Evidence map›Paper›PMID 37689749›Full record

ArticleNPJ breast cancer2023

High-dose alkylating chemotherapy in BRCA-altered triple-negative breast cancer: the randomized phase III NeoTN trial.

Sonja Vliek, Florentine S Hilbers, Erik van Werkhoven, Ingrid Mandjes, Rob Kessels, Sieta Kleiterp, Esther H Lips, Lennart Mulder, Mutamba T Kayembe, Claudette E Loo and 21 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in NPJ breast cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01057069 (Randomized Phase II/III Study of Individualized Neoadjuvant Chemotherapy in ' Triple Negative' Breast Tumors), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 21% 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.

NCT01057069 phase2 / phase3active not recruitingnot on this map

Randomized Phase II/III Study of Individualized Neoadjuvant Chemotherapy in ' Triple Negative' Breast Tumors

TypeinterventionalSponsorThe Netherlands Cancer InstituteRan2010 to 2029Enrolled310ConditionsBreast CancerArmsCarboplatin and Paclitaxel, Doxorubicin, cyclophosphamide, Doxorubicin, cyclophosphamide, carboplatin, thiotepa, cyclophosphamide
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Review
  3. 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

31 authors at 13 institutions in 2 countries.

Sonja Vliek *Department of Molecular Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0002-7300-7436
Florentine S Hilbers *Department of Molecular Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Erik van WerkhovenDepartment of Biometrics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0001-7469-7427
Ingrid MandjesDepartment of Biometrics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Rob KesselsDepartment of Biometrics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Sieta KleiterpDepartment of Molecular Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Esther H LipsDepartment of Molecular Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0003-3488-4935
Lennart MulderDepartment of Molecular Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Mutamba T KayembeDepartment of Biometrics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Claudette E LooDepartment of Radiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Nicola S RussellDepartment of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0003-3507-9620
Marie-Jeanne T F D Vrancken PeetersDepartment of Surgical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0003-4472-4257
Marjo J HoltkampDepartment of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Margaret SchotDepartment of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Joke W BaarsDepartment of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Aafke H HonkoopDepartment of Internal Medicine, Isala Klinieken, Zwolle, The Netherlands.
Annelie J E VulinkDivision of Medical Oncology, Reinier de Graaf Hospital, Delft, The Netherlands.
Alex L T ImholzDepartment of Internal Medicine, Deventer Ziekenhuis, Deventer, The Netherlands.
Suzan VrijaldenhovenDepartment of Internal Medicine, Northwest Clinics, Alkmaar, The Netherlands.
Franchette W P J van den BerkmortelDepartment of Oncology, Zuyderland Medisch Centrum, Heerlen-Geleen, The Netherlands.
Jetske M Meerum TerwogtDepartment of Internal Medicine, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
Jolanda G SchramaDepartment of Internal Medicine, Spaarne Gasthuis, Hoofddorp, The Netherlands.
Philomeen KuijerDepartment of Internal Medicine, Spaarne Gasthuis, Hoofddorp, The Netherlands.
Judith R KroepDepartment of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
Annemieke van der Padt-PruijstenDepartment of Internal Medicine, Maasstad Hospital, Rotterdam, The Netherlands.
Jelle WesselingDepartment of Molecular Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0002-8940-2676
Gabe S SonkeDepartment of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Kenneth G A GilhuijsImage Sciences Institute, University Medical Center Utrecht, Utrecht, Netherlands.
Agnes JagerDepartment of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.ORCID http://orcid.org/0000-0002-7713-1450
Petra NederlofDepartment of Molecular diagnostics, The Netherlands Cancer Institute, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0002-2358-9765
Sabine C LinnDepartment of Molecular Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. s.linn@nki.nl.ORCID http://orcid.org/0000-0001-5541-0347
The Netherlands Cancer Institute · NLLeiden University Medical Center · NLSpaarne Ziekenhuis · NLDeventer Ziekenhuis · NLErasmus MC Cancer Institute · NLIsala · NLMaasstad Ziekenhuis · NLNorthwest Hospital · USOLVG · NLReinier de Graaf Hospital · NLUniversity Medical Center Utrecht · NLUtrecht University · NLZuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Exploratory analyses of high-dose alkylating chemotherapy trials have suggested that BRCA1 or BRCA2-pathway altered (BRCA-altered) breast cancer might be particularly sensitive to this type of treatment. In this study, patients with BRCA-altered tumors who had received three initial courses of dose-dense doxorubicin and cyclophosphamide (ddAC), were randomized between a fourth ddAC course followed by high-dose carboplatin-thiotepa-cyclophosphamide or conventional chemotherapy (initially ddAC only or ddAC-capecitabine/decetaxel [CD] depending on MRI response, after amendment ddAC-carboplatin/paclitaxel [CP] for everyone). The primary endpoint was the neoadjuvant response index (NRI). Secondary endpoints included recurrence-free survival (RFS) and overall survival (OS). In total, 122 patients were randomized. No difference in NRI-score distribution (p = 0.41) was found. A statistically non-significant RFS difference was found (HR 0.54; 95% CI 0.23-1.25; p = 0.15). Exploratory RFS analyses showed benefit in stage III (n = 35; HR 0.16; 95% CI 0.03-0.75), but not stage II (n = 86; HR 1.00; 95% CI 0.30-3.30) patients. For stage III, 4-year RFS was 46% (95% CI 24-87%), 71% (95% CI 48-100%) and 88% (95% CI 74-100%), for ddAC/ddAC-CD, ddAC-CP and high-dose chemotherapy, respectively. No significant differences were found between high-dose and conventional chemotherapy in stage II-III, triple-negative, BRCA-altered breast cancer patients. Further research is needed to establish if there are patients with stage III, triple negative BRCA-altered breast cancer for whom outcomes can be improved with high-dose alkylating chemotherapy or whether the current standard neoadjuvant therapy including carboplatin and an immune checkpoint inhibitor is sufficient. Trial Registration: NCT01057069.

Identifiers

PMID37689749
PMCPMC10492793
OpenAlexW4386572703

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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.