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Predictors of early death, serious hemorrhage, and differentiation syndrome in Japanese patients with acute promyelocytic leukemia.

Division of Hematology, Shiga University of Medical Science, Seta Tsukinowa-cho, Otsu, Shiga, 520-2192, Japan. minamigh@belle.shiga-med.ac.jp. Hematology, Saiseikai Yokohama Nanbu Hospital, Yokohama, Japan. The Japanese Data Center for Hematopoietic Cell Transplantation, Nagoya, Japan. Department of Healthcare Administration, Nagoya University Graduate School of Medicine, Nagoya, Japan. International Medical Center, Saitama Medical University, Hidaka, Japan. Hematology, Saiseikai Maebashi Hospital, Maebashi, Japan. Hematology/Oncology, Kurashiki Central Hospital, Kurashiki, Japan. Hematology and Oncology, Anjo Kosei Hospital, Anjo, Japan. Clinical Oncology and Hematology, The Jikei University School of Medicine, Tokyo, Japan. Hematology and Rheumatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan. Hematology and Oncology, Tokai University Faculty of Medicine, Isahara, Japan. Hematology and Rheumatology, Nihon University School of Medicine, Tokyo, Japan. Hematology, Fujita Health University School of Medicine, Toyoake, Japan. Hematology, Japanese Red Cross Ise Hospital, Ise, Japan. Hematology and Clinical Immunology, Yokohama City University School of Medicine, Yokohama, Japan. Hematology, Fujisawa City Hospital, Fujisawa, Japan. Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan. Hematology, Oncology and Respiratory Medicine, Okayama University Medical School, Okayama, Japan. Clinical Epidemiology, Nagasaki University School of Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. Hematology, National Cancer Center Hospital, Tokyo, Japan. Hematology, International University of Health and Welfare, Mita Hospital, Tokyo, Japan. Kanazawa University, Kanazawa, Japan. Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan. Hematology, Atomic Bomb Disease Institute, Nagasaki University, Nagasaki, Japan. National Hospital Organization Nagoya Medical Center, Nagoya, Japan. Transfusion and Cell Therapy, Hamamatsu University School of Medicine, Hamamatsu, Japan.

Annals of hematology. 2020;(12):2787-2800
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Abstract

Significant advancements have been achieved with regard to the outcomes of acute promyelocytic leukemia (APL) patients through the introduction of all-trans retinoic acid; however, early hemorrhagic death and differentiation syndrome remain the major causes of remission induction failure in patients with APL. To investigate early death, serious hemorrhage, and differentiation syndrome during remission induction therapy in terms of incidence, risk factors, influence on outcomes, and prophylactic effects of several new anticoagulants, the results of 344 patients enrolled in the Acute Promyelocytic Leukemia 204 study conducted by the Japan Adult Leukemia Study Group were analyzed. Early death was observed in 16 patients (4.7%), of whom 14 had serious hemorrhage and 2 had differentiation syndrome. Serious hemorrhage and differentiation syndrome of grade 2 or higher were observed in 21 and 54 patients, respectively. Patients who achieved complete remission had a 7-year disease-free survival of 84.8% if they did not experience serious hemorrhage and 40.0% if they experienced serious hemorrhage during remission induction therapy (P = 0.001). Risk factor analyses showed that higher white blood cell count was associated with early death, higher white blood cell count and lower platelet count with serious hemorrhage, and leukocytosis during induction therapy and higher body surface area with differentiation syndrome. In conclusion, these results indicate that patients with such high-risk features may benefit from more intensive supportive care. The hemorrhagic risk was not relieved by the introduction of new anticoagulants. Further studies are required to establish the predictive impact of body surface area on differentiation syndrome. This trial is registered with UMIN-CTR as C000000154 on September 13, 2005.

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Publication Type : Clinical Trial

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