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Göteborgs universitets publikationer

Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase 3 trial

Författare och institution:
Mats Brune (-); Sylvie Castaigne (-); John Catalano (-); Kurt Gehlsen (-); Anthony D Ho (-); Wolf-Karsten Hofmann (-); Donna E Hogge (-); Bo Nilsson (-); Reuven Or (-); Ana Romero (-); Jacob M Rowe (-); Bengt Simonsson (-); Ruth Spearing (-); Edward A Stadtmauer (-); Jeff Szer (-); Elisabeth Wallhult (-); Kristoffer Hellstrand (Institutionen för biomedicin, avdelningen för infektionssjukdomar)
Publicerad i:
Blood, 108 ( 1 ) s. 88-96
0006-4971 (Print)
Artikel, refereegranskad vetenskaplig
Sammanfattning (abstract):
The primary objective of this phase 3 study was to determine whether postconsolidation immunotherapy with interleukin-2 (IL-2) and histamine dihydrochloride (HDC) improved the leukemia-free survival (LFS) of adult patients with acute myeloid leukemia (AML) in complete remission (CR). Three hundred twenty patients with AML (median age, 57 years; range, 18-84 years) were stratified by CR1 or subsequent CR (CR > 1) and randomly assigned to treatment with HDC/IL-2 or no treatment (control). Treatment comprised 10 21-day cycles with IL-2 (16 400 U/kg) plus HDC (0.5 mg); both compounds were administered by subcutaneous injection twice daily. Study arms were balanced for age, sex, previous treatment, leukemic karyotypes, time from CR to inclusion, and frequency of secondary leukemia. Three years after enrollment of the last patient, treatment with HDC/IL-2 was found to improve LFS over control in the study population (CR1 + CR > 1, n = 320; P < .01, log-rank test). For patients in CR1 (n = 261), treatment significantly improved LFS (P = .01) with 3-year LFS estimates of 40% (HDC/IL-2) compared with 26% (control). Side effects were typically mild to moderate. These results indicate that HDC/IL-2 treatment offers an efficacious and tolerable treatment for patients with AML in remission.
Ämne (baseras på Högskoleverkets indelning av forskningsämnen):
Acute Disease, Adolescent, Adult, Aged, Aged, 80 and over, Disease-Free Survival, Female, Histamine/adverse effects/ therapeutic use, Humans, Immunotherapy, Interleukin-2/adverse effects/ therapeutic use, Leukemia, Myeloid/ therapy, Male, Middle Aged, Proportional Hazards Models, Recurrence, Remission Induction, Survival Rate, Treatment Outcome
Postens nummer:
Posten skapad:
2007-10-18 10:47
Posten ändrad:
2011-01-20 09:59

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