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Göbell, Peter J.; Stähler, Michael; Müller, Lothar; Nusch, Arnd; Scheffler, Michael; Sauer, Annette; Verschür, Ulla von; Tech, Susanne; Kruggel, Lisa; Jänicke, Martina; Marschner, Norbert (2018): Changes in Treatment Reality and Survival of Patients With Advanced Clear Cell Renal Cell Carcinoma - Analyses From the German Clinical RCC-Registry. In: Clinical Genitourinary Cancer, Vol. 16, No. 6, E1101-E1115
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Abstract

We analyzed a prospective registry cohort of 1085 German routine patients with advanced clear cell renal cell carcinoma receiving systemic therapy to demonstrate that, over the past decade, newly approved treatments have quickly been applied to routine care. High-risk or trial-ineligible patients still have poor outcomes. Survival times in trial-eligible patients are similar to those reported from randomized clinical trials. Introduction: Because the treatment landscape for metastatic renal cell carcinoma (mRCC) has evolved dramatically over the past decade, data on patient's treatment and outcomes in routine practice, so called "real-world data", are important to complement clinical trial data. We present choice of systemic first-/second-line treatments, number and sequences of treatment lines, and survival of patients with clear cell mRCC. Patients and Methods: A total of 1085 patients with clear cell mRCC who were recruited at the start of first-line treatment into the prospective German clinical cohort study (RCCRegistry) by 122 sites between December 2007 and May 2017 were analyzed. Results: The choice of first-/second-line treatment and changes over time reflect the chronologic approval of different targeted agents: from mainly tyrosine kinase inhibitors (TKIs), to TKIs/mechanistic target of rapamycin inhibitors, to now TKIs/mechanistic target of rapamycin inhibitors/checkpoint inhibitor. The median first-line overall survival ranged from 7.2 months (95% confidence interval [CI], 4.8-10.9 months) in high MSKCC (Memorial Sloan Kettering Cancer Center) risk to 36.7 months (95% CI, 27.9-43.0 months) in low-risk patients. For trial-ineligible routine patients meeting common exclusion criteria of clinical trials, the median overall survival was 14.6 months (95% CI, 11.5-18.0 months) compared with 26.2 months (95% CI, 22.1-31.5 months) for potentially trial-eligible patients. Conclusion: This is the first prospective long-term cohort study showing changes in treatment reality and survival of routine patients with clear cell mRCC. Newly approved treatments are quickly applied in routine care. Patients with unfavorable prognosis, including trial-ineligible patients, have inferior outcomes. Survival times of potentially trial-eligible patients are similar to those reported from clinical trials.