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document
Adjuvant subcutaneous interleukin-2 in patients with resected renal cell carcinoma : a pilot study . BACKGROUND A pilot study was conducted to investigate the toxicity and tolerance to low-dose subcutaneous interleukin-2 ( IL-2 ) for patients with resected renal cell carcinoma ( RCC ) at high risk for recurrent disease ( TNM stages III and IV resected distant metastases ) . PATIENTS AND METHODS Patients with surgically resected locally advanced ( T3-4 or N1-2 ) or metastatic RCC were randomly assigned to 1 of 4 treatment groups that received different dose levels and schedules of subcutaneous IL-2 as follows : dose level 1 , 4 MIU/m2 per day , every other week for 24 weeks ( n = 10 ) ; dose level 2 , 8 MIU/m2 per day , every other week for 24 weeks ( n = 9 ) ; dose level 3 , 4 MIU/m2 per day , weeks 1-4 , 9-12 , and 17-20 ( n = 11 ) ; and dose level 4 , 8 MIU/m2 per day , weeks 1-4 , 9-12 , and 17-20 ( n = 10 ) . Interleukin-2 was administered in 2 daily doses on days 1-5 of each week indicated . A dose level was considered tolerable if no more than 2 patients experienced grade 3/4 toxicity . RESULTS Forty-one patients were entered in the study and 40 were evaluable for toxicity . Therapy was well tolerated at all dose levels and schedules , with most patients ( 98 % ) experiencing mild-to-moderate constitutional symptoms . Grade 3/4 toxicity was seen in 8 patients ( 20 % ) . Interleukin-2 dose reductions were required in 7 patients , and no patient discontinued therapy secondary to toxicity . Of 39 patients evaluable for efficacy , 31 have experienced relapse ( 79 % ) , and 15 have died ( 38 % ) . Median survival was 1.4 years , and the 3-year disease-free survival rate was 33 % . Median overall survival has not been reached ; however , the 3-year survival rate was 70 % . There was no statistically significant difference between any of the treatment arms with respect to disease-free survival or 3-year survival ( P > 0.54 and P > or= 0.09 for all pairwise comparisons ) , schedules ( dose level 1/2 vs. 3/4 ; P = 0.46 and P = 0.5 ) , or dose of IL-2 administered ( dose level 1/3 vs. 2/4 ; P = 0.99 and P = 0.1 ) . CONCLUSION Subcutaneous IL-2 was well tolerated for 6 months in patients with surgically resected RCC at high risk of recurrence . Future adjuvant trials in this setting are not likely to include IL-2 in view of the clinical efficacy and favorable toxicity profiles of selected multitargeted kinase inhibitors .
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Intervention_Pharmacological
interleukin-2
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Intervention_Pharmacological
subcutaneous interleukin-2 ( IL-2 )
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Intervention_Pharmacological
IL-2
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Intervention_Pharmacological
Interleukin-2
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Intervention_Pharmacological
Interleukin-2
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Intervention_Pharmacological
Subcutaneous IL-2
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Intervention_Pharmacological
IL-2
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Outcome_Adverse-effects
toxicity
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Outcome_Other
tolerance
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Outcome_Other
tolerable
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Outcome_Adverse-effects
grade 3/4 toxicity .
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Outcome_Adverse-effects
toxicity .
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Outcome_Other
tolerated
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Outcome_Adverse-effects
mild-to-moderate constitutional symptoms
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Outcome_Adverse-effects
Grade 3/4 toxicity
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Outcome_Adverse-effects
Interleukin-2 dose reductions
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Outcome_Adverse-effects
toxicity .
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Outcome_Adverse-effects
relapse
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Outcome_Mortality
died
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Outcome_Mortality
Median survival
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Outcome_Mortality
3-year disease-free survival rate
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Outcome_Mortality
Median overall survival
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Outcome_Mortality
3-year survival rate
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Outcome_Mortality
disease-free survival or 3-year survival
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Outcome_Other
tolerated
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Outcome_Other
clinical efficacy
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Outcome_Other
favorable toxicity
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Participant_Condition
Adjuvant subcutaneous interleukin-2 in patients with resected renal cell carcinoma :
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Participant_Condition
patients with resected renal cell carcinoma ( RCC ) at high risk for recurrent disease ( TNM stages III and IV resected distant metastases ) .
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Participant_Condition
Patients with surgically resected locally advanced ( T3-4 or N1-2 ) or metastatic RCC
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Participant_Age
Forty-one patients were entered in the study and 40 were evaluable for toxicity .
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Participant_Condition
patients with surgically resected RCC at high risk of recurrence .