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From Watchful Waiting to Early Treatment of Asymptomatic Chronic Lymphocytic Leukemia

Web Exclusives — May 17, 2021

Some patients receiving a diagnosis of chronic lymphocytic leukemia (CLL) may be surprised when their oncologist does not recommend immediate treatment. Despite significant advances over the past 4 decades, and improvements in the number and efficacy of treatments, about 80% of patients with CLL show no symptoms at diagnosis and therefore do not meet the medical criteria for initiating treatment.1

The reason for withholding treatment from these patients, and instead pursuing a “watch-and-wait” approach, is that the benefits of early treatment do not outweigh the risks. Historical studies have shown that patients with early-stage disease who receive chemotherapy may have delayed disease progression, but their life expectancy is the same as those who do not receive early treatment.1 Although delayed disease progression can be a welcome result for patients, chemotherapy is associated with a number of side effects that generally offset these outcomes.1

An important consideration of these results—and those of any clinical trial—is that they report the average outcome of the entire group of patients who were treated. Individual patients may have unique characteristics that affect their disease progression or response to treatment. It is well known that some patients with CLL can go treatment-free for decades with no disease progression, whereas others have rapid disease progression within a few years despite receiving treatment. Determining which patients with early-stage disease are at high risk for disease progression and likely to need early treatment, and which are best served by a “watch-and-wait” approach is a very active and important part of today’s CLL research.1

At the same time, several clinical studies exploring the use of newer agents in early-stage CLL are planned or already ongoing.1 Over the past 10 years, new agents, such as the Bruton tyrosine kinase inhibitors ibrutinib and acalabrutinib and the B-cell lymphoma 2 inhibitor venetoclax, have revolutionized CLL therapy.1 Investigators are now assessing the effect of these medications in patients with asymptomatic, early-stage CLL. In the largest clinical trial of patients with asymptomatic CLL—the ongoing CLL12 study—515 patients with intermediate-, high-, or very high-risk asymptomatic CLL are receiving ibrutinib or placebo for up to 5 years or until their disease progresses.1 Although the study is currently ongoing, data from the halfway point suggest that patients receiving ibrutinib may have fewer CLL-related events than those receiving placebo.1 Notably, and unlike what was previously seen with chemotherapy, both placebo and ibrutinib groups are reporting a similar number of side effects.1

Another study, EVOLVE, is currently recruiting patients in North America who have previously untreated early-stage CLL at high or very high risk for disease progression.1,2 Patients will receive venetoclax and the immunotherapy obinutuzumab, either at diagnosis or after their disease has progressed, to determine whether early treatment affects their life expectancy.1

When the results of these studies are finalized in the coming years, many more newly diagnosed patients with CLL may find themselves receiving early treatment than today. Until then, we watch and wait.


References

  1. Muchtar E, Kay NE, Parikh SA. Early intervention in asymptomatic chronic lymphocytic leukemia. Clin Adv Hematol Oncol. 2021;19:92-103.
  2. ClinicalTrials.gov. Testing the effects of early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab for newly diagnosed patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma who do not have symptoms, the EVOLVE CLL/SLL study. Updated April 9, 2021. https://clinicaltrials.gov/ct2/show/study/NCT04269902. Accessed April 12, 2021.

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