Intrathecal chemotherapy

The COG AALL1131 (NCT02883049) study for NCI high-risk patients and NCI standard-risk B-ALL patients with slow early response (defined by day 8 peripheral blood MRD and/or day 29 marrow MRD) randomly assigned patients aged 1 to 30 years to receive either postinduction intrathecal methotrexate or triple intrathecal chemotherapy (methotrexate, cytarabine, and hydrocortisone). Patients with CNS3 disease were not eligible, and patients on this trial did not receive cranial radiation. Postinduction intrathecal therapy was administered for a total of 21 to 26 doses. Neurocognitive assessments were performed in a subset of patients aged 6 to 12 years at initial diagnosis.[25]

The COG AALL1131 (NCT02883049) study for NCI high-risk patients and NCI standard-risk B-ALL patients with slow early response (defined by day 8 peripheral blood MRD and/or day 29 marrow MRD) randomly assigned patients aged 1 to 30 years to receive either postinduction intrathecal methotrexate or triple intrathecal chemotherapy (methotrexate, cytarabine, and hydrocortisone). Patients with CNS3 disease were not eligible, and patients on this trial did not receive cranial radiation. Postinduction intrathecal therapy was administered for a total of 21 to 26 doses. Neurocognitive assessments were performed in a subset of patients aged 6 to 12 years at initial diagnosis.[25]

The 5-year postinduction disease-free survival (DFS) rates were 93.2% (± 2.1%) for patients randomly assigned to intrathecal methotrexate and 90.6% (± 2.3%) (P = .85) for patients assigned to triple intrathecal chemotherapy.

The COG AALL1131 (NCT02883049) study for NCI high-risk patients and NCI standard-risk B-ALL patients with slow early response (defined by day 8 peripheral blood MRD and/or day 29 marrow MRD) randomly assigned patients aged 1 to 30 years to receive either postinduction intrathecal methotrexate or triple intrathecal chemotherapy (methotrexate, cytarabine, and hydrocortisone). Patients with CNS3 disease were not eligible, and patients on this trial did not receive cranial radiation. Postinduction intrathecal therapy was administered for a total of 21 to 26 doses. Neurocognitive assessments were performed in a subset of patients aged 6 to 12 years at initial diagnosis.[25]

The OS rates were 96.3% (± 1.5%) for patients who received intrathecal methotrexate and 96.7% (± 1.4%) (P = .77) for patients who received triple intrathecal chemotherapy.

The COG AALL1131 (NCT02883049) study for NCI high-risk patients and NCI standard-risk B-ALL patients with slow early response (defined by day 8 peripheral blood MRD and/or day 29 marrow MRD) randomly assigned patients aged 1 to 30 years to receive either postinduction intrathecal methotrexate or triple intrathecal chemotherapy (methotrexate, cytarabine, and hydrocortisone). Patients with CNS3 disease were not eligible, and patients on this trial did not receive cranial radiation. Postinduction intrathecal therapy was administered for a total of 21 to 26 doses. Neurocognitive assessments were performed in a subset of patients aged 6 to 12 years at initial diagnosis.[25]

There were no differences in the cumulative incidence of isolated bone marrow relapse, isolated CNS relapse, or combined bone marrow and CNS relapse between the two arms.

The COG AALL1131 (NCT02883049) study for NCI high-risk patients and NCI standard-risk B-ALL patients with slow early response (defined by day 8 peripheral blood MRD and/or day 29 marrow MRD) randomly assigned patients aged 1 to 30 years to receive either postinduction intrathecal methotrexate or triple intrathecal chemotherapy (methotrexate, cytarabine, and hydrocortisone). Patients with CNS3 disease were not eligible, and patients on this trial did not receive cranial radiation. Postinduction intrathecal therapy was administered for a total of 21 to 26 doses. Neurocognitive assessments were performed in a subset of patients aged 6 to 12 years at initial diagnosis.[25]

There were no significant differences in neurological toxicities or in assessments of neurocognitive functioning during treatment for patients who received intrathecal methotrexate compared with patients who received triple intrathecal chemotherapy.