Survival Is Not a Good Outcome for Randomized Trials With Effective Subsequent Therapies

Our careful position on this matter is reflected in the concluding paragraph of the Discussion section where we stated that "…novel evidence is provided suggesting that loss of Nuc-pYStat5 is associated with elevated risk of failure of antiestrogen therapy.However, conclusive validation of the response-predictive value of Nuc-pYStat5 will require quantitative analyses in tumors from patients randomized for antiestrogen therapy, and prospective analyses in a CLIA-certified laboratory to overcome additional limitations of retrospective studies."This conclusion was also incorporated into the Abstract to relay to readers that further validation of this candidate predictive marker will be needed.