Real world evidence from a retrospective multi-center analysis on first-line therapy for metastatic renal cell carcinoma with non-clear cell and/or sarcomatoid histologies.

Authors

null

Pia Paffenholz

Department of Urology, Uro-Oncology, Robot Assisted and Reconstructive Urologic Surgery, University of Cologne Faculty of Medicine and University Hospital Cologne, Cologne, Germany

Pia Paffenholz , Stefanie Zschaebitz , Jozefina Casuscelli , Emily Rinderknecht , Angelika Mattigk , Melis Gür , Philipp Ivanyi , Thomas Hilser , Christopher Darr , Subhajit Mandal , Katrin Schlack , Daniel Seidl , Analena Handke , Melanie Klee , Tim Nestler , Marc Rehlinghaus , Sameh Hijazi , Axel Heidenreich , Viktor Grünwald , Martin Schostak

Organizations

Department of Urology, Uro-Oncology, Robot Assisted and Reconstructive Urologic Surgery, University of Cologne Faculty of Medicine and University Hospital Cologne, Cologne, Germany, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany, Department of Urology, University Hospital, LMU Munich, Munich, Germany, Department of Urology, Caritas-St. Josef Medical Center, University of Regensburg, Regensburg, Germany, Department of Urology, University Hospital Ulm, Ulm, Germany, Department for Urology, Urooncology, Robot-Assisted and Focal Treatment, University of Madgeburg, Magdeburg, Germany, Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Claudia-von Schelling Comprehensive Cancer Center, Hannover Medical School, Hannover, Germany, Department of Medical Oncology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany, Department of Urology, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany, Department of Urology, University of Marburg, Marburg, Germany, Department of Urology and pediatric Urology, University Hospital Münster, Münster, Germany, Department of Urology, Diakonie-Klinikum Stuttgart, Stuttgart, Germany, Department of Urology, Ruhr University Bochum, Marienhospital Herne, Herne, Germany, Department of Urology, University Hospital Schleswig-Holstein, Campus Luebeck, Luebeck, Germany, Department of Urology, Federal Armed Services Hospital Koblenz, Koblenz, Germany, Department of Urology, University Hospital Düsseldorf, Düsseldorf, Germany, Department of Urology, Ibbenbueren Hospital, Ibbenbueren, Germany, Department of Urology, University Hospital Cologne, Cologne, Germany, Clinic for Internal Medicine (Tumor Research) and Department of Urology, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany, University Hospital of Magdeburg, Magdeburg, Germany

Research Funding

No funding sources reported

Background: Papillary (pRCC), chromophob (chRCC) and predominantly sarcomatoid renal cell carcinoma (sRCC) as well as RCC with sarcomatoid features are rare cancers. We evaluated real-world treatment outcomes of 1st line treatment in these cohorts in Germany. Methods: We retrospectively analyzed patients with non-clear cell RCC treated at 17 German tertiary cancer centres. Adverse events (AE) were reported according to CTCAE 5.0, objective response rate (ORR) according to RECIST 1.1. Progression free survival (PFS) and overall survival (OS) were calculated from start of treatment to progression or death, respectively and determined by KM plots. Results: We included 189 patients with a median age of 63 years (IQR 54-72). Of these, 49% were pRCC, 12% chRCC, 12% sRCC. 17% of all RCC had a sarcomatoid features. 87% had an ECOG PS of 0/1. IMDC risk was favorable/intermediate/poor in 15/54/31%. 74% received prior nephrectomy. Lymphatic (63%) and pulmonary (51%) metastases were the most common metastatic sites. 72% patients received first-line IO-combinations (IO-IO: 36%, TKI-IO: 64%) and 28% patients TKI-monotherapy, predominantly sunitinib. AE of all grades occurred in 86% and 72% during IO-based therapy or TKI monotherapy, and CTCAE grade ≥ 3 in 46% or 36%, of which led to discontinuation of treatment in 42% or 29% of patients, respectively. ORR and survival outcomes with median follow-up of 17 months (IQR 9-30) are described in the table. Conclusions: IO-combinations are frequently applied in pRCC, chRCC and sRCC. Our data suggests that first-line IO-combinations yields higher ORR compared to single agent TKI in sRCC, but not in chRCC. However, the retrospective nature and small sample size are major limitations of our analysis. Additional analyses to tailor treatment strategies in patients with metastatic nccRCC or sRCC is warranted.

ParameterpRCC (n=70)chRCC (n=17)sRCC + sarcomatoid features (n=38)
TKI
n=29
IO
n=41
TKI
n=4
IO
n=13
TKI
n=4
IO
n=34
ORR (CR+PR)38%46%50%31%0%59%
SD34%32%25%23%25%15%
PD28%22%25%46%75%26%
ORR vs. SD vs. PDp=0.867p=0.007p=0.072
ParameterpRCC (n=92)chRCC (n=19)sRCC + sarcomatoid features (n=38)
TKI
n=37
IO
n=55
TKI
n=6
IO
n=13
TKI
n=4
IO
n=34
mPFS, months, 95% CI7 (5.2-8.8)3 (0.2-5.8)4 (2.5-5.5)
8 (4.9-11.1)6 (4.2-7.7)10 (4.9-15.1)1 (NA)2 (NA)4 (2.8-5.2)
mOS;
months, 95% CI
34 (23.2-44.8)28 (21.7-34.3)34 (11.3-56.7)
38 (19.7-56.8)32 (16.6-47.4)24 (7.0-41.0)28 (17.5-38.5)22 (0-52.4)not reached

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Abstract Details

Meeting

2024 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer; Adrenal, Penile, and Testicular Cancers

Track

Renal Cell Cancer,Adrenal Cancer,Penile Cancer,Testicular Cancer

Sub Track

Quality of Care/Quality Improvement and Real-World Evidence

Citation

J Clin Oncol 42, 2024 (suppl 4; abstr 392)

DOI

10.1200/JCO.2024.42.4_suppl.392

Abstract #

392

Poster Bd #

F16

Abstract Disclosures