Evidence map›Paper›PMID 26492567›Full record

Trial reportBritish journal of haematology2016

Phase II trial of R-CHOP plus bortezomib induction therapy followed by bortezomib maintenance for newly diagnosed mantle cell lymphoma: SWOG S0601.

Brian G Till, Hongli Li, Steven H Bernstein, Richard I Fisher, W Richard Burack, Lisa M Rimsza, Justin D Floyd, Marco A DaSilva, Dennis F Moore, Olga Pozdnyakova and 3 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of haematology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
4.4field-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

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Review
  11. Article
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  15. Article
  16. Review
  17. Mantle cell lymphoma and its management: where are we now?Experimental hematology & oncology · 2019
    Review
  18. Review
  19. Article
  20. 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

13 authors at 10 institutions in 1 country.

Brian G TillFred Hutchinson Cancer Research Center, Seattle, WA, USA.
Hongli LiSWOG Statistical Center, Seattle, WA, USA.
Steven H BernsteinJames P. Wilmot Cancer Center, University of Rochester, Rochester, NY, USA.
Richard I FisherFox Chase Cancer Center, Temple University School of Medicine, Philadelphia, PA, USA.
W Richard BurackJames P. Wilmot Cancer Center, University of Rochester, Rochester, NY, USA.
Lisa M RimszaArizona Cancer Center, University of Arizona, Tucson, AZ, USA.
Justin D FloydHeartland NCORP/Saint Francis Medical Center, Cape Girardeau, MO, USA.
Marco A DaSilvaSoutheast Cancer Consortium-Upstate NCORP/Kingsport Hem & Onc Associates, Kingsport, TN, USA.
Dennis F MooreWichita NCORP/Cancer Center of Kansas, Wichita, KS, USA.
Olga PozdnyakovaBrigham and Women's Hospital, Boston, MA, USA.
Sonali M SmithUniversity of Chicago Hospitals, Chicago, IL, USA.
Michael LeBlancSWOG Statistical Center, Seattle, WA, USA.
Jonathan W FriedbergJames P. Wilmot Cancer Center, University of Rochester, Rochester, NY, USA.
University of Rochester · USCancer Research And Biostatistics · USBallad Health · USBrigham and Women's Hospital · USCancer Center of Kansas · USFred Hutch Cancer Center · USSaint Francis Medical Center · USTemple University · USUniversity of Arizona · USUniversity of Chicago · US

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
WORD PROCESSING CENTER--COREP30CA006927 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI Margaret von Mehren · 1985 to 2026
$138.8M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
Heartland Cancer Research NCORPUG1CA189830 · NCI · DECATUR MEMORIAL HOSPITAL · PI Bryan A. Faller · 2014 to 2026
$40.9M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
Cancer Research Consortium of West Michigan (CRCWM)UG1CA189860 · NCI · COREWELL HEALTH · PI KATHLEEN YOST BUTLER · 2014 to 2026
$29.1M
The Pacific Cancer Research Consortium (PCRC), an NCORP Community SiteUG1CA189953 · NCI · SWEDISH MEDICAL CENTER, FIRST HILL · PI Alison Katherine Conlin, Charles Drescher · 2014 to 2026
$27.4M
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
The Hawaii NCORPUG1CA189804 · NCI · UNIVERSITY OF HAWAII AT MANOA · PI Jared Acoba, Jeffrey Lee Berenberg · 2014 to 2026
$15.7M
Montana Cancer Consortium NCORPUG1CA189872 · NCI · MONTANA CANCER CONSORTIUM · PI Jeffrey Warren Allen, John M. Schallenkamp · 2014 to 2026
$11.0M
Dayton Clinical Oncology ProgramUG1CA189957 · NCI · DAYTON CLINICAL ONCOLOGY PROGRAM · PI Howard M Gross · 2014 to 2026
$10.7M
Columbus NCORP RFA-CA-18-016UG1CA189954 · NCI · COLUMBUS COMMUNITY CLINICAL ONCOLOGY PRG · PI Aruna Gowda, Malolan S Rajagopalan · 2014 to 2026
$9.8M
NCI NIH HHS CA11083NCI NIH HHS CA180818NCI NIH HHS CA180819NCI NIH HHS CA180834NCI NIH HHS CA180888NCI NIH HHS CA189804NCI NIH HHS CA189808NCI NIH HHS CA189830NCI NIH HHS CA189858NCI NIH HHS CA189860NCI NIH HHS CA189872NCI NIH HHS CA189953NCI NIH HHS CA189954NCI NIH HHS CA189957NCI NIH HHS K23 CA154874NCI NIH HHS N01 CA035119NCI NIH HHS P30 CA006927NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA180818NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180828NCI NIH HHS U10 CA180834NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189804NCI NIH HHS UG1 CA189808NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA189860NCI NIH HHS UG1 CA189872NCI NIH HHS UG1 CA189953NCI NIH HHS UG1 CA189954NCI NIH HHS UG1 CA189957
6 · The paper itself

Abstract

Bortezomib is active in mantle cell lymphoma (MCL), with approval in upfront and relapsed settings. Given inevitable recurrence following induction chemoimmunotherapy, maintenance approaches are a rational strategy to improve clinical outcomes. We conducted a phase II study to evaluate the safety and efficacy of six cycles of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) plus bortezomib (1.3 mg/m2 days 1 and 4 of 21 d cycles) followed by bortezomib maintenance (1.3 mg/m2 days 1, 4, 8, and 11 every 3 months for 2 years). Sixty-five eligible patients were enrolled. The treatment was well tolerated and toxicities were mainly haematological. The rate of grade ≥3 peripheral neuropathy was low (5%). With a median follow-up of 6.8 years, 2-year progression-free survival (PFS) was 62%, and 2-year overall survival (OS) was 85%. At 5 years, PFS was 28% and OS was 66%. MCL International Prognostic Index scores were significantly associated with 2-year PFS, but did not predict long-term (≥5-year) PFS. Baseline Ki-67 index was significantly associated with survival. Combination R-CHOP with bortezomib followed by maintenance bortezomib appears to improve outcomes compared historically with R-CHOP alone, with prolonged remissions in a subset of patients. These results suggest that inclusion of bortezomib with induction chemotherapy and/or maintenance is promising in MCL and warrants further exploration.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsBortezomibCyclophosphamideDisease ProgressionDoxorubicinDrug Administration ScheduleFemaleFollow-Up StudiesHematologic DiseasesHumansLymphoma, Mantle-CellMaleAntibodies, Monoclonal, Murine-DerivedBortezomibCyclophosphamideDoxorubicinPrednisoneR-CHOP protocolRituximabVincristinechemotherapylymphomamaintenance therapymantle cell lymphomaproteasome inhibition

Identifiers

PMID26492567
PMCPMC4710555
OpenAlexW2137478135

What OpenQuestion holds

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Registered trials

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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.