Bendamustine plus rituximab in Japanese patients with relapsed or refractory diffuse large B-cell lymphoma

被引：5

作者：

Murayama, Kayoko ^{[1
]}

Kiguchi, Toru ^{[2
,3
]}

Izutsu, Koji ^{[4
]}

Kameoka, Yoshihiro ^{[5
,6
]}

Hidaka, Michihiro ^{[7
]}

Kato, Harumi ^{[8
]}

Rai, Shinya ^{[9
]}

Kuroda, Junya ^{[10
]}

Ishizawa, Kenichi ^{[11
]}

Ichikawa, Satoshi ^{[12
]}

Ando, Kiyoshi ^{[13
]}

Ogura, Michinori ^{[14
]}

Fukushima, Koji ^{[15
]}

Terui, Yasuhito ^{[16
,17
]}

机构：

[1] Gunma Prefectural Canc Ctr, Dept Hematol, Ota, Japan

[2] Chugoku Cent Hosp, Dept Hematol, Fukuyama, Hiroshima, Japan

[3] Dokkyo Med Univ, Saitama Med Ctr, Dept Diabet Endocrinol & Hematol, 2-1-50 Minami Koshigaya, Koshigaya, Saitama 3438555, Japan

[4] Natl Canc Ctr, Dept Hematol Tokyo, Tokyo, Japan

[5] Akita Univ, Grad Sch Med, Dept Hematol Nephrol & Rheumatol, Akita, Japan

[6] Akita Univ, Fac Med, Akita, Japan

[7] Natl Hosp Org Kumamoto Med Ctr, Dept Hematol, Kumamoto, Japan

[8] Aichi Canc Ctr Hosp, Dept Hematol & Cell Therapy, Nagoya, Aichi, Japan

[9] Kindai Univ, Fac Med, Dept Hematol & Rheumatol, Osakasayama, Japan

[10] Kyoto Prefectural Univ Med, Dept Med, Div Hematol & Oncol, Kyoto, Japan

[11] Yamagata Univ, Fac Med, Dept Internal Med 3, Yamagata, Japan

[12] Tohoku Univ, Grad Sch Med, Dept Hematol & Rheumatol, Sendai, Miyagi, Japan

[13] Tokai Univ, Sch Med, Dept Hematol & Oncol, Isehara, Kanagawa, Japan

[14] Kasugai Municipal Hosp, Dept Hematol & Oncol, Kasugai, Aichi, Japan

[15] SymBio Pharmaceut Ltd, Med Affairs Dept, Res & Dev Div, Tokyo, Japan

[16] Canc Inst Hosp JFCR, Dept Hematol Oncol, Tokyo, Japan

[17] Saitama Med Univ, Dept Hematol, Saitama, Japan

来源：

ANNALS OF HEMATOLOGY | 2022年 / 101卷 / 05期

关键词：

Bendamustine hydrochloride; Lymphoma; Large B cell; Diffuse; Recurrence; Rituximab; Salvage therapy; MULTICENTER PHASE-II;

D O I：

10.1007/s00277-022-04801-2

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

This single-arm phase 3 study was conducted to confirm the results of our phase 2 study of bendamustine (B)-rituximab (R) in patients with relapsed/refractory diffuse large B cell lymphoma (rrDLBCL). The primary endpoint was overall response rate (ORR). Autologous stem cell transplantation-ineligible rrDLBCL patients with <= 2 prior chemotherapy regimens received R 375 mg/m(2) IV on day 1 and B 120 mg/m(2)/day IV on days 2 and 3 every 21 days up to 6 cycles. Thirty-eight patients with a median age of 74 years (range, 43-86) received BR. The ORR and complete response rates were 76.3% and 47.4%, respectively. With a median follow-up of 19.5 months including long-term follow-up, median progression-free survival was 11.9 months. Median OS was 29.2 months. Discontinuation of treatment due to Gr3-5 TEAE was observed among 13 of 38 patients (34.2%). One patient with cytomegalovirus enterocolitis died during follow-up. This BR regimen was confirmed to be effective and tolerable in studied patients. ClinicalTrials.gov Identifier: NCT03372837 registered on 14 December 2017, NCT04354402 registered on 21 April, 2020.

引用

页码：979 / 989

页数：11

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