A total of 732 prospectively recruited German patients with metastatic renal cell carcinoma were classified as either “trial-eligible” or “trial-ineligible” in accordance with the common exclusion criteria for clinical trials. The “trial-ineligible” patients had shorter progression-free and overall survival compared with the “trial-eligible” patients, whose outcomes were comparable with those from clinical trials. Physicians should be aware of these differences when discussing the treatment options and outcome expectations with patients.Introduction:
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.Patients and Methods:
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”.Results:
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.Conclusion:
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.