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11q Deletion (del11q) Is Not a Prognostic Factor for Adverse Outcomes for Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Treated with Ibrutinib: Pooled Data from 3 Randomized Phase 3 Studies

Conference Correspondent - Conference Correspondent, ASH 2016 - Chronic Lymphocytic Leukemia

Cytogenetic abnormality del11q is detected in up to 20% of patients with chronic lymphocytic leukemia (CLL) at diagnosis, with higher rates in relapsed/refractory (R/R) populations.1,2 Patients with CLL who have del11q tend to have relatively short remission durations and shorter overall survival (OS) with standard chemotherapy regimens.3 In phase 3 studies, treatment with single-agent ibrutinib (ibr) was superior to treatment with ofatumumab in R/R CLL or chlorambucil in treatment-naïve CLL4,5; treatment with ibr + bendamustine/rituximab (BR) was also superior to treatment with BR in R/R CLL.6 Kipps and colleagues now examined the outcome of patients in these 3 studies (RESONATE, RESONATE-2, and HELIOS) who did or did not have del11q to determine the impact of del11q on clinical outcomes.

A total of 1210 patients with del11q data were pooled and included in the analysis: 609 in the ibr pool (179 with del11q, 430 without del11q) versus 601 in the comparator pool (149 with del11q, 452 without del11q). At the time of the primary analysis, median treatment durations in the ibr pool were 20.0 months with del11q and 18.7 months without del11q; in the comparator pool, 5.3 months with del11q and 8.5 months without del11q. Overall, ibr-treated patients had a higher overall response rate (ORR) and complete response (CR) rates and longer progression-free survival (PFS) and OS than comparator-treated patients regardless of del11q status (Table). In the ibr pool, the presence of del11q was associated with a trend of longer PFS and OS, whereas in the comparator pool, patients with del11q had shorter PFS compared with patients without del11q (Table). By multivariate analysis, in the comparator pool, del11q, male sex, >1 prior therapy, presence of cytopenias, and unmutated IGHV (in R/R only) were associated with shorter PFS. However, these differences were not found in the ibr pool. The presence of del11q did not unfavorably impact the tempo of reductions in lymphadenopathy for ibr-treated patients, but did for comparator-treated patients. Adverse events leading to discontinuation were similar in ibr- and comparator-treated patients with or without del11q.

The authors concluded that the presence of del11q was not an adverse prognostic factor for PFS in ibr-treated patients, but was for comparator-treated patients. With a median follow-up of 21.0 months, presence versus absence of del11q was associated with prolonged PFS and OS in ibr-treated patients, but shorter PFS in comparator-treated patients. Moreover, treatment with ibr resulted in superior clinical outcomes versus comparators regardless of del11q status.

Kipps TJ, et al. ASH 2016. Abstract 2042.

  1. Dohner H, et al. Blood. 1997;89:2516-2522.
  2. Gribben JG, et al. Blood. 2010;115:187-197.
  3. Giertlova M, et al. Neoplasma. 2011;58:82-88.
  4. Byrd JC, et al. N Engl J Med. 2013;369:32-42.
  5. Burger JA, et al. N Engl J Med. 2015;373:2425-2437.
  6. Chanan-Khan A, et al. Lancet Oncol. 2016;17:200-211.


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Last modified: August 30, 2021