https://orcid.org/0000-0003-1388-5330
Key Points
Co-administration of leucovorin resulted in significant reduction in rates of Grade 2 and Grade 3 mucositis, with minimal side effects.
Leucovorin thus can be considered a prophylactic therapy in the prevention of mucositis in patients receiving pralatrexate treatment.
Abstract
Pralatrexate (Folotyn®) is an antifolate indicated for treatment of relapsed/refractory peripheral T-cell lymphoma (PTCL), and although durable clinical benefit has been demonstrated, oral and gastrointestinal mucositis and/or skin reactions are frequent toxicity complications associated with pralatrexate treatment. Leucovorin (d,l-folinic acid) administration has been used as standard rescue for patients receiving high dose methotrexate therapy and has recently been studied in patients with PTCL and cutaneous T-cell lymphoma (CTCL) receiving pralatrexate. We describe results from a multi-center, phase 2, single-arm, open-label trial, conducted with the primary objective to evaluate the effect of leucovorin in preventing or reducing the incidence of Grade 2 or higher oral mucositis associated with pralatrexate treatment in Cycle 1. Patients were administered pralatrexate, 30 mg/m2 as an intravenous (IV) push, once weekly for 6 weeks in each cycle, followed by a week of rest (no treatment). Leucovorin 25 mg tablets were administered three times daily (tid) for two days (a total of six doses [150 mg cumulative weekly dose]), initiated 24 hours (±2 hours) after each pralatrexate dose. The evaluable population included 34 patients, mean age 63.7 year, 60% male, of which two (5.9%) developed Grade 2 oral mucositis during the study period (p<0.0001) and no reports of Grade ≥3. Dose modifications, including omissions, delays or reductions, due to oral mucositis were limited to one patient. Co-administration of leucovorin resulted in a significant reduction in mucositis and can be considered a prophylactic therapy in patients receiving pralatrexate treatment. Clinical trial # NCT02106650
