Table 1.

Relevant gemtuzumab ozogamicin single-agent studies in adult patients

ReferenceSample sizeMedian age (range)Dose and scheduleAML statusCR/CRp (%)Median RFS
Sievers et al. (16)14261 (22–84)9 mg/m2 D1 and D15First relapse AML16/136.8 mo
Taksin et al. (62)5764 (22–80)3 mg/m2 D1, 4, and 7First relapse AML26/711.0 mo
Piccaluga et al. (63)2463 (20–75)6 or 9 mg/m2 for 2–3 dosesRelapsed, refractory AML13/86.0 mob
Lo-Coco et al. (38)1652 (17–77)6 mg/m2 for 2–3 dosesMolecularly relapsed APL88/015 moc
Amadori et al. (64)56a78 (62–86)Arm A: 3 mg/m2 D1, 3, and 5Untreated AML21/0Not reported
Arm B: 6 mg/m2 D1 and 818/4Not reported
Amadori et al. (65)4076 (61–89)9 mg/m2 D1 and D15Untreated AML10/76.1 mod
Nabhan et al. (66)1275 (66–79)9 mg/m2 D1 and D15Untreated AML27/0Not 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.