Adding nelarabine to hyper-CVAD appears safe, effective in adults with T-ALL
SAN DIEGO — The addition of nelarabine to a standard hyper-CVAD regimen demonstrated durable overall response and complete remission rates in adults with previously untreated or minimally pretreated T-cell acute lymphoblastic leukemia and T-lymphoblastic lymphoma, according to study findings presented at the ASH Annual Meeting and Exposition.
Yasmin Abaza, MD, from The University of Texas MD Anderson Cancer Center, and colleagues conducted a single-arm phase 2 study of 67 adults to determine complete remission and overall response rates, as well as to assess the safety of adding nelarabine to standard hyper-CVAD in this patient population.
The researchers administered eight induction cycles of hyper-CVAD during odd courses 1, 3, 5 and 7 and alternated with high-dose methotrexate and cytarabine at even courses. Following induction treatment, patients then were administered monthly vincristine, prednisone, 6- mercaptopurine and methotrexate (POMP) maintenance therapy for 30 months.
Patients received nelarabine (Arranon, GlaxoSmithKline) daily at 650 mg/m2 intravenously for more than 2 hours for 5 days after the eight-cycle induction therapy. The protocol was amended after the first 30 patients to deliver nelarabine after cycles 4 and 5 of induction.
Sixty percent of patients that presented to the study were diagnosed with T-ALL. The median age of the patients was 37 years and more than half (76%) were male.
The researchers eliminated 11 patients after determining they had reached complete response at the time of initial presentation.
Ninety-six percent of patients reached an overall response rate, while 93% achieved complete remission.
Complete remission occurred in 87% of patients with T-ALL and 100% of patients with T-LL.
Forty-four patients were alive at a median follow-up of 35 months and 93% of those patients were in remission.
The probability of CR and overall survival at 3 years was 68% and 65%, respectively. The median OS was 82 months.
The most common neurotoxicity that patients experienced was peripheral neuropathy (69%) and only one patient reported a grade 3 or grade 4 experience.
“Novel strategies, such as the addition of asparaginase and perhaps venetoclax to induction [might] improve outcomes in adult T-cell ALL and T-cell lymphoblastic lymphoma,” Abaza said during the presentation. – by Ryan McDonald
Reference: Abaza Y, et al. Abstract 177. Presented at: ASH Annual Meeting and Exposition; Dec. 3-6, 2016; San Diego.
Disclosure: Abaza reports no relevant financial disclosures. Please see the full study for a list of all other relevant financial disclosures.