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Article ; Online: Model-Assisted Designs for Early-Phase Clinical Trials: Simplicity Meets Superiority.

Yuan, Ying / Lee, J Jack / Hilsenbeck, Susan G

JCO precision oncology

2019 Volume 3

Abstract: Drug development enterprise is struggling because of prohibitively high costs and slow progress. There is urgent need for adoption of novel adaptive designs to improve the efficiency and success of clinical trials. A major barrier is that many ... ...

Abstract	Drug development enterprise is struggling because of prohibitively high costs and slow progress. There is urgent need for adoption of novel adaptive designs to improve the efficiency and success of clinical trials. A major barrier is that many conventional designs are inadequate for modern drug development, yet most novel adaptive designs are difficult to understand, require complicated statistical modeling, demand complex computation, and need expensive infrastructure for implementation. The objective of this article is to introduce and review a class of novel adaptive designs, known as model-assisted designs, to remove this barrier and increase the use of novel adaptive designs. Model-assisted designs enjoy superior performance comparable to more complicated, model-based adaptive designs, but their decision rule can be pretabulated and included in the protocol-thus implemented as simply as the conventional designs. We review state-of-the-art model-assisted designs for phase I clinical trials for single-agent, drug-combination and late-onset toxicity scenarios. We also briefly introduce model-assisted designs for phase II trials to handle binary, coprimary endpoints and delayed response. Freely available user-friendly software and trial examples (trialdesign.org) facilitate the adoption of model-assisted designs.
Language	English
Publishing date	2019-10-24
Publishing country	United States
Document type	Journal Article ; Review
ISSN	2473-4284
ISSN (online)	2473-4284
DOI	10.1200/PO.19.00032
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Article ; Online: The novel phosphatase NUDT5 is a critical regulator of triple-negative breast cancer growth.

Qian, Jing / Ma, Yanxia / Tahaney, William M / Moyer, Cassandra L / Lanier, Amanda / Hill, Jamal / Coleman, Darian / Koupaei, Negar / Hilsenbeck, Susan G / Savage, Michelle I / Page, Brent D G / Mazumdar, Abhijit / Brown, Powel H

Breast cancer research : BCR

2024 Volume 26, Issue 1, Page(s) 23

Abstract: Background: The most aggressive form of breast cancer is triple-negative breast cancer (TNBC), which lacks expression of the estrogen receptor (ER) and progesterone receptor (PR), and does not have overexpression of the human epidermal growth factor ... ...

Abstract	Background: The most aggressive form of breast cancer is triple-negative breast cancer (TNBC), which lacks expression of the estrogen receptor (ER) and progesterone receptor (PR), and does not have overexpression of the human epidermal growth factor receptor 2 (HER2). Treatment options for women with TNBC tumors are limited, unlike those with ER-positive tumors that can be treated with hormone therapy, or those with HER2-positive tumors that can be treated with anti-HER2 therapy. Therefore, we have sought to identify novel targeted therapies for TNBC. In this study, we investigated the potential of a novel phosphatase, NUDT5, as a potential therapeutic target for TNBC. Methods: The mRNA expression levels of NUDT5 in breast cancers were investigated using TCGA and METABRIC (Curtis) datasets. NUDT5 ablation was achieved through siRNA targeting and NUDT5 inhibition with the small molecule inhibitor TH5427. Xenograft TNBC animal models were employed to assess the effect of NUDT5 inhibition on in vivo tumor growth. Proliferation, death, and DNA replication assays were conducted to investigate the cellular biological effects of NUDT5 loss or inhibition. The accumulation of 8-oxo-guanine (8-oxoG) and the induction of γH Results: In this study, we demonstrated the significant role of an overexpressed phosphatase, NUDT5, in regulating oxidative DNA damage in TNBCs. Our findings indicate that loss of NUDT5 results in suppressed growth of TNBC both in vitro and in vivo. This growth inhibition is not attributed to cell death, but rather to the suppression of proliferation. The loss or inhibition of NUDT5 led to an increase in the oxidative DNA lesion 8-oxoG, and triggered the DNA damage response in the nucleus. The interference with DNA replication ultimately inhibited proliferation. Conclusions: NUDT5 plays a crucial role in preventing oxidative DNA damage in TNBC cells. The loss or inhibition of NUDT5 significantly suppresses the growth of TNBCs. These biological and mechanistic studies provide the groundwork for future research and the potential development of NUDT5 inhibitors as a promising therapeutic approach for TNBC patients.
MeSH term(s)	Animals ; Female ; Humans ; Cell Line, Tumor ; Cell Proliferation ; Pyrophosphatases/genetics ; Receptors, Estrogen/metabolism ; Triple Negative Breast Neoplasms/drug therapy ; Triple Negative Breast Neoplasms/genetics ; Triple Negative Breast Neoplasms/pathology
Chemical Substances	NUDT5 protein, human (EC 3.6.1.-) ; Pyrophosphatases (EC 3.6.1.-) ; Receptors, Estrogen
Language	English
Publishing date	2024-02-05
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2015059-3
ISSN	1465-542X ; 1465-5411
ISSN (online)	1465-542X
ISSN	1465-5411
DOI	10.1186/s13058-024-01778-w
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Article ; Online: Correction: The novel phosphatase NUDT5 is a critical regulator of triple-negative breast cancer growth.

Breast cancer research : BCR

2024 Volume 26, Issue 1, Page(s) 53

Language	English
Publishing date	2024-03-26
Publishing country	England
Document type	Published Erratum
ZDB-ID	2015059-3
ISSN	1465-542X ; 1465-5411
ISSN (online)	1465-542X
ISSN	1465-5411
DOI	10.1186/s13058-024-01814-9
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Article ; Online: Phase I / II trial of metformin as a chemo-radiosensitizer in a head and neck cancer patient population.

Kemnade, Jan O / Florez, Marcus / Sabichi, Anita / Zhang, Jun / Jhaveri, Pavan / Chen, George / Chen, Albert / Miller-Chism, Courtney / Shaun, Bulsara / Hilsenbeck, Susan G / Hernandez, David J / Skinner, Heath D / Sandulache, Vlad C

Oral oncology

2023 Volume 145, Page(s) 106536

Abstract: Objectives: Retrospective studies have shown that head and neck squamous cell carcinoma (HNSCC) patients taking metformin demonstrate superior survival compared to their counterparts. We sought to determine whether metformin combined with chemoradiation ...

Abstract	Objectives: Retrospective studies have shown that head and neck squamous cell carcinoma (HNSCC) patients taking metformin demonstrate superior survival compared to their counterparts. We sought to determine whether metformin combined with chemoradiation would improve HNSCC patient survival compared to historical controls. Materials and methods: We conducted a Phase I/II prospective, single arm clinical trial in patients with newly diagnosed HNSCC (NCT02949700). Patients received platinum-based chemoradiation in combination with orally dosed metformin at one of 2 doses- 850 mg BID or 1500 mg BID administered during radiation, with a 2-week lead-in phase. Toxicity, disease response and survival metrics were ascertained throughout the study period. Results: A total of 25 patients were evaluable for toxicity and survival; 9 failed to reach the predetermined 70% compliance with the study drug. No dose limiting toxicities were identified in the Phase I component and there were no grade 4 adverse events likely related to metformin throughout the study. The primary outcome for the Phase II component was met with a response rate of 96%. Three-year overall survival was ∼70% in the per protocol p16 + cohort and 0% in the per protocol p16- cohort. Survival among participants with a ≥70% metformin compliance to <70% metformin compliance demonstrated a trend towards improvement in the ≥70% compliance cohort, though this did not reach significance. Conclusion: Metformin is well tolerated during concurrent chemoradiation for HNSCC. Its effectiveness as a chemo-radiosensitizer remains unclear and will require further study with randomized controlled clinical trials in this patient population.
MeSH term(s)	Humans ; Squamous Cell Carcinoma of Head and Neck/drug therapy ; Retrospective Studies ; Metformin/therapeutic use ; Prospective Studies ; Head and Neck Neoplasms/drug therapy
Chemical Substances	Metformin (9100L32L2N)
Language	English
Publishing date	2023-08-08
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1120465-5
ISSN	1879-0593 ; 0964-1955 ; 1368-8375
ISSN (online)	1879-0593
ISSN	0964-1955 ; 1368-8375
DOI	10.1016/j.oraloncology.2023.106536
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Zs.A 4869: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.A 456: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)

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Article ; Online: Self-Sampling for Human Papillomavirus Testing: Acceptability in a U.S. Safety Net Health System.

Parker, Susan L / Amboree, Trisha L / Bulsara, Shaun / Daheri, Maria / Anderson, Matthew L / Hilsenbeck, Susan G / Jibaja-Weiss, Maria L / Zare, Mohammed / Schmeler, Kathleen M / Deshmukh, Ashish A / Chiao, Elizabeth Y / Scheurer, Michael E / Montealegre, Jane R

American journal of preventive medicine

2023 Volume 66, Issue 3, Page(s) 540–547

Abstract: Introduction: Self-sampling for human papillomavirus testing is increasingly recognized as a strategy to expand cervical cancer screening access and utilization. Acceptability is a key determinant of uptake. This study assesses the acceptability of and ... ...

Abstract	Introduction: Self-sampling for human papillomavirus testing is increasingly recognized as a strategy to expand cervical cancer screening access and utilization. Acceptability is a key determinant of uptake. This study assesses the acceptability of and experiences with mailed self-sampling kits for human papillomavirus testing among underscreened patients in a safety net health system. Methods: A nested telephone survey was administered between 2021 and 2023 to a sample (n=272) of the 2,268 participants enrolled in the Prospective Evaluation of Self-Testing to Increase Screening trial. Trial participants include patients of a safety net health system aged 30-65 years who were not up to date on screening. Participants were asked about barriers to provider-performed screening. Kit users and nonusers were asked about their experiences. Results: Prevalent barriers to provider-performed screening included perceived discomfort of pelvic examination (69.4%), being uncomfortable with male providers (65.4%), and embarrassment (57.0%). Among participants who reported using the mailed kit (n=164), most reported good experiences (84.8%). Most reported self-sampling as more/equally convenient (89.0%), less/equally embarrassing (99.4%), and less/equally stressful (95.7%) than provider-performed screening. Among kit nonusers (n=43), reasons for not using the kit included forgetting about it (76.7%), preferring provider-performed screening (76.7%), and fearing cancer (67.4%). Conclusions: Prospective Evaluation of Self-Testing to Increase Screening trial participants generally had a positive experience with self-sampling for human papillomavirus testing. Increased comfort and reduced embarrassment/anxiety with self-sampling are relevant attributes because these were the most prevalent reported barriers to provider-performed screening. High acceptability suggests potentially high uptake when self-sampling for human papillomavirus testing receives regulatory approval and is available in safety net health systems.
MeSH term(s)	Female ; Humans ; Male ; Human Papillomavirus Viruses ; Uterine Cervical Neoplasms/prevention & control ; Self Care ; Early Detection of Cancer ; Papillomavirus Infections/diagnosis ; Papillomaviridae ; Mass Screening ; Patient Acceptance of Health Care ; Vaginal Smears
Language	English
Publishing date	2023-11-05
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	632646-8
ISSN	1873-2607 ; 0749-3797
ISSN (online)	1873-2607
ISSN	0749-3797
DOI	10.1016/j.amepre.2023.10.020
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Zs.A 2096: Show issues

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Article ; Online: LOAd703, an oncolytic virus-based immunostimulatory gene therapy, combined with chemotherapy for unresectable or metastatic pancreatic cancer (LOKON001): results from arm 1 of a non-randomised, single-centre, phase 1/2 study.

The Lancet. Oncology

2024 Volume 25, Issue 4, Page(s) 488–500

Abstract: Background: Pancreatic ductal adenocarcinoma is characterised by low immunogenicity and an immunosuppressive tumour microenvironment. LOAd703, an oncolytic adenovirus with transgenes encoding TMZ-CD40L and 4-1BBL, lyses cancer cells selectively, ... ...

Abstract	Background: Pancreatic ductal adenocarcinoma is characterised by low immunogenicity and an immunosuppressive tumour microenvironment. LOAd703, an oncolytic adenovirus with transgenes encoding TMZ-CD40L and 4-1BBL, lyses cancer cells selectively, activates cytotoxic T cells, and induces tumour regression in preclinical models. The aim of this study was to evaluate the safety and feasibility of combining LOAd703 with chemotherapy for advanced pancreatic ductal adenocarcinoma. Methods: LOKON001 was a non-randomised, phase 1/2 study conducted at the Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX, USA, and consisted of two arms conducted sequentially; the results of arm 1 are presented here. In arm 1, patients 18 years or older with previously treated or treatment-naive unresectable or metastatic pancreatic ductal adenocarcinoma were treated with standard 28-day cycles of intravenous nab-paclitaxel 125 mg/m Findings: Between Dec 2, 2016, and Oct 17, 2019, 23 patients were assessed for eligibility, leading to 22 patients being enrolled. One patient withdrew consent, resulting in 21 patients (13 [62%] men and eight [38%] women) assigned to a dose group (three to dose 1, four to dose 2, and 14 to dose 3). 21 patients were evaluable for safety. Median follow-up time was 6 months (IQR 4-10), and data cutoff was Jan 5, 2023. The most common treatment-emergent adverse events overall were anaemia (96 [8%] of 1237 events), lymphopenia (86 [7%] events), hyperglycaemia (70 [6%] events), leukopenia (63 [5%] events), hypertension (62 [5%] events), and hypoalbuminaemia (61 [5%] events). The most common adverse events attributed to LOAd703 were fever (14 [67%] of 21 patients), fatigue (eight [38%]), chills (seven [33%]), and elevated liver enzymes (alanine aminotransferase in five [24%], alkaline phosphatase in four [19%], and aspartate aminotransferase in four [19%]), all of which were grade 1-2, except for a transient grade 3 aminotransferase elevation occurring at dose 3. A maximum tolerated dose was not reached, thereby establishing dose 3 as the highest-evaluated safe dose when combined with nab-paclitaxel plus gemcitabine. Proportions of CD8 Interpretation: Combining LOAd703 with nab-paclitaxel plus gemcitabine in patients with advanced pancreatic ductal adenocarcinoma was feasible and safe. To build upon this novel chemoimmunotherapeutic approach, arm 2 of LOKON001, which combines LOAd703, nab-paclitaxel plus gemcitabine, and atezolizumab, is ongoing. Funding: Lokon Pharma, the Swedish Cancer Society, and the Swedish Research Council.
MeSH term(s)	Male ; Humans ; Female ; Gemcitabine ; Oncolytic Viruses/genetics ; Bayes Theorem ; Pancreatic Neoplasms/therapy ; Pancreatic Neoplasms/drug therapy ; Paclitaxel ; Anemia/chemically induced ; Thrombocytopenia/chemically induced ; Adenocarcinoma/therapy ; Adenocarcinoma/drug therapy ; Albumins ; Genetic Therapy/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Tumor Microenvironment
Chemical Substances	Gemcitabine ; Paclitaxel (P88XT4IS4D) ; Albumins
Language	English
Publishing date	2024-03-28
Publishing country	England
Document type	Clinical Trial, Phase II ; Clinical Trial, Phase I ; Journal Article
ZDB-ID	2049730-1
ISSN	1474-5488 ; 1470-2045
ISSN (online)	1474-5488
ISSN	1470-2045
DOI	10.1016/S1470-2045(24)00079-2
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Zs.A 5696: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 460: Show issues

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Article ; Online: Making sense of clinical trial data: is inverse probability of censoring weighted analysis the answer to crossover bias?

Rimawi, Mothaffar / Hilsenbeck, Susan G

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2012 Volume 30, Issue 4, Page(s) 453–458

Abstract: Ideally, therapeutic interventions are evaluated through randomized clinical trials. These trials are commonly analyzed with an intent-to-treat (ITT) approach, whereby patients are analyzed in their assigned treatment group regardless of actual treatment ...

Abstract	Ideally, therapeutic interventions are evaluated through randomized clinical trials. These trials are commonly analyzed with an intent-to-treat (ITT) approach, whereby patients are analyzed in their assigned treatment group regardless of actual treatment received. If an interim analysis of such trials demonstrates compelling evidence of a difference in benefit, ethical considerations often dictate that the trial be unblinded and participants be provided access to the more efficacious agent. Because interim analysis may not address longer-term outcomes of interest, important clinical questions such as overall survival benefit-the ultimate test of efficacy to many-may remain unanswered. The ensuing crossover disturbs randomization and may lead to biased longer-term analysis, compromising the utility of clinical data. This has been especially apparent in recent adjuvant and prevention breast cancer trials. We consider four such trials: HERA (Herceptin Adjuvant), NSABP P-1 (National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention P-1), MA.17, and BIG 1-98 (Breast International Group 1-98), the long-term outcomes of which were complicated by unblinding and selective crossover. We also discuss the biases associated with ITT analysis and, alternatively, censoring of follow-up data (ie, dropping out) after selective crossover. Moreover, we discuss how the statistical procedure of inverse probability of censoring weighted (IPCW) analysis may be used to account for selective crossover as an alternative to ITT or censoring analysis, as was recently done for the BIG 1-98 trial. Notably, IPCW analysis may be particularly suited for detecting overall survival benefits that otherwise would not be detected with an ITT approach, as reported for the BIG 1-98 trial.
MeSH term(s)	Breast Neoplasms/drug therapy ; Chemotherapy, Adjuvant ; Cross-Over Studies ; Data Interpretation, Statistical ; Disease-Free Survival ; Female ; Humans ; Randomized Controlled Trials as Topic/methods ; Research Design ; Survival Analysis
Language	English
Publishing date	2012-02-01
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.2010.34.2808
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Zs.A 1847: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 650: Show issues

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Article ; Online: Endoscopic assessment of radiological stage IVA cervical cancer: A bivariate meta-analysis supporting an evidence-based staging algorithm proposal.

Sapienza, Lucas G / Thomas, Justin J / Showalter, Timothy N / Echeverria, Alfredo E / Ludwig, Michelle S / Chen, Albert C / Jo, Eunji / Calsavara, Vinícius F / Hilsenbeck, Susan G / Jhingran, Anuja / Frumovitz, Michael M / Baiocchi, Glauco

Gynecologic oncology

2022 Volume 165, Issue 3, Page(s) 642–649

Abstract: Objective: To optimize the use of confirmatory endoscopic exams (cystoscopy/proctoscopy) in the staging of locally advanced cervical cancer (LACC), the present study evaluates the predictive value of radiological exams (CT and MRI) to detect bladder/ ... ...

Abstract	Objective: To optimize the use of confirmatory endoscopic exams (cystoscopy/proctoscopy) in the staging of locally advanced cervical cancer (LACC), the present study evaluates the predictive value of radiological exams (CT and MRI) to detect bladder/rectum invasion. Methods: A systematic search of databases (PubMed and EMBASE) was performed (CRD42021270329). The inclusion criteria were: a) cervix cancer diagnosis; b) staging CT and/or MRI (index test); c) staging cystoscopy and/or proctoscopy (standard test); and d) numbers of true positives (TP), true negatives (TN), false positives (FP), and false negatives (FN) provided. A random-effects bivariate meta-analysis of positive predictive value (PPV) and negative predictive value (NPV) was performed with moderator analyses by imaging modality (CT and MRI) and prevalence. Results: Nineteen studies met the inclusion criteria, totaling 3480 and 1641 patients for bladder and rectum analyses, respectively. For bladder invasion (prevalence ranged from 0.9% to 34.5%), the overall PPV was 45% (95% confidence interval, 33%-57%, based on 19 studies). Per subgroup, the PPV was 31% for MRI/prevalence ≤6%, 33% for CT/prevalence ≤6%, and 69% for CT/prevalence >6%. For rectal invasion (prevalence ranged from 0.4% to 20.0%), the overall PPV was 30% (95% confidence interval, 17%-47%, based on 8 studies). Per subgroup, the PPV was 36% for MRI/prevalence ≤1%, 17% for MRI/prevalence >1%, and 38% for CT/prevalence >1%. The overall NPV for bladder invasion and rectal invasion were 98% (95% confidence interval, 97%-99%) and 100% (95% confidence interval, 99%-100%), respectively. Considering prevalence and radiological modality, the point estimate of NPV varied from 95% to 100% for bladder invasion and from 99% to 100% for rectum invasion. Conclusions: Due to low PPV (<50%) of radiological staging, endoscopic exams may be necessary to correctly assess radiological stage IVA LACC. However, they are not necessary after negative radiological exam (NPV ≥95%).
MeSH term(s)	Algorithms ; Cystoscopy ; Female ; Humans ; Magnetic Resonance Imaging/methods ; Neoplasm Staging ; Radiography ; Uterine Cervical Neoplasms/pathology
Language	English
Publishing date	2022-04-08
Publishing country	United States
Document type	Journal Article ; Meta-Analysis ; Review
ZDB-ID	801461-9
ISSN	1095-6859 ; 0090-8258
ISSN (online)	1095-6859
ISSN	0090-8258
DOI	10.1016/j.ygyno.2022.03.026
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Article: Bayesian Optimal Interval Design: A Simple and Well-Performing Design for Phase I Oncology Trials.

Yuan, Ying / Hess, Kenneth R / Hilsenbeck, Susan G / Gilbert, Mark R

Clinical cancer research : an official journal of the American Association for Cancer Research

2016 Volume 22, Issue 17, Page(s) 4291–4301

Abstract: Despite more than two decades of publications that offer more innovative model-based designs, the classical 3 + 3 design remains the most dominant phase I trial design in practice. In this article, we introduce a new trial design, the Bayesian optimal ... ...

Abstract	Despite more than two decades of publications that offer more innovative model-based designs, the classical 3 + 3 design remains the most dominant phase I trial design in practice. In this article, we introduce a new trial design, the Bayesian optimal interval (BOIN) design. The BOIN design is easy to implement in a way similar to the 3 + 3 design, but is more flexible for choosing the target toxicity rate and cohort size and yields a substantially better performance that is comparable with that of more complex model-based designs. The BOIN design contains the 3 + 3 design and the accelerated titration design as special cases, thus linking it to established phase I approaches. A numerical study shows that the BOIN design generally outperforms the 3 + 3 design and the modified toxicity probability interval (mTPI) design. The BOIN design is more likely than the 3 + 3 design to correctly select the MTD and allocate more patients to the MTD. Compared with the mTPI design, the BOIN design has a substantially lower risk of overdosing patients and generally a higher probability of correctly selecting the MTD. User-friendly software is freely available to facilitate the application of the BOIN design. Clin Cancer Res; 22(17); 4291-301. ©2016 AACR.
Language	English
Publishing date	2016-09-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-16-0592
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Zs.A 4223: Show issues

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Article ; Online: Targeting the Pro-survival Protein BCL-2 to Prevent Breast Cancer.

Young, Adelaide / Bu, Wen / Jiang, Weiyu / Ku, Amy / Kapali, Jyoti / Dhamne, Sagar / Qin, Lan / Hilsenbeck, Susan G / Du, Yi-Chieh Nancy / Li, Yi

Cancer prevention research (Philadelphia, Pa.)

2021 Volume 15, Issue 1, Page(s) 3–10

Abstract: Current chemopreventive strategies require 3-5 years of continuous treatment and have the concerns of significant side effects; therefore, new chemopreventive agents that require shorter and safer treatments are urgently needed. In this study, we ... ...

Abstract	Current chemopreventive strategies require 3-5 years of continuous treatment and have the concerns of significant side effects; therefore, new chemopreventive agents that require shorter and safer treatments are urgently needed. In this study, we developed a new murine model of breast cancer that mimics human breast cancer initiation and is ideal for testing the efficacy of chemopreventive therapeutics. In this model, introduction of lentivirus carrying a PIK3CA gene mutant commonly found in breast cancers infects a small number of the mammary cells, leading to atypia first and then to ductal carcinomas that are positive for both estrogen receptor and progesterone receptor. Venetoclax is a BH3 mimetic that blocks the anti-apoptotic protein BCL-2 and has efficacy in treating breast cancer. We found that venetoclax treatment of atypia-bearing mice delayed the progression to tumors, improved overall survival, and reduced pulmonary metastasis. Therefore, prophylactic treatment to inhibit the pro-survival protein BCL-2 may provide an alternative to the currently available regimens in breast cancer prevention. PREVENTION RELEVANCE: This study demonstrates that prophylactic treatment with the BCL2-specific antagonist venetoclax prevents breast cancer initiated by a mutated and activated PIK3CA, the most common breast oncogene.
MeSH term(s)	Animals ; Apoptosis ; Apoptosis Regulatory Proteins ; Breast Neoplasms/pathology ; Female ; Humans ; Mice ; Proto-Oncogene Proteins c-bcl-2 ; Receptors, Estrogen
Chemical Substances	Apoptosis Regulatory Proteins ; Proto-Oncogene Proteins c-bcl-2 ; Receptors, Estrogen
Language	English
Publishing date	2021-10-19
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2434717-6
ISSN	1940-6215 ; 1940-6207
ISSN (online)	1940-6215
ISSN	1940-6207
DOI	10.1158/1940-6207.CAPR-21-0031
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In stock of ZB MED Cologne/Königswinter

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