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Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia.
Kantarjian, Hagop M; DeAngelo, Daniel J; Stelljes, Matthias; Martinelli, Giovanni; Liedtke, Michaela; Stock, Wendy; Gökbuget, Nicola; O'Brien, Susan; Wang, Kongming; Wang, Tao; Paccagnella, M Luisa; Sleight, Barbara; Vandendries, Erik; Advani, Anjali S.
Afiliação
  • Kantarjian HM; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
  • DeAngelo DJ; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
  • Stelljes M; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
  • Martinelli G; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
  • Liedtke M; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
  • Stock W; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
  • Gökbuget N; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
  • O'Brien S; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
  • Wang K; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
  • Wang T; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
  • Paccagnella ML; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
  • Sleight B; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
  • Vandendries E; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
  • Advani AS; From the University of Texas MD Anderson Cancer Center, Houston (H.M.K.); the Dana-Farber Cancer Institute, Boston (D.J.D.), and Pfizer, Cambridge (E.V.) - both in Massachusetts; Universitätsklinikum Münster, Münster (M.S.), and Goethe University, Frankfurt (N.G.) - both in Germany; Institute Seràgn
N Engl J Med ; 375(8): 740-53, 2016 Aug 25.
Article em En | MEDLINE | ID: mdl-27292104
BACKGROUND: The prognosis for adults with relapsed acute lymphoblastic leukemia is poor. We sought to determine whether inotuzumab ozogamicin, an anti-CD22 antibody conjugated to calicheamicin, results in better outcomes in patients with relapsed or refractory acute lymphoblastic leukemia than does standard therapy. METHODS: In this phase 3 trial, we randomly assigned adults with relapsed or refractory acute lymphoblastic leukemia to receive either inotuzumab ozogamicin (inotuzumab ozogamicin group) or standard intensive chemotherapy (standard-therapy group). The primary end points were complete remission (including complete remission with incomplete hematologic recovery) and overall survival. RESULTS: Of the 326 patients who underwent randomization, the first 218 (109 in each group) were included in the primary intention-to-treat analysis of complete remission. The rate of complete remission was significantly higher in the inotuzumab ozogamicin group than in the standard-therapy group (80.7% [95% confidence interval {CI}, 72.1 to 87.7] vs. 29.4% [95% CI, 21.0 to 38.8], P<0.001). Among the patients who had complete remission, a higher percentage in the inotuzumab ozogamicin group had results below the threshold for minimal residual disease (0.01% marrow blasts) (78.4% vs. 28.1%, P<0.001); the duration of remission was longer in the inotuzumab ozogamicin group (median, 4.6 months [95% CI, 3.9 to 5.4] vs. 3.1 months [95% CI, 1.4 to 4.9]; hazard ratio, 0.55 [95% CI, 0.31 to 0.96]; P=0.03). In the survival analysis, which included all 326 patients, progression-free survival was significantly longer in the inotuzumab ozogamicin group (median, 5.0 months [95% CI, 3.7 to 5.6] vs. 1.8 months [95% CI, 1.5 to 2.2]; hazard ratio, 0.45 [97.5% CI, 0.34 to 0.61]; P<0.001); the median overall survival was 7.7 months (95% CI, 6.0 to 9.2) versus 6.7 months (95% CI, 4.9 to 8.3), and the hazard ratio was 0.77 (97.5% CI, 0.58 to 1.03) (P=0.04). In the safety population, the most frequent grade 3 or higher nonhematologic adverse events with inotuzumab ozogamicin were liver-related. Veno-occlusive liver disease of any grade occurred in 15 patients (11%) who received inotuzumab ozogamicin and in 1 patient (1%) who received standard therapy. CONCLUSIONS: The rate of complete remission was higher with inotuzumab ozogamicin than with standard therapy, and a higher percentage of patients in the inotuzumab ozogamicin group had results below the threshold for minimal residual disease. Both progression-free and overall survival were longer with inotuzumab ozogamicin. Veno-occlusive liver disease was a major adverse event associated with inotuzumab ozogamicin. (Funded by Pfizer; INO-VATE ALL ClinicalTrials.gov number, NCT01564784.).
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Lectina 2 Semelhante a Ig de Ligação ao Ácido Siálico / Leucemia-Linfoma Linfoblástico de Células Precursoras / Anticorpos Monoclonais Humanizados Idioma: En Ano de publicação: 2016 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Lectina 2 Semelhante a Ig de Ligação ao Ácido Siálico / Leucemia-Linfoma Linfoblástico de Células Precursoras / Anticorpos Monoclonais Humanizados Idioma: En Ano de publicação: 2016 Tipo de documento: Article