Evidence map›Paper›PMID 19074748›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2009

Bortezomib in patients with relapsed or refractory mantle cell lymphoma: updated time-to-event analyses of the multicenter phase 2 PINNACLE study.

A Goy, S H Bernstein, B S Kahl, B Djulbegovic, M J Robertson, S de Vos, E Epner, A Krishnan, J P Leonard, S Lonial and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02446236 (Phase Ib Dose Finding Study of Bruton's Tyrosine Kinase), which is not on this map. Cited by 134 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
134citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT02446236 phase1active not recruitingnot on this mapstarted 2015, after this paper: background citation

Phase Ib Dose Finding Study of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma (MCL)

TypeinterventionalSponsorHackensack Meridian HealthRan2015 to 2026Enrolled27ConditionsMantle Cell LymphomaArmsLenalidomide, Ibrutinib, Rituximab
3 · Its place in the literature

Who cites it

134 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Non-Hodgkin's lymphomas, version 4.2014.Journal of the National Comprehensive Cancer Network : JNCCN · 2014
    Guideline
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Phase II Study of Yttrium-90 Ibritumomab Tiuxetan Plus High-Dose BCNU, Etoposide, Cytarabine, and Melphalan for Non-Hodgkin Lymphoma: The Role of Histology.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2017
    Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study.Annals of oncology : official journal of the European Society for Medical Oncology · 2013
    Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

74 more citing papers are in PubMed but not listed here.

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

15 authors.

A GoyThe Cancer Center at Hackensack University Medical Center, Hackensack, NJ 07601, USA. agoy@humed.com
S H Bernstein
B S Kahl
B Djulbegovic
M J Robertson
S de Vos
E Epner
A Krishnan
J P Leonard
S Lonial
S Nasta
O A O'Connor
H Shi
A L Boral
R I Fisher

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI AMY TRENTHAM-DIETZ · 1985 to 2026
$142.6M
NCI NIH HHS P30 CA014520
6 · The paper itself

Abstract

backgroundWe previously reported results of the phase 2, multicenter PINNACLE study, which confirmed the substantial single-agent activity of bortezomib in patients with relapsed or refractory mantle cell lymphoma (MCL). MATERIALS AND

methodsWe report updated time-to-event data, in all patients and by response to treatment, after extended follow-up (median 26.4 months).

resultsMedian time to progression (TTP) was 6.7 months. Median time to next therapy (TTNT) was 7.4 months. Median overall survival (OS) was 23.5 months. In responding patients, median TTP was 12.4 months, median duration of response (DOR) was 9.2 months, median TTNT was 14.3 months, and median OS was 35.4 months. Patients achieving complete response had heterogeneous disease characteristics; among these patients, median TTP and DOR were not reached, and median OS was 36.0 months. One-year survival rate was 69% overall and 91% in responding patients. Median OS from diagnosis was 61.1 months, after median follow-up of 63.7 months. Activity was seen in patients with refractory disease and patients relapsing following high-intensity treatment. Toxicity was generally manageable.

conclusionsSingle-agent bortezomib is associated with lengthy responses and notable survival in patients with relapsed or refractory MCL, with considerable TTP and TTNT in responding patients, suggesting substantial clinical benefit.

Indexed as

AgedAntineoplastic AgentsBoronic AcidsBortezomibFemaleHumansLymphoma, Mantle-CellMaleMiddle AgedPyrazinesSurvival RateTreatment OutcomeAntineoplastic AgentsBoronic AcidsBortezomibPyrazines

Identifiers

PMID19074748
PMCPMC4592328

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.