Evidence map›Paper›PMID 29045554›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2018

Veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in patients with BRCA1/2 locally recurrent/metastatic breast cancer: randomized phase II study.

H S Han, V Diéras, M Robson, M Palácová, P K Marcom, A Jager, I Bondarenko, D Citrin, M Campone, M L Telli and 16 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01506609 (A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer), which is not on this map. Cited by 88 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 12 pooled it
11.1field-weighted citation impact, top 1% 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.

NCT01506609 phase2completednot on this map

A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

TypeinterventionalSponsorAbbVieRan2012 to 2020Enrolled294ConditionsMetastatic Breast CancerArmsPlacebo, Veliparib, Carboplatin, Temozolomide, Paclitaxel
3 · Its place in the literature

Who cites it

88 citing papers in PubMed, 12 syntheses or guidelines pooled it, 201 citations in OpenAlex.

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  10. Platinum-containing regimens for triple-negative metastatic breast cancer.The Cochrane database of systematic reviews · 2020
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  14. [BRCA-like breast cancer patients benefit from cisplatin plus veliparib-results from the S1416 phase II study].Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2023
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28 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 20 institutions in 9 countries.

H S HanMoffitt Cancer Center, Tampa, USA.
V DiérasInstitut Curie, Paris, France, USA.
M RobsonWeill Cornell Medical College, New York, USA.
M PalácováMasarykuv Onkologický Ústav, Brno, Czech Republic, Durham, USA.
P K MarcomDuke University, Durham, USA.
A JagerErasmus MC Cancer Institute, Rotterdam, The Netherlands.
I BondarenkoDnepropetrovsk Medical Academy, City Hospital #4, Dnipro, Ukraine.
D CitrinMidwestern Regional Medical Center, Zion, USA.
M CamponeInstitut de Cancérologie de l'Ouest, Saint Herblain, France.
M L TelliStanford University School of Medicine, Stanford, USA.
S M DomchekUniversity of Pennsylvania, Philadelphia, USA.
M FriedlanderPrince of Wales Hospital, Sydney, Australia.
B KaufmanSheba Medical Center, Tel Hashomer, Israel.
J E GarberDana-Farber Cancer Institute, Boston, USA.
Y ShparykChemotherapy Department, Lviv State Regional Treatment and Diagnostics Oncology Center, Lviv, Ukraine.
E ChmielowskaDepartment of Clinical Oncology, Oncology Centre, Bydgoszcz, UMK, Torun, Poland.
E H JakobsenDepartment of Oncology, Vejle Hospital/Lillebaelt Hospital, Vejle, Denmark.
V KaklamaniCancer Therapy and Research Center, University of Texas Health Science Center at San Antonio, San Antonio, USA.
W GradisharDivision of Hematology/Oncology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, USA.
C K RatajczakAbbVie Inc., North Chicago, USA.
C NicknerAbbVie Inc., North Chicago, USA.
Q QinAbbVie Inc., North Chicago, USA.
J QianAbbVie Inc., North Chicago, USA.
S P ShepherdAbbVie Inc., North Chicago, USA.
S J IsakoffMassachusetts General Hospital, Boston, USA.
S PuhallaUniversity of Pittsburgh Cancer Institute, Pittsburgh, USA.
AbbVie (United States) · USCornell University · USDana-Farber Cancer Institute · USDnipro State Medical University · UADuke University · USErasmus MC Cancer Institute · NLInstitut Curie · FRInstitut de Cancérologie de l'Ouest · FRMasaryk University · CZMassachusetts General Hospital · USMidwestern Regional Medical Center · USMoffitt Cancer Center · USNorthwestern University · USPrince of Wales Hospital · AUSheba Medical Center · ILStanford University · USThe University of Texas Health Science Center at San Antonio · USUniversity of Pennsylvania · USUPMC Hillman Cancer Center · USVejle Sygehus · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Homologous recombination defects in BRCA1/2-mutated tumors result in sensitivity to poly(ADP-ribose) polymerase inhibitors, which interfere with DNA damage repair. Veliparib, a potent poly(ADP-ribose) polymerase inhibitor, enhanced the antitumor activity of platinum agents and temozolomide in early phase clinical trials. This phase II study examined the safety and efficacy of intermittent veliparib with carboplatin/paclitaxel (VCP) or temozolomide (VT) in patients with BRCA1/2-mutated breast cancer. Patients and methods: Eligible patients ≥18 years with locally recurrent or metastatic breast cancer and a deleterious BRCA1/2 germline mutation were randomized 1 : 1 : 1 to VCP, VT, or placebo plus carboplatin/paclitaxel (PCP). Primary end point was progression-free survival (PFS); secondary end points included overall survival (OS) and overall response rate (ORR). Results: Of 290 randomized patients, 284 were BRCA+, confirmed by central laboratory. For VCP versus PCP, median PFS was 14.1 and 12.3 months, respectively [hazard ratio (HR) 0.789; 95% CI 0.536-1.162; P = 0.227], interim median OS 28.3 and 25.9 months (HR 0.750; 95% CI 0.503-1.117; P = 0.156), and ORR 77.8% and 61.3% (P = 0.027). For VT (versus PCP), median PFS was 7.4 months (HR 1.858; 95% CI 1.278-2.702; P = 0.001), interim median OS 19.1 months (HR 1.483; 95% CI 1.032-2.131; P = 0.032), and ORR 28.6% (P < 0.001). Safety profile was comparable between carboplatin/paclitaxel arms. Adverse events (all grades) of neutropenia, anemia, alopecia, and neuropathy were less frequent with VT versus PCP. Conclusion: Numerical but not statistically significant increases in both PFS and OS were observed in patients with BRCA1/2-mutated recurrent/metastatic breast cancer receiving VCP compared with PCP. The addition of veliparib to carboplatin/paclitaxel significantly improved ORR. There was no clinically meaningful increase in toxicity with VCP versus PCP. VT was inferior to PCP. An ongoing phase III trial is evaluating VCP versus PCP, with optional continuation single-agent therapy with veliparib/placebo if chemotherapy is discontinued without progression, in this patient population. Clinical trial information: NCT01506609.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBreast NeoplasmsBreast Neoplasms, MaleCarboplatinFemaleGenes, BRCA1Genes, BRCA2Germ-Line MutationHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalBenzimidazolesCarboplatinPaclitaxelPlacebosTemozolomideveliparibmetastatic breast cancerPARP inhibitorsplatinumtemozolomide

Identifiers

PMID29045554
PMCPMC5834075
OpenAlexW2763602017

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.