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ALFA-0701

Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study

Phase 3N = 280NCT00927498

Population
Patients aged 50 to 70 years with previously untreated de novo acute myeloid leukaemia (139 analysed in each group).
Design
Randomised 1:1 (block size four), open-label phase 3 in 26 haematology centres in France; standard treatment with or without five doses of gemtuzumab ozogamicin 3 mg/m2 (days 1, 4 and 7 of induction and day 1 of each of two consolidation courses). Primary endpoint event-free survival; analysis by intention to treat (as stated in the abstract); registered with EudraCT 2007-002933-36.
Primary endpoint
EFS
Arms
  • Standard chemotherapy (control, n = 140): Standard front-line chemotherapy (daunorubicin plus cytarabine induction and two consolidation courses)
  • Standard chemotherapy plus gemtuzumab ozogamicin (experimental, n = 140): Standard chemotherapy plus gemtuzumab ozogamicin 3 mg/m2 on days 1, 4 and 7 of induction and day 1 of each of two consolidation courses
People
Castaigne S, Acute Leukemia French Association
EFSHR 0.58 (95% CI 0.43–0.78)Δ 24-month EFS+23.7 pointsOSHR 0.69 (95% CI 0.49–0.98)Δ 24-month OS+11.3 pointsRFSHR 0.52 (95% CI 0.36–0.75)Δ 24-month RFS+27.6 points
Show the numbers
Results reported for ALFA-0701
EndpointAnalysisStandard chemotherapy plus gemtuzumab ozogamicinStandard chemotherapyEffect
EFSprimaryCastaigne 201240.8% at 2 y (32.8–50.8%)17.1% at 2 y (10.8–27.1%)HR 0.58 (95% CI 0.43–0.78)P=0.0003Persistent thrombocytopenia was more common with gemtuzumab ozogamicin (22 of 139, 16%, versus 4 of 139, 3%; p<0.0001), without an increase in the risk of death from toxicity, as stated in the abstract.
OSprimaryCastaigne 201253.2% at 2 y (44.6–63.5%)41.9% at 2 y (33.1–53.1%)HR 0.69 (95% CI 0.49–0.98)P=0.0368
RFSprimaryCastaigne 201250.3% at 2 y (41.0–61.6%)22.7% at 2 y (14.5–35.7%)HR 0.52 (95% CI 0.36–0.75)P=0.0003
Complete remission rateprimaryCastaigne 201281%75%P=0.25Complete response with or without incomplete platelet recovery: 104 of 139 versus 113 of 139. The odds ratio printed in the abstract is not recorded here.
Results reported for ALFA-0701
EndpointAnalysisStandard chemotherapy plus gemtuzumab ozogamicinStandard chemotherapyEffect
EFSprimaryCastaigne 201240.8% at 2 y (32.8–50.8%)17.1% at 2 y (10.8–27.1%)HR 0.58 (95% CI 0.43–0.78)P=0.0003Persistent thrombocytopenia was more common with gemtuzumab ozogamicin (22 of 139, 16%, versus 4 of 139, 3%; p<0.0001), without an increase in the risk of death from toxicity, as stated in the abstract.
OSprimaryCastaigne 201253.2% at 2 y (44.6–63.5%)41.9% at 2 y (33.1–53.1%)HR 0.69 (95% CI 0.49–0.98)P=0.0368
RFSprimaryCastaigne 201250.3% at 2 y (41.0–61.6%)22.7% at 2 y (14.5–35.7%)HR 0.52 (95% CI 0.36–0.75)P=0.0003
Complete remission rateprimaryCastaigne 201281%75%P=0.25Complete response with or without incomplete platelet recovery: 104 of 139 versus 113 of 139. The odds ratio printed in the abstract is not recorded here.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
EFSOSRFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
EFS0.580.43–0.78
OS0.690.49–0.98
RFS0.520.36–0.75
Primary publication: Castaigne S, Pautas C, Terré C, Raffoux E, Bordessoule D, Bastie JN, et al. Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study. Lancet. 2012;379(9825):1508-16. PubMedDOI

Appears in

Sources

  1. Castaigne S, Pautas C, Terré C, Raffoux E, Bordessoule D, Bastie JN, et al. Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study. Lancet. 2012;379(9825):1508-16.

    PubMedDOI