Presenter: Nilanjan Ghosh, MD, PhD, Chief, Lymphoma Division, Levine Cancer Institute, Atrium Health, Charlotte, NC
Co-Authors: Jacqueline C. Barrientos, MD, MS, Division of Medical Oncology and Hematology, Northwell Health Cancer Institute, Donald & Barbara Zucker School of Medicine at Hofstra/Northwell, Lake Success, NY; Jeff P. Sharman, MD, Willamette Valley Cancer Institute & Research Center, Eugene, OR; Danielle Brander, MD, Duke University Health System, Durham, NC; Meghan Gutierrez, Lymphoma Research Foundation, New York, NY; Karen Kadish, APRN-BC, MSN, OCN, Tufts Medical Center, Boston, MA; Israel Arango Hisijara, MD, Pharmacyclics, an AbbVie Company, Sunnyvale, CA; Sandhya Upasani, MS, Pharmacyclics, an AbbVie Company, Sunnyvale, CA; Jennifer Han, PharmD, Janssen Scientific Affairs, Horsham, PA; Qing Huang, Janssen Scientific Affairs, Horsham, PA; Reethi Iyengar, PhD, Pharmacyclics, an AbbVie Company, Sunnyvale, CA; Anthony R. Mato, MD, Memorial Sloan Kettering Cancer Center, New York, NY
Background: The informCLL registry is the largest prospective, US-based observational registry of patients who received treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in the era of novel agents.
Objective: To report baseline characteristics, prognostic biomarker testing, and treatment patterns in routine clinical practice for patients enrolled in the informCLL registry.
Methods: From October 2015 to June 2019, the informCLL registry enrolled eligible patients aged ≥18 years with CLL or SLL who had initiated FDA-approved treatment for CLL or SLL within ≥45 days of enrollment. Based on the index treatment at enrollment, patients were classified into 5 groups: ibrutinib (single-agent or combination), chemoimmunotherapy, chemotherapy, immunotherapy, and other novel agents.
Results: The informCLL registry enrolled 1461 patients; 855 (59%) patients were treatment-naïve and 606 (41%) had relapsed or refractory disease; the median age was 71 years, 64% of the patients were male, and 88% had ECOG performance status of 0/1. For patients with staging performed (N = 852), 51% had Rai stage III/IV. Most (93%) enrolling sites were community-based practices. The median time from diagnosis to index treatment for untreated patients was 18.6 months and 84.27 months for patients with relapsed or refractory disease. The median follow-up was 14.9 months for untreated patients and 15.3 months for patients with relapsed or refractory disease. Overall, prognostic biomarker testing was infrequent: fluorescence in situ hybridization testing was performed in 28% of patients, testing for TP53 mutation in 11%, and testing for IGHV mutation was 12%. Of patients who had prognostic biomarker testing, 24% (100/415) had deletion 17p, 27% (43/162) had TP53 mutation, and 71% (121/171) had wild-type IGHV. Overall, the most common treatment was ibrutinib (46%), and 87% started ibrutinib at the recommended dose of 420 mg daily. For patients continuing ibrutinib therapy, 75% did not require dose modifications. At 12 months or 24 months, 77% (307/401) and 68% (126/184) of patients continued ibrutinib therapy, respectively. For patients who completed chemoimmunotherapy regimens, bendamustine plus rituximab (BR) and fludarabine, cyclophosphamide, and rituximab (FCR) were the most common chemoimmunotherapy regimens received; 80% and 85% of patients who received BR and FCR, respectively, received <6 cycles. Only 6% of patients had index treatment of other novel agents.
Conclusion: Results from the informCLL registry allow for a prospective assessment of CLL treatment patterns in the era of novel agents. Ibrutinib was the most common index treatment received, and most ibrutinib-treated patients continued therapy at 2 years of follow-up; 33% of patients received chemoimmunotherapy. Prognostic biomarker testing was infrequent, especially for TP53 and IGHV mutational status, indicating that prognostic marker testing results may not always guide treatment selection for patients with high-risk disease.