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Heng, D. Y. C.,Choueiri, T. K.,Rini, B. I.,Lee, J.,Yuasa, T.,Pal, S. K.,Srinivas, S.,Bjarnason, G. A.,Knox, J. J.,MacKenzie, M.,Vaishampayan, U. N.,Tan, M. H.,Rha, S. Y.,Donskov, F.,Agarwal, N.,Kollma Oxford University Press 2014 ANNALS OF ONCOLOGY Vol.25 No.1
<P>This study focuses on the outcomes of a large international cohort of patients with metastatic RCC who would not have met the eligibility criteria for clinical trials and compares these to those that would have eligible. The proportion of patients who would have been ineligible and the reason for ineligibility are also discussed.</P>
First-, second-, third-line therapy for mRCC: benchmarks for trial design from the IMDC
Ko, J J,Choueiri, T K,Rini, B I,Lee, J-L,Kroeger, N,Srinivas, S,Harshman, L C,Knox, J J,Bjarnason, G A,MacKenzie, M J,Wood, L,Vaishampayan, U N,Agarwal, N,Pal, S K,Tan, M-H,Rha, S Y,Yuasa, T,Donskov, Nature Publishing Group 2014 The British journal of cancer Vol.110 No.8
<P><B>Background:</B></P><P>Limited data exist on outcomes for metastatic renal cell carcinoma (mRCC) patients treated with multiple lines of therapy. Benchmarks for survival are required for patient counselling and clinical trial design.</P><P><B>Methods:</B></P><P>Outcomes of mRCC patients from the International mRCC Database Consortium database treated with 1, 2, or 3+ lines of targeted therapy (TT) were compared by proportional hazards regression. Overall survival (OS) and progression-free survival (PFS) were calculated using different population inclusion criteria.</P><P><B>Results:</B></P><P>In total, 2705 patients were treated with TT of which 57% received only first-line TT, 27% received two lines of TT, and 16% received 3+ lines of TT. Overall survival of patients who received 1, 2, or 3+ lines of TT were 14.9, 21.0, and 39.2 months, respectively, from first-line TT (<I>P</I><0.0001). On multivariable analysis, 2 lines and 3+ lines of therapy were each associated with better OS (HR=0.738 and 0.626, <I>P</I><0.0001). Survival outcomes for the subgroups were as follows: for all patients, OS 20.9 months and PFS 7.2 months; for those similar to eligible patients in the first-line ADAPT trial, OS 14.7 months and PFS 5.6 months; for those similar to patients in first-line TIVO-1 trial, OS 24.8 months and PFS 8.2 months; for those similar to patients in second-line INTORSECT trial, OS 13.0 months and PFS 3.9 months; and for those similar to patients in the third-line GOLD trial, OS 18.0 months and PFS 4.4 months.</P><P><B>Conclusions:</B></P><P>Patients who are able to receive more lines of TT live longer. Survival benchmarks provide context and perspective when interpreting and designing clinical trials.</P>