Evidence map›Paper›PMID 26300664›Full record

ArticleCurrent oncology (Toronto, Ont.)2015

An open-label expanded-access trial of bendamustine in patients with rituximab-refractory indolent non-Hodgkin lymphoma or previously untreated chronic lymphocytic leukemia: BEND-ACT.

C T Kouroukis, M Crump, D MacDonald, J F Larouche, D A Stewart, J Johnston, S Sauvageau, E Beausoleil, P Sage, S G Dubois and 3 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Current oncology (Toronto, Ont.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 37% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
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

13 authors at 8 institutions in 3 countries.

C T KouroukisDepartment of Oncology, McMaster University, and Juravinski Cancer Centre and Hospital, Hamilton, ON;
M CrumpDepartment of Medical Oncology and Hematology, University of Toronto, Toronto, ON;
D MacDonaldDalhousie University and QEII Health Sciences Centre, Halifax, NS;
J F LaroucheHematology-Oncology, CHU de Québec, Hôpital Enfant-Jésus, Montreal, QC;
D A StewartDepartment of Oncology and Medicine, University of Calgary, and Tom Baker Cancer Centre, Calgary, AB;
J JohnstonDepartment of Internal Medicine, University of Manitoba, and Cancer Care Manitoba, Winnipeg, MB;
S SauvageauLundbeck Canada Inc., Montreal, QC;
E BeausoleilLundbeck Canada Inc., Montreal, QC;
P SageLundbeck Canada Inc., Montreal, QC;
S G DuboisLundbeck Canada Inc., Montreal, QC;
A ChristofidesNew Evidence, Toronto, ON;
S Di ClementeNew Evidence, Toronto, ON;
L SehnUniversity of British Columbia and BC Cancer Agency, Vancouver, BC.
Lundbeck (Denmark) · DKEvidence (Italy) · ITDalhousie University · CAHôpital de l'Enfant-Jésus · CAMcMaster University · CAUniversity of Calgary · CAUniversity of Manitoba · CAUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBendamustine is a bifunctional alkylating agent with unique properties that distinguish it from other agents in its class. Bendamustine is used as monotherapy or in combination with other agents to treat patients with non-Hodgkin lymphoma (nhl) and chronic lymphocytic leukemia (cll).

methodsThe prospective interventional open-label bend-act trial evaluated bendamustine in patients with rituximab-refractory indolent nhl (inhl) and previously untreated cll. Study objectives were to assess the safety and tolerability of bendamustine monotherapy and to provide patients with access to bendamustine before Health Canada approval. The study aimed to enrol up to 100 patients. All patients with inhl received an intravenous dose of bendamustine 120 mg/m(2) over 60 minutes on days 1 and 2 for up to eight 21- or 28-day treatment cycles. All patients with cll received an intravenous dose of bendamustine 100 mg/m(2) over 30 minutes on days 1 and 2 for up to six 28-day treatment cycles.

resultsOf 90 patients treated on study (16 with cll and 74 with inhl), 35 completed the study (4 with cll and 31 with inhl). The most common treatment-emergent adverse events (teaes) were nausea (70%), fatigue (57%), vomiting (40%), and diarrhea (33%)-mostly grades 1 and 2. Ondansetron was the most common supportive medication used in the patients (63.5% of those with inhl and 68.8% of those with cll). Neutropenia (32%), anemia (23%), and thrombocytopenia (21%) were the most frequent hematologic teaes, with neutropenia being the most common grade 3 or 4 teae leading to dose modification. Dose delays occurred in 28 patients (31.3%) because of grade 3 or 4 teaes, with a higher incidence of dose delays being observed in inhl patients on the 21-day treatment cycle than in those on the 28-day treatment cycle (50.0% vs. 24.1%). During the study, 33 patients (36.7%) experienced at least 1 serious adverse event, and 4 deaths were reported (all in patients with inhl).

conclusionsThe type and frequency of the teaes reported accorded with observations in earlier clinical trials and post-marketing experiences, thus confirming the acceptable and manageable safety profile of bendamustine.

Indexed as

bendamustinechronic lymphocytic leukemiaClinical trialsexpanded-accessindolent non-Hodgkin lymphomaopen-labelsafety

Identifiers

PMID26300664
PMCPMC4530811
OpenAlexW2116137820

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.