Randomized trial of @entity904 versus observation as adjuvant therapy in high-risk primary XXXX : a Southwest Oncology Group study.

@entity1 @entity137 @entity75 @entity904 @entity121 @entity320
PURPOSE: A national cooperative group trial was conducted in @entity1 with early-stage cutaneous @entity320 to determine if oral @entity904 can increase disease-free survival or survival. @entity1 AND METHODS: Two hundred forty-eight @entity1 with completely resected @entity320 of @entity121 greater than 0.75 mm and clinically negative lymph nodes were randomized to oral @entity904 (100,000 IU/d) for 18 months or to observation. @entity1 were stratified by @entity121 of @entity75 (0.76 to 1.50 mm, 1.51 to 3.00 mm, or > 3.00 mm), sex, and type of therapy (excision, excision plus node dissection, excision plus perfusion, or excision plus both). The median duration of follow-up observation of living @entity1 is greater than 8 years. The relative risk (RR) in disease-free survival and overall survival in the treatment compared with the observation group was calculated using Cox proportional hazards models. RESULTS: Overall, there was no difference in disease-free survival or overall survival between the two groups. Examination of treatment by stratification interactions and subset analysis did not show any treatment-effect differences based on sex or type of therapy. There was also no difference between groups in disease-free survival based on @entity121 of the @entity75 . Overall, 12% of @entity1 who received @entity904 experienced grade 3 or 4 @entity137 . CONCLUSION: Based on the lack of overall survival benefit, further evaluation of @entity904 as adjuvant therapy for @entity320 does not appear warranted.
