Table 2.

Relevant gemtuzumab ozogamicin studies of combination therapy in adult patients

Single-arm studies
ReferenceSample size (N)Median age (range)GO dose and scheduleAML statusCombined withCR/CRp (%)
Stone et al. (67)3764 (55–70)9 mg/m2 D7Relapsed, refractory AMLHigh dose Ara-C32/3
Chevallier et al. (68)6256 (16–71)9 mg/m2 D4Relapsed, refractory AMLAra-C and mitoxantrone50/13
Tsimberidou et al. (69)3253 (18–78)6 mg/m2 D1Relapsed, refractory AMLFludarabine, Ara-C, cyclosporine28/6
Ravandi et al. (35)25a47 (14–81)9 mg/m2 D1Untreated high risk APLATRA and ATO81/0
Estey et al. (37)1545 (NR)9 mg/m2 D1Untreated high risk APLATRA and ATO73/0
Estey et al. (39)1950 (NR)9 mg/m2 D1 or D5Untreated APLATRA84/0
Candoni et al. (70)3053 (25–65)3 mg/m2 D6Untreated AMLFludarabine, Ara-C, idarubicin90/0
Eom et al. (71)3764 (55–76)6 mg/m2 D1Untreated AMLIdarubicin and BH-AC76/3
Tsimberidou et al. (72)5957 (27–76)6 mg/m2 D1Untreated AMLbFludarabine, Ara-C, cyclosporine46/2
Kell et al. (73)6447 (17–59)3 or 6 mg/m2 D1Untreated AMLDaunorubicin, Ara-C, 6-TG; or fludarabine, Ara-C, idarubicin84
Amadori et al. (74)5768 (61–75)9 mg/m2 D1 or D15Untreated AMLMitoxantrone, Ara-C, etoposide35/19
Clavio et al. (75)4666 (60–80)3 mg/m2 at D4Untreated AMLFludarabine, Ara-C, idarubicin52/0
Randomized phase II studies
ReferenceSample size (N)Median age (range)GO dose and scheduleAML statusTreatmentCR/CRp (%)
Litzow et al. (76)8260 (27–75)6 mg/m2 D5Relapsed, refractory (>50%) AMLArm A: Ara-C + GO8/4
52 (27–85)NAArm B: Ara-C + L daunorubicin7/0
53 (25–78)NAArm C: CAT regimen4/0
Randomized phase III studies
ReferenceSample size (N)Median age (range)GO dose and scheduleAML statusCombined with5-year OS
Burnett et al. (17)1,11349 (0–71)3 mg/m2 D1 of inductionUntreated AMLInduction: with DA, ADE, or FLAG-Ida43%c
Control arm: no GO41%
Petersdorf et al. (41)627NR (18–60)6 mg/m2 at D4 of inductionUntreated AMLInduction: with DA31 mod
Control arm: no GO35 mo
Löwenberg et al. (77)23267 (60–78)6 mg/m2 × 3 doses after inductionUntreated AMLGO after induction therapy28%c
Control arm: no further therapy21%

Abbreviations: 6-TG, 6-Tioguanine; ADE, cytarabine, daunorubicin, and etoposide; Ara-C, cytarabine; ATO, arsenic trioxide; ATRA, all-trans-retinoic acid; BH-AC, N4-behenoyl-1-b-arabinofuranosyl cytosine; CAT, cyclophosphamide with mesna, cytarabine, topotecan; CRp, complete remission with incomplete platelet recovery; D, day; DA, daunorubicin and cytarabine; FLAG-Ida, fludarabine, cytarabine, granulocyte colony-stimulating factor, and idarubicin; L, liposomal; NA, not applicable; NR, not reported; OS, overall survival.

  • aSubset of patients.

  • bIncludes 20 patients with refractory anemia with excess blasts.

  • cNot statistically significant.

  • dEstimated median overall survival, not statistically significant.