Fabio Efficace1, Franco Mandelli2, Giuseppe Avvisati2, Francesco Cottone2, Felicetto Ferrara2, Eros Di Bona2, Giorgina Specchia2, Massimo Breccia2, Alessandro Levis2, Simona Sica2, Olimpia Finizio2, Maria Grazia Kropp2, Giuseppe Fioritoni2, Elisa Cerqui2, Marco Vignetti2, Sergio Amadori2, Richard F Schlenk2, Uwe Platzbecker2, Francesco Lo-Coco2. 1. Fabio Efficace, Franco Mandelli, Francesco Cottone, and Marco Vignetti, Gruppo Italiano Malattie Ematologiche dell'Adulto; Giuseppe Avvisati, Università Campus Biomedico; Massimo Breccia, Università "La Sapienza,"; Simona Sica, Università Cattolica Sacro Cuore; Sergio Amadori and Francesco Lo-Coco, Università Tor Vergata; Francesco Lo-Coco, Fondazione Santa Lucia, Roma; Felicetto Ferrara, Ospedale Cardarelli; Olimpia Finizio, Ospedale Cardarelli, Napoli; Eros Di Bona, Ospedale San Bortolo, Vicenza; Giorgina Specchia, Università di Bari, Bari; Alessandro Levis, Ospedale SS Antonio e Biagio, Alessandria; Maria Grazia Kropp, Azienda Ospedaliera Pugliese Ciaccio, Catanzaro; Giuseppe Fioritoni, Ospedale Civile, Pescara; Elisa Cerqui, Spedali Civili, Brescia, Italy; Richard F. Schlenk, University of Ulm, Ulm; and Uwe Platzbecker, Universitatsklinikum Carl Gustav Carus, Dresden, Germany. f.efficace@gimema.it. 2. Fabio Efficace, Franco Mandelli, Francesco Cottone, and Marco Vignetti, Gruppo Italiano Malattie Ematologiche dell'Adulto; Giuseppe Avvisati, Università Campus Biomedico; Massimo Breccia, Università "La Sapienza,"; Simona Sica, Università Cattolica Sacro Cuore; Sergio Amadori and Francesco Lo-Coco, Università Tor Vergata; Francesco Lo-Coco, Fondazione Santa Lucia, Roma; Felicetto Ferrara, Ospedale Cardarelli; Olimpia Finizio, Ospedale Cardarelli, Napoli; Eros Di Bona, Ospedale San Bortolo, Vicenza; Giorgina Specchia, Università di Bari, Bari; Alessandro Levis, Ospedale SS Antonio e Biagio, Alessandria; Maria Grazia Kropp, Azienda Ospedaliera Pugliese Ciaccio, Catanzaro; Giuseppe Fioritoni, Ospedale Civile, Pescara; Elisa Cerqui, Spedali Civili, Brescia, Italy; Richard F. Schlenk, University of Ulm, Ulm; and Uwe Platzbecker, Universitatsklinikum Carl Gustav Carus, Dresden, Germany.
Abstract
PURPOSE: A randomized clinical trial compared efficacy and toxicity of standard all-trans-retinoic acid (ATRA) plus chemotherapy versus ATRA plus arsenic trioxide in patients with newly diagnosed, low- or intermediate-risk acute promyelocytic leukemia (APL). Here, we report health-related quality-of-life (HRQOL) results. PATIENTS AND METHODS: HRQOL was a secondary end point of this trial. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 was used to assess HRQOL at end of induction and after consolidation therapy. All analyses were based on 156 patients who received at least one dose of treatment, with groups defined according to randomly assigned treatment. Primary analysis was performed, estimating mean HRQOL score over time and differences between treatment arms using a linear mixed model. RESULTS: Overall, 162 patients age 18 to 70 years were enrolled. Of these, 150 and 142 patients were evaluable for HRQOL after induction therapy and third consolidation course, respectively. Overall compliance with HRQOL forms was 80.1%. The largest difference, favoring patients treated with ATRA plus arsenic trioxide, was found for fatigue severity (mean score difference, -9.3; 95% CI, -17.8 to -0.7; P = .034) at end of induction therapy. This difference was also clinically relevant. HRQOL differences between treatment arms at end of consolidation showed that for several scales, differences between treatment arms were marginal. CONCLUSION: Overall, current HRQOL findings further support the use of ATRA plus arsenic trioxide as preferred first-line treatment in patients with low- or intermediate-risk APL.
RCT Entities:
PURPOSE: A randomized clinical trial compared efficacy and toxicity of standard all-trans-retinoic acid (ATRA) plus chemotherapy versus ATRA plus arsenic trioxide in patients with newly diagnosed, low- or intermediate-risk acute promyelocytic leukemia (APL). Here, we report health-related quality-of-life (HRQOL) results. PATIENTS AND METHODS: HRQOL was a secondary end point of this trial. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 was used to assess HRQOL at end of induction and after consolidation therapy. All analyses were based on 156 patients who received at least one dose of treatment, with groups defined according to randomly assigned treatment. Primary analysis was performed, estimating mean HRQOL score over time and differences between treatment arms using a linear mixed model. RESULTS: Overall, 162 patients age 18 to 70 years were enrolled. Of these, 150 and 142 patients were evaluable for HRQOL after induction therapy and third consolidation course, respectively. Overall compliance with HRQOL forms was 80.1%. The largest difference, favoring patients treated with ATRA plus arsenic trioxide, was found for fatigue severity (mean score difference, -9.3; 95% CI, -17.8 to -0.7; P = .034) at end of induction therapy. This difference was also clinically relevant. HRQOL differences between treatment arms at end of consolidation showed that for several scales, differences between treatment arms were marginal. CONCLUSION: Overall, current HRQOL findings further support the use of ATRA plus arsenic trioxide as preferred first-line treatment in patients with low- or intermediate-risk APL.
Authors: Max S Topp; Zachary Zimmerman; Paul Cannell; Hervé Dombret; Johan Maertens; Anthony Stein; Janet Franklin; Qui Tran; Ze Cong; Andre C Schuh Journal: Blood Date: 2018-05-08 Impact factor: 22.113