original articles
Annals of Oncology
Annals of Oncology 25: 149–154, 2014 doi:10.1093/annonc/mdt492
Outcomes of patients with metastatic renal cell carcinoma that do not meet eligibility criteria for clinical trials D. Y. C. Heng1*, T. K. Choueiri2, B. I. Rini3, J. Lee4, T. Yuasa5, S. K. Pal6, S. Srinivas7, G. A. Bjarnason8, J. J. Knox9, M. MacKenzie10, U. N. Vaishampayan11, M. H. Tan12, S. Y. Rha13, F. Donskov14, N. Agarwal15, C. Kollmannsberger16, S. North17 & L. A. Wood18 1
Received 1 August 2013; revised 27 September 2013; accepted 1 October 2013
Background: Targeted 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 Methods: mRCC 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) 2× the upper limit of normal, corrected calcium ≥12 mg/dl, platelet count of
Annals of Oncology
Annals of Oncology 25: 149–154, 2014 doi:10.1093/annonc/mdt492
Outcomes of patients with metastatic renal cell carcinoma that do not meet eligibility criteria for clinical trials D. Y. C. Heng1*, T. K. Choueiri2, B. I. Rini3, J. Lee4, T. Yuasa5, S. K. Pal6, S. Srinivas7, G. A. Bjarnason8, J. J. Knox9, M. MacKenzie10, U. N. Vaishampayan11, M. H. Tan12, S. Y. Rha13, F. Donskov14, N. Agarwal15, C. Kollmannsberger16, S. North17 & L. A. Wood18 1
Received 1 August 2013; revised 27 September 2013; accepted 1 October 2013
Background: Targeted 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 Methods: mRCC 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) 2× the upper limit of normal, corrected calcium ≥12 mg/dl, platelet count of
