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Clinical Trial
. 2020 Sep 1;105(9):2308-2315.
doi: 10.3324/haematol.2019.231076.

DA-EPOCH-R combined with high-dose methotrexate in patients with newly diagnosed stage II-IV CD5-positive diffuse large B-cell lymphoma: a single-arm, open-label, phase II study

Kana Miyazaki  1 , Naoko Asano  2 , Tomomi Yamada  3 , Kohta Miyawaki  4 , Rika Sakai  5 , Tadahiko Igarashi  6 , Momoko Nishikori  7 , Kinya Ohata  8 , Kazutaka Sunami  9 , Isao Yoshida  10 , Go Yamamoto  11 , Naoki Takahashi  12 , Masataka Okamoto  13 , Hiroki Yano  14 , Yuki Nishimura  15 , Satoshi Tamaru  15 , Masakatsu Nishikawa  15 , Koji Izutsu  16 , Tomohiro Kinoshita  17 , Junji Suzumiya  18 , Koichi Ohshima  19 , Koji Kato  4 , Naoyuki Katayama  20 , Motoko Yamaguchi  20
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Clinical Trial

DA-EPOCH-R combined with high-dose methotrexate in patients with newly diagnosed stage II-IV CD5-positive diffuse large B-cell lymphoma: a single-arm, open-label, phase II study

Kana Miyazaki et al. Haematologica. .

Abstract

CD5-positive diffuse large B-cell lymphoma (CD5+ DLBCL) is characterized by poor prognosis and a high frequency of central nervous system relapse after standard immunochemotherapy. We conducted a phase II study to investigate the efficacy and safety of dose-adjusted (DA)- EPOCH-R (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) combined with high-dose methotrexate (HD-MTX) in newly diagnosed patients with CD5+ DLBCL. Previously untreated patients with stage II to IV CD5+ DLBCL according to the 2008 World Health Organization classification were eligible. Four cycles of DA-EPOCH-R followed by two cycles of HD-MTX and four additional cycles of DAEPOCH- R (DA-EPOCH-R/HD-MTX) were planned as the protocol treatment. The primary end point was 2-year progression-free survival (PFS). Between September 25, 2012, and November 11, 2015, we enrolled 47 evaluable patients. Forty-five (96%) patients completed the protocol treatment. There were no deviations or violations in the DA-EPOCH-R dose levels. The complete response rate was 91%, and the overall response rate was 94%. At a median follow up of 3.1 years (range, 2.0-4.9 years), the 2- year PFS was 79% [95% confidence interval (CI): 64-88]. The 2-year overall survival was 89% (95%CI: 76-95). Toxicity included grade 4 neutropenia in 46 (98%) patients, grade 4 thrombocytopenia 12 (26%) patients, and febrile neutropenia in 31 (66%) patients. No treatment-related death was noted during the study. DA-EPOCH-R/HD-MTX might be a first-line therapy option for stage II-IV CD5+ DLBCL and warrants further investigation. (Trial registered at: UMIN-CTR: UMIN000008507.).

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Figures

Figure 1.
Figure 1.
Trial profile.
Figure 2.
Figure 2.
Survival curves for patients with CD5-positive diffuse large B-cell lymphoma. (A) Progression-free survival and (B) overall survival for all patients (n=47).
Figure 3.
Figure 3.
Central nervous system (CNS) relapse in CD5-positive diffuse large B-cell lymphoma patients (n=47). (A) Probability of CNS relapse. (B) Probability of CNS relapse according to the CNS-International Prognostic Index.
See this image and copyright information in PMC

References

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