Table 4.
Neurologic events and CRS leading to treatment interruption in long-term survivors
Patient No.* | Blinatumomab dose (μg/m2/d) | Cycle | Adverse event, CTCAE grade | Blinatumomab dose at restart of treatment (μg/m2/d) | Prophylaxis | Response, RFS, OS | Alive/In remission |
---|---|---|---|---|---|---|---|
5 | 15 | 1 | Convulsion, grade 2 | 5 | Clobazam | CRh, | Yes/No (relapse) |
RFS 17.5 mo, | |||||||
OS 38.6 mo | |||||||
20 | 30 | 2 | Encephalopathy, grade 3 | 5 | No | CR, | Yes/Yes |
RFS 34.1 mo, | |||||||
OS 36.9 mo | |||||||
10 | 5 | 1 | CRS, grade 4 | 5 | Prephase dexamethasone† | CRh, | Yes/Yes |
RFS 22.4 mo, | |||||||
OS 30.0 mo‡ |
Long-term survivors were defined as patients with an OS ≥30 mo.
CTCAE, Common Terminology Criteria for Adverse Events (Version 4.0).
Patient No. refers to patients listed in supplemental Table 1.
Up to 24 mg/d dexamethasone for up to 5 d and/or 200 mg/m2/d cyclophosphamide for up to 4 d before blinatumomab infusion.
Patient first achieved remission on study day 99 and had to restart cycle 1 after interruptions.