Sequential Combination of Gemtuzumab Ozogamicin and Standard Chemotherapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia: Results of a Randomized Phase III Trial by the EORTC and GIMEMA Consortium (AML-17)

Abstract

As used in this trial, the sequential combination of GO and standard chemotherapy provides no benefit for older patients with AML and is too toxic for those age ≥ 70 years.

Acute myeloid leukemia: 2016 Update on risk‐stratification and management

“…The data in (Fig. 18) are consistent with a report from CIBMTR suggesting 30% of patients aged .65 were living >3 years after RIC-HCT and that age had no effect on outcome (55 patients were aged .65 (median 67, range [65][66][67][68][69][70][71][72][73][74][75][76][77][78] [ (Fig. 19) [103] An analysis comparing patients with and without allo HCT donors ("genetic randomization") reported an advantage for the donor group as a surrogate for RIC [104].…”

“…Use of GO prior to 7 1 3 [65], its addition to low dose cytarabine (LDAC) in older patients [66], or its use alone in patients in remission [67] has not appeared successful. A trial randomizing 237 patients aged > 60 between BSC and GO (6 mg/m2 day 1, 3 mg/m2 day 8) found statistically superior survival with GO, but the differences were modest (medians 4.9 and 3.6 months) [68].…”

Fludarabine, Cytarabine and Gentuzumab Ozogamicin (FLA-GO) as Salvage Therapy and Bridge to Transplant in Adult Relapsed Acute Myeloid Leukemia (AML) Patients

“…Even liver toxicity was negligible and no instances of SOS were observed in the overall population and in patients submitted to ASCT [31,[33][34][35][36]. Overall, ED rate was in line or even lower than what observed in other chemotherapy trials [8,25].…”

Treatment and prognostic assessment of acute myeloid leukemia

“…43 Recent phase III clinical trials have shown that Gemtuzumab ozogamicin does not improve either complete remission rate or overall survival, both in younger and elderly patients. 44,45 Since later studies failed to show the survival benefit, on the advice of USFDA, the manufacturers withdrew the drug from the market.…”