57948
document
Are tyrosine kinase inhibitors still active in patients with metastatic renal cell carcinoma previously treated with a tyrosine kinase inhibitor and everolimus ? Experience of 36 patients treated in France in the RECORD-1 Trial . BACKGROUND Because the response to treatment is limited , patients with metastatic renal cell carcinoma ( mRCC ) typically receive multiple treatments . Guidelines recommend everolimus for patients previously treated with tyrosine kinase inhibitors ( TKI ) sunitinib or sorafenib . This study evaluated the efficacy of TKI re-treatment in patients with disease progression after a TKI-everolimus sequence . PATIENTS AND METHODS Data were reviewed for patients enrolled in RECORD-1 ( Renal Cell Cancer Treatment With Oral RAD001 Given Daily ) at French sites . Response , progression-free survival ( PFS ) , and overall survival were evaluated in patients treated with a TKI-everolimus-TKI sequence . RESULTS Thirty-six patients received a TKI after everolimus : sunitinib in 17 patients , sorafenib in 15 , and dovitinib ( TKI258 ) in 4 . The response rate with TKI re-treatment was 8 % , and the disease-control rate ( response plus stable disease ) was 75 % . The median PFS with each component of the TKI-everolimus-TKI sequence was 10.7 months ( 95 % CI , 1.8-28.5 months ) , 8.9 months ( 95 % CI , 1.7-34.6 months ) , and 8.2 months ( 95 % CI , 5.2-11.9 months ) , respectively . The median overall survival from the start of everolimus was 29.1 months ( 95 % CI 21.1 to not reached months ) , which suggests a benefit in using TKI in this setting . CONCLUSIONS Administration of a TKI-everolimus-TKI sequence may be associated with clinical benefit and should be prospectively investigated .
57949
Intervention_Pharmacological
tyrosine kinase inhibitors
57950
Intervention_Pharmacological
tyrosine kinase inhibitor
57951
Intervention_Pharmacological
everolimus
57952
Intervention_Pharmacological
everolimus
57953
Intervention_Pharmacological
tyrosine kinase inhibitors ( TKI ) sunitinib
57954
Intervention_Pharmacological
sorafenib
57955
Intervention_Pharmacological
TKI
57956
Intervention_Pharmacological
TKI-everolimus sequence
57957
Intervention_Pharmacological
TKI-everolimus-TKI sequence
57958
Intervention_Pharmacological
TKI
57959
Intervention_Pharmacological
everolimus
57960
Intervention_Pharmacological
sunitinib
57961
Intervention_Pharmacological
sorafenib
57962
Intervention_Pharmacological
dovitinib
57963
Intervention_Pharmacological
TKI
57964
Intervention_Pharmacological
TKI-everolimus-TKI
57965
Intervention_Pharmacological
everolimus
57966
Intervention_Pharmacological
TKI
57967
Intervention_Pharmacological
TKI-everolimus-TKI sequence
57968
Outcome_Other
efficacy
57969
Outcome_Physical
Response
57970
Outcome_Mortality
, progression-free survival ( PFS ) , and overall survival
57971
Outcome_Physical
response rate
57972
Outcome_Physical
disease-control rate ( response plus stable disease )
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Outcome_Mortality
median PFS
57974
Outcome_Mortality
median overall survival
57975
Outcome_Physical
clinical benefit
57976
Participant_Condition
metastatic renal cell carcinoma previously treated with a tyrosine kinase inhibitor and everolimus
57977
Participant_Sample-size
36
57978
Participant_Condition
metastatic renal cell carcinoma ( mRCC )
57979
Participant_Condition
disease progression after a TKI-everolimus sequence
57980
Participant_Sample-size
Thirty-six