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Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial

Overview of attention for article published in Lancet Oncology, December 2015
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  • In the top 25% of all research outputs scored by Altmetric
  • High Attention Score compared to outputs of the same age (94th percentile)
  • High Attention Score compared to outputs of the same age and source (85th percentile)

Mentioned by

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2 news outlets
policy
2 policy sources
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16 X users
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1 Facebook page
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1 Google+ user

Citations

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137 Dimensions

Readers on

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193 Mendeley
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Title
Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial
Published in
Lancet Oncology, December 2015
DOI 10.1016/s1470-2045(15)00447-7
Pubmed ID
Authors

Mathias Rummel, Ulrich Kaiser, Christina Balser, Martina Stauch, Wolfram Brugger, Manfred Welslau, Norbert Niederle, Christoph Losem, Hans-Peter Boeck, Eckhart Weidmann, Ulrich von Gruenhagen, Lothar Mueller, Michael Sandherr, Lars Hahn, Julia Vereshchagina, Frank Kauff, Wolfgang Blau, Axel Hinke, Juergen Barth, Study group indolent Lymphomas

Abstract

Fludarabine-based chemoimmunotherapy with rituximab is frequently used in patients with indolent and mantle-cell lymphomas who relapse after alkylating chemotherapy. We aimed to compare the efficacy and safety of rituximab with bendamustine or fludarabine in patients with relapsed, indolent, non-Hodgkin lymphoma and mantle-cell lymphoma. For this randomised, non-inferiority, open-label, phase 3 trial, we recruited patients from 55 centres in Germany, who were subsequently randomised centrally according to prespecified randomisation lists with permuted blocks of randomly variable block size to rituximab (375 mg/m(2), day 1) plus either bendamustine (90 mg/m(2), days 1 and 2) or fludarabine (25 mg/m(2), days 1-3) every 28 days for a maximum of six 28-day cycles. Patients were aged 18 years or older with a WHO performance status of 0-2 and had relapsed or refractory indolent or mantle-cell lymphoma; patients refractory to regimens that included rituximab, bendamustine, or purine analogue drugs were excluded. Patients were stratified by histological subtypes of lymphoma and by their latest previous therapies. Treatment allocation was not masked. The primary endpoint was progression-free survival and the final analysis was completed per protocol. Non-inferiority of bendamustine plus rituximab versus fludarabine plus rituximab was defined as a difference of less than 15% in 1-year progression-free survival. The protocol was amended in July, 2006, after approval of rituximab maintenance (375 mg/m(2) every 3 months for up to 2 years), which was then given to patients achieving a response to either trial treatment. This study is registered with ClinicalTrials.gov, number NCT01456351 (closed to enrolment, follow-up is ongoing). Between Oct 8, 2003, and Aug 5, 2010, we randomly assigned 230 patients to treatment groups (116 bendamustine plus rituximab, 114 fludarabine plus rituximab). 11 patients were excluded for protocol violations and were not followed up further (two in the bendamustine plus rituximab group and nine in the fludarabine plus rituximab group). Thus, 219 patients were included in the per-protocol analysis (114 bendamustine plus rituximab, 105 fludarabine plus rituximab). 1-year progression-free survival with bendamustine plus rituximab was 0·76 (95% CI 0·68-0·84) and 0·48 (0·39-0·58) with fludarabine plus rituximab (non-inferiority p<0·0001). At a median follow-up of 96 months (IQR 73·2-112·9), median progression-free survival with bendamustine plus rituximab was 34·2 months (95% CI 23·5-52·7) and 11·7 months (8·0-16·1) with fludarabine plus rituximab (hazard ratio [HR] 0·54 [95% CI 0·38-0·72], log-rank test p<0·0001). Safety outcomes were similar in both groups, with 46 serious adverse events recorded (23 in the bendamustine plus rituximab group and 23 in the fludarabine plus rituximab group), most commonly myelosuppression and infections. In combination with rituximab, bendamustine was more effective than fludarabine, suggesting that bendamustine plus rituximab may be the preferred treatment option for patients with relapsed indolent and mantle-cell lymphomas. Roche Pharma AG, Ribosepharm GmbH, Mundipharma GmbH, Studiengruppe indolente Lymphome (StiL).

X Demographics

X Demographics

The data shown below were collected from the profiles of 16 X users who shared this research output. Click here to find out more about how the information was compiled.
Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 193 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United Kingdom 1 <1%
Germany 1 <1%
Unknown 191 99%

Demographic breakdown

Readers by professional status Count As %
Researcher 40 21%
Other 24 12%
Student > Bachelor 14 7%
Student > Postgraduate 12 6%
Student > Doctoral Student 12 6%
Other 43 22%
Unknown 48 25%
Readers by discipline Count As %
Medicine and Dentistry 95 49%
Pharmacology, Toxicology and Pharmaceutical Science 11 6%
Biochemistry, Genetics and Molecular Biology 9 5%
Agricultural and Biological Sciences 8 4%
Nursing and Health Professions 3 2%
Other 10 5%
Unknown 57 30%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 31. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 17 February 2022.
All research outputs
#1,279,799
of 25,374,647 outputs
Outputs from Lancet Oncology
#1,477
of 6,882 outputs
Outputs of similar age
#21,279
of 394,918 outputs
Outputs of similar age from Lancet Oncology
#23
of 162 outputs
Altmetric has tracked 25,374,647 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 94th percentile: it's in the top 10% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 6,882 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 35.2. This one has done well, scoring higher than 78% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 394,918 tracked outputs that were published within six weeks on either side of this one in any source. This one has done particularly well, scoring higher than 94% of its contemporaries.
We're also able to compare this research output to 162 others from the same source and published within six weeks on either side of this one. This one has done well, scoring higher than 85% of its contemporaries.