Outcomes of patients with metastatic renal cell carcinoma that do not meet eligibility criteria for clinical trials |
| |
| Affiliation: | 1. Tom Baker Cancer Center, Calgary, AB, Canada;2. Dana-Farber Cancer Institute, Harvard Medical School, Boston;3. Taussig Cancer Institute, Cleveland Clinic, Cleveland, USA;4. University of Ulsan College of Medicine, Asan, South Korea;5. Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan;6. Department of Medical Oncology and Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte;7. School of Medicine, Stanford Cancer Institute, Stanford University, Stanford, USA;8. Sunnybrook Odette Cancer Centre, Toronto, ON;9. Princess Margaret Hospital, University of Toronto, Toronto, ON;10. London Health Sciences Center, London, ON, Canada;11. Karmanos Cancer Institute, Wayne State University, Detroit, USA;12. Department of Medical Oncology, National Cancer Centre and Institute of Bioengineering and Nanotechnology, Singapore;13. Yonsei Cancer Centre, Yonsei University College of Medicine, Seoul, South Korea;14. Department of Oncology, Aarhus University Hospital, Aarhus, Denmark;15. University of Utah Huntsman Cancer Institute, Salt Lake City, USA;16. British Columbia Cancer Agency, Vancouver Cancer Center, Vancouver;17. Cross Cancer Center, University of Alberta, Edmonton, AB;18. Queen Elizabeth II Health Sciences Center, Halifax, NS, Canada |
| |
| Abstract: | BackgroundTargeted therapies in metastatic renal cell carcinoma (mRCC) have been approved based on registration clinical trials that have strict eligibility criteria. The clinical outcomes of patients treated with targeted agents but are ineligible for trials are unknown.Patients and MethodsmRCC patients treated with vascular endothelial growth factor-targeted therapy were retrospectively deemed ineligible for clinical trials (according to commonly used inclusion/exclusion criteria) if they had a Karnofsky performance status (KPS) <70%, nonclear-cell histology, brain metastases, hemoglobin ≤9 g/dl, creatinine >2× the upper limit of normal, corrected calcium ≥12 mg/dl, platelet count of <100 × 103/uL, or neutrophil count <1500/mm3.ResultsOverall, 768 of 2210 (35%) patients in the International Metastatic RCC Database Consortium (IMDC) were deemed ineligible for clinical trials by the above criteria. Between ineligible versus eligible patients, the response rate, median progression-free survival (PFS) and median overall survival of first-line targeted therapy were 22% versus 29% (P = 0.0005), 5.2 versus 8.6 months, and 12.5 versus 28.4 months (both P < 0.0001), respectively. Second-line PFS (if applicable) was 2.8 months in the trial ineligible versus 4.3 months in the trial eligible patients (P = 0.0039). When adjusted by the IMDC prognostic categories, the HR for death between trial ineligible and trial eligible patients was 1.55 (95% confidence interval 1.378–1.751, P < 0.0001).ConclusionsThe number of patients that are ineligible for clinical trials is substantial and their outcomes are inferior. Specific trials addressing the unmet needs of protocol ineligible patients are warranted. |
| |
| Keywords: | |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
