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document
Phase III , randomised , multicentre trial of maintenance immunotherapy with low-dose interleukin-2 and interferon-alpha for metastatic renal cell cancer . This is the first phase III randomised trial to evaluate maintenance immunotherapy in metastatic renal cell cancer ( mRCC ) . Patients were randomised to receive treatment with a 4-week cycle of subcutaneous low doses IL-2 + IFN in months 1 , 3 and 5 , and then every 3 months until the first documented disease progression ( arm A , suspension ) , or the same regimen , with chronic maintenance of immunotherapy , regardless of tumour response , until death or intolerable toxicity ( arm B , maintenance ) . The primary endpoint was overall survival ( OS ) ; secondary endpoints were time from first progression to death ( TFPTD ) and tolerability . One hundred and eighty-three patients were enrolled between January 1998 and November 2003 . After a median follow-up of 53.9 months , response rate , median OS and median TFPTD were 14.7 % ( 6.3 % CR ) versus 11.3 % ( 5.5 % CR ) , 14 versus 14 months , 6 versus 5 months , in arms A and B , respectively with no significant differences between the groups . Cox regression analysis showed that the use of chemotherapy after first progression ( HR 0.54 ; 95 % CI 0.35-0.86 ; p = 0.008 ) , PS = 0 ( HR 0.53 ; 95 % CI 0.35-0.81 ; p = 0.001 ) and female gender ( HR 0.63 ; 95 % CI 0.41-0.98 ; p = 0.038 ) were significantly associated with a longer TFPTD ; treatment arm was not significant ( HR 0.88 ; 95 % CI 0.60-1.31 ; p = 0.54 ) . Toxicity was mainly limited to WHO grades 1 or 2 . Chronic maintenance immunotherapy after disease progression is feasible , but does not significantly increase OS or the TFPTD .
41970
Intervention_Physical
immunotherapy
41971
Intervention_Pharmacological
interleukin-2
41972
Intervention_Pharmacological
interferon-alpha
41973
Intervention_Pharmacological
subcutaneous low doses IL-2 + IFN
41974
Intervention_Physical
chemotherapy
41975
Intervention_Physical
Chronic maintenance immunotherapy
41976
Outcome_Mortality
overall survival ( OS ) ;
41977
Outcome_Mortality
time from first progression to death ( TFPTD )
41978
Outcome_Mortality
tolerability
41979
Outcome_Mortality
response rate
41980
Outcome_Mortality
median OS
41981
Outcome_Mortality
median TFPTD
41982
Outcome_Mortality
TFPTD
41983
Outcome_Adverse-effects
Toxicity
41984
Outcome_Mortality
OS
41985
Outcome_Mortality
TFPTD
41986
Participant_Condition
metastatic renal cell cancer
41987
Participant_Condition
metastatic renal cell cancer