Leukemia, B-cell Lymphoma Management Not Always Evidence Based55th American Society of Hematology Annual Meeting and Exposition.
“Rapid advances in the understanding of the biology of CML, ALL, and B-cell lymphomas have led to novel therapeutic interventions that have increased the clinical complexity of decision making in patient care,” noted lead author Kevin Obholz, PhD, of Clinical Care Options, LLC, in Reston, VA, and colleagues. But results of the new study “suggest that a significant proportion of US hematology/oncology specialists are not applying optimal care for patients with CML, AML, and B-cell malignancies.”
To identify and quantify professional practice gaps and “barriers to optimal care” for these patients at academic and community cancer centers in the United States, the authors recruited 250 hematologists and oncologists for a two-phase study.
“In the initial qualitative exploratory phase of the study, participants (n = 27) were asked to complete a brief online case-based survey and complete a 45-minute telephone interview focusing on the personal, contextual, and behavioral factors that influence a provider's clinical reasoning process in diagnosis and treatment,” Dr. Obholz explained.
Selected interviews were then transcribed and analyzed using “thematic analysis.” Findings shaped the subsequent, quantitative phase of the study, in which 121 participants completed an online survey of multiple-choice questions, differential rating scales, and case vignettes.
“A group of nine core practice gaps were identified through combined analysis of data from the online surveys and in-depth interviews,” the authors reported. Core practice gaps included such challenges as the selection of first-line TKI therapy in chronic-phase CML, monitoring responses, lack of clinician knowledge about promising investigational agents, and proactively addressing patient nonadherence.
“Of note, 33% of participants agreed with evidence-based expert opinion that early molecular responses to tyrosine kinase inhibitor (TKI) therapy correlate with long-term clinical outcomes for patients with chronic phase (CP) CML. Likewise, only 38% of participants agreed with the expert faculty that achieving a major molecular response to TKI therapy substantially decreases the patient's risk of disease progression.”
Expert recommendations regarding timing and frequency of cytogenetic analysis by bone marrow biopsy to assess responses to first-line TKI therapy for CP CML were matched by only 22% of practicing clinicians surveyed, and “fewer than 30%” of participants knew the mechanisms of action for agents undergoing phase 3 clinical trial assessment, such as inotuzumab ozogamicin, blinatumomab , fostamatinib , idelalisib, and obinutuzumab, the authors reported—potentially representing “missed opportunities to enroll eligible patients on clinical trials.”
“Most notably, study participants did not adequately recognize that early molecular response to TKI therapy is significantly associated with long-term survival outcomes, which could impact clinical decisions for patients with chronic phase CML,” Obholz said. “The overuse of bone marrow cytogenetic analysis by community oncologists could impact quality of life of patients with CML.”
The study was funded with a grant by Pfizer.