Kantarjian H, et al. - Inotuzumab ozogamicin has efficacy in patients with relapsed or refractory acute lymphoblastic leukaemia (ALL). The purpose of the current study was to evaluate inotuzumab ozogamicin with low-intensity chemotherapy in elderly patients with ALL. It was shown that notuzumab ozogamicin plus mini-hyper-CVD chemotherapy is effective and well-tolerated as first-line therapy in elderly patients with newly diagnosed ALL.

Methods

• This was a single-arm, phase 2 study.
• The eligibility criteria were as follows: greater than or equal to 60 years; newly diagnosed Philadelphia chromosome-negative ALL; and an Eastern Cooperative Oncology Group performance status less than or equal to 3.
• The induction chemotherapy regimen was mini-hyper-CVD.
• Intravenous inotuzumab ozogamicin was administered on day 3 of the first 4 cycles (1.3–1.8 mg/m2 at cycle 1, then 1.0 −1.3 mg/m2 in subsequent cycles).
• Dose-reduced POMP served as maintenance therapy for 3 years.
• Two-year progression-free survival (PFS) was the primary endpoint.

Results

• 52 patients (mean age, 68 years) were enrolled.
• Over a 29-month follow-up period, the 2-year PFS was 59%.
• The following grade 3–4 adverse events occurred: prolonged thrombocytopenia (81%); infections during induction (52%) and consolidation chemotherapy (69%); hyperglycaemia (54%); hypokalaemia (31%), increased aminotransferases (19%); hyperbilirubinaemia (17%); haemorrhage (15%); and veno-occlusive disease (8%).
• Six treatment-related deaths occurred (sepsis [10%] and veno-occlusive disease [1%]).