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Abstract
Abbreviations AE adverse event ASCT autologous stem cell transplantation CI confidence interval CR complete response MCL mantle cell lymphoma ORR overall response rate OS overall survival PFS progression-free survival PR partial response RR relapsed or refractory RT radiation therapy Dear Editor, Despite the introduction of novel front-line therapies including rituximab plus high-dose cytarabine followed by consolidative autologous stem cell transplantation (ASCT) and salvage therapy with bendamustine, lenalidomide or bortezomib, mantle cell lymphoma (MCL) is still considered incurable and most patients experience relapse or refractory (RR) disease. The median progression-free survival (PFS) from the front-line treatment was 24.0 months (95% confidence interval [CI]: 21.6-28.2 months), and the median duration of response was 26.7 months (95% CI: 22.5-31.1 months). Collectively, an overall response rate (ORR) of ∼65% and a median PFS of ∼12 months were observed. TABLE 1 Cross-trials comparison of prospective and retrospective studies dealing with RR MCL patients treated with ibrutinib (median (range) for age and prior lines of therapy; median [95% CI] for DoR, PFS, and OS) Trials Number of patients Age (year, [median, range]) Prior lines Prognostic indices ORR (%) DoR (months) PFS (months) OS (months) Discontinue therapy due to AEs (%) Pooled analysis of three prospective trials [ 4] 370 N/A 2 (1-9) 31.8% high-risk simplified MIPI 69.7 21.8 (17.2-26.4) 12.5 (9.8-16.6) 26.7 (22.5-38.4) 10.3 US retrospective trial [ 5] 97 63 (39-87) 2 (1-8) 27% high-risk MIPI 65 17 15 22 N/A Italian retrospective trial [ 6] 77 68.6 (38.5-83.7) 3 (1-10) N/A 36.4 36 12.9 16 16.9 French observational trial [ 7] 106 74 (49-88) 1 (39%); 2 (31%); ≥3 (30%); N/A 76.4 27.4 (17.3 – N/A) 23.7 (18.3-30.4) 29.9 (23.2-39.2) 9.3 US retrospective trial [ 8] 159 71 (48-90) 2 (1-3) N/A N/A N/A 19.6 (16.5 – 24.3) 25.8 (19.9 – not reached) 25.6 Current study 88 71 (42-92) 1 (1-6) 40.9% high-risk MIPI 64.8 26.7 (22.5-31.1) 20.8 (10.8-30.8) 2-year OS rate 79.5% 6.8 N/A, not available; CI, confidence interval Compared to previous studies [ 10], the post-ibrutinib OS was more favorable in the present study at 19.4 months (vs. 5.8 months).
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1 Division of Hematology-Oncology, Department of Medicine, Chung-Ang University, Dongjak-gu, Seoul, Korea
2 Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Gangnam-gu, Seoul, Korea
3 Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Songpa-gu, Seoul, Korea
4 National Health Insurance Corporation Ilsan Hospital, Ilsandong-gu, Goyang, Korea
5 Department of Hemato-Oncology, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Gwangju, Korea
6 Department of Hematology and Oncology, Ulsan University Hospital, University of Ulsan College of Medicine, Dong-gu, Ulsan, Korea
7 Department of Internal Medicine, Yonsei University Wonju College of Medicine, Gangwon-Do, Wonju, Korea
8 Department of Internal Medicine, National Cancer Center, Goyang-si Gyeonggi-do, Goyang, Korea
9 Department of Internal Medicine, Seoul National University Bundang Hospital, Bundang-gu, Seongnam, Korea
10 Department of Internal Medicine, ChungBuk National University Hospital, Chungbuk, Cheongju, Korea
11 Department of Internal Medicine, Jeju National University Hospital, Jeju National University School of Medicine, Jeju, Korea
12 Department of Hematology-Oncology, Wonkwang University Hospital, Iksan-daero, Iksan, Korea
13 Department of Internal Medicine, Jeonbuk National University Medical School, Jeollabuk-do, Jeonju, Korea
14 Division of Hematology-Oncology, Department of Internal Medicine, Soonchunhyang University, College of Medicine, Bucheon Hospital, Wonmi-gu, Bucheon, Korea
15 Division of Hematology-Oncology, Department of Internal Medicine, Korea University Guro Hospital, Guro-gu, Seoul, Korea
16 Division of Hematology-Oncology, Department of Internal Medicine, Dong-A University College of Medicine, Seo-gu, Busan, Korea
17 Department of Internal Medicine, Division of Hematology-Oncology, Catholic University of Daegu, Daegu, Korea
18 Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Dongan-gu, Anyang, Korea