Evidence map›Paper›PMID 31573746›Full record

Trial reportCancer medicine2019

Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma after first-line immunochemotherapy: Results of the RBMDGELTAMO08 phase II trial.

Francisco-Javier Peñalver, José-Antonio Márquez, Soledad Durán, Pilar Giraldo, Alejandro Martín, Carlos Montalbán, Juan-Manuel Sancho, María-José Ramírez, María-José Terol, Francisco-Javier Capote and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01133158 (Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine, Mitoxantrone, Dexamethasone), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 31% 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.

NCT01133158 phase2completednot on this map

Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine, Mitoxantrone, Dexamethasone (R-BMD) in Patients With Follicular Lymphoma Refractory or Relapsed

TypeinterventionalSponsorGrupo Español de Linfomas y Transplante Autólogo de Médula ÓseaRan2009 to 2016Enrolled61ConditionsNon-Hodgkin's LymphomaArmsRituximab, Bendamustine, Mitoxantrone, Dexamethasone
3 · Its place in the literature

Who cites it

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

  1. Guideline
  2. Trial
  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

18 authors at 15 institutions in 1 country.

Francisco-Javier PeñalverHospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain.
José-Antonio MárquezHospital de Basurto, Vizcaya, Spain.
Soledad DuránComplejo Hospitalario de Jaén, Jaén, Spain.
Pilar GiraldoHospital Universitario Miguel Servet, Zaragoza, Spain.
Alejandro MartínHospital Universitario de Salamanca, IBSAL, CIBERONC, Salamanca, Spain.
Carlos MontalbánHospital Universitario Ramón y Cajal, Madrid, Spain.
Juan-Manuel SanchoICO-IJC Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain.
María-José RamírezHospital de Especialidades de Jerez de la Frontera, Cádiz, Spain.
María-José TerolHospital Clínico Universitario de Valencia, Valencia, Spain.
Francisco-Javier CapoteHospital Puerta del Mar, Cádiz, Spain.
Antonio GutiérrezHospital Universitario Son Dureta, Palma de Mallorca, Spain.ORCID 0000-0001-9062-077X
Blanca SánchezHospital del Mar, Barcelona, Spain.
Andrés LópezHospital Vall d'Hebron, Barcelona, Spain.
Antonio SalarHospital del Mar, Barcelona, Spain.ORCID 0000-0002-4652-4825
Gil Rodríguez-CaravacaUniversidad Rey Juan Carlos, Madrid, Spain.
Miguel CanalesHospital Universitario La Paz, Madrid, Spain.
María-Dolores CaballeroHospital Universitario de Salamanca, IBSAL, CIBERONC, Salamanca, Spain.
GELTAMO (The Spanish Lymphoma Cooperative Group)
Hospital Del Mar · ESInstituto de Investigación Biomédica de Salamanca · ESComplejo Hospitalario de Jaén · ESHospital Clínico Universitario de Valencia · ESHospital de Basurto · ESHospital Jerez Puerta del Sur · ESHospital Universitari Germans Trias i Pujol · ESHospital Universitario Fundación Alcorcón · ESHospital Universitario La Paz · ESHospital Universitario Miguel Servet · ESHospital Universitario Puerta del Mar · ESHospital Universitario Ramón y Cajal · ESHospital Universitario Son Dureta · ESUniversidad Rey Juan Carlos · ESVall d'Hebron Hospital Universitari · ES

Funding

Mundipharma SpainRoche Pharma Spain
6 · The paper itself

Abstract

backgroundConsensus is lacking regarding the optimal salvage therapy for patients with follicular lymphoma who relapse after or are refractory to immunochemotherapy.

methodsThis phase II trial evaluated the efficacy and safety of response-adapted therapy with rituximab, bendamustine, mitoxantrone, and dexamethasone (RBMD) in follicular lymphoma patients who relapsed after or were refractory to first-line immunochemotherapy. Sixty patients received three treatment cycles, and depending on their response received an additional one (complete/unconfirmed complete response) or three (partial response) cycles. Patients who responded to induction received rituximab maintenance therapy for 2 years.

resultsThirty-three (55%) and 42 (70%) patients achieved complete/unconfirmed complete response after three cycles and on completing induction therapy (4-6 cycles), respectively (final overall response rate, 88.3%). Median progression-free survival was 56.4 months (median follow-up, 28.3 months; 95% CI, 15.6-51.2). Overall survival was not reached. Progression-free survival did not differ between patients who received four vs six cycles (P = .6665), nor between patients who did/did not receive rituximab maintenance after first-line therapy (P = .5790). Median progression-free survival in the 10 refractory patients was 25.5 months (95% CI, 0.6-N/A) and was longer in patients who had shown progression of disease after 24 months of first-line therapy (median, 56.4 months; 95% CI, 19.8-56.4) than in those who showed early progression (median, 42.31 months; 95% CI, 24.41-NA) (P = .4258). Thirty-six (60%) patients had grade 3/4 neutropenia. Grade 3/4 febrile neutropenia and infection were recorded during induction (4/60 [6.7%] and 5/60 [8.3%] patients, respectively) and maintenance (2/43 [4.5%] and 4/43 [9.1%] patients, respectively).

conclusionsThis response-adapted treatment with RBMD followed by rituximab maintenance is an effective and well-tolerated salvage treatment for relapsed/refractory follicular lymphoma following first-line immunochemotherapy. CLINICAL

trial registrationClinicalTrials.gov # NCT01133158.

Indexed as

Salvage TherapyAdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideDexamethasoneDrug Resistance, NeoplasmFemaleHumansImmunotherapyLymphoma, FollicularMaleMiddle AgedMitoxantroneNeoplasm Recurrence, LocalAntineoplastic AgentsBendamustine HydrochlorideDexamethasoneMitoxantroneRituximabbendamustinefollicular lymphomaimmunochemotherapyrefractoryrelapsed

Identifiers

PMID31573746
PMCPMC6853826
OpenAlexW2979270751

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.