Evidence map›Paper›PMID 30531832›Full record

Trial reportBritish journal of cancer2019

A phase 2 randomised study of veliparib plus FOLFIRI±bevacizumab versus placebo plus FOLFIRI±bevacizumab in metastatic colorectal cancer.

Vera Gorbunova, J Thaddeus Beck, Ralf-Dieter Hofheinz, Pilar Garcia-Alfonso, Marina Nechaeva, Antonio Cubillo Gracian, Laszlo Mangel, Elena Elez Fernandez, Dustin A Deming, Ramesh K Ramanathan and 4 more

Erratum issuedAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 29 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 4 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.

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

29 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  11. Targeted Treatment against Cancer Stem Cells in Colorectal Cancer.International journal of molecular sciences · 2024
    Review
  12. PARP Inhibitors in Colorectal Malignancies: A 2023 Update.Reviews on recent clinical trials · 2024
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Vera GorbunovaN.N. Blokhin Russian Cancer Research Center, Moscow, Russia.
J Thaddeus BeckHighlands Oncology, Rogers/Fayetteville, AR, USA.
Ralf-Dieter HofheinzInterdisciplinary Tumor Center, University Hospital Mannheim, University of Heidelberg, Heidelberg, Germany.
Pilar Garcia-AlfonsoHospital General Universitario Gregorio Marañón, Madrid, Spain.
Marina NechaevaArkhangelsk Clinical Oncology Center, Arkhangelsk, Russia.
Antonio Cubillo GracianCentro Integral Oncológico Clara Campal Hospital Universitario Madrid Sanchinarro, Madrid, Spain, and Departamento de Ciencias Médicas Clínicas, Universidad CEU San Pablo, Madrid, Spain.
Laszlo MangelPecsi Tudomanyegyetem Klinikai Kozpont, Onkoterapias Intezet, Pécs, Hungary.
Elena Elez FernandezVall d'Hebron University Hospital, Barcelona, Spain.
Dustin A DemingUniversity of Wisconsin, Madison, WI, USA.
Ramesh K RamanathanMayo Clinic, Scottsdale, AZ, USA.
Alison H TorresAbbVie Inc., North Chicago, IL, USA.
Danielle SullivanAbbVie Inc., North Chicago, IL, USA.
Yan LuoAbbVie Inc., North Chicago, IL, USA.
Jordan D BerlinVanderbilt-Ingram Cancer Center, Nashville, TN, USA. jordan.berlin@vumc.org.

Funding

Translational Analysis CoreP30DK058404 · NIDDK · VANDERBILT UNIVERSITY MEDICAL CENTER · PI RICHARD M. PEEK · 2002 to 2026
$29.9M
NIDDK NIH HHS P30 DK058404
6 · The paper itself

Abstract

backgroundMetastatic colorectal cancer (mCRC) has low survival rates. We assessed if addition of veliparib, concurrent to FOLFIRI, improves survival in patients with previously untreated mCRC.

methodsThis study compared veliparib (200 mg BID for 7 days of each 14-day cycle) to placebo, each with FOLFIRI. Bevacizumab was allowed in both arms. The primary endpoint was progression-free survival (PFS).

resultsPatients were randomised to receive veliparib (n = 65) or placebo (n = 65) in combination with FOLFIRI. Median PFS was 12 vs 11 months (veliparib vs placebo) [HR = 0.94 (95% CI: 0.60, 1.48)]. Median OS was 25 vs 27 months [HR = 1.26 (95% CI: 0.74, 2.16)]. Response rate was 57% vs 62%. Median DOR was 11 vs 9 months [HR = 0.73 (95% CI: 0.38, 1.40)]. AEs with significantly higher frequency (p < 0.05) in the veliparib group were anaemia (39% vs 19%, p = 0.019) and neutropenia (66% vs 37%, p = 0.001) for common AEs (≥20%); neutropenia (59% vs 22%, p < 0.001) for common Grade 3/4 AEs (≥5%); none in serious AEs. Haematopoietic cytopenias were more common with veliparib (79% vs 52%, p = 0.003). Fourteen percent of patients on veliparib and 15% on placebo discontinued treatment due to AEs.

conclusionVeliparib added to FOLFIRI ± bevacizumab demonstrated similar efficacy as FOLFIRI ± bevacizumab in frontline mCRC patients. No unexpected safety concerns occurred.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBevacizumabCamptothecinColorectal NeoplasmsDrug-Related Side Effects and Adverse ReactionsFemaleFluorouracilHumansKaplan-Meier EstimateLeucovorinMaleMiddle AgedBenzimidazolesBevacizumabCamptothecinFluorouracilLeucovorinveliparib

Identifiers

PMID30531832
PMCPMC6342906

What OpenQuestion holds

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LicenceCC BY
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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.