BACKGROUND:Chemotherapy for elderly patients with acute myeloid leukemia (AML) results in a median overall survival (OS) of ≤ 1 year. Elderly patients often present with cardiac comorbidity. Gemtuzumab ozogamicin (GO) is active in elderly (≥ 60 years) patients with relapsed AML with low cardiac toxicity. PATIENTS AND METHODS: This randomized phase II study compared a standard combination of ara-C and daunorubicin (DNR; 7+3) versus ara-C plus gemtuzumab ozogamicin (7+GO) as the first course of induction therapy. Primary objectives were comparison of blast clearance on day 16, event-free survival (EFS), and remission duration. OS, complete remission (CR), and tolerability were secondary objectives. RESULTS:One hundred and nineteen patients with de novo AML, treatment-related AML, AML with a history of myelodysplastic syndrome (MDS), or high-risk MDS entered the study. Median age of 115 patients (intent-to-treat population) was 69 years. Protocol outlined a second course 7+3 for patients without blast clearance and two courses of high-dose ara-C consolidation upon CR. Both treatments were equally effective in blast clearance, CR, EFS, remission duration, or OS (median: 7+3, 9 months; 7+GO, 10 months). Induction death rate was higher in the GO group due to veno-occlusive disease. CONCLUSION: The study did not show significant superiority of 7+GO over standard 7+3.
RCT Entities:
BACKGROUND: Chemotherapy for elderly patients with acute myeloid leukemia (AML) results in a median overall survival (OS) of ≤ 1 year. Elderly patients often present with cardiac comorbidity. Gemtuzumab ozogamicin (GO) is active in elderly (≥ 60 years) patients with relapsed AML with low cardiac toxicity. PATIENTS AND METHODS: This randomized phase II study compared a standard combination of ara-C and daunorubicin (DNR; 7+3) versus ara-C plus gemtuzumab ozogamicin (7+GO) as the first course of induction therapy. Primary objectives were comparison of blast clearance on day 16, event-free survival (EFS), and remission duration. OS, complete remission (CR), and tolerability were secondary objectives. RESULTS: One hundred and nineteen patients with de novo AML, treatment-related AML, AML with a history of myelodysplastic syndrome (MDS), or high-risk MDS entered the study. Median age of 115 patients (intent-to-treat population) was 69 years. Protocol outlined a second course 7+3 for patients without blast clearance and two courses of high-dose ara-C consolidation upon CR. Both treatments were equally effective in blast clearance, CR, EFS, remission duration, or OS (median: 7+3, 9 months; 7+GO, 10 months). Induction death rate was higher in the GO group due to veno-occlusive disease. CONCLUSION: The study did not show significant superiority of 7+GO over standard 7+3.
Authors: Robert K Hills; Sylvie Castaigne; Frederick R Appelbaum; Jacques Delaunay; Stephen Petersdorf; Megan Othus; Elihu H Estey; Hervé Dombret; Sylvie Chevret; Norbert Ifrah; Jean-Yves Cahn; Christian Récher; Lucy Chilton; Anthony V Moorman; Alan K Burnett Journal: Lancet Oncol Date: 2014-07-06 Impact factor: 41.316
Authors: Eyal C Attar; Jeffrey L Johnson; Philip C Amrein; Gerard Lozanski; Martha Wadleigh; Daniel J DeAngelo; Jonathan E Kolitz; Bayard L Powell; Peter Voorhees; Eunice S Wang; William Blum; Richard M Stone; Guido Marcucci; Clara D Bloomfield; Barry Moser; Richard A Larson Journal: J Clin Oncol Date: 2012-11-05 Impact factor: 44.544
Authors: C Müller-Tidow; P Tschanter; C Röllig; C Thiede; A Koschmieder; M Stelljes; S Koschmieder; M Dugas; J Gerss; T Butterfaß-Bahloul; R Wagner; M Eveslage; U Thiem; S W Krause; U Kaiser; V Kunzmann; B Steffen; R Noppeney; W Herr; C D Baldus; N Schmitz; K Götze; A Reichle; M Kaufmann; A Neubauer; K Schäfer-Eckart; M Hänel; R Peceny; N Frickhofen; M Kiehl; A Giagounidis; M Görner; R Repp; H Link; A Kiani; R Naumann; T H Brümmendorf; H Serve; G Ehninger; W E Berdel; U Krug Journal: Leukemia Date: 2015-11-02 Impact factor: 11.528