An effective and chemotherapy-free strategy of all-trans retinoic acid and arsenic trioxide for acute promyelocytic leukemia in all risk groups (APL15 trial)
Abstract The combination of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) has been demonstrated to have comparable effectiveness or better to ATRA and chemotherapy (CHT) in non-high-risk acute promyelocytic leukemia (APL). However, the efficacy of ATRA-ATO compared to ATRA-ATO plus CHT i...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Nature Publishing Group
2022-11-01
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| Series: | Blood Cancer Journal |
| Online Access: | https://doi.org/10.1038/s41408-022-00753-y |
| _version_ | 1811211061543567360 |
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| author | Huai-Yu Wang Sha Gong Guo-Hui Li Ya-Zhou Yao Yin-Suo Zheng Xiao-Hong Lu Su-Hua Wei Wei-Wei Qin Hai-Bo Liu Meng-Chang Wang Jie-Ying Xi Li-Mei Chen Mei Zhang Xin-Xin Zhang Hui-Yun Zhang Cheng-Sheng Zhang David N. Wald Hong-Hu Zhu Li Liu Peng-Cheng He |
| author_facet | Huai-Yu Wang Sha Gong Guo-Hui Li Ya-Zhou Yao Yin-Suo Zheng Xiao-Hong Lu Su-Hua Wei Wei-Wei Qin Hai-Bo Liu Meng-Chang Wang Jie-Ying Xi Li-Mei Chen Mei Zhang Xin-Xin Zhang Hui-Yun Zhang Cheng-Sheng Zhang David N. Wald Hong-Hu Zhu Li Liu Peng-Cheng He |
| author_sort | Huai-Yu Wang |
| collection | DOAJ |
| description | Abstract The combination of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) has been demonstrated to have comparable effectiveness or better to ATRA and chemotherapy (CHT) in non-high-risk acute promyelocytic leukemia (APL). However, the efficacy of ATRA-ATO compared to ATRA-ATO plus CHT in high-risk APL remains unknown. Here we performed a randomized multi-center non-inferiority phase III study to compare the efficacy of ATRA-ATO and ATRA-ATO plus CHT in newly diagnosed all-risk APL to address this question. Patients were assigned to receive ATRA-ATO for induction, consolidation, and maintenance or ATRA-ATO plus CHT for induction followed by three cycles of consolidation therapy, and maintenance therapy with ATRA-ATO. In the non-CHT group, hydroxyurea was used to control leukocytosis. A total of 128 patients were treated. The complete remission rate was 97% in both groups. The 2-year disease-free, event-free survival rates in the non-CHT group and CHT group in all-risk patients were 98% vs 97%, and 95% vs 92%, respectively (P = 0.62 and P = 0.39, respectively). And they were 94% vs 87%, and 85% vs 78% in the high-risk patients (P = 0.52 and P = 0.44, respectively). This study demonstrated that ATRA-ATO had the same efficacy as the ATRA-ATO plus CHT in the treatment of patients with all-risk APL. |
| first_indexed | 2024-04-12T05:06:21Z |
| format | Article |
| id | doaj.art-8ff8843d3692431d8c1052988b524ede |
| institution | Directory Open Access Journal |
| issn | 2044-5385 |
| language | English |
| last_indexed | 2024-04-12T05:06:21Z |
| publishDate | 2022-11-01 |
| publisher | Nature Publishing Group |
| record_format | Article |
| series | Blood Cancer Journal |
| spelling | doaj.art-8ff8843d3692431d8c1052988b524ede2022-12-22T03:46:52ZengNature Publishing GroupBlood Cancer Journal2044-53852022-11-0112111810.1038/s41408-022-00753-yAn effective and chemotherapy-free strategy of all-trans retinoic acid and arsenic trioxide for acute promyelocytic leukemia in all risk groups (APL15 trial)Huai-Yu Wang0Sha Gong1Guo-Hui Li2Ya-Zhou Yao3Yin-Suo Zheng4Xiao-Hong Lu5Su-Hua Wei6Wei-Wei Qin7Hai-Bo Liu8Meng-Chang Wang9Jie-Ying Xi10Li-Mei Chen11Mei Zhang12Xin-Xin Zhang13Hui-Yun Zhang14Cheng-Sheng Zhang15David N. Wald16Hong-Hu Zhu17Li Liu18Peng-Cheng He19Department of Hematology, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Hematology, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Hematology, Tangdu Hospital, Air Force Medical UniversityDepartment of Hematology, Baoji Central HospitalDepartment of Hematology, Baoji Central HospitalDepartment of Rheumatology, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Hematology, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Hematology, Tangdu Hospital, Air Force Medical UniversityDepartment of Hematology, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Hematology, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Hematology, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Hematology, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Hematology, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Hematology, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Oncology, Qinghai Provincial People’s HospitalPrecision Medicine Center, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Pathology, Case Western Reserve UniversityDepartment of Hematology, The First Affiliated Hospital, Zhejiang University School of MedicineDepartment of Hematology, Tangdu Hospital, Air Force Medical UniversityDepartment of Hematology, The First Affiliated Hospital of Xi’an Jiaotong UniversityAbstract The combination of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) has been demonstrated to have comparable effectiveness or better to ATRA and chemotherapy (CHT) in non-high-risk acute promyelocytic leukemia (APL). However, the efficacy of ATRA-ATO compared to ATRA-ATO plus CHT in high-risk APL remains unknown. Here we performed a randomized multi-center non-inferiority phase III study to compare the efficacy of ATRA-ATO and ATRA-ATO plus CHT in newly diagnosed all-risk APL to address this question. Patients were assigned to receive ATRA-ATO for induction, consolidation, and maintenance or ATRA-ATO plus CHT for induction followed by three cycles of consolidation therapy, and maintenance therapy with ATRA-ATO. In the non-CHT group, hydroxyurea was used to control leukocytosis. A total of 128 patients were treated. The complete remission rate was 97% in both groups. The 2-year disease-free, event-free survival rates in the non-CHT group and CHT group in all-risk patients were 98% vs 97%, and 95% vs 92%, respectively (P = 0.62 and P = 0.39, respectively). And they were 94% vs 87%, and 85% vs 78% in the high-risk patients (P = 0.52 and P = 0.44, respectively). This study demonstrated that ATRA-ATO had the same efficacy as the ATRA-ATO plus CHT in the treatment of patients with all-risk APL.https://doi.org/10.1038/s41408-022-00753-y |
| spellingShingle | Huai-Yu Wang Sha Gong Guo-Hui Li Ya-Zhou Yao Yin-Suo Zheng Xiao-Hong Lu Su-Hua Wei Wei-Wei Qin Hai-Bo Liu Meng-Chang Wang Jie-Ying Xi Li-Mei Chen Mei Zhang Xin-Xin Zhang Hui-Yun Zhang Cheng-Sheng Zhang David N. Wald Hong-Hu Zhu Li Liu Peng-Cheng He An effective and chemotherapy-free strategy of all-trans retinoic acid and arsenic trioxide for acute promyelocytic leukemia in all risk groups (APL15 trial) Blood Cancer Journal |
| title | An effective and chemotherapy-free strategy of all-trans retinoic acid and arsenic trioxide for acute promyelocytic leukemia in all risk groups (APL15 trial) |
| title_full | An effective and chemotherapy-free strategy of all-trans retinoic acid and arsenic trioxide for acute promyelocytic leukemia in all risk groups (APL15 trial) |
| title_fullStr | An effective and chemotherapy-free strategy of all-trans retinoic acid and arsenic trioxide for acute promyelocytic leukemia in all risk groups (APL15 trial) |
| title_full_unstemmed | An effective and chemotherapy-free strategy of all-trans retinoic acid and arsenic trioxide for acute promyelocytic leukemia in all risk groups (APL15 trial) |
| title_short | An effective and chemotherapy-free strategy of all-trans retinoic acid and arsenic trioxide for acute promyelocytic leukemia in all risk groups (APL15 trial) |
| title_sort | effective and chemotherapy free strategy of all trans retinoic acid and arsenic trioxide for acute promyelocytic leukemia in all risk groups apl15 trial |
| url | https://doi.org/10.1038/s41408-022-00753-y |
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