Urologische und Kinderurologische Universitätsklinik, Erlangen Erlangen, Germany
Background Multiple novel treatments options have emerged for advanced renal cell carcinoma (mRCC) including several tyrosine kinase inhibitors (TKIs), mTOR inhibitors (mTOR), and checkpoint-inhibitors (CPIs). Here, we analysed changes in sequential treatment patterns over time since 2008. Methods CARAT (NCT03374267) is a prospective, observational, multicentre clinical registry, which continues the preceding Tumor Registry Renal Cell Carcinoma (RCC Registry) in Germany. By April 2021, about 2084 patients in total have been enrolled with about 600 patients since the start of CARAT in 2017. Patients are recruited at start of first-line treatment, independent of their treatment. Details on treatments, patient and tumour characteristics, clinical and patient-reported outcomes are collected. Follow-Up is until death or up to 3 years. For the analyses reported herein, all patients with at least one year of follow-up (N=1477, start of treatment prior to 31/12/2019, database cut 31/12/2020) were considered. Results Of 1477 patients, 52% started a second-line treatment, while 26% died during first-line treatment. For 13% first-line treatment was ongoing, 9% were lost to follow-up. Patients who died prior to 2nd-line treatment were older (median 72 vs. 69 years) and more often had poor risk IMDC score (38% vs. 16%) and/or comorbidities (Charlson-Comorbidity-Index ≥1 31% vs. 21%). At the time of analysis, 69% of patients with start of treatment since 2018 were alive. Conclusions Sequential treatments of patients with mRCC are changing showing that novel treatment options are quickly implemented into routine care in Germany. Currently, sequential use of TKI and CPI are the preferred choice. At least a quarter of patients dies prior to receiving second-line treatment highlighting an unmet medical need for this high-risk population. With longer follow-up, clinical and patient-reported outcomes of sequential treatments we will provide valuable additional evidence to guide treatment strategies in the future.