期刊
BLOOD ADVANCES
卷 5, 期 23, 页码 4807-4816出版社
ELSEVIER
DOI: 10.1182/bloodadvances.2021005039
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类别
资金
- Intramural Research Program, National Institutes of Health, National Cancer Institute, Center for Cancer Research
- intramural program of the National Cancer Institute
- GeneTech, Inc.
The study demonstrated that CDAR is effective in treating HCLv, with a high complete remission rate and prolonged duration of MRD-negative CR. Patients who achieved MRD-negative CR had better progression-free survival and overall survival outcomes.
Hairy cell leukemia variant (HCLv) responds poorly to purine analogue monotherapy. Rituximab concurrent with cladribine (CDAR) improves response rates, but long-term outcomes are unknown. We report final results of a phase 2 study of CDAR for patients with HCLv. Twenty patients with 0 to 1 prior courses of cladribine and/or rituximab, including 8 who were previously untreated, received dadribine 0.15 mg/kg on days 1 to 5 with 8 weekly rituximab doses of 375 mg/m(2) beginning day 1. Patients received a second rituximab course >= 6 months after dadribine, if and when minimal residual disease (MRD) was detected in blood. The complete remission (CR) rate from CDAR was 95% (95% confidence interval, 75-100). Sixteen (80%) of 20 patients (95% confidence interval, 56-94) became MRD negative according to bone marrow at 6 months. The median duration of MRD-negative CR was 70.1 months, and 7 of 16 are still MRD negative up to 120 months. With a median follow-up of 69.7 months, 11 patients received delayed rituximab, and the 5-year progression-free survival (PFS) and overall survival (OS) were 63.3% and 73.9%, respectively. Five patients with TP53 mutations had shorter PFS (median, 36.4 months vs unreached; P = .0024) and OS (median, 52.4 months vs unreached; P = .032). MRD-negative CR at 6 months was significantly associated with longer PFS (unreached vs 17.4 months; P < .0001) and OS (unreached vs 38.2 months; P < .0001). Lack of MRD in blood at 6 months was also predictive of longer PFS and OS (P < .0001). After progression following CDAR, median OS was 29.7 months. CDAR is effective in HCLv, with better outcomes in patients who achieve MRD-negative CR.
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