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| 024 | 7 | _ | |a 0020-7136 |2 ISSN |
| 024 | 7 | _ | |a 1097-0215 |2 ISSN |
| 037 | _ | _ | |a DKFZ-2025-02666 |
| 041 | _ | _ | |a English |
| 082 | _ | _ | |a 610 |
| 100 | 1 | _ | |a Dinkel, Hendrik |0 0000-0001-7264-6335 |b 0 |
| 245 | _ | _ | |a Real-world efficacy and toxicity of ipilimumab and nivolumab as a first-line treatment for advanced renal cell carcinoma according to IMDC risk criteria-A multi-center retrospective analysis on behalf of the GUARDIANS group. |
| 260 | _ | _ | |a Bognor Regis |c 2025 |b Wiley-Liss |
| 336 | 7 | _ | |a article |2 DRIVER |
| 336 | 7 | _ | |a Output Types/Journal article |2 DataCite |
| 336 | 7 | _ | |a Journal Article |b journal |m journal |0 PUB:(DE-HGF)16 |s 1764600535_815121 |2 PUB:(DE-HGF) |
| 336 | 7 | _ | |a ARTICLE |2 BibTeX |
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| 336 | 7 | _ | |a Journal Article |0 0 |2 EndNote |
| 500 | _ | _ | |a epub |
| 520 | _ | _ | |a Ipilimumab and nivolumab are recommended as first-line therapy for patients with metastatic or advanced renal cell carcinoma (aRCC) and International Metastatic RCC Database Consortium (IMDC) intermediate or poor risk. We retrospectively evaluated efficacy and safety in a multi-center real-world cohort with 356 patients initiating ipilimumab and nivolumab from 17 centers in Germany and Switzerland. Median age was 64 years, most patients were male (69.1%) and had clear cell histology (74.1%). IMDC risk was intermediate in 61.8% and poor in 28.7%. About 37.1% of cases did not meet the inclusion criteria for the CheckMate 214 pivotal study (e.g., poor Eastern Cooperative Oncology Group [Performance Status Scale] [ECOG] status, comorbidities, brain metastases, and impaired renal function). After a median follow-up of 17.5 months, complete response was seen in 8.7%, partial response in 28.7% of patients. Median progression-free survival (PFS) was 8 (95% confidence interval [CI] 5.4-10.6) and median overall survival (OS) 39 months (95% CI 27.5-50.5). Subgroup analysis of patients with non-clear cell histology showed a shorter PFS and OS. Other negative predictors were poor ECOG, fewer induction cycles, ineligibility to pivotal study, and hepatic metastases. Adverse events occurred in 76.4% of patients (35.4% ≥ grade 3). High-dose corticosteroids were applied in 27.3% of cases. Cabozantinib was most frequently administered (63.4%) as subsequent therapy and showed superior OS and PFS compared to other second-line options. Our data support ipilimumab and nivolumab as a first-line treatment of aRCC with robust efficacy and safety. Patient selection was less restrictive in our clinical practice and may explain differences to CheckMate 214 trial. |
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| 650 | _ | 7 | |a immunotherapy |2 Other |
| 650 | _ | 7 | |a ipilimumab |2 Other |
| 650 | _ | 7 | |a nivolumab |2 Other |
| 650 | _ | 7 | |a real‐world |2 Other |
| 650 | _ | 7 | |a renal cell carcinoma |2 Other |
| 700 | 1 | _ | |a Materna, Linus |b 1 |
| 700 | 1 | _ | |a Stelmach, Ramona |0 0000-0002-2083-5561 |b 2 |
| 700 | 1 | _ | |a Zschäbitz, Stefanie |b 3 |
| 700 | 1 | _ | |a Neuberger, Stephanie |b 4 |
| 700 | 1 | _ | |a Aydogdu, Can D |b 5 |
| 700 | 1 | _ | |a Casuscelli, Jozefina |b 6 |
| 700 | 1 | _ | |a Egenolf, Timo |b 7 |
| 700 | 1 | _ | |a Silberg, Matteo |b 8 |
| 700 | 1 | _ | |a Steinestel, Julie |b 9 |
| 700 | 1 | _ | |a Strauss, Arne |b 10 |
| 700 | 1 | _ | |a Kirchhoff, Florian |b 11 |
| 700 | 1 | _ | |a Ahrens, Marit |b 12 |
| 700 | 1 | _ | |a Paffenholz, Pia |b 13 |
| 700 | 1 | _ | |a Cathomas, Richard |b 14 |
| 700 | 1 | _ | |a Özdemir, Berna C |b 15 |
| 700 | 1 | _ | |a Gossler, Christopher |b 16 |
| 700 | 1 | _ | |a Ivanyi, Philipp |b 17 |
| 700 | 1 | _ | |a Rehlinghaus, Marc |b 18 |
| 700 | 1 | _ | |a Hilser, Thomas |0 P:(DE-HGF)0 |b 19 |
| 700 | 1 | _ | |a Grünwald, Viktor |0 P:(DE-HGF)0 |b 20 |
| 700 | 1 | _ | |a Schlack, Katrin |b 21 |
| 773 | _ | _ | |a 10.1002/ijc.70267 |g p. ijc.70267 |0 PERI:(DE-600)1474822-8 |p nn |t International journal of cancer |v nn |y 2025 |x 0020-7136 |
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