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document
Randomized trial of adoptive transfer of melanoma tumor-infiltrating lymphocytes as adjuvant therapy for stage III melanoma . The aim of this study was to demonstrate the interest of using tumor-infiltrating lymphocytes ( TIL ) as adjuvant therapy for stage III ( regional lymph nodes ) melanoma . After lymph node excision , patients without any detectable metastases were randomly assigned to receive either TIL plus interleukin-2 ( IL-2 ) for 2 months , or IL-2 only . The primary endpoint was determination of the duration of the relapse-free interval . Eighty-eight patients determined as eligible for treatment were enrolled in the study . After a median follow-up of 46.9 months , for the study population the analysis did not show a significant extension of the relapse-free interval or overall survival . However , a significant interaction ( P < 0.001 ) was found between the treatment and the number of invaded lymph nodes . In the group with only one invaded lymph node , the estimated relapse rate was significantly lower ( P ( adjusted ) =0.0285 ) and the overall survival was increased ( P ( adjusted ) =0.039 ) in the TIL+IL-2 arm compared with the IL-2 only arm . No differences between the two arms , either as regards the duration of disease-free survival or overall survival , were noted in the group with more than one invaded lymph node whatever the number of invaded lymph nodes . Treatment was compatible with normal daily activity . This study demonstrates for the first time that the efficiency of TIL in stage III melanoma ( AJCC ) is directly related to the number of invaded lymph nodes , indicating that tumor burden might be a crucial factor in the efficacy and/or in vitro expansion of T cells specific for autologous tumor antigen , a finding which could be of value in future vaccine development for the treatment of melanoma .
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Intervention_Physical
tumor-infiltrating lymphocytes
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Intervention_Physical
tumor-infiltrating lymphocytes ( TIL )
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Intervention_Pharmacological
TIL plus interleukin-2 ( IL-2 )
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Intervention_Pharmacological
IL-2
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Intervention_Pharmacological
TIL+IL-2
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Intervention_Pharmacological
IL-2
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Intervention_Pharmacological
TIL
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Outcome_Other
duration of the
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Outcome_Mortality
relapse-free interval
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Outcome_Mortality
relapse-free interval
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Outcome_Mortality
overall survival
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Outcome_Physical
number of invaded lymph nodes
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Outcome_Other
estimated
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Outcome_Physical
relapse rate
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Outcome_Mortality
overall survival
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Outcome_Mortality
duration of disease-free survival
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Outcome_Mortality
overall survival
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Participant_Condition
stage III melanoma
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Participant_Condition
stage III ( regional lymph nodes ) melanoma
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Participant_Condition
metastases
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Participant_Sample-size
Eighty-eight