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Original Article

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Blood Res 2023; 58(4):

Published online December 31, 2023

https://doi.org/10.5045/br.2023.2023206

© The Korean Society of Hematology

A multi-center and non-interventional registry of brentuximab vedotin in patients with relapsed or refractory CD30-positive lymphoma: the CISL1803/BRAVO study

Seok Jin Kim1, Young Rok Do2, Ho-Sup Lee3, Won-Sik Lee4, Jee Hyun Kong5,6, Jae-Yong Kwak7, Hyeon-Seok Eom8, Joon Ho Moon9, Jun Ho Yi10, Jeong-Ok Lee11, Jae-Cheol Jo12, Deok-Hwan Yang13

Author Info. +

1Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Department of Internal Medicine, 2Dongsan Medical Center, Daegu, 3Kosin University Gospel Hospital, 4Inje University Busan Paik Hospital, Busan, 5Division of Hematology-Oncology, Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, 6Center of Evidence Based Medicine, Institute of Convergence Science, Yonsei University, Seoul, 7Department of Internal Medicine, Jeonbuk National University Medical School, Jeonju, 8Hematology-Oncology Clinic, National Cancer Center, Goyang, Department of Internal Medicine, 9Kyungpook National University Hospital, Daegu, 10Chung-Ang University Hospital, Seoul, 11Seoul National University Bundang Hospital, Seongnam, Department of Hematology and Oncology, 12Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, 13Chonnam National University Medical School and Hwasun Hospital, Hwasun, Korea

Correspondence to : Seok Jin Kim, M.D., Ph.D.
Deok-Hwan Yang, M.D., Ph.D.
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro Gangnam-gu, Seoul 06351, Korea (S.J.K.)
Department of Hematology-Oncology, Chonnam National University Medical School and Hwasun Hospital, 322 Seoyang-ro, Hwasun-eup, Hwasun 58128, Korea (D.H.Y.)
E-mail: S.J.K., kstwoh@skku.edu
D.H.Y., drydh1685@hotmail.com

*This study was supported by Takeda Pharmaceuticals.

Received: October 23, 2023; Revised: November 19, 2023; Accepted: November 22, 2023

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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Background
Brentuximab vedotin (BV), a potent antibody-drug conjugate, targets the CD30 antigen. In Korea, BV has been approved for the treatment of relapsed or refractory Hodgkin lymphoma (HL), anaplastic large-cell lymphoma (ALCL), and cutaneous T-cell lymphomas, including mycosis fungoides (MF). However, there are limited data reflecting real-world experiences with BV treatment for HL, ALCL, and MF.
Methods
This was a multicenter, non-interventional registry study of the efficacy and safety of BV in patients with relapsed or refractory CD30-positive lymphoma (CISL1803/BRAVO). Outcomes were determined based on the occurrence of relapse or progression and overall survival after BV treatment.
Results
A total of 85 patients were enrolled in this study. The median number of BV cycles was 10 (range, 2‒16) in the patients with HL. The objective response rate (ORR) of patients with HL to BV was 85.4% (41/48), comprising 27 complete responses (CRs) and 14 partial responses (PRs). The ORR of ALCL was 88% (22/25), consisting of 17 CRs and five PRs, whereas the ORR of MF was 92% (11/12). At the median follow-up of 44.6 months after BV treatment, the median post-BV progression-free survival of HL, ALCL, and MF patients was 23.6 months, 29.0 months, and 16.7 months, respectively (P=0.641). The most common side effect of BV was peripheral neuropathy; 22 patients (25.9%, 22/85) experienced peripheral neuropathy (all grades).
Conclusion
The treatment outcomes of patients with relapsed or refractory CD30-positive lymphoma improved with BV treatment, and the safety profile was manageable.

Graphical Abstract

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Keywords: Brentuximab vedotin, CD30, Lymphoma, Outcome

Article

Original Article

Blood Res 2023; 58(4): 194-200

Published online December 31, 2023 https://doi.org/10.5045/br.2023.2023206

Copyright © The Korean Society of Hematology.

A multi-center and non-interventional registry of brentuximab vedotin in patients with relapsed or refractory CD30-positive lymphoma: the CISL1803/BRAVO study

Seok Jin Kim1, Young Rok Do2, Ho-Sup Lee3, Won-Sik Lee4, Jee Hyun Kong5,6, Jae-Yong Kwak7, Hyeon-Seok Eom8, Joon Ho Moon9, Jun Ho Yi10, Jeong-Ok Lee11, Jae-Cheol Jo12, Deok-Hwan Yang13

1Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Department of Internal Medicine, 2Dongsan Medical Center, Daegu, 3Kosin University Gospel Hospital, 4Inje University Busan Paik Hospital, Busan, 5Division of Hematology-Oncology, Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, 6Center of Evidence Based Medicine, Institute of Convergence Science, Yonsei University, Seoul, 7Department of Internal Medicine, Jeonbuk National University Medical School, Jeonju, 8Hematology-Oncology Clinic, National Cancer Center, Goyang, Department of Internal Medicine, 9Kyungpook National University Hospital, Daegu, 10Chung-Ang University Hospital, Seoul, 11Seoul National University Bundang Hospital, Seongnam, Department of Hematology and Oncology, 12Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, 13Chonnam National University Medical School and Hwasun Hospital, Hwasun, Korea

Correspondence to:Seok Jin Kim, M.D., Ph.D.
Deok-Hwan Yang, M.D., Ph.D.
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro Gangnam-gu, Seoul 06351, Korea (S.J.K.)
Department of Hematology-Oncology, Chonnam National University Medical School and Hwasun Hospital, 322 Seoyang-ro, Hwasun-eup, Hwasun 58128, Korea (D.H.Y.)
E-mail: S.J.K., kstwoh@skku.edu
D.H.Y., drydh1685@hotmail.com

*This study was supported by Takeda Pharmaceuticals.

Received: October 23, 2023; Revised: November 19, 2023; Accepted: November 22, 2023

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
Brentuximab vedotin (BV), a potent antibody-drug conjugate, targets the CD30 antigen. In Korea, BV has been approved for the treatment of relapsed or refractory Hodgkin lymphoma (HL), anaplastic large-cell lymphoma (ALCL), and cutaneous T-cell lymphomas, including mycosis fungoides (MF). However, there are limited data reflecting real-world experiences with BV treatment for HL, ALCL, and MF.
Methods
This was a multicenter, non-interventional registry study of the efficacy and safety of BV in patients with relapsed or refractory CD30-positive lymphoma (CISL1803/BRAVO). Outcomes were determined based on the occurrence of relapse or progression and overall survival after BV treatment.
Results
A total of 85 patients were enrolled in this study. The median number of BV cycles was 10 (range, 2‒16) in the patients with HL. The objective response rate (ORR) of patients with HL to BV was 85.4% (41/48), comprising 27 complete responses (CRs) and 14 partial responses (PRs). The ORR of ALCL was 88% (22/25), consisting of 17 CRs and five PRs, whereas the ORR of MF was 92% (11/12). At the median follow-up of 44.6 months after BV treatment, the median post-BV progression-free survival of HL, ALCL, and MF patients was 23.6 months, 29.0 months, and 16.7 months, respectively (P=0.641). The most common side effect of BV was peripheral neuropathy; 22 patients (25.9%, 22/85) experienced peripheral neuropathy (all grades).
Conclusion
The treatment outcomes of patients with relapsed or refractory CD30-positive lymphoma improved with BV treatment, and the safety profile was manageable.

Keywords: Brentuximab vedotin, CD30, Lymphoma, Outcome

Fig 1.

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Figure 1.Response to brentuximab vedotin and treatment duration. (A) Comparison of response to brentuximab vedotin based on diagnosis. (B) Comparison of number of treatment cycles based on diagnosis.
Blood Research 2023; 58: 194-200https://doi.org/10.5045/br.2023.2023206

Fig 2.

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Figure 2.Response and survival outcomes in Hodgkin lymphoma patients. (A) Comparison of response to brentuximab vedotin (BV) based on the risk of Internal Prognostic Score (IPS). (B) Comparison of post-BV progression-free survival based on risk of IPS.
Blood Research 2023; 58: 194-200https://doi.org/10.5045/br.2023.2023206

Fig 3.

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Figure 3.Survival outcomes after brentuximab vedotin treatment. (A) Progression-free survival and (B) overall survival after brentuximab vedotin treatment.
Blood Research 2023; 58: 194-200https://doi.org/10.5045/br.2023.2023206

Characteristics of patients..


Total (N=85)Hodgkin lymphoma (N=48)Anaplastic large cell lymphoma (N=25)Mycosis fungoides (N=12)
Median age at BV (range, yr)48 (18–84)34 (19–83)55 (18–84)62 (32–84)
Age at BV treatment
Age ≤60 years56 (66)37 (77)14 (56)5 (42)
Age >60 years29 (34)11 (23)11 (44)7 (58)
Sex
Male51 (60)34 (71)13 (52)4 (33)
Female34 (40)14 (29)12 (48)8 (67)
ECOG PS prior to BV
061 (72)32 (67)19 (76)10 (83)
115 (18)11 (23)2 (8)2 (17)
29 (10)5 (10)4 (16)0 (0)
Stage at diagnosis
I/II8/33 (48)4/23 (56)3/4 (28)1/6 (58)
III/IV18/26 (52)6/15 (44)7/11 (72)5/0 (42)
Stage prior to BV
I/II4/35 (46)2/22 (50)1/7 (28)1/6 (58)
III/IV18/28 (54)9/15 (50)5/12 (72)4/1 (42)
Mediastinum
Not involved50 (59)15 (31)23 (92)12 (100)
Involved35 (41)33 (69)2 (8)0 (0)
IPS at diagnosis
Low (0–3 points)35 (73)
High (4–7 points)13 (27)
IPS prior to BV
Low (0–3 points)37 (77)
High (4–7 points)11 (23)
Refractory to 1st-line Tx
No46 (54)27 (56)14 (56)5 (42)
Yes39 (46)21 (44)11 (44)7 (58)
Previous RT before BV
Not done73 (86)38 (79)25 (100)10 (83)
Done12 (14)10 (81)0 (0)2 (17)
Previous ASCT before BV
Not done70 (82)36 (75)22 (88)12 (100)
Done15 (18)12 (25)3 (12)0 (0)
Previous Tx before BV
One line32 (38)8 (17)17 (68)7 (58)
Two lines33 (39)23 (48)7 (28)3 (25)
More than two lines20 (23)17 (35)1 (4)2 (17)
Time between Dx and BV
<12 months26 (30)10 (21)12 (48)4 (33)
12–36 months32 (38)21 (44)6 (24)5 (42)
>36 months27 (32)17 (35)7 (28)3 (25)

Abbreviations: ASCT, autologous stem cell transplantation; BV, brentuximab vedotin; Dx, diagnosis; ECOG, Eastern Cooperative Oncology Group; IPS, International Prognostic Score; PS, performance status..

Safety profile..


Patients (N=85)
All grades G3G4
Anemia730
Anorexia700
Constipation830
Diarrhea521
Fatigue1000
Febrile neutropenia1150
Fever1140
Insomnia300
Nausea1000
Neutropenia1341
Peripheral neuropathy2252
Pneumonia420
Skin rash400
Thrombocytopenia1250
Vomiting200
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