Evidence map›Paper›PMID 20626754›Full record

Trial reportCancer science2010

Multicenter phase II study of bendamustine for relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma.

Ken Ohmachi, Kiyoshi Ando, Michinori Ogura, Toshiki Uchida, Kuniaki Itoh, Nobuko Kubota, Kenichi Ishizawa, Joji Yamamoto, Takashi Watanabe, Naokuni Uike and 7 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer science, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 2 pooled it
4.9field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 67 citations in OpenAlex.

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  7. The PARP Inhibitor Veliparib Can Be Safely Added to Bendamustine and Rituximab and Has Preliminary Evidence of Activity in B-Cell Lymphoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 10 institutions in 3 countries.

Ken OhmachiDepartment of Internal Medicine, Tokai University School of Medicine, Kanagawa, Japan.
Kiyoshi Ando
Michinori Ogura
Toshiki Uchida
Kuniaki Itoh
Nobuko Kubota
Kenichi Ishizawa
Joji Yamamoto
Takashi Watanabe
Naokuni Uike
Ilseung Choi
Yasuhito Terui
Kensuke Usuki
Hirokazu Nagai
Nobuhiko Uoshima
Kensei Tobinai
Japanese Bendamustine Lymphoma Study Group
Tokai University · JPNational Cancer Center · USNational Cancer Center Hospital East · JPNational Hospital Organization Kyushu Cancer Center · JPRed Cross Hospital · GRTohoku University Hospital · JPJapanese Foundation For Cancer Research · JPMatsushita Memorial Hospital · JPNational Hospital Organization · JPNTT Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Bendamustine is a unique cytotoxic agent that has demonstrated efficacy in the treatment of indolent B-cell non-Hodgkin lymphomas (B-NHLs). In this multicenter phase II trial, the efficacy and safety of bendamustine were evaluated in Japanese patients with relapsed or refractory indolent B-NHL or mantle-cell lymphoma (MCL). Patients received bendamustine (120 mg/m(2) ) on days 1-2 of a 21-day cycle, for up to six cycles. The primary endpoint was the overall response rate (ORR) as assessed by an extramural committee according to International Workshop Response Criteria (IWRC). Secondary endpoints included complete response (CR) rate, ORR according to Revised Response Criteria (revised RC), progression-free survival (PFS), and safety. Fifty-eight patients with indolent B-NHL and 11 with MCL were enrolled. By IWRC, bendamustine produced an ORR of 91% (95% confidence interval [CI], 82-97%; 90% and 100% in patients with indolent B-NHL and MCL, respectively), with a CR rate of 67% (95% CI, 54-78%). ORR and CR rates according to revised RC were 93% (95% CI, 84-98%) and 57% (95% CI, 44-68%), respectively. After a median follow-up of 12.6 months, median PFS had not been reached. Estimated PFS rates at 1 year were 70% and 90% among indolent B-NHL and MCL patients, respectively. Bendamustine was generally well tolerated. Reversible myelosuppression, including grade 3/4 leukopenia (65%) and neutropenia (72%), was the most clinically significant toxicity observed. Common non-hematologic toxicities included mild gastrointestinal events and fatigue. These results demonstrate the high efficacy and tolerability of single-agent bendamustine in relapsed patients with indolent B-NHL or MCL histologies.

Indexed as

AdultAgedAntineoplastic AgentsBendamustine HydrochlorideDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHumansKaplan-Meier EstimateLeukopeniaLymphoma, B-CellLymphoma, Mantle-CellMaleMiddle AgedNauseaNeoplasm StagingAntineoplastic AgentsBendamustine HydrochlorideNitrogen Mustard Compounds

Identifiers

PMID20626754
PMCPMC11159261
OpenAlexW2083329993

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.