Evidence map›Paper›PMID 29878040›Full record

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

nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial.

D A Yardley, R Coleman, P Conte, J Cortes, A Brufsky, M Shtivelband, R Young, C Bengala, H Ali, J Eakel and 10 more

3 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
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 3 registered trials, which are not on this map. Cited by 68 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 5 pooled it
5.1field-weighted citation impact, top 3% 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.

NCT02027428 phase3completednot on this map

A Phase III, Randomized, Open-Label, Multi-Center, Safety and Efficacy Study to Evaluate Nab-Paclitaxel (Abraxane®) as Maintenance Treatment After Induction With Nab-Paclitaxel Plus Carboplatin in Subjects With Squamous Cell Non-Small Cell Lung Cancer (NSCLC)

TypeinterventionalSponsorCelgeneRan2014 to 2019Enrolled427ConditionsSquamous Cell Carcinoma, Non-Small-Cell LungArmsAbraxane (Induction), Carboplatin (Induction), Abraxane (Maintenance), Best Supportive Care (Maintenance)
NCT02250326 phase2completednot on this map

A Phase 2, Open-Label, Multi-Center Study to Assess Safety and Efficacy of Second/Third-Line Treatment With NAB®-Paclitaxel (ABI-007) In Combination With Epigenetic Modifying Therapy Of CC-486, Or Immunotherapy of Durvalumab (MEDI4736), Or As Monotherapy In Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC): Abound.2L+

TypeinterventionalSponsorCelgeneRan2015 to 2023Enrolled240ConditionsCarcinoma, Non-Small-Cell LungArmsnab-paclitaxel IV, CC-486, Duravalumab
NCT04248998 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Targeting Triple Negative BREAst Cancer Metabolism With a Combination of Chemotherapy and a Diet Mimicking FASTing Plus/Minus Metformin in the Preoperative Setting: the BREAKFAST Trial

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2020 to 2024Enrolled30ConditionsTriple-negative Breast CancerArmsFasting-mimicking diet, Metformin, Preoperative chemotherapy
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 5 syntheses or guidelines pooled it, 132 citations in OpenAlex.

  1. Pooled it
  2. Guideline
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  4. Platinum-containing regimens for triple-negative metastatic breast cancer.The Cochrane database of systematic reviews · 2020
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8 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

20 authors at 13 institutions in 6 countries.

D A YardleySarah Cannon Research Institute and Tennessee Oncology PLLC, Medical Oncology, Nashville, USA. Electronic address: dyardley@tnonc.com.
R ColemanDepartment of Oncology and Metabolism, Weston Park Hospital, University of Sheffield, Sheffield, UK.
P ConteDepartment of Surgery, Oncology and Gastroenterology, University of Padova and Medical Oncology 2, Istituto Oncologico Veneto, Padova, Italy.
J CortesMedical Oncology, Ramon y Cajal University Hospital, Madrid; Vall d'Hebron Institute of Oncology, Barcelona, Spain.
A BrufskyHematology/Oncology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, USA.
M ShtivelbandMedical Oncology, Ironwood Physicians, PC, Chandler, USA.
R YoungMedical Oncology, The Center for Cancer and Blood Disorders, Fort Worth, USA.
C BengalaMedical Oncology, Misericordia General Hospital, Grosseto, Italy.
H AliMedical Oncology, Henry Ford Health System, Detroit, USA.
J EakelHematology and Oncology, Florida Cancer Specialists, Sarasota, USA.
A SchneeweissGynecology and Medical Oncology, Heidelberg University Hospital, Heidelberg, Germany.
L de la Cruz-MerinoClinical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain.
S WilksHematology and Medical Oncology, Texas Oncology, San Antonio, USA.
J O'ShaughnessyHematology, Medical Oncology, Baylor Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, USA.
S GlückGMA Early Assets, Celgene Corporation, Summit, USA.
H LiDepartment of Biostatistics, Celgene Corporation, Summit, USA.
J MillerClinical Research and Development, Hematology/Oncology, Celgene Corporation, Summit, USA.
D BartonClinical Research and Development, Hematology/Oncology, Celgene Corporation, Summit, USA.
N HarbeckBreast Cancer Center, University of Munich, Munich, Germany.
tnAcity investigators
Texas Oncology · USCenter for Cancer and Blood Disorders · USFlorida Cancer Specialists & Research Institute · USHenry Ford Health System · USHospital Universitario Virgen Macarena · ESInstituto Cajal · ESIstituto Oncologico Veneto · ITLudwig-Maximilians-Universität München · DEOspedale Misericordia - Grosseto · ITTennessee Oncology · USUniversity Hospital Heidelberg · DEUniversity of Pittsburgh · USWeston Park Cancer Centre · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Metastatic triple-negative breast cancer (mTNBC) has a poor prognosis and aggressive clinical course. tnAcity evaluated the efficacy and safety of first-line nab-paclitaxel plus carboplatin (nab-P/C), nab-paclitaxel plus gemcitabine (nab-P/G), and gemcitabine plus carboplatin (G/C) in patients with mTNBC. Patients and methods: Patients with pathologically confirmed mTNBC and no prior chemotherapy for metastatic BC received (1 : 1 : 1) nab-P 125 mg/m2 plus C AUC 2, nab-P 125 mg/m2 plus G 1000 mg/m2, or G 1000 mg/m2 plus C AUC 2, all on days 1, 8 q3w. Phase II primary end point: investigator-assessed progression-free survival (PFS); secondary end points included overall response rate (ORR), overall survival (OS), percentage of patients initiating cycle 6 with doublet therapy, and safety. Results: In total, 191 patients were enrolled (nab-P/C, n = 64; nab-P/G, n = 61; G/C, n = 66). PFS was significantly longer with nab-P/C versus nab-P/G [median, 8.3 versus 5.5 months; hazard ratio (HR), 0.59 [95% CI, 0.38-0.92]; P = 0.02] or G/C (median, 8.3 versus 6.0 months; HR, 0.58 [95% CI, 0.37-0.90]; P = 0.02). OS was numerically longer with nab-P/C versus nab-P/G (median, 16.8 versus 12.1 months; HR, 0.73 [95% CI, 0.47-1.13]; P = 0.16) or G/C (median, 16.8 versus 12.6 months; HR, 0.80 [95% CI, 0.52-1.22]; P = 0.29). ORR was 73%, 39%, and 44%, respectively. In the nab-P/C, nab-P/G, and G/C groups, 64%, 56%, and 50% of patients initiated cycle 6 with a doublet. Grade ≥3 adverse events were mainly hematologic. Conclusions: First-line nab-P/C was active in mTNBC and resulted in a significantly longer PFS and improved risk/benefit profile versus nab-P/G or G/C.

Indexed as

AdultAgedAged, 80 and overAlbuminsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinChemotherapy, AdjuvantDeoxycytidineDisease-Free SurvivalFemaleGemcitabineHumansKaplan-Meier EstimateMastectomyMiddle AgedPaclitaxel130-nm albumin-bound paclitaxelAlbuminsCarboplatinDeoxycytidineGemcitabinePaclitaxel

Identifiers

PMID29878040
PMCPMC6096741
OpenAlexW2806830990

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.