Evolution in the management of chronic lymphocytic leukemia in Japan: should MRD negativity be the goal?

Real World Treatment Practices for Chronic Lymphocytic Leukemia in Japan: An Observational Database Research Study (CLIMBER-DBR)

“…Bendamustine was approved for CLL in 2016, whereas ibrutinib was approved for relapsed/refractory CLL in 2016 and as first-line treatment in 2018. 5 Our study suggests that Japanese physicians often prescribed cyclophosphamide- or fludarabine-based regimens as the main first-line treatments for CLL before the approval of novel targeted drugs such as ibrutinib. The most common second-line treatments were ibrutinib, BR, bendamustine, rituximab, and fludarabine.…”

“…Therefore, it is important to start treatment by identifying the disease stage and activity. A recent review proposed an evolution of initial CLL therapy in Japan, 5 extending the previous 2018 guidelines issued by the Japanese Society of Hematology (JSH), 6 , 7 which are now mostly in line with the International Workshop on Chronic Lymphocytic Leukemia guidelines. 8 The JSH guidelines recommend a “watch and wait” approach initially for patients without active disease.…”

“…In recent years, there have been marked changes to the treatment landscape in Japan, with the approval of rituximab for CLL in 2019 (previously approved for B-cell non-Hodgkin lymphoma in 2003), bendamustine in 2016, ibrutinib for relapsed/refractory CLL in 2016 and as first-line treatment in 2018, and venetoclax for relapsed/refractory CLL in 2019. 5 Overseas, other new treatments have been incorporated into the 2020 National Comprehensive Cancer Network Clinical Practice Guidelines, 9 which recommend ibrutinib, acalabrutinib ± obinutuzumab, or venetoclax + obinutuzumab as first-line treatment, of which only ibrutinib is approved in this setting in Japan.…”

“…In addition, it remains largely obscure which treatment regimens are used or preferred by physicians in real-world practice, especially considering the recent changes to the treatment landscape in Japan. 5 Information is also needed on the impact of CLL on healthcare resource utilization and expenditure.…”