Lenalidomide for anemia correction in lower-risk del(5q) myelodysplastic syndrome patients of Asian ethnicity

Junshik Hong; Yoo Jin Lee; Sung Hwa Bae; Jun Ho Yi; Sungwoo Park; Myung Hee Chang; Young Hoon Park; Shin Young Hyun; Joo-Seop Chung; Ji Eun Jang; Joo Young Jung; So-Yeon Jeon; Seo-Young Song; Hawk Kim; Dae Sik Kim; Sung-Hyun Kim; Min Kyoung Kim; Sang Hoon Han; Seonyang Park; Yoo-Jin Kim; Je-Hwan Lee; on behalf of the AML/MDS Working Party of the Korean Society of Hematology

doi:10.5045/br.2021.2021086

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Original Article

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Blood Res 2021; 56(2):

Published online June 30, 2021

https://doi.org/10.5045/br.2021.2021086

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

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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

Received: April 23, 2021; Accepted: June 2, 2021

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

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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

Article

Original Article

Blood Res 2021; 56(2): 102-108

Published online June 30, 2021 https://doi.org/10.5045/br.2021.2021086

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

Received: April 23, 2021; Accepted: June 2, 2021

Abstract

Keywords: 5q deletion syndrome, Myelodysplastic syndrome, Lenalidomide, Anemia

Abstract

Fig 1.

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Figure 1.Hemoglobin level changes in responders after lenalidomide treatment (mean±SEM).

Blood Research 2021; 56: 102-108https://doi.org/10.5045/br.2021.2021086

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..

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..

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..

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