title: Survival of Patients With Advanced or Metastatic Renal Cell Carcinoma in Routine Practice Differs From That in Clinical Trials-Analyses From the German Clinical RCC Registry.
abstract: Because "real-life" patients often do not meet the strict eligibility criteria of clinical trials, we assessed the trial eligibility of patients with advanced or metastatic renal cell carcinoma (mRCC) in routine practice and compared the survival of "trial-ineligible" and potentially "trial-eligible" patients.
  
  
  
  The present prospective, multicenter German cohort study is recruiting patients from 110 oncology/urology outpatient centers and hospitals at initiation of systemic first-line treatment. The demographic, clinical, treatment, and survival data were collected. We defined patients as "trial-ineligible" when ≥ 1 exclusion criterion (Karnofsky performance status < 80%, hemoglobin less than the lower limit of normal, non-clear cell carcinoma histology) was documented. Otherwise, the patients were considered "trial-eligible".
  
  
  
  Of 732 patients included, 57% were classified as "trial-ineligible". Overall, the median first-line progression-free survival (PFS) was 7.9 months (95% confidence interval [CI], 6.9-8.9 months). The median first-line PFS of "trial-eligible" and "trial-ineligible" patients was 11.0 months (95% CI, 9.6-13.1 months) and 5.3 months (95% CI, 4.6-6.5 months), respectively. The median OS of the "trial-eligible" and "trial-ineligible" patients was 26.0 months (95% CI, 22.1-29.7 months) and 12.6 months (95% CI, 10.6-15.8 months), respectively.
  
  
  
  Our data suggest that patients in routine practice differ from patients treated in clinical trials and that almost 60% of mRCC patients in German routine practice would be ineligible for participation in clinical trials. While their first-line PFS and OS were shorter than those of "trial-eligible" patients, the PFS and OS of "trial-eligible" patients were comparable with the results from clinical trials. Physicians should be aware of these differences when discussing treatment options and outcome expectations with patients.
authors.affiliation: Outpatient Centre for Interdisciplinary Oncology and Haematology, Freiburg, Germany. Electronic address: norbert.marschner@onkologie-freiburg.de.
authors.forename: Norbert
authors.initials: N
authors.lastname: Marschner
authors.affiliation: Ludwig Maximilian University of Munich, University Hospital Campus Grosshadern, Urological Clinic and Outpatients Clinic, Munich, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Staehler
authors.affiliation: Oncology Outpatient Centre Unter-Ems, Leer, Germany.
authors.forename: Lothar
authors.initials: L
authors.lastname: Müller
authors.affiliation: Outpatient Centre for Haematology and Internistic Oncology, Ratingen, Germany.
authors.forename: Arnd
authors.initials: A
authors.lastname: Nusch
authors.affiliation: iOMEDICO, Freiburg, Germany.
authors.forename: Johanna
authors.initials: J
authors.lastname: Harde
authors.affiliation: iOMEDICO, Freiburg, Germany.
authors.forename: Michaela
authors.initials: M
authors.lastname: Koska
authors.affiliation: iOMEDICO, Freiburg, Germany.
authors.forename: Martina
authors.initials: M
authors.lastname: Jänicke
authors.affiliation: Ambulatory Uro-Oncological Therapy Unit Erlangen (AURONTE), Urological Hospital and Hospital for Haematology and Internistic Oncology, University Hospital Erlangen, Erlangen, Germany.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Goebell
mesh_terms: D000368:Aged; D002292:Carcinoma, Renal Cell / Q000401:mortality*; D002986:Clinical Trials as Topic; D018572:Disease-Free Survival; D004608:Eligibility Determination; D005260:Female; D005858:Germany; D006801:Humans; D007680:Kidney Neoplasms / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D012042:Registries; D016896:Treatment Outcome
keywords: Cohort study; Kidney diseases; Outpatients; Overall survival; Prognosis; Progression-free survival; Registry