Reading PFS and Cross-Trial Comparisons in Treatment-Naive CLL

Sameh Gaballa, MD, of Moffitt Cancer Center, asks what the faculty look for when they read randomized trials in treatment-naive chronic lymphocytic leukemia (CLL). M. Yair Levy, MD, of Texas Oncology–Baylor Charles A. Sammons Cancer Center, acknowledges that cross-trial comparison is discouraged but unavoidable, because the pivotal trials compared targeted agents with chemoimmunotherapy rather than with each other. Andrew H. Lipsky, MD, of Columbia University Irving Medical Center, focuses on progression-free survival (PFS) while noting that patients who progress after time-limited therapy can be retreated. He points out that a median PFS is known only for ibrutinib, at 8.9 years, with 7 years of follow-up for SEQUOIA and 10 years for CLL14, citing roughly 5 years for unmutated and 9 years for mutated immunoglobulin heavy chain variable region disease in CLL14. Dr Gaballa adds that many patients will need only one line of therapy.