Yazarlar : Efficace F1, Mandelli F2, Avvisati G2, Cottone F2, Ferrara F2, Di Bona E2, Specchia G2, Breccia M2, Levis A2, Sica S2, Finizio O2, Kropp MG2, Fioritoni G2, Cerqui E2, Vignetti M2, Amadori S2, Schlenk RF2, Platzbecker U2, Lo-Coco F2.

Yayın : J Clin Oncol. 2014 Sep 22. pii: JCO.2014.55.3453. [Epub ahead of print]

Yayın Yılı : 2014

Pubmed Linki : http://www.ncbi.nlm.nih.gov/pubmed/25245446

Konu : Lösemi

Literatür İçeriği : 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. ©American Society of Clinical Oncology.

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