Original Article
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Blood Res 2021; 56(2):
Published online June 30, 2021
https://doi.org/10.5045/br.2021.2021086
© The Korean Society of Hematology
Lenalidomide for anemia correction in lower-risk del(5q) myelodysplastic syndrome patients of Asian ethnicity
Correspondence to : Je-Hwan Lee, M.D., Ph.D.
University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea
E-mail: jhlee3@amc.seoul.kr
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background
To estimate real-world outcomes in East Asian populations, we conducted a nationwide retrospective analysis of the efficacy and safety of lenalidomide for del(5q) myelodysplastic syndrome (MDS) patients with transfusion-dependent anemia in Korea.
Methods
Patients aged ≥19 years who had received lenalidomide for the treatment of lower-risk, red blood cell (RBC) transfusion-dependent del(5q) MDS were selected. A filled case report form (CRF) with information from electronic medical records was requested from members of the acute myeloid leukemia (AML)/MDS Working Party of the Korean Society of Hematology. All the CRFs were gathered and analyzed.
Results
A total of 31 patients were included in this study. Of 28 evaluable patients, 19 (67.9%) achieved RBC transfusion independence (RBC-TI). Female sex and the development of thrombocytopenia during treatment were associated with achieving RBC-TI. The most common non-hematologic toxicities were pruritus, fatigue, and rashes. All non-hematologic toxicities of grades ≥3 were limited to rash (12.9%) and pruritus (6.5%). Dose reduction was required in 15 of the 19 responders (78.9%). The most common final stable dosing schedule for the responders was 5 mg once every other day (31.6%).
Conclusion
Lenalidomide efficacy and tolerability were similar in the Asian del(5q) MDS patients and western patients. Dose reduction during treatment was common, but it was not associated with inferior outcomes.
Keywords 5q deletion syndrome, Myelodysplastic syndrome, Lenalidomide, Anemia
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Original Article
Blood Res 2021; 56(2): 102-108
Published online June 30, 2021 https://doi.org/10.5045/br.2021.2021086
Copyright © The Korean Society of Hematology.
Lenalidomide for anemia correction in lower-risk del(5q) myelodysplastic syndrome patients of Asian ethnicity
Junshik Hong1, Yoo Jin Lee2, Sung Hwa Bae3, Jun Ho Yi4, Sungwoo Park5, Myung Hee Chang6, Young Hoon Park7, Shin Young Hyun8, Joo-Seop Chung9, Ji Eun Jang10, Joo Young Jung11, So-Yeon Jeon12, Seo-Young Song13, Hawk Kim14, Dae Sik Kim15, Sung-Hyun Kim16, Min Kyoung Kim17, Sang Hoon Han18, Seonyang Park19, Yoo-Jin Kim20, Je-Hwan Lee21, on behalf of the AML/MDS Working Party of the Korean Society of Hematology
1Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, 2Department of Hematology and Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, 3Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu Catholic University Hospital, Daegu, 4Division of Hematology-Oncology, Chung-Ang University Hospital, Seoul, Department of Internal Medicine, 5Gyeongsang National University Hospital, Gyeongsang National University School of Medicine, Jinju, 6National Health Insurance Service Ilsan Hospital, Goyang, 7Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, 8Yonsei University Wonju College of Medicine, Wonju, 9Pusan National University College of Medicine, Pusan National University Hospital, Busan, 10Division of Hematology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, 11Department of Internal Medicine, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, 12Division of Oncology and Hematology, Department of Internal Medicine, Jeonbuk National University Hospital-Jeonbuk National University Medical School, Jeonju, 13Department of Internal Medicine, Kangwon National University College of Medicine, Kangwon National University Hospital, Chuncheon, 14Division of Hematology, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Division of Hematology-Oncology, Department of Internal Medicine, 15Korea University Guro Hospital, Seoul, 16Dong-A University College of Medicine, Dong-A University Hospital, Busan, 17Yeungnam University College of Medicine, Daegu, Department of Internal Medicine, 18Jeju National University Hospital, Jeju National University School of Medicine, Jeju, 19Inje University Haeundae Paik Hospital, Busan, 20Seoul St. Mary’s Hematology Hospital, College of Medicine, The Catholic University of Korea, 21University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
Correspondence to:Je-Hwan Lee, M.D., Ph.D.
University of Ulsan College of Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea
E-mail: jhlee3@amc.seoul.kr
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background
To estimate real-world outcomes in East Asian populations, we conducted a nationwide retrospective analysis of the efficacy and safety of lenalidomide for del(5q) myelodysplastic syndrome (MDS) patients with transfusion-dependent anemia in Korea.
Methods
Patients aged ≥19 years who had received lenalidomide for the treatment of lower-risk, red blood cell (RBC) transfusion-dependent del(5q) MDS were selected. A filled case report form (CRF) with information from electronic medical records was requested from members of the acute myeloid leukemia (AML)/MDS Working Party of the Korean Society of Hematology. All the CRFs were gathered and analyzed.
Results
A total of 31 patients were included in this study. Of 28 evaluable patients, 19 (67.9%) achieved RBC transfusion independence (RBC-TI). Female sex and the development of thrombocytopenia during treatment were associated with achieving RBC-TI. The most common non-hematologic toxicities were pruritus, fatigue, and rashes. All non-hematologic toxicities of grades ≥3 were limited to rash (12.9%) and pruritus (6.5%). Dose reduction was required in 15 of the 19 responders (78.9%). The most common final stable dosing schedule for the responders was 5 mg once every other day (31.6%).
Conclusion
Lenalidomide efficacy and tolerability were similar in the Asian del(5q) MDS patients and western patients. Dose reduction during treatment was common, but it was not associated with inferior outcomes.
Keywords: 5q deletion syndrome, Myelodysplastic syndrome, Lenalidomide, Anemia
Fig 1.
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Table 1 . Patient characteristics..
Parameter N (%) Age at lenalidomide initiation (yr) Median (range) 66 (46–83) Sex Male 8 (25.8) Female 23 (74.2) Time from initial MDS diagnosis to lenalidomide initiation (wk) Median 56 Range 0–424 Transfusion dependence At MDS diagnosis 23 (74.2) At lenalidomide initiation 31 (100) Karyotype Isolated del(5q) only 28 (90.3) +1 additional abnormality 3 (9.7) WHO classification MDS with isolate del(5q) 27 (87.1) MDS, multilineage dysplasia 2 (6.5) MDS, excess blast-1 1 (3.2) MDS, unclassifiable 1 (3.2) International Prognosis Scoring System (IPSS) Low 16 (51.6) Intermediate-1 15 (48.4) Intermediate-2 or high 0 (0%) IPSS-revised (IPSS-R) Very low 2 (6.5) Low 16 (51.6) Intermediate 15 (41.9) High/very high 0 (0) Abbreviaion: MDS, myelodysplastic syndrome..
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Table 2 . Evaluation of potential predictors for RBC-TI..
Response no Response yes P Male 5 2 0.020 Female 4 17 Age 7 8 0.086 Age≥median 2 11 MDS diagnosis to lenalidomide initiation<2 yr 4 11 0.410 MDS diagnosis to lenalidomide initiation≥2 yr 5 8 IPSS low 5 10 0.604 IPSS intermediate-1 4 9 Pre-treatment red blood cell transfusion≤4 U/8 wk 3 11 0.210 Pre-treatment red blood cell transfusion>4U/8 wk 6 8 Pre-treatment neutrophil≥1,000/mL 5 16 0.123 Pre-treatment neutrophil<1,000/mL 4 3 Pre-treatment platelet≥150K/mL 5 17 0.064 Pre-treatment platelet<150K/mL 4 2 Development of thrombocytopenia during treatment 1 7 0.038 No development of thrombocytopenia during treatment 8 12 Abbreviation: IPSS, International prognostic scoring system..
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Table 3 . Hematologic and non-hematologic toxicities (worst during treatment)..
Toxicity None Grade 1 Grade 2 Grade 3 Grade 4 Any (%) Grade 3/4 (%) Hematologic Neutropenia 7 1 1 13 9 24 (77.4) 22 (71.0) Lymphopenia 20 5 3 3 0 8 (25.8) 3 (9.7) Thrombocytopenia 11 9 3 3 5 20 (64.5) 8 (25.8) Febrile neutropenia 28 -a) -a) 3 0 3 (9.7) 3 (9.7) Non-hematologic Pruritus 16 8 5 2 0 15 (48.4) 2 (6.5) Fatigue 17 12 2 0 0 14 (45.2) 0 Rash 22 5 0 4 0 9 (29.0) 4 (12.9) Diarrhea 26 3 2 0 0 5 (16.2) 0 Dyspepsia 28 1 2 0 0 3 (9.7) 0 Constipation 29 2 0 0 0 2 (6.5) 0 Headache 30 0 1 0 0 1 (3.2) 0 Insomnia 30 0 1 0 0 1 (3.2) 0 Deep vein thrombosis 30 0 1 0 0 1 (3.2) 0 Dyspnea 30 1 0 0 0 1 (3.2) 0 Tongue discoloration 30 1 0 0 0 1 (3.2) 0 Loss of appetite 30 1 0 0 0 1 (3.2) 0 Increased creatinine 30 0 1 0 0 1 (3.2) 0 a)Grade 1 or 2 febrile neutropenia is not defined in the Common Toxicity Criteria for Adverse Events v5.0..
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Table 4 . Final stable dose of lenalidomide for responders (N=19)..
Lenalidomide dosing Patient No. Dose intensity
(mg/day)10 mg once daily 1 10 10 mg once daily for 3 wk, 1-wk rest 3 7.5 10 mg once every other day 1 5 5 mg once daily 4 5 5 mg once daily for 3 wk, 1-wk rest 4 3.75 5 mg once every other day 6 2.5
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