Table 1.
Regimen and cycle length | Treatment and dosage | Cycle day |
|||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
−4 to 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12+ | |||
Naxitamab monotherapya 28-day cycles |
Naxitamab 3 mg/kg/day i.v. (9 mg/kg/cycle) | X | X | X | |||||||||||
GM-CSF 500 μg/m2/day s.c. | X | X | X | X | X | ||||||||||
GM-CSF 250 μg/m2/day s.c. | X | ||||||||||||||
Naxitamab chemoimmunotherapyb,19 21-day cycles |
Naxitamab 2.25 mg/kg/day i.v. (9 mg/kg/cycle) | X | X | X | X | ||||||||||
Irinotecan 50 mg/m2/day i.v. + temozolomide 150 mg/m2/day p.o. | X | X | X | X | X | ||||||||||
GM-CSF 250 μg/m2/day s.c. | X | X | X | X | X |
BM, bone marrow; CR, complete response/remission; GM-CSF, granulocyte–macrophage colony-stimulating factor; HR, high risk; HSJD, Hospital Sant Joan de Déu; i.v., intravenous; MR, minor response; p.o., oral; PR, partial response; R/R, relapsed and/or refractory; s.c., subcutaneous; SD, stable disease.
Naxitamab monotherapy is suggested for three groups of patients at HSJD: patients with R/R HR disease limited to bone or BM who have demonstrated PR, MR, or SD to prior therapy; or as consolidation in patients with relapsed disease who achieve a CR following latest therapy, or patients with HR disease who achieve a CR following frontline therapy.
Naxitamab chemoimmunotherapy is suggested for two groups of patients at HSJD: patients with persistent soft-tissue disease; or patients who are refractory to or relapse following naxitamab monotherapy.