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
| Autor: | Kohta Miyawaki, Koji Kato, Naoyuki Katayama, Isao Yoshida, Satoshi Tamaru, Kazutaka Sunami, Kinya Ohata, Go Yamamoto, Tadahiko Igarashi, Koji Izutsu, Masakatsu Nishikawa, Naoko Asano, Masataka Okamoto, Junji Suzumiya, Koichi Ohshima, Hiroki Yano, Kana Miyazaki, Yuki Nishimura, Motoko Yamaguchi, Tomohiro Kinoshita, Tomomi Yamada, Momoko Nishikori, Rika Sakai, Naoki Takahashi |
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| Rok vydání: | 2020 |
| Předmět: |
Vincristine
medicine.medical_specialty Phases of clinical research Neutropenia Gastroenterology Article 03 medical and health sciences 0302 clinical medicine immune system diseases Median follow-up hemic and lymphatic diseases Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans EPOCH (chemotherapy) Cyclophosphamide Etoposide business.industry Hematology medicine.disease Methotrexate Doxorubicin 030220 oncology & carcinogenesis Prednisone Rituximab Lymphoma Large B-Cell Diffuse Neoplasm Recurrence Local business Diffuse large B-cell lymphoma Febrile neutropenia 030215 immunology medicine.drug |
| Zdroj: | Haematologica |
| ISSN: | 1592-8721 0390-6078 |
| Popis: | 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.) |
| Databáze: | OpenAIRE |
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