902P - Prognostic factors for overall survival of patients with advanced renal cell carcinoma – data from the German prospective RCC-Registry

Abstract

Background: The identification of prognostic factors is a central question in oncology. They help to predict the course of disease and ideally support the oncologist in treatment decision making in clinical practice. We analysed prognostic factors identified by MSKCC and additional factors for the overall survival (OS) of patients (pts) treated with currently approved agents. Methods: The prospective German renal cell carcinoma (RCC) Registry includes pts with advanced or metastatic renal cell carcinoma at start of systemic first-line therapy. > 300 oncologists are recruiting pts since 2007. Pts and tumour characteristics, data on all systemic therapies and outcome are collected. The prognostic factors for OS were assessed using a multivariate cox regression model. Results: Median OS of the 1039 pts (median age 70 years) was 18.6 months (95% CI 16.0 - 20.5 months, 55% events). Median OS in months for low, intermediate and high risk pts according to MSKCC 1999 was 27.3 (23.7-33.8, 48% events), 16.0 (12.7-18.8, 58% events) and 5.3 (3.7-7.2, 74% events). The following factors were significantly associated with shorter OS (p < 0.05: *; p < 0.01: **; p < 0,001: ***): higher age*, non-clear cell histology**, grading G3/4 at diagnosis*, Karnofsky Performance Status <80%***, haemoglobin < lower limit of normal (LLN)***, LDH >1.5x upper limit of normal (ULN)***. Factors significantly associated with longer OS were time from primary diagnosis to metastasis***, BMI 25-30 versus (vs) <25***, BMI>30 vs < 25***, lung metastasis only at start of treatment*, non-visceral metastasis only at start of treatment* and hypertension*. Factors not significantly associated with OS were sex, tumour stage at diagnosis (IV vs <IV), total calcium >ULN, tumour localisation (right/left), congestive heart failure, renal disease, diabetes and total nephrectomy. Conclusions: 3 out of 5 MSKCC factors were significantly associated with OS in our cohort. Still, a clear separation of OS between pts with low, intermediate and high risk according to MSKCC could be confirmed. In addition, we identified novel factors also associated with OS. Clinical trial identification: ClinicalTrial.gov registry: study number: NCT00610012 Legal entity responsible for the study: iOMEDICO AG Funding: Bayer Vital GmbH, GlaxoSmithKline GmbH & Co. KG, Novatis Pharma GmbH, Pfizer Pharma GmbH, Roche Pharma AG Disclosure: P.J. Goebell: Received honoraria for paticipation in expert rounds and honoraria/support as a speaker from Astellas, AstraZeneca, Bayer, Bristol-Myers Squib, Eisai, Ipsen, Janssen, Novartis, Pfizer, Sanofi. M. Staehler: Consultant, Honoria and Research Funding: Pfizer, GlaxoSmithKline, Novartis, Bayer, AVEO, Ipsen, Exelixis, EISAI Consultant and Honoria: EUSAPharm, Astellas, Pelloton Consultant and Research funding: Roche Research funding: Immatics, Wilex. N. Marschner: Employed by iOMEDICO which performs the tumorregistry RCC as an CRO Member of advisory boards regarding RCC treatment and Travel grants: Roche, Novartis, Pfizer, Bayer, GSK Corporate sponsored research: Novartis, Pfizer Roche. All other authors have declared no conflicts of interest.