest statement

The authors declare no competing interests.

Dr. Bedke has received institutional research funding from AstraZeneca, Astellas, BMS, Eisai, Ipsen, MSD, Novartis, Nektar, Pfizer, Roche, and Seattle Genetics; received honoraria from BMS and MSD on an institutional basis and from AstraZeneca, Astellas, BMS, Eisai, EUSA Pharma, Ipsen, MSD, Merck Serono, Novartis, Pfizer, and Roche on a personal basis.

Dr. Stenzl: Consultancies and Speaker´s Bureau: Ipsen, Roche, Janssen, BMS, Alere, Stebabiotech, Synergo, Ferring, Astellas, Amgen, Sanofi Aventis, CureVac and study participation or research grants with institutional funding: Johnson & Johnson, Roche, Cepheid, Amgen, Bayer, CureVac, GemeDx biotechnologies GmbH, Novartis, Karl Storz, immatics biotechnologies GmbH.

All other authors: declare no conflict of interest.

Figures

Fig. 1
Fig. 1
A Sequential treatment strategies over time in patients with mRCC. Percentages may not add to 100% due to rounding. B-C Kaplan–Meier analyses for PFS depending on first-line systemic therapy with TKI-IO vs. TKI monotherapy (B) and vs. IO-IO combination (C). PFS defined as time from first systemic therapy to tumor progression. D-F Kaplan–Meier analyses for OS depending on first-line systemic therapy with IO-based therapy vs. TKI monotherapy (D), TKI monotherapy vs. TKI-IO (E) or vs. IO-IO (F). OS defined as time from start first systemic therapy to death/last follow up
See this image and copyright information in PMC

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