Phase III study of interferon alfa-NL as adjuvant treatment for resectable XXXX : an Eastern Cooperative Oncology Group/Intergroup trial.

@entity1 @entity137 @entity308 @entity5 @entity1295 @entity1398 @entity1358 @entity925
PURPOSE: To evaluate the role of adjuvant interferon alfa after complete resection of locally extensive @entity1358 . @entity1 AND METHODS: A total of 283 eligible @entity1 with pT3-4a and/or node-positive disease were randomly assigned after radical nephrectomy and lymphadenectomy to observation or to interferon alfa-NL (Wellferon, Burroughs-Wellcome, Research Park, NC) given daily for 5 days every 3 weeks for up to 12 cycles. @entity1 were stratified on the basis of pathologic stage. @entity1 remained on treatment until documented recurrence, excessive @entity137 , or @entity1 /physician preference deemed removal appropriate. RESULTS: At median follow-up of 10.4 years, median survival was 7.4 years in the observation arm and 5.1 year in the treatment arm (log-rank P =.09). Median recurrence-free survival was 3.0 years in the observation arm and 2.2 years in the interferon arm (P =.33). Performance status (P =.003), nodal status (N2 v N0, P <.0001), and @entity5 stage (P =.0002) were significant prognostic factors in multivariate analysis. A proportional hazards model examining the effects of treatment arm and time to recurrence on survival after recurrence among @entity1 who recurred found that random assignment to interferon treatment (P =.009) and shorter time to recurrence (P <.0001) were independent predictors of shorter survival after recurrence. Although no lethal @entity137 were observed, severe (grade 4) @entity137 including @entity1398 , @entity925 , @entity1295 , @entity308 , and other @entity137 occurred in 11.4% of those randomly assigned to interferon treatment. CONCLUSION: Adjuvant treatment with interferon did not contribute to survival or relapse-free survival in this group of @entity1 .
