|The following article features coverage from the American Society of Hematology 2020 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
In a real-world study, first-line treatment of high-risk chronic lymphocytic leukemia (CLL) with ibrutinib resulted in improved outcomes compared with chemoimmunotherapy (CIT), according to results of a retrospective study presented at the virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
“To our knowledge, this is the largest real-world study to date comparing clinical outcomes in high-risk CLL patients on ibrutinib vs chemoimmunotherapy in patients with high-risk CLL,” Lori A. Leslie, MD, of the John Theurer Cancer Center in Hackensack, New Jersey, and presenter of the study, said.
“In current clinical practice, chemoimmunotherapy is still commonly used, and the prevalence of testing for high-risk CLL in the frontline setting is uncertain,” Dr Leslie added.
The study analyzed medical record data from 516 patients with CLL from 40 clinical practices in the United States, including 68% community-based practices. Patients were defined as high risk if their disease harbored a del(17p), del (11q), TP53 mutation, unmutated IGHV, or complex karyotype.
At baseline, 52.5% of patients were considered high risk. The mean age was 66 years, and 40% of patients were female. The majority of patients had a Rai stage 3 to 4 disease. The median duration of follow-up was 33.3 and 35.3 months for patients with high-risk and non–high risk disease, respectively, and the duration of first-line therapy was 28.6 and 5.5 months, respectively.
Time to next treatment (TTNT) was significantly longer among patients with high-risk disease treated with ibrutinib, with a median TTNT not yet reached compared with 34.4 months with CIT (hazard ratio [HR], 0.46; 95% CI, 0.34-0.62; P <.01).
Among patients treated with ibrutinib, there was no significant difference in TTNT between patients with high-risk or non–high-risk disease (HR, 2.2; 95% CI, 0.96-4.96; P =.06). However, TTNT was shorter among patients with high-risk disease treated with CIT compared with patients with lower-risk disease (HR, 2.43; 95% CI, 1.58-3.47; P <.01).
Additional lines of therapy were more common among patients treated with CIT, particularly among patients with high-risk disease. Among patients with high-risk disease, 81.7% of patients treated with ibrutinib had received only 1 line of therapy compared with 45.7% of patients who were treated with CIT. Among patients with non–high-risk disease, 91.5% of patients treated with ibrutinib received only 1 line of therapy compared with 69.9% of patients treated with CIT.
The median duration of first-line therapy was 26.6 and 28.8 months among high- and non–high-risk patients, respectively, who were treated with ibrutinib compared with 5.3 and 5.1 months among high- and non–high-risk patients, respectively, treated with CIT.
For patients treated with second-line therapy, the most common regimens were ibrutinib for the patients treated with CIT in the front line and venetoclax with or without rituximab for patients treated with upfront ibrutinib.
Dr Leslie concluded that “ibrutinib therapy also provided sustained clinical benefit regardless of risk status, which is concordant with use in the first-line setting.” She noted that “this study highlights the prognostic and predictive value of cytogenetic and molecular [testing] when choosing CIT as a first-line treatment regimen, which was consistent with what has been repeatedly demonstrated in clinical trials.”
Disclosures: Some of the presenters disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the presentation abstract.
Read more of Cancer Therapy Advisor‘s coverage of the ASH 2020 meeting by visiting the conference page.
Huang Q, Deering KL, Harshaw Q, Bhagnani T, Leslie LA. Clinical outcomes among real-world patients with chronic lymphocytic leukemia (CLL) initiating first-line ibrutinib or chemoimmunotherapy (CIT) stratified by risk status: Results from a US retrospective chart review study. Presented at: 62nd American Society of Hematology (ASH) Annual Meeting and Exposition; December 5-9, 2020. Abstract 372.