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Vincristine sulfate liposome injection with combination chemotherapy in children and young adults with relapsed ALL
Vincristine is a key therapy for treating children with ALL; however, it is associated with severe peripheral neuropathy, limiting dose-escalation.1 Vincristine sulphate liposome injection (VSLI) is approved for the treatment of adults with R/R ALL and may offer a more tolerable option for children and young adults. Results from a pilot trial (NCT02879643) from the Therapeutic Advances in Childhood Leukemia and Lymphoma Consortium evaluating the safety and feasibility of VSLI vs standard vincristine with combination chemotherapy in children and young adults with relapsed ALL (N = 29) were published in Pediatric Blood and Cancer by Shah et al.1 Cohort A (n = 16) assessed VSLI + UK ALL R3 reinduction regimen (dexamethasone, mitoxantrone, and asparaginase) vs vincristine + UK ALL R3.1 Cohort B (n = 8) evaluated VSLI vs vincristine + UK ALL R3, without mitoxantrone. Cohort C (n = 5) assessed a single dose of VSLI along with maintenance chemotherapy (dexamethasone, methotrexate, and mercaptopurine). VSLI DL1 of 1.5 mg/m2 and DL2 of 2 mg/m2 were evaluated.1
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Key learnings |
Two patients in Cohort A and one patient in Cohort B experienced DLTs at DL2, both requiring dose de-escalations. No DLTs were experienced at DL1 in Cohorts A and B. |
87.5% of patients in Cohort A, 37.5% of patients in Cohort B, and 20% of patients in Cohort C achieved CR/CRi. The overall 2-year OS was 48%; 75% for Cohort A and 80.8% for patients across all cohorts proceeding to HSCT. |
The most common VSLI-related toxicities included Grade 3 febrile neutropenia (21%) and increased AAT (17%). Grade ≥3 infections related to VSLI or the whole regimen were experienced by 5 patients; 4 of whom were treated at DL2. Peripheral neuropathy was experienced by 4 patients; at Grade 3 in one patient. |
These findings demonstrate the safety and feasibility of VSLI as a replacement for standard vincristine in combination chemotherapy in children and young adults with relapsed ALL. Further evaluation of VSLI may help improve outcomes in this population. |
Abbreviations: AAT, alanine aminotransferase; ALL, acute lymphoblastic leukemia; CR, complete remission; CRi, complete remission with incomplete count recovery; DL1, dose level 1; DL2, dose level 2; DLT, dose-limiting toxicity; R/R, relapsed/refractory; SAE, serious adverse event; VSLI, vincristine sulfate liposome injection.
References
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