Evidence map›Paper›PMID 36759673›Full record

Trial reportNature medicine2023

Oncolytic T-VEC virotherapy plus neoadjuvant chemotherapy in nonmetastatic triple-negative breast cancer: a phase 2 trial.

Hatem Soliman, Deanna Hogue, Hyo Han, Blaise Mooney, Ricardo Costa, Marie C Lee, Bethany Niell, Angela Williams, Alec Chau, Shannon Falcon and 10 more

Erratum issued 2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 83 papers.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed
21.9field-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.

NCT02779855 phase1 / phase2completednot on this map

A Phase 1/2 Study of Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

TypeinterventionalSponsorH. Lee Moffitt Cancer Center and Research InstituteRan2017 to 2025Enrolled50ConditionsBreast Cancer, Ductal Carcinoma, Invasive Breast Carcinoma, Invasive Ductal Breast CarcinomaArmsTalimogene laherparepvec, Paclitaxel
NCT06686043 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase 2 Study of HPV L1 Vaccine in Combination With Imiquimod and Metformin in Cervical, Vaginal, and Vulvar Cancers

TypeinterventionalSponsorBaylor College of MedicineRan2024 to 2028Enrolled85ConditionsCervical Carcinoma, Vaginal Carcinoma, Vulvar Carcinoma, HPV (Human Papillomavirus)-Associated CarcinomaArmsHPV vaccine, Imiquimod, and metformin combination therapy
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 70 citations in OpenAlex.

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  6. Oncolytic adenovirus in treating malignant ascites: A phase II trial and longitudinal single-cell study.Molecular therapy : the journal of the American Society of Gene Therapy · 2024
    Trial
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  9. Observational
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  11. Article
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  18. Intravenous infusion of engineered megakaryocytes to produce oncolytic platelets in vivo for enhanced cancer immunotherapy.Proceedings of the National Academy of Sciences of the United States of America · 2026
    Article
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23 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 1 institution in 1 country.

Hatem SolimanDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, FL, USA. Hatem.soliman@moffitt.org.ORCID http://orcid.org/0000-0001-6644-2264
Deanna HogueClinical Trials Office, Moffitt Cancer Center, Tampa, FL, USA.ORCID http://orcid.org/0000-0002-0991-3338
Hyo HanDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Blaise MooneyDepartment of Radiology, Moffitt Cancer Center, Tampa, FL, USA.ORCID http://orcid.org/0000-0003-1030-5054
Ricardo CostaDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Marie C LeeDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, FL, USA.ORCID http://orcid.org/0000-0002-1756-7279
Bethany NiellDepartment of Radiology, Moffitt Cancer Center, Tampa, FL, USA.
Angela WilliamsDepartment of Radiology, Moffitt Cancer Center, Tampa, FL, USA.
Alec ChauDepartment of Radiology, Moffitt Cancer Center, Tampa, FL, USA.
Shannon FalconDepartment of Radiology, Moffitt Cancer Center, Tampa, FL, USA.
Aixa SoyanoDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Avan ArmaghaniDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Nazanin KhakpourDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Robert J WeinfurtnerDepartment of Radiology, Moffitt Cancer Center, Tampa, FL, USA.ORCID http://orcid.org/0000-0002-4245-8744
Susan HooverDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, FL, USA.
John KilukDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Christine LarongaDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Marilin RosaDepartment of Pathology, Moffitt Cancer Center, Tampa, FL, USA.
Hung KhongDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Brian CzernieckiDepartment of Breast Oncology, Moffitt Cancer Center, Tampa, FL, USA.
Moffitt Cancer Center · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI Christine O'Connell · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

Talimogene laherparepvec (T-VEC) is an oncolytic virus hypothesized to enhance triple-negative breast cancer (TNBC) responses to neoadjuvant chemotherapy (NAC). This article describes the phase 2 trial of T-VEC plus NAC (ClinicalTrials.gov ID: NCT02779855 ). Patients with stage 2-3 TNBC received five intratumoral T-VEC injections with paclitaxel followed by doxorubicin and cyclophosphamide and surgery to assess residual cancer burden index (RCB). The primary end point was RCB0 rate. Secondary end points were RCB0-1 rate, recurrence rate, toxicity and immune correlates. Thirty-seven patients were evaluated. Common T-VEC toxicities were fevers, chills, headache, fatigue and injection site pain. NAC toxicities were as expected. Four thromboembolic events occurred. The primary end point was met with an estimated RCB0 rate = 45.9% and RCB0-1 descriptive rate = 65%. The 2-year disease-free rate is equal to 89% with no recurrences in RCB0-1 patients. Immune activation during treatment correlated with response. T-VEC plus NAC in TNBC may increase RCB0-1 rates. These results support continued investigation of T-VEC plus NAC for TNBC.

Indexed as

MelanomaOncolytic VirotherapyTriple Negative Breast NeoplasmsBiological ProductsHerpesvirus 1, HumanHumansNeoadjuvant TherapyBiological Productstalimogene laherparepvec

Identifiers

PMID36759673
OpenAlexW4319812743

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.