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Cancer Research and Treatment > Accepted Articles
doi: https://doi.org/10.4143/crt.2022.004    [Accepted]
Busulfan, Melphalan, and Etoposide (BuME) Showed an Equivalent Effect to Busulfan, Cyclophosphamide, and Etoposide (BuCE) as Conditioning Therapy for Autologous Stem Cell Transplantation in Patients with Relapsed or High Risk Non-Hodgkin’s Lymphoma: A Multicenter Randomized Phase II Study by the Consortium for Improving Survival of Lymphoma (CISL)
Kyoung Ha Kim1 , Jae Hoon Lee2, Mark Lee3, Hoon-Gu Kim4, Young Rok Do5, Yong Park6, Sung Yong Oh7, Ho-Jin Shin8, Won Seog Kim9, Sung-Kyu Park10, Jee Hyun Kong11, Moo-Rim Park12, Deok-Hwan Yang13, Jae-Yong Kwak14, Hye Jin Kang15, Yeung-Chul Mun16, Jong-Ho Won1
1Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea
2Deparment of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea
3Department of Internal Medicine, Konkuk University Medical Center and School of Medicine, Seoul, Korea
4Department of Internal Medicine, Institute of Health Sciences, Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, Korea
5Division of Hematology-Oncology, Department of Medicine, Dongsan Medical Center, Keimyung University, Daegu, Korea
6Division of Hematology/Oncology, Department of Internal Medicine, Korea University School of Medicine, Seoul, Korea
7Department of Internal Medicine, Dong-A University College of Medicine, Pusan, Korea
8Division of Hematology-Oncology, Department of Internal Medicine, Pusan National University School of Medicine and Medical Research Institute, Pusan National University Hospital, Pusan, Korea
9Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
10Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea
11Division of Oncology and Hematology, Department of Internal Medicine, Wonju Severance Christian Hospital,Yonsei University Wonju College of Medicine, Wonju, Korea
12Department of Internal Medicine, Wonkwang University School of Medicine, Iksan, Korea
13Department of Hematology/Oncology, Chonnam National University Hwasun Hospital, Hwasun, Korea
14Division of Hematology/Oncology, Department of Internal Medicine, Chonbuk National University Medical School, Jeonju, Korea
15Division of Hematology-Oncology, Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Science, Seoul, Korea
16Department of Internal Medicine, Ewha Womans University School of Medicine, Seoul, Korea
Correspondence  Jong-Ho Won ,Tel: 82-2-709-9203, Fax: 82-2-709-9200, Email: jhwon@schmc.ac.kr
Received: January 3, 2022;  Accepted: March 29, 2022.  Published online: March 30, 2022.
ABSTRACT
Purpose
High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) is the standard management for relapsed or high-risk non-Hodgkin’s lymphoma (NHL). We reported the busulfan/melphalan/etoposide (BuME) conditioning regimen was effective in patients with relapsed or high-risk NHL. Moreover, the busulfan/cyclophosphamide/etoposide (BuCE) conditioning regimen has been used widely in ASCT for NHL. Therefore, based on these encouraging results, this randomized phase II multicenter trial compared the outcomes of BuME and BuCE as conditioning therapies for ASCT in patients with NHL.
Materials and Methods
Patients were randomly assigned to receive either BuME (n=36) or BuCE (n=39). The BuME regimen was comprised of busulfan (3.2 mg/kg/day, intravenous [i.v.]) administered on Days -7, -6, and -5, etoposide (400 mg/m2 i.v.) on Days -5 and -4, and melphalan (50 mg/m2/day i.v.) on Days- 3 and -2. The BuCE regimen was comprised of busulfan (3.2 mg/kg/day i.v.) on Days -7, -6, and -5, etoposide (400 mg/m2/day i.v.) on Days -5 and -4, and cyclophosphamide (50 mg/kg/day i.v.) on Days -3 and -2. The primary endpoint was 2-year progression-free survival (PFS).
Results
Seventy-five patients were enrolled. Eleven (30.5%) patients in the BuME group and 13 (33.3%) patients in the BuCE group had disease progression or died. The 2-year PFS rate was 65.4% in the BuME group and 60.6% in the BuCE group (p=0.75). There were no non-relapse mortalities within 100 days after transplantation.
Conclusion
There were no significant differences in PFS between the two groups. Therefore, busulfan-based conditioning regimens, BuME and BuCE, may be important treatment substitutes for the BCNU-containing regimens.
Key words: Autologous stem cell transplantation, Non-Hodgkin’s lymphoma, Busulfan
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