Peter J Goebell1, Michael Staehler2, Lothar Müller3, Arnd Nusch4, Michael Scheffler5, Annette Sauer6, Ulla von Verschuer7, Susanne Tech8, Lisa Kruggel8, Martina Jänicke8, Norbert Marschner9. 1. Ambulatory Uro-Oncological Therapy Unit Erlangen (AURONTE), Department of Urology l and Clinic for Haematology and Internistic Oncology, University Hospital Erlangen, Erlangen, Germany. 2. Department of Urology, Ludwig-Maximilians-University of Munich, University Hospital Campus Grosshadern, Munich, Germany. 3. Oncology Outpatient Centre Unter-Ems, Leer, Germany. 4. Outpatient Centre for Haematology and Internistic Oncology, Ratingen, Germany. 5. Outpatient Centre for Urology, Zwickau, Germany. 6. Ambulatory Health Care Centre for Haematology and Oncology, Potsdam, Germany. 7. Ambulatory Health Care Centre for Haematology and Oncology, Essen, Germany. 8. Clinical Epidemiology and Health Economics, iOMEDICO, Freiburg, Germany. 9. Outpatient Centre for Interdisciplinary Oncology and Haematology, Freiburg, Germany. Electronic address: manuskript@onkologie-freiburg.de.
Abstract
INTRODUCTION: Because the treatment landscape for metastatic renal cell carcinoma (mRCC) has evolved dramatically over the past decade, data on patients' 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 (RCC-Registry) 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.
INTRODUCTION: Because the treatment landscape for metastatic renal cell carcinoma (mRCC) has evolved dramatically over the past decade, data on patients' 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 (RCC-Registry) 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.
Authors: Kathleen Nguyen; Nicola Schieda; Nick James; Matthew D F McInnes; Mark Wu; Rebecca E Thornhill Journal: Eur Radiol Date: 2020-09-10 Impact factor: 5.315
Authors: Michael Staehler; Peter J Goebell; Lothar Müller; Till-Oliver Emde; Natalie Wetzel; Lisa Kruggel; Martina Jänicke; Norbert Marschner Journal: Int J Cancer Date: 2019-11-22 Impact factor: 7.396