Evidence map›Paper›PMID 31573078›Full record

Trial reportBritish journal of haematology2020

Safety of switching from intravenous to subcutaneous rituximab during first-line treatment of patients with non-Hodgkin lymphoma: the Spanish population of the MabRella study.

Ricardo García-Muñoz, Cristina Quero, Ernesto Pérez-Persona, Abel Domingo-García, Cristina Pérez-López, Teresa Villaescusa-de-la-Rosa, Ana M Martínez-Castro, José M Arguiñano-Pérez, Juan F Parra-Cuadrado, Carlos Panizo

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in British journal of haematology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 17% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
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

10 authors at 10 institutions in 1 country.

Ricardo García-MuñozDepartment of Haematology, Complejo Hospitalario San Millán-San Pedro, Logroño, Spain.
Cristina QueroDepartment of Medical Oncology, Hospital Universitario Virgen de la Victoria, Málaga, Spain.
Ernesto Pérez-PersonaDepartment of Haematology, Hospital de Txagorritxu, Vitoria-Gasteiz, Spain.
Abel Domingo-GarcíaDepartment of Haematology, Hospital General de Granollers, Granollers, Spain.
Cristina Pérez-LópezDepartment of Haematology, Hospital Universitario Clínico San Carlos, Madrid, Spain.
Teresa Villaescusa-de-la-RosaDepartment of Haematology, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
Ana M Martínez-CastroDepartment of Haematology, Complejo Hospitalario Universitario de Vigo, Vigo, Spain.
José M Arguiñano-PérezDepartment of Haematology, Hospital de Navarra, Pamplona, Spain.
Juan F Parra-CuadradoMedical Department, Roche Farma S.A., Madrid, Spain.
Carlos PanizoDepartment of Haematology, Clínica Universidad de Navarra, Pamplona, Spain.ORCID 0000-0002-3945-585X
Clinica Universidad de Navarra · ESComplejo Hospitalario de Navarra · ESHospital Clínico San Carlos · ESHospital Clínico Universitario Virgen de la Victoria · ESHospital General de Granollers · ESHospital San Pedro · ESHospital Txagorritxu · ESHospital Universitario Fundación Jiménez Díaz · ESRoche (Spain) · ESUniversity Hospital Complex Of Vigo · ES

Funding

Roche Farma S.A.
6 · The paper itself

Abstract

Rituximab is a standard treatment for non-Hodgkin diffuse large B-cell (DLBCL) and follicular (FL) lymphomas. A subcutaneous formulation was developed to improve the resource use of intravenous rituximab, with comparable efficacy and safety profiles except for increased administration-related reactions (ARRs). MabRella was a phase IIIb trial to assess the safety of switching from intravenous to subcutaneous administration of rituximab during first-line induction/maintenance for DLBCL or FL, focusing on ARRs. Efficacy, satisfaction and quality of life were also assessed. Patients received subcutaneous rituximab plus standard induction chemotherapy for DLBCL or FL for 4-7 cycles, and/or every 2 months maintenance monotherapy for FL for 6-12 cycles. The study included 140 patients: DLBCL, n = 29; FL, n = 111. Ninety-five percent of patients experienced adverse events, reaching grade ≥3 in 38·6% and were serious in 30·0%. AARs occurred in 48·6%, mostly (84·9%) at the injection site, with only 2·1% of patients reaching grade 3. The end-of-induction complete/unconfirmed complete response rate was 69·6%. After a median follow-up of 33·5 months, median disease-/event-/progression-free and overall survivals were not attained. The Rituximab Administration Satisfaction Questionnaire showed improvements in overall satisfaction and the EuroQoL-5D a good quality-of-life perception at induction/maintenance end. Therefore, switching to subcutaneous rituximab showed no new safety issues and maintained efficacy with improved satisfaction and quality of life.

Indexed as

Quality of LifeSafetyAdministration, IntravenousAdolescentAdultAgedAged, 80 and overDisease-Free SurvivalFemaleHumansInfusions, SubcutaneousLymphoma, Large B-Cell, DiffuseMaleMiddle AgedRituximabSpainRituximabadministration-related reactionsfollicular lymphomanon-Hodgkin diffuse large B-cell lymphomarituximabsafety

Identifiers

PMID31573078
PMCPMC7065214
OpenAlexW2978163532

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.