Relevant gemtuzumab ozogamicin single-agent studies in adult patients
Reference | Sample size | Median age (range) | Dose and schedule | AML status | CR/CRp (%) | Median RFS |
---|---|---|---|---|---|---|
Sievers et al. (16) | 142 | 61 (22–84) | 9 mg/m2 D1 and D15 | First relapse AML | 16/13 | 6.8 mo |
Taksin et al. (62) | 57 | 64 (22–80) | 3 mg/m2 D1, 4, and 7 | First relapse AML | 26/7 | 11.0 mo |
Piccaluga et al. (63) | 24 | 63 (20–75) | 6 or 9 mg/m2 for 2–3 doses | Relapsed, refractory AML | 13/8 | 6.0 mob |
Lo-Coco et al. (38) | 16 | 52 (17–77) | 6 mg/m2 for 2–3 doses | Molecularly relapsed APL | 88/0 | 15 moc |
Amadori et al. (64) | 56a | 78 (62–86) | Arm A: 3 mg/m2 D1, 3, and 5 | Untreated AML | 21/0 | Not reported |
Arm B: 6 mg/m2 D1 and 8 | 18/4 | Not reported | ||||
Amadori et al. (65) | 40 | 76 (61–89) | 9 mg/m2 D1 and D15 | Untreated AML | 10/7 | 6.1 mod |
Nabhan et al. (66) | 12 | 75 (66–79) | 9 mg/m2 D1 and D15 | Untreated AML | 27/0 | Not reported |
NOTE: This table includes published studies only. Phase II studies with heterogeneous diagnosis and/or mixed AML status were excluded.
Abbreviations: CRp, complete remission with incomplete platelet recovery; D, day; RFS, relapse-free survival.
↵aRandomized phase II study. Patients on arm C (n = 28) received best supportive care. The rate of disease nonprogression, the primary endpoint, was 38% in arm A vs. 63% in arm B; the D1+8 schedule met the statistical criteria for phase III comparison.
↵bMedian duration of response.
↵cSeven patients who remained in sustained molecular remission for a median of 15 months.
↵dPatients with CR.