Addition of gemtuzumab ozogamicin

In a meta-analysis of more than 3,000 patients, the addition of the CD33-directed immunotoxin gemtuzumab ozogamicin to cytarabine plus anthracycline or clofarabine plus anthracycline led to a small increase in the OS rate at 5 years (30.7% vs. 34.6%; HR, 0.90; 95% CI, 0.82−0.98; P = .01).[9] The FDA label for gemtuzumab ozogamicin includes a boxed warning about the risk of hepatotoxicity, including severe or fatal hepatic sinusoidal obstruction syndrome.

In a meta-analysis of more than 3,000 patients, the addition of the CD33-directed immunotoxin gemtuzumab ozogamicin to cytarabine plus anthracycline or clofarabine plus anthracycline led to a small increase in the OS rate at 5 years (30.7% vs. 34.6%; HR, 0.90; 95% CI, 0.82−0.98; P = .01).[9] The FDA label for gemtuzumab ozogamicin includes a boxed warning about the risk of hepatotoxicity, including severe or fatal hepatic sinusoidal obstruction syndrome.

The improvement in the 5-year OS rate was seen across all ages, but this effect was greatest in patients with favorable-risk cytogenetics (55.2% vs. 76.3%; HR, 0.47; 95% CI, 0.31−0.73; P = .0005), and to a lesser extent with intermediate-risk cytogenetics (34.1% vs. 39.4%; HR, 0.84; 95% CI, 0.75−0.95; P = .007). It was not seen in patients with an adverse-risk karyotype.[9][Level of evidence A1]

In a meta-analysis of more than 3,000 patients, the addition of the CD33-directed immunotoxin gemtuzumab ozogamicin to cytarabine plus anthracycline or clofarabine plus anthracycline led to a small increase in the OS rate at 5 years (30.7% vs. 34.6%; HR, 0.90; 95% CI, 0.82−0.98; P = .01).[9] The FDA label for gemtuzumab ozogamicin includes a boxed warning about the risk of hepatotoxicity, including severe or fatal hepatic sinusoidal obstruction syndrome.

In contrast, gemtuzumab ozogamicin did not improve the 1-year survival rate of older patients who received low-dose cytarabine, although the CR rate increased from 17% to 30% (odds ratio [OR], 0.48; 95% CI, 0.32–0.73; P = .006).[17]