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Sökning: WFRF:(Hellstrand M) > (2010-2014) > Leukemia-free survi...

Leukemia-free survival as a surrogate end point for overall survival in the evaluation of maintenance therapy for patients with acute myeloid leukemia in complete remission

Buyse, M (författare)
Michiels, S (författare)
Squifflet, P (författare)
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Lucchesi, KJ (författare)
Hellstrand, Kristoffer, 1956 (författare)
Gothenburg University,Göteborgs universitet,Institutionen för biomedicin,Institute of Biomedicine
Brune, Mats, 1950 (författare)
Gothenburg University,Göteborgs universitet,Institutionen för biomedicin,Institute of Biomedicine
Castaigne, S (författare)
Rowe, JM (författare)
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 (creator_code:org_t)
2011-05-05
2011
Engelska.
Ingår i: HAEMATOLOGICA-THE HEMATOLOGY JOURNAL. - : Ferrata Storti Foundation (Haematologica). - 0390-6078. ; 96:8, s. 1106-1112
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • BACKGROUND: In trials designed to evaluate new therapies for hematologic malignancies, end points such as leukemia-free survival are often used as surrogates for overall survival in acute leukemia. We aimed to assess whether leukemia-free survival is an acceptable statistical surrogate for overall survival when applied to remission maintenance therapy for acute myeloid leukemia. DESIGN AND METHODS: Data were analyzed from a randomized Phase III trial of remission maintenance immunotherapy with histamine dihydrochloride plus low-dose interleukin-2 versus no treatment in adults with acute myeloid leukemia. A two-stage surrogate validation model was applied in which correlations between Kaplan-Meier estimates of leukemia-free survival and overall survival, and between log hazard ratios reflecting treatment effects were analyzed. Country of patient enrollment was the unit of analysis. RESULTS: Kaplan-Meier estimates of overall survival at 36, 48, and 60 months and leukemia-free survival at 24 months were reasonably correlated (R(2) ranging from 0.44 to 0.84) both for the overall (n=320) and first complete remission (n=261) populations. The effects of histamine dihydrochloride/interleukin-2 on log hazard ratios for leukemia-free survival and overall survival were well correlated (R(2)=0.88-0.93). CONCLUSIONS: The significant correlations between overall survival and the surrogate end point (leukemia-free survival) and between the effect of histamine dihydrochloride/interleukin-2 on leukemia-free survival and overall survival satisfy the two-stage surrogate validation model.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Immunology in the medical area (hsv//eng)

Nyckelord

leukemia-free survival
overall survival
immunotherapy
statistical analyses
clinical trial interpretation

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ref (ämneskategori)
art (ämneskategori)

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