Department of Urology, University Hospital Erlangen, Erlangen, Germany
Peter J. Goebell , Lothar Mueller , Friedrich Overkamp , A. Lueck , Michele Vogt , Norbert Marschner
Background: During the last few years, several efficacious therapeutic options have been developed for patients with metastatic renal cell carcinoma (mRCC). Due to the variety of multiple new targeted therapeutic options evidence based solely on randomized clinical trails is lacking. Registry data represents an important supplement providing insight into the treatment course and evidence on various outcomes. However, results provided by registry data may be influenced by many factors such as patient characteristic and comorbidities. Matched-pair analyses provide an interesting tool to compare different treatment options. Material & Methods: Over 100 oncology and urology outpatient centers in Germany are actively participating in this registry. The enrolment of the first 1000 mRCC patient data-sets with a maximum follow-up of three years has recently been completed. Among other information, data on patient and tumor characteristics, all systemic antineoplastic treatments, dosages, as well as response rates, progression free survival and overall survival are documented. Results: At the start of systemic therapy mean age were 66.2 years for male and 69.0 years for female patients, respectively. For all patients at least one comorbidity was indicated (Charlson Comorbidity Index 1.0). More than 94% of patients had metastases at inclusion. Investigating the most prominent TKIs used in sequential treatment in the registry, we identified time from initial diagnosis to treatment start as one of the most important factors predicting overall survival. Surprisingly, when controlling for this factor in a matched-pair analysis together with age, gender and risk, outcome in terms of progression-free survival appears to be similar in first line treatment with either Sunitinib or Sorafenib. Conclusions: Registry data can provide missing pieces of evidence on treatment outcomes. The registry demonstrates once more its hypothesis generating character and thus adds to the body of evidence as established from clinical trials. A direct comparison of efficacy can only be provided by clinical trails whereas registry data represent effectiveness of real-life treatment.
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