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Dive into the research topics where Nola M. Hylton is active.

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Featured researches published by Nola M. Hylton.


Clinical Pharmacology & Therapeutics | 2009

I‐SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy

Anna Barker; Cc Sigman; Gary J. Kelloff; Nola M. Hylton; Da Berry; Laura Esserman

I‐SPY 2 (investigation of serial studies to predict your therapeutic response with imaging and molecular analysis 2) is a process targeting the rapid, focused clinical development of paired oncologic therapies and biomarkers. The framework is an adaptive phase II clinical trial design in the neoadjuvant setting for women with locally advanced breast cancer. I‐SPY 2 is a collaborative effort among academic investigators, the National Cancer Institute, the US Food and Drug Administration, and the pharmaceutical and biotechnology industries under the auspices of the Foundation for the National Institutes of Health Biomarkers Consortium.


Journal of Clinical Oncology | 1999

Utility of Magnetic Resonance Imaging in the Management of Breast Cancer: Evidence for Improved Preoperative Staging

Laura Esserman; Nola M. Hylton; Leila Yassa; John Barclay; Steven D. Frankel; Edward A. Sickles

PURPOSE The staging and treatment for breast cancer are changing; there is an increase in the incidence of ductal carcinoma-in-situ, the use of fine-needle aspiration and stereotactic biopsy for diagnosis, and the use of neoadjuvant chemotherapy. Thus, there is a need for a tool to assess more precisely the extent of cancer in the breast before surgery. To better plan surgical and chemotherapeutic interventions, we evaluated high-resolution magnetic resonance imaging (MRI) as such a tool. PATIENTS AND METHODS Fifty-seven patients with 58 cases of breast cancer were evaluated preoperatively with MRI using a technique called the triple-acquisition rapid gradient echo technique to maximize anatomic detail. Imaging results were compared with mammography and subsequent pathology results. RESULTS Magnetic resonance imaging correctly identified residual or primary cancer in 55 of 58 cases and accurately predicted the extent of the cancer in 54 of 58 cases. The anatomic extent was more accurately defined with MRI compared with mammography (98% v 55%). Magnetic resonance imaging added the greatest value in cases of multifocal disease. CONCLUSION By applying MRI selectively to patients with a known diagnosis of cancer and focusing on defining the extent of malignant lesions, we were able to obtain clear and accurate anatomic information. Our results suggest that MRI could provide very valuable information for preoperative planning and single-stage resection in breast cancer. Based on preliminary data from our series, MRI would be valuable as a staging tool in the preoperative setting even if the cost is in the range of


Journal of Clinical Oncology | 2006

Dynamic Contrast-Enhanced Magnetic Resonance Imaging As an Imaging Biomarker

Nola M. Hylton

1,300 to


Cancer | 2005

Screening women at high risk for breast cancer with mammography and magnetic resonance imaging

Constance D. Lehman; Jeffrey D. Blume; Paul T. Weatherall; David Thickman; Nola M. Hylton; Ellen Warner; Etta D. Pisano; Stuart J. Schnitt; Constantine Gatsonis; Mitchell D. Schnall

2,000. It is already significantly less than the target cost, so it is reasonable to refine this technique for clinical use to help plan the most appropriate surgical intervention and possibly reduce costs as well. A careful prospective study is warranted to validate our findings.


Journal of Magnetic Resonance Imaging | 2001

Development, standardization, and testing of a lexicon for reporting contrast-enhanced breast magnetic resonance imaging studies

Debra M. Ikeda; Nola M. Hylton; Karen Kinkel; Mary G. Hochman; Christiane K. Kuhl; Werner A. Kaiser; Jeffrey C. Weinreb; Stanley F. Smazal; Hadassah Degani; Petra Viehweg; John Barclay; Mitchell D. Schnall

Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is being used in oncology as a noninvasive method for measuring properties of the tumor microvasculature. There is potential for DCE-MRI to be used as an imaging biomarker to measure antiangiogenic effects of cancer treatments. This article reviews the general methodology for performing DCE-MRI and discusses existing data and challenges to applying DCE-MRI for treatment response assessment in clinical trials.


Journal of Clinical Oncology | 2012

Pathologic Complete Response Predicts Recurrence-Free Survival More Effectively by Cancer Subset: Results From the I-SPY 1 TRIAL—CALGB 150007/150012, ACRIN 6657

Laura Esserman; Donald A. Berry; Angela DeMichele; Lisa A. Carey; Sarah E. Davis; Meredith Buxton; C. Hudis; Joe W. Gray; Charles M. Perou; Christina Yau; Chad A. Livasy; Helen Krontiras; Leslie Montgomery; Debasish Tripathy; Constance D. Lehman; Minetta C. Liu; Olufunmilayo I. Olopade; Hope S. Rugo; John T. Carpenter; Lynn G. Dressler; David C. Chhieng; Baljit Singh; Carolyn Mies; Joseph T. Rabban; Yunn-Yi Chen; Dilip Giri; Laura J. van 't Veer; Nola M. Hylton

The authors compared the performance of screening mammography versus magnetic resonance imaging (MRI) in women at genetically high risk for breast cancer.


Radiology | 2012

Locally Advanced Breast Cancer: MR Imaging for Prediction of Response to Neoadjuvant Chemotherapy—Results from ACRIN 6657/I-SPY TRIAL

Nola M. Hylton; Jeffrey D. Blume; Wanda K. Bernreuter; Etta D. Pisano; Mark A. Rosen; Elizabeth A. Morris; Paul T. Weatherall; Constance D. Lehman; Gillian M. Newstead; Sandra M. Polin; Helga S. Marques; Laura Esserman; Mitchell D. Schnall

The purpose of this study was to develop, standardize, and test reproducibility of a lexicon for reporting contrast‐enhanced breast magnetic resonance imaging (MRI) examinations. To standardize breast MRI lesion description and reporting, seven radiologists with extensive breast MRI experience developed consensus on technical detail, clinical history, and terminology reporting to describe kinetic and architectural features of lesions detected on contrast‐enhanced breast MR images. This lexicon adapted American College of Radiology Breast Imaging and Data Reporting System terminology for breast MRI reporting, including recommendations for reporting clinical history, technical parameters for breast MRI, descriptions for general breast composition, morphologic and kinetic characteristics of mass lesions or regions of abnormal enhancement, and overall impression and management recommendations. To test morphology reproducibility, seven radiologists assessed morphology characteristics of 85 contrast‐enhanced breast MRI studies. Data from each independent reader were used to compute weighted and unweighted kappa (κ) statistics for interobserver agreement among readers. The MR lexicon differentiates two lesion types, mass and non‐mass‐like enhancement based on morphology and geographical distribution, with descriptors of shape, margin, and internal enhancement. Lexicon testing showed substantial agreement for breast density (κ = 0.63) and moderate agreement for lesion type (κ = 0.57), mass margins (κ = 0.55), and mass shape (κ = 0.42). Agreement was fair for internal enhancement characteristics. Unweighted kappa statistics showed highest agreement for the terms dense in the breast composition category, mass in lesion type, spiculated and smooth in mass margins, irregular in mass shape, and both dark septations and rim enhancement for internal enhancement characteristics within a mass. The newly developed breast MR lexicon demonstrated moderate interobserver agreement. While breast density and lesion type appear reproducible, other terms require further refinement and testing to lead to a uniform standard language and reporting system for breast MRI. J. Magn. Reson. Imaging 2001;13:889–895.


Journal of Clinical Oncology | 2009

Ductal Carcinoma in Situ: State of the Science and Roadmap to Advance the Field

Henry M. Kuerer; Constance Albarracin; Wei Yang; Robert D. Cardiff; Abenaa M. Brewster; W. Fraser Symmans; Nola M. Hylton; Lavinia P. Middleton; Savitri Krishnamurthy; George H. Perkins; Gildy Babiera; Mary E. Edgerton; Brian J. Czerniecki; Banu Arun; Gabriel N. Hortobagyi

PURPOSE Neoadjuvant chemotherapy for breast cancer provides critical information about tumor response; how best to leverage this for predicting recurrence-free survival (RFS) is not established. The I-SPY 1 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging and Molecular Analysis) was a multicenter breast cancer study integrating clinical, imaging, and genomic data to evaluate pathologic response, RFS, and their relationship and predictability based on tumor biomarkers. PATIENTS AND METHODS Eligible patients had tumors ≥ 3 cm and received neoadjuvant chemotherapy. We determined associations between pathologic complete response (pCR; defined as the absence of invasive cancer in breast and nodes) and RFS, overall and within receptor subsets. RESULTS In 221 evaluable patients (median tumor size, 6.0 cm; median age, 49 years; 91% classified as poor risk on the basis of the 70-gene prognosis profile), 41% were hormone receptor (HR) negative, and 31% were human epidermal growth factor receptor 2 (HER2) positive. For 190 patients treated without neoadjuvant trastuzumab, pCR was highest for HR-negative/HER2-positive patients (45%) and lowest for HR-positive/HER2-negative patients (9%). Achieving pCR predicted favorable RFS. For 172 patients treated without trastuzumab, the hazard ratio for RFS of pCR versus no pCR was 0.29 (95% CI, 0.07 to 0.82). pCR was more predictive of RFS by multivariate analysis when subtype was taken into account, and point estimates of hazard ratios within the HR-positive/HER2-negative (hazard ratio, 0.00; 95% CI, 0.00 to 0.93), HR-negative/HER2-negative (hazard ratio, 0.25; 95% CI, 0.04 to 0.97), and HER2-positive (hazard ratio, 0.14; 95% CI, 0.01 to 1.0) subtypes are lower. Ki67 further improved the prediction of pCR within subsets. CONCLUSION In this biologically high-risk group, pCR differs by receptor subset. pCR is more highly predictive of RFS within every established receptor subset than overall, demonstrating that the extent of outcome advantage conferred by pCR is specific to tumor biology.


The New England Journal of Medicine | 2016

Adaptive Randomization of Veliparib–Carboplatin Treatment in Breast Cancer

Hope S. Rugo; Olufunmilayo I. Olopade; Angela DeMichele; Christina Yau; Laura J. van 't Veer; Meredith Buxton; Michael Hogarth; Nola M. Hylton; Melissa Paoloni; Jane Perlmutter; W. Fraser Symmans; Douglas Yee; A. Jo Chien; Anne M. Wallace; Henry G. Kaplan; Judy C. Boughey; Tufia C. Haddad; Kathy S. Albain; Minetta C. Liu; Claudine Isaacs; Qamar J. Khan; Julie E. Lang; Rebecca K. Viscusi; Lajos Pusztai; Stacy L. Moulder; Stephen Y. Chui; Kathleen A. Kemmer; Anthony Elias; Kirsten K. Edmiston; David M. Euhus

PURPOSE To compare magnetic resonance (MR) imaging findings and clinical assessment for prediction of pathologic response to neoadjuvant chemotherapy (NACT) in patients with stage II or III breast cancer. MATERIALS AND METHODS The HIPAA-compliant protocol and the informed consent process were approved by the American College of Radiology Institutional Review Board and local-site institutional review boards. Women with invasive breast cancer of 3 cm or greater undergoing NACT with an anthracycline-based regimen, with or without a taxane, were enrolled between May 2002 and March 2006. MR imaging was performed before NACT (first examination), after one cycle of anthracyline-based treatment (second examination), between the anthracycline-based regimen and taxane (third examination), and after all chemotherapy and prior to surgery (fourth examination). MR imaging assessment included measurements of tumor longest diameter and volume and peak signal enhancement ratio. Clinical size was also recorded at each time point. Change in clinical and MR imaging predictor variables were compared for the ability to predict pathologic complete response (pCR) and residual cancer burden (RCB). Univariate and multivariate random-effects logistic regression models were used to characterize the ability of tumor response measurements to predict pathologic outcome, with area under the receiver operating characteristic curve (AUC) used as a summary statistic. RESULTS Data in 216 women (age range, 26-68 years) with two or more imaging time points were analyzed. For prediction of both pCR and RCB, MR imaging size measurements were superior to clinical examination at all time points, with tumor volume change showing the greatest relative benefit at the second MR imaging examination. AUC differences between MR imaging volume and clinical size predictors at the early, mid-, and posttreatment time points, respectively, were 0.14, 0.09, and 0.02 for prediction of pCR and 0.09, 0.07, and 0.05 for prediction of RCB. In multivariate analysis, the AUC for predicting pCR at the second imaging examination increased from 0.70 for volume alone to 0.73 when all four predictor variables were used. Additional predictive value was gained with adjustments for age and race. CONCLUSION MR imaging findings are a stronger predictor of pathologic response to NACT than clinical assessment, with the greatest advantage observed with the use of volumetric measurement of tumor response early in treatment.


Annals of Surgical Oncology | 2003

Magnetic resonance imaging in patients diagnosed with ductal carcinoma-in-situ: value in the diagnosis of residual disease, occult invasion, and multicentricity.

E. Shelley Hwang; Karen Kinkel; Laura Esserman; Ying Lu; Noel Weidner; Nola M. Hylton

PURPOSE Ductal carcinoma in situ (DCIS) is the fourth leading cancer for women in the United States. Understanding of the biology and clinical behavior of DCIS is imperfect. This article highlights the current knowledge base and the scientific roadmap needed to advance the field. METHODS This article is based on work done by and consultations obtained from leading experts in the field over a 6-month period that culminated in a full-day symposium designed to systematically review the most pertinent MEDLINE published reports and develop a roadmap to elucidate the molecular steps of carcinogenesis, reduce the extent or prevent the need for therapies, eliminate recurrences, and reduce morbidity. RESULTS Expression profiling of pure DCIS will help elucidate the molecular characteristics that distinguish high-risk lesions from clinically irrelevant lesions. The development of new methods of extracting RNA from processed tissues may provide opportunities for research. Mammography often underestimates the pathologic extent of DCIS; other imaging methods need to be investigated for detection and monitoring of disease stability or progression. Novel biologic agents are being delivered in neoadjuvant clinical trials, and alternative methods for breast irradiation are being studied. Future trials of treatment versus no treatment for biologically selected cases of DCIS should be developed. CONCLUSION There is a critical need for a concerted international effort among patients with DCIS, clinicians, and basic scientists to conduct the research necessary to improve fundamental understanding of the biology and clinical behavior of DCIS and prevent development of invasive breast cancer.

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Laura Esserman

University of California

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Lisa J. Wilmes

University of California

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Bonnie N. Joe

University of California

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Jessica Gibbs

University of California

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Angela DeMichele

University of Pennsylvania

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Leon Kaufman

University of California

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