First-Line Treatment With Four-Drug Regimen in Young Patients With CLL
Posted: Tuesday, March 3, 2020
Young, fit patients with IgHV-mutated chronic lymphocytic leukemia (CLL) and without del(17p) or the TP53 mutation appeared to respond well to first-line treatment with ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab in three chemotherapy cycles, according to Nitin Jain, MD, and colleagues from The University of Texas MD Anderson Cancer Center. The phase II study was presented at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 357) and published in Blood.
The research team enrolled 45 previously untreated patients who were diagnosed with IgHV-mutated CLL without del(17p) or mutated TP53. Patients were treated with ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab. To decrease chemotherapy exposure, the research team administered only three cycles of concurrent chemotherapy.
After a median follow-up of 30.2 months, 39% of the patients achieved complete responses, and 89% achieved undetectable minimal residual disease in bone marrow samples. Responses improved among patients who continued to receive ibrutinib and obinutuzumab. Overall, 41 patients completed the planned 12 cycles of therapy. Of them, 73% achieved complete responses. All of the patients who completed the 12 cycles also achieved undetectable minimal residual disease in bone marrow samples.
According to the investigators, none of the patients experienced disease progression, developed Richter transformation, or had minimal residual disease recurrence. A single patient died due to heart failure, and another patient developed therapy-related myelodysplastic syndromes. Grade 3 or 4 neutropenia and thrombocytopenia occurred in 58% and 40% of patients, respectively. Neutropenic fever occurred in six patients. Other infectious complications included pneumonia, cellulitis, pulmonary mycobacterium avium complex infection, fever, acute cholecystitis, and colitis.
Disclosure: For full disclosures of the study authors, visit ashpublications.org.
