Dexamethasone versus prednisolone for adult acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) patients - final results of the ALL-4 randomized, Phase III trial of the EORTC Leukemia Group

Labar, Boris and Suciu, Stefan and Willemze, Roel and Muus, Petra and Marie, Jean-Pierre and Fillet, Georges and Berneman, Zwi and Jakšić, Branimir and Fereman, Walter and Bron, Dominique and Sinnige, Harm and Mistrik, Martin and Vreugdenhil, Gerard and de Bock, Robrecht and Nemet, Damir and Gilotay, Caroline and Amadori, Sergio and De Witte, Theo (2010) Dexamethasone versus prednisolone for adult acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) patients - final results of the ALL-4 randomized, Phase III trial of the EORTC Leukemia Group. Haematologica, 95 (9). pp. 1489-1495. ISSN 0390-6078

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Abstract

Background Corticosteroids are the standard component for the treatment of ALL and LL patients. Our aim was to assess whether dexamethasone (DXM) result in a better outcome than Prednisolone (PDN). Design and Metdhods Adult ALL and LL patients were randomized to receive in induction on days 1-8, 15-22, either DXM 8 mg/m(2) or PDN 60 mg/m(2). Those who reached complete remission (CR), two courses of consolidation (HAM and MA) were administered. Subsequently patient younger than 50 years, with a donor, had to receive AlloSCT, whereas the others, either autoSCT or high dose maintenance chemotherapy with prophylactic CNS irradiation. Randomization was done with a minimization technique. The primary endpoint was event-free survival (EFS). Analysis were done by intention to treat. RESULTS: Between August 1995 and October 2003, 325 patients between 15 to 72 years of age were randomized to receive either DXM (163 patients) or PDN (162 patients). After induction and first consolidation course, 131 (80,4%) patients in DXM group and 124(76,5%) in PDN group achieved CR. No significant difference was observed between the 2 treatment groups regarding EFS: P=0.82, hazard ratio 0.97, 95% confidence interval 0.75-1.25, the 6-year EFS rates (+/-SE) were 25.9%(3.6%) vs. 28.7% (3.5%). Disease-Free survival (DFS) from CR was similar in DXM and PDN group: hazard ratio1.03, 95% confindence interval 0.76-1.40. The 6-year DFS rate was 32.3% (DXM) vs. 37,5% (PDN) group, the 6-year cummulative incidence of relapse was 32.3 (DXM) vs. 37.5% (PDN) group, the 6-year cumulative incidence of relapse was 49.8% vs. 53.5% (Gray test: P=0.30) and of death was 18% vs. 9% (Gray test: P=0.07). Conclusions In the ALL-4 trial in adult patients, DXM did not show any advantage compared to PDN. This study is registered with Clinical Trials gov. number NCT00002700.

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