Nelarabine May Improve Disease-Free Survival in Pediatric and Young Adult T-cell ALL
The efficacy of nelarabine among newly diagnosed patients with T-cell ALL has not been fully explored.
|The following article features coverage from the American Society of Clinical Oncology (ASCO) 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
Nelarabine may improve disease-free survival (DFS) among newly diagnosed children and young adults with T-cell acute lymphoblastic leukemia (T-ALL), according to an oral presentation that will be given at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, on Saturday, June 2.1
Previous studies have demonstrated that nelarabine improves outcomes for patients with relapsed/refractory T-ALL and T-cell lymphoblastic lymphoma (T-LL), leading to U.S. Food Drug and Safety Administration approval. However, its efficacy among newly diagnosed patients has not been fully explored.
In the phase 3 COG AALL0434 study (ClinicalTrials.gov Identifier: NCT00408005), researchers enrolled 1895 patients who were diagnosed between 2007 and 2014, and assigned them using a 2x2 pseudo-factorial randomization using the ABFM chemotherapy regimen. Patients received escalating dose methotrexate (MTX) without leucovorin rescue plus pegaspargase (CMTX) or high-dose MTX (HDMTX) plus leucovorin rescue, with or without nelarabine.
Among all study patients with T-ALL, the 4-year DFS rate was 84.3% ± 1.1% and the overall survival rate was 90.2% ± 0.9%.
For T-ALL patients treated with nelarabine the 4-year DFS rate was 88.9% ± 2.2% versus 83.3% ± 2.5% among patients who did not receive nelarabine (P = .0332).
The 4-year DFS among patients with T-ALL assigned to receive CMTX with nelarabine was 92.2% ± 2.8% compared with 89.8% ± 3.0% among patients who did not receive nelarabine (P = .3825). The 4-year DFS among patients with T-ALL assigned to receive HDMTX with nelarabine was 86.2% ± 3.2% compared with 78.0% ± 3.7% among patients who did not receive nelarabine (P = .024).
The 4-arm comparison had significantly different DFS rates (P = .002), and there were no significant interactions between MTX and nelarabine randomization (P = .41).
Patients with T-ALL who did not respond to induction that received HDMTX plus nelarabine had a 4-year DFS of 54.8% ± 8.9%.
High-risk T-LL patients did not have significant improvements in 4-year DFS after receiving nelarabine (85.0% ± 5.6%) compared with patients who did not (89.0% ± 4.7%; P = .2788).
The 4 study arms had a tolerable overall toxicity and neurotoxicity profile, and did not significantly differ between the groups.
The authors concluded that “nelarabine improves DFS for children and young adults with T-ALL and should become a new standard of care for this population.”
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- Dunsmore KP, Winter S, Devidas M, et al. COG AALL0434: a randomized trial testing nelarabine in newly diagnosed t-cell malignancy. Oral presentation at: 2018 ASCO Annual Meeting; June 1-5, 2018; Chicago, IL.