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3. Adjuvant Trastuzumab Emtansine Versus Paclitaxel Plus Trastuzumab for Stage I Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: 5-Year Results and Correlative Analyses From ATEMPT.

Author

Tarantino, Paolo, Tayob, Nabihah, Villacampa, Guillermo, Dang, Chau, Yardley, Denise, Isakoff, Steven, Valero, Vicente, Faggen, Meredith, Mulvey, Therese, Bose, Ron, Weckstein, Douglas, Wolff, Antonio, Reeder-Hayes, Katherine, Rugo, Hope, Ramaswamy, Bhuvaneswari, Zuckerman, Dan, Hart, Lowell, Gadi, Vijayakrishna, Constantine, Michael, Cheng, Kit, Garrett, Audrey, Marcom, P, Albain, Kathy, DeFusco, Patricia, Tung, Nadine, Ardman, Blair, Nanda, Rita, Jankowitz, Rachel, Rimawi, Mothaffar, Abramson, Vandana, Pohlmann, Paula, Van Poznak, Catherine, Forero-Torres, Andres, Liu, Minetta, Ruddy, Kathryn, Waks, Adrienne, DeMeo, Michelle, Burstein, Harold, Partridge, Ann, DellOrto, Patrizia, Russo, Leila, Krause, Emma, Newhouse, Daniel, Kurt, Busem, Mittendorf, Elizabeth, Schneider, Bryan, Prat, Aleix, Winer, Eric, Krop, Ian, and Tolaney, Sara

Subjects
Humans, Female, Breast Neoplasms, Receptor, ErbB-2, Paclitaxel, Ado-Trastuzumab Emtansine, Middle Aged, Antineoplastic Combined Chemotherapy Protocols, Trastuzumab, Chemotherapy, Adjuvant, Adult, Neoplasm Staging, Aged, Disease-Free Survival
Abstract

PURPOSE: Long-term outcomes of patients with stage I human epidermal growth factor receptor 2 (HER2)-positive breast cancer receiving adjuvant trastuzumab emtansine (T-DM1) remain undefined, and prognostic predictors represent an unmet need. METHODS: In the ATEMPT phase II trial, patients with stage I centrally confirmed HER2-positive breast cancer were randomly assigned 3:1 to adjuvant T-DM1 for 1 year or paclitaxel plus trastuzumab (TH). Coprimary objectives were to compare the incidence of clinically relevant toxicities between arms and to evaluate invasive disease-free survival (iDFS) with T-DM1. Correlative analyses included the HER2DX genomic tool, multiomic evaluations of HER2 heterogeneity, and predictors of thrombocytopenia. RESULTS: After a median follow-up of 5.8 years, 11 iDFS events were observed in the T-DM1 arm, consistent with a 5-year iDFS of 97.0% (95% CI, 95.2 to 98.7). At 5 years, the recurrence-free interval (RFI) was 98.3% (95% CI, 97.0 to 99.7), the overall survival was 97.8% (95% CI, 96.3 to 99.3), and the breast cancer-specific survival was 99.4% (95% CI, 98.6 to 100). Comparable iDFS was observed with T-DM1 irrespective of tumor size, hormone receptor status, centrally determined HER2 immunohistochemical score, and receipt of T-DM1 for more or less than 6 months. Although ATEMPT was not powered for this end point, the 5-year iDFS in the TH arm was 91.1%. Among patients with sufficient tissue for HER2DX testing (n = 187), 5-year outcomes significantly differed according to HER2DX risk score, with better RFI (98.1% v 81.8%, hazard ratio [HR], 0.10, P = .01) and iDFS (96.3% v 81.8%, HR, 0.20, P = .047) among patients with HER2DX low-risk versus high-risk tumors, respectively. CONCLUSION: Adjuvant T-DM1 for 1 year leads to outstanding long-term outcomes for patients with stage I HER2-positive breast cancer. A high HER2DX risk score predicted a higher risk of recurrence in ATEMPT.

Published
2024

4. Major Prophets

Author

Begg, Christopher T., Hieke, Thomas, Urbrock, William J., Mason, Eric F., Hayes, Katherine M., and Jensen, Joseph E.

Published
2019
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5. The Prophets

Author

Begg, Christopher T., Hayes, Katherine M., Vogels, WF, Walter A., and Duggan, Michael W.

Published
2019
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6. Historical Books

Author

Urbrock, William J., Begg, Christopher T., McMillion, Phillip E., Hayes, Katherine M., and Tosco, Lorenzo A.

Published
2019
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23. Harnessing the NEON data revolution to advance open environmental science with a diverse and data‐capable community

Author

Nagy, R Chelsea, Balch, Jennifer K, Bissell, Erin K, Cattau, Megan E, Glenn, Nancy F, Halpern, Benjamin S, Ilangakoon, Nayani, Johnson, Brian, Joseph, Maxwell B, Marconi, Sergio, O’Riordan, Catherine, Sanovia, James, Swetnam, Tyson L, Travis, William R, Wasser, Leah A, Woolner, Elizabeth, Zarnetske, Phoebe, Abdulrahim, Mujahid, Adler, John, Barnes, Grenville, Bartowitz, Kristina J, Blake, Rachael E, Bombaci, Sara P, Brun, Julien, Buchanan, Jacob D, Chadwick, K Dana, Chapman, Melissa S, Chong, Steven S, Chung, Y Anny, Corman, Jessica R, Couret, Jannelle, Crispo, Erika, Doak, Thomas G, Donnelly, Alison, Duffy, Katharyn A, Dunning, Kelly H, Duran, Sandra M, Edmonds, Jennifer W, Fairbanks, Dawson E, Felton, Andrew J, Florian, Christopher R, Gann, Daniel, Gebhardt, Martha, Gill, Nathan S, Gram, Wendy K, Guo, Jessica S, Harvey, Brian J, Hayes, Katherine R, Helmus, Matthew R, Hensley, Robert T, Hondula, Kelly L, Huang, Tao, Hundertmark, Wiley J, Iglesias, Virginia, Jacinthe, Pierre‐Andre, Jansen, Lara S, Jarzyna, Marta A, Johnson, Tiona M, Jones, Katherine D, Jones, Megan A, Just, Michael G, Kaddoura, Youssef O, Kagawa‐Vivani, Aurora K, Kaushik, Aleya, Keller, Adrienne B, King, Katelyn BS, Kitzes, Justin, Koontz, Michael J, Kouba, Paige V, Kwan, Wai‐Yin, LaMontagne, Jalene M, LaRue, Elizabeth A, Li, Daijiang, Li, Bonan, Lin, Yang, Liptzin, Daniel, Long, William Alex, Mahood, Adam L, Malloy, Samuel S, Malone, Sparkle L, McGlinchy, Joseph M, Meier, Courtney L, Melbourne, Brett A, Mietkiewicz, Nathan, Morisette, Jeffery T, Moustapha, Moussa, Muscarella, Chance, Musinsky, John, Muthukrishnan, Ranjan, Naithani, Kusum, Neely, Merrie, Norman, Kari, Parker, Stephanie M, Rocha, Mariana Perez, Petri, Laís, Ramey, Colette A, Record, Sydne, Rossi, Matthew W, SanClements, Michael, and Scholl, Victoria M

Subjects
Quality Education, community, continental-scale ecology, diversity, inclusion, National Ecological Observatory Network, open data, open science, Special Feature, Harnessing the Neon Data Revolution, Ecological Applications, Ecology, Zoology
Abstract

It is a critical time to reflect on the National Ecological Observatory Network (NEON) science to date as well as envision what research can be done right now with NEON (and other) data and what training is needed to enable a diverse user community. NEON became fully operational in May 2019 and has pivoted from planning and construction to operation and maintenance. In this overview, the history of and foundational thinking around NEON are discussed. A framework of open science is described with a discussion of how NEON can be situated as part of a larger data constellation—across existing networks and different suites of ecological measurements and sensors. Next, a synthesis of early NEON science, based on >100 existing publications, funded proposal efforts, and emergent science at the very first NEON Science Summit (hosted by Earth Lab at the University of Colorado Boulder in October 2019) is provided. Key questions that the ecology community will address with NEON data in the next 10 yr are outlined, from understanding drivers of biodiversity across spatial and temporal scales to defining complex feedback mechanisms in human–environmental systems. Last, the essential elements needed to engage and support a diverse and inclusive NEON user community are highlighted: training resources and tools that are openly available, funding for broad community engagement initiatives, and a mechanism to share and advertise those opportunities. NEON users require both the skills to work with NEON data and the ecological or environmental science domain knowledge to understand and interpret them. This paper synthesizes early directions in the community’s use of NEON data, and opportunities for the next 10 yr of NEON operations in emergent science themes, open science best practices, education and training, and community building.

Published
2021

28. Adaptive Systems for Student Resilience in the Context of COVID-19

Author

Herbers, Janette E., Hayes, Katherine R., and Cutuli, J. J.

Abstract

The coronavirus disease 2019 (COVID-19) pandemic is a disaster, defined as an event that suspends normal activities and threatens or causes severe, community-wide damage (Masten & Motti-Stefanidi, 2020). While all school children and their families have been impacted by COVID-19 to some degree, the burdens are disproportionately being borne by children experiencing poverty and children from minority racial and ethnic groups. In this article, we consider resilience and risk in the context of the COVID-19 pandemic by focusing on children's developing adaptive systems. When adaptive systems are functioning well, most children will demonstrate resilience to disaster. The capacity of children's adaptive systems to function well depends upon their developmental histories and the social and community resources available to them. We discuss how these factors contribute to children's adaptation and close with recommendations for communities looking to support resilience to the varied adversities of COVID-19.

Published
2021
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38. Longitudinal trajectories of a claims-based frailty measure during adjuvant chemotherapy in women with stage I-III breast cancer.

Author

Duchesneau, Emilie D, Reeder-Hayes, Katherine, Stürmer, Til, Kim, Dae Hyun, Edwards, Jessie K, and Lund, Jennifer L

Subjects
WOMEN, RESEARCH funding, BREAST tumors, FRAIL elderly, RESEARCH methodology evaluation, DESCRIPTIVE statistics, ADJUVANT chemotherapy, ODDS ratio, RESEARCH methodology, TUMOR classification, DATA analysis software, CONFIDENCE intervals
Abstract

Background Frailty is a dynamic syndrome characterized by reduced physiological reserve to maintain homeostasis. Prospective studies have reported frailty worsening in women with breast cancer during chemotherapy, with improvements following treatment. We evaluated whether the Faurot frailty index, a validated claims-based frailty measure, could identify changes in frailty during chemotherapy treatment and identified predictors of trajectory patterns. Methods We included women (65+ years) with stage I-III breast cancer undergoing adjuvant chemotherapy in the SEER-Medicare database (2003-2019). We estimated the Faurot frailty index (range: 0-1; higher scores indicate greater frailty) at chemotherapy initiation, 4 months postinitiation, and 10 months postinitiation. Changes in frailty were compared to a matched noncancer comparator cohort. We identified patterns of frailty trajectories during the year following chemotherapy initiation using K-means clustering. Results Twenty-one thousand five hundred and ninety-nine women initiated adjuvant chemotherapy. Mean claims-based frailty increased from 0.037 at initiation to 0.055 4 months postchemotherapy initiation and fell to 0.049 10 months postinitiation. Noncancer comparators experienced a small increase in claims-based frailty over time (0.055-0.062). We identified 6 trajectory patterns: a robust group (78%), 2 resilient groups (16%), and 3 nonresilient groups (6%). Black women and women with claims for home hospital beds, wheelchairs, and Parkinson's disease were more likely to experience nonresilient trajectories. Conclusions We observed changes in a claims-based frailty index during chemotherapy that are consistent with prior studies using clinical measures of frailty and identified predictors of nonresilient frailty trajectories. Our study demonstrates the feasibility of using claims-based frailty indices to assess changes in frailty during cancer treatment. [ABSTRACT FROM AUTHOR]

Published
2024
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39. Cancer information and population health resource: a resource for catchment area data and cancer outcomes research.

Author

Baggett, Christopher D, Jackson, Bradford E, Green, Laura, Kuo, Tzy-Mey, Kim, KyungSu, Zhou, Xi, Reeder-Hayes, Katherine E, Lund, Jennifer L, Wheeler, Stephanie B, and Olshan, Andrew F

Subjects
WATERSHEDS, HEALTH insurance, POPULATION health, CANCER diagnosis, DATABASES
Abstract

Background The University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center has developed a novel data resource, the Cancer Information and Population Health Resource (CIPHR), for conducting catchment area evaluation and cancer population health research that links the North Carolina Central Cancer Registry (NCCCR) to medical and pharmacy claims data from Medicare, Medicaid, and private plans operating within North Carolina. This study's aim was to describe the CIPHR data and provide examples of potential cohorts available in those data. Methods We present the underlying populations included in the NCCCR and claims data before linkage and demonstrate estimated sample sizes when these data are linked and commonly used insurance enrollment criteria are applied. Results Data for the years 2003-2020 are present in CIPHR and include 947 977 cancer cases from the NCCCR and 21.6 million enrollees in public and private health insurance (cancer and noncancer cases). When limited to first or only cancers (n = 672 377), 86% could be linked to insurance enrollment for at least 1 month during 2003-2020 (n = 582 638), with 62% of individuals linking to enrollment during the month of cancer diagnosis. Among all registry cancer cases, 47% (n = 317 898) had continuous insurance enrollment for at least 12 months before and after cancer diagnosis. Conclusion CIPHR illustrates the utility of establishing and maintaining a statewide, comprehensive cancer population health database. This resource serves to characterize the cancer center catchment area and aids in tracking cancer outcomes and trends in care delivery as well as identifying disparities that require intervention and policy focus. [ABSTRACT FROM AUTHOR]

Published
2024
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44. Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial

Author

Barroso-Sousa, Romualdo, Tarantino, Paolo, Tayob, Nabihah, Dang, Chau, Yardley, Denise A., Isakoff, Steven J., Valero, Vicente, Faggen, Meredith, Mulvey, Therese, Bose, Ron, Hu, Jiani, Weckstein, Douglas, Wolff, Antonio C., Reeder-Hayes, Katherine, Rugo, Hope S., Ramaswamy, Bhuvaneswari, Zuckerman, Dan, Hart, Lowell, Gadi, Vijayakrishna K., Constantine, Michael, Cheng, Kit, Briccetti, Frederick, Schneider, Bryan, Garrett, Audrey Merrill, Marcom, Kelly, Albain, Kathy, DeFusco, Patricia, Tung, Nadine, Ardman, Blair, Nanda, Rita, Jankowitz, Rachel C., Rimawi, Mothaffar, Abramson, Vandana, Pohlmann, Paula R., Van Poznak, Catherine, Forero-Torres, Andres, Liu, Minetta, Ruddy, Kathryn J., Zheng, Yue, Rosenberg, Shoshana M., Gelber, Richard D., Trippa, Lorenzo, Barry, William, DeMeo, Michelle, Burstein, Harold, Partridge, Ann, Winer, Eric P., Krop, Ian, and Tolaney, Sara M.

Published
2022
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45. Lessening the Impact of Financial Toxicity (LIFT): a protocol for a multi-site, single-arm trial examining the effect of financial navigation on financial toxicity in adult patients with cancer in rural and non-rural settings

Author

Wheeler, Stephanie B., Biddell, Caitlin B., Manning, Michelle L., Gellin, Mindy S., Padilla, Neda R., Spees, Lisa P., Rogers, Cynthia D., Rodriguez-O’Donnell, Julia, Samuel-Ryals, Cleo, Birken, Sarah A., Reeder-Hayes, Katherine E., Petermann, Victoria M., Deal, Allison M., and Rosenstein, Donald L.

Published
2022
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47. Supplementary Table S1 from Disparities in OncotypeDx Testing and Subsequent Chemotherapy Receipt by Geography and Socioeconomic Status

Author

Van Alsten, Sarah C., primary, Dunn, Matthew R., primary, Hamilton, Alina M., primary, Ivory, Joannie M., primary, Gao, Xiaohua, primary, Kirk, Erin L., primary, Nsonwu-Farley, Joseph S., primary, Carey, Lisa A., primary, Abdou, Yara, primary, Reeder-Hayes, Katherine E., primary, Roberson, Mya L., primary, Wheeler, Stephanie B., primary, Emerson, Marc A., primary, Hyslop, Terry, primary, and Troester, Melissa A., primary

Published
2024
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48. Supplementary Figure S1 from Disparities in OncotypeDx Testing and Subsequent Chemotherapy Receipt by Geography and Socioeconomic Status

Author

Van Alsten, Sarah C., primary, Dunn, Matthew R., primary, Hamilton, Alina M., primary, Ivory, Joannie M., primary, Gao, Xiaohua, primary, Kirk, Erin L., primary, Nsonwu-Farley, Joseph S., primary, Carey, Lisa A., primary, Abdou, Yara, primary, Reeder-Hayes, Katherine E., primary, Roberson, Mya L., primary, Wheeler, Stephanie B., primary, Emerson, Marc A., primary, Hyslop, Terry, primary, and Troester, Melissa A., primary

Published
2024
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49. Data from Disparities in OncotypeDx Testing and Subsequent Chemotherapy Receipt by Geography and Socioeconomic Status

Author

Van Alsten, Sarah C., primary, Dunn, Matthew R., primary, Hamilton, Alina M., primary, Ivory, Joannie M., primary, Gao, Xiaohua, primary, Kirk, Erin L., primary, Nsonwu-Farley, Joseph S., primary, Carey, Lisa A., primary, Abdou, Yara, primary, Reeder-Hayes, Katherine E., primary, Roberson, Mya L., primary, Wheeler, Stephanie B., primary, Emerson, Marc A., primary, Hyslop, Terry, primary, and Troester, Melissa A., primary

Published
2024
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