Table 2.

Significance of a positive direct antiglobulin test (DAT) pretreatment and the development of autoimmune hemolytic anemia (AHA) during treatment in the LRF CLL4 Trial.

DAT Positivity before Treatment 

  • Incidence: 14%

  • Associated with stage C disease, high β2-microglobin

  • Predicted AHA or not in 83% (positive predictive value 28% and negative predictive value 93%)

  • Lower complete response rate

  • Poorer progression-free and overall survival

  • Patients treated with fludarabine alone most likely to stay DAT positive or change from negative to positive after treatment

 
Development of AHA during Treatment

  • Incidence: 10%

  • Associated with stage C disease, high β2-microglobin, older age and DAT positivity

  • 3-fold higher risk for patients treated with fludarabine or chlorambucil compared to fludarabine with cyclophosphamide (FC)

  • Lower overall response and complete response rates

  • 4 deaths (2% of all patients) (all fludarabine treated)

  • Poorer progression-free and overall survival

 
DAT Positivity before Treatment 

  • Incidence: 14%

  • Associated with stage C disease, high β2-microglobin

  • Predicted AHA or not in 83% (positive predictive value 28% and negative predictive value 93%)

  • Lower complete response rate

  • Poorer progression-free and overall survival

  • Patients treated with fludarabine alone most likely to stay DAT positive or change from negative to positive after treatment

 
Development of AHA during Treatment

  • Incidence: 10%

  • Associated with stage C disease, high β2-microglobin, older age and DAT positivity

  • 3-fold higher risk for patients treated with fludarabine or chlorambucil compared to fludarabine with cyclophosphamide (FC)

  • Lower overall response and complete response rates

  • 4 deaths (2% of all patients) (all fludarabine treated)

  • Poorer progression-free and overall survival

 
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