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Tamibarotene maintenance improved relapse-free survival of acute promyelocytic leukemia: a final result of prospective, randomized, JALSG-APL204 study.

Transfusion and Cell Therapy, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu, 431-3192, Japan. akihirot@hama-med.ac.jp. International Medical Center, Saitama Medical University, 1397-1 Yamane, Hidaka, 350-1298, Japan. The Japanese Data Center for Hematopoietic Cell Transplantation, 1-1-20 Taikou-minami, Higashiku, Nagoya, 461-0047, Japan. Hematology, Saiseikai Maebashi Hospital, 564-1 Kamishindenmachi, Maebashi, 371-0821, Japan. Hematology/Oncology, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, 710-8602, Japan. Hematology and Oncology, Anjo Kosei Hospital, 28 Higashikurokute, Anjochou, Anjo, 446-8602, Japan. Clinical Oncology and Hematology, The Jikei University School of Medicine, 3-19-18 Nishisinbashi, Minatoku, Tokyo, 105-8471, Japan. Hematology and Rheumatology, Kindai University Faculty of Medicine, 377-2 Ohnohigashi, Ohsakasayama, 589-8511, Japan. Hematology and Oncology, Tokai University School of Medicine, 143 Shimokasuya, Isahara, 259-1193, Japan. Hematology and Rheumatology, Nihon University School of Medicine, 30-1 Ohyaguchi Kamichou, Itabashiku, Tokyo, 173-8610, Japan. Hematology, Japanese Red Cross Ise Hospital, 1-471-2 Funae, Ise, 516-8512, Japan. Hematology and Clinical Immunology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawaku, Yokohama, 236-0004, Japan. Hematology, Fujisawa City Hospital, 2-6-1 Fujisawa, Fujisawa, 251-8550, Japan. Transfusion and Cell Therapy, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashiku, Hamamatsu, 431-3192, Japan. Hematology, Saiseikai Yokohama Nanbu Hospital, 3-2-10 Kounandai, Kounanku, Yokohama, 234-0054, Japan. Hematology, Fujita Health University School of Medicine, 1-98 Dengakugakubo, Kutsukakecho, Toyoake, 470-1192, Japan. Hematology, Oncology and Respiratory Medicine, Okayama University Medical School, 2-5-1 Shikatachou, Kitaku, Okayama, 700-8558, Japan. National Cancer Center Hospital, 5-1-1 Tsukiji, Chuouku, Tokyo, 104-0045, Japan. Hematology and Oncology, Nagoya University Graduate School of Medicine, 65 Tsurumaichou, Showaku, Nagoya, 466-8550, Japan. Kanazawa University, Kakumamachi, Kanazawa, 920-1192, Japan. National Hospital Organization Nagoya Medical Center, 4-1-1 Sannomaru, Nakaku, Nagoya, 460-0001, Japan. Hematology, Atomic Bomb Disease Institute, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan.

Leukemia. 2019;(2):358-370
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Abstract

Between April 2004 and December 2010, we conducted a prospective randomized controlled study comparing tamibarotene with all-trans retinoic acid (ATRA) in the maintenance therapy of newly diagnosed acute promyelocytic leukemia (APL), and here report the final results of this study with a median follow-up of 7.3 years. Of 344 eligible patients who had received ATRA and chemotherapy, 319 (93%) achieved complete remission (CR). After completion of three courses of consolidation chemotherapy, 269 patients in molecular remission underwent maintenance randomization, 135 to ATRA (45 mg/m2 daily), and 134 to tamibarotene (6 mg/m2 daily) for 14 days every 3 months for 2 years. The primary endpoint was relapse-free survival (RFS). The 7-year RFS was 84% in the ATRA arm and 93% in the tamibarotene arm (p = 0.027, HR = 0.44, 95% CI, 0.21 to 0.93). The difference was prominent in high-risk patients with initial leukocytes ≥ 10.0 × 109/L (62% vs. 89%; p = 0.034). Tamibarotene was significantly superior to ATRA by decreasing relapse in high-risk patients. Overall survival after randomization did not differ (96% vs. 97%; p = 0.520). Secondary hematopoietic disorders developed in nine patients, secondary malignancies in 11, and grade 3 or more late cardiac comorbidities in three. These late complications did not differ between the two arms.

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Publication Type : Randomized Controlled Trial

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