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1. Neoadjuvant Trebananib plus Paclitaxel-based Chemotherapy for Stage II/III Breast Cancer in the Adaptively Randomized I-SPY2 Trial-Efficacy and Biomarker Discovery.

Author

Albain, Kathy, Yau, Christina, Petricoin, Emanuel, Wolf, Denise, Lang, Julie, Chien, A, Haddad, Tufia, Forero-Torres, Andres, Wallace, Anne, Kaplan, Henry, Pusztai, Lajos, Euhus, David, Nanda, Rita, Elias, Anthony, Clark, Amy, Godellas, Constantine, Boughey, Judy, Isaacs, Claudine, Tripathy, Debu, Lu, Janice, Yung, Rachel, Gallagher, Rosa, Wulfkuhle, Julia, Brown-Swigart, Lamorna, Krings, Gregor, Chen, Yunn, Potter, David, Stringer-Reasor, Erica, Blair, Sarah, Asare, Smita, Wilson, Amy, Hirst, Gillian, Singhrao, Ruby, Buxton, Meredith, Clennell, Julia, Sanil, Ashish, Berry, Scott, Asare, Adam, Matthews, Jeffrey, DeMichele, Angela, Hylton, Nola, Melisko, Michelle, Perlmutter, Jane, Rugo, Hope, Symmans, W, Vant Veer, Laura, Yee, Douglas, Berry, Donald, and Esserman, Laura

Subjects
Female, Humans, Antineoplastic Combined Chemotherapy Protocols, Bayes Theorem, Breast Neoplasms, Neoadjuvant Therapy, Paclitaxel, Receptor, ErbB-2, Receptor, TIE-2, Recombinant Fusion Proteins, Trastuzumab
Abstract

PURPOSE: The neutralizing peptibody trebananib prevents angiopoietin-1 and angiopoietin-2 from binding with Tie2 receptors, inhibiting angiogenesis and proliferation. Trebananib was combined with paclitaxel±trastuzumab in the I-SPY2 breast cancer trial. PATIENTS AND METHODS: I-SPY2, a phase II neoadjuvant trial, adaptively randomizes patients with high-risk, early-stage breast cancer to one of several experimental therapies or control based on receptor subtypes as defined by hormone receptor (HR) and HER2 status and MammaPrint risk (MP1, MP2). The primary endpoint is pathologic complete response (pCR). A therapy graduates if/when it achieves 85% Bayesian probability of success in a phase III trial within a given subtype. Patients received weekly paclitaxel (plus trastuzumab if HER2-positive) without (control) or with weekly intravenous trebananib, followed by doxorubicin/cyclophosphamide and surgery. Pathway-specific biomarkers were assessed for response prediction. RESULTS: There were 134 participants randomized to trebananib and 133 to control. Although trebananib did not graduate in any signature [phase III probabilities: Hazard ratio (HR)-negative (78%), HR-negative/HER2-positive (74%), HR-negative/HER2-negative (77%), and MP2 (79%)], it demonstrated high probability of superior pCR rates over control (92%-99%) among these subtypes. Trebananib improved 3-year event-free survival (HR 0.67), with no significant increase in adverse events. Activation levels of the Tie2 receptor and downstream signaling partners predicted trebananib response in HER2-positive disease; high expression of a CD8 T-cell gene signature predicted response in HR-negative/HER2-negative disease. CONCLUSIONS: The angiopoietin (Ang)/Tie2 axis inhibitor trebananib combined with standard neoadjuvant therapy increased estimated pCR rates across HR-negative and MP2 subtypes, with probabilities of superiority >90%. Further study of Ang/Tie2 receptor axis inhibitors in validated, biomarker-predicted sensitive subtypes is warranted.

Published
2024

14. Hexyl-(cuban-1-yl-methyl)-biguanide (HCB) inhibits hormone therapy resistant breast cancer cells, in part by Inhibiting CYP3A4 arachidonic acid epoxygenase activity.

Author

Guo, Zhijun, Lei, Jianxun, Hong, Kwon Ho, Norris, Beverly, Flory, Craig M, Jayaraman, Swaathi, McDermott, Connor, Ambrose, Elizabeth, Sevrioukova, Irina, Poulos, Tom, Denisov, Ilia, Sliga, Stephen, Schumacher, Robert J, Georg, Gunda I, Hawse, John R, Goetz, Matthew P, and Potter, David A

Subjects
Oncology and Carcinogenesis, Oncology & Carcinogenesis, Biochemistry and cell biology, Oncology and carcinogenesis
Published
2021

18. Kinetic studies of ether low temperature combustion mechanisms using laser photolysis and modelling

Author

Potter, David George, Seakins, P. W., and Tomlin, Alison

Subjects
660
Abstract

The laser flash photolysis – laser-induced fluorescence technique has been used to study the reaction kinetics of several potential biofuel ethers under low temperature combustion conditions, in order to extend the understanding of the reactions that occur in novel combustion engines. Biofuels offer a potentially carbon-neutral energy source that could contribute to climate change mitigation, and commercial interest has been given to the ether family of compounds, which display desirable fuel characteristics such as high energy densities and favourable ignition properties. Chapter 3 presents a study of the reaction between the OH radical and trimethyl orthoformate (TMOF), diethyl- (DEE), di-n-butyl- (DBE), methyl tert-butyl- (MTBE), and dimethyl ether (DME), from 298 – 744 K in 13 – 190 Torr of nitrogen. This constitutes the first temperature-dependent study of OH + trimethyl orthoformate, and a significant extension of the temperature range of previous studies on the OH + di-n-butyl ether and OH + diethyl ether reactions. The temperature dependences of the rate coefficients for OH + ether (all in units of cm3 molecule–1 s–1) can be parameterised by: kOH+TMOF(298–744 K) = (8.0 ± 12.2) × 10–13 [(T/298)(2.6±1.2) + (T/298)(–8.1±4.6)] × e(2.7±3.9)/RT, kOH+DEE(298–727 K) = (1.28 ± 0.21) × 10–11 × e(–0.11±0.59)/RT, kOH+DBE(298–732 K) = (3.05 ± 7.13) × 10–12 (T/298)1.3±1.6 × e(6.4±5.8)/RT, kOH+MTBE(298–680 K) = (9.8 ± 21.6) × 10–13 (T/298)2.7±1.5 × e(2.5±5.6)/RT, and kOH+DME(298–656 K) = (1.22 ± 2.83) × 10–15 (T/298)6.9±0.5 × e(19.1±3.8)/RT. Chapter 4 presents a technique for determining R + O2 rate coefficients and OH yields by the observation of OH regeneration from chemical activation. This technique was verified using the CH3OCH2 + O2 reaction in the dimethyl ether system via comparison with previous measurements, and analyses using numerical integration software determined the optimum experimental conditions for the method. Potentially, this technique can be used to obtain rate parameters important for the combustion modelling of a wide range of potential fuel molecules. Rate coefficients for the system are reported at 291 – 483 K, in 4.1 – 32.6 Torr of nitrogen, and the mean room temperature rate coefficient was determined to be kCH3OCH2+O2 = (0.94 ± 0.04) × 10–11 cm3 molecule–1 s–1, across all pressures explored. Chapter 5 employed the technique described in Chapter 4 to present novel measurements of the C2H5OC2H4 + O2 reaction rate coefficient integral to the low temperature combustion of diethyl ether under experimental conditions of 298 – 464 K, in 5.2 – 28.4 Torr of nitrogen. The mean 298 K rate coefficient was determined to be kC2H5OC2H4+O2 = (3.10 ± 0.55) × 10–11 cm3 molecule–1 s–1. OH yields and rate coefficients were compared to ab initio calculations of the diethyl ether low temperature oxidation surface at the CCSD(T)/Jun-cc-pVTZ//M06-2X/Jun-cc-pVTZ level, using master equation methods. The transition state barrier to the OH product was required to be lowered by ~7 kcal mol–1 in order to achieve good agreement between experimental data and theoretical calculations. Chapter 6 reports some initial observations of subsequent OH regeneration following the R + O2 reaction at higher temperatures (~500 K and above), and some interesting unwanted chemistry occurring under high temperature and high O2 conditions. The main recommendations for future work are further explorations of the source of this extraneous chemistry, and development of the data interpretation under such conditions. The investigation of a wide range of fuels’ R + O2 reactions using the method presented in Chapter 4 should also be carried out to improve estimated rates in combustion models.

Published
2019

19. Erratum: Author Correction: Surgical Standards for Management of the Axilla in Breast Cancer Clinical Trials with Pathological Complete Response Endpoint.

Author

Boughey, Judy C, Alvarado, Michael D, Lancaster, Rachael B, Symmans, W Fraser, Mukhtar, Rita, Wong, Jasmine M, Ewing, Cheryl A, Potter, David A, Tuttle, Todd M, Hieken, Tina J, Carter, Jodi M, Jakub, James W, Kaplan, Henry G, Buchanan, Claire L, Jaskowiak, Nora T, Sattar, Husain A, Mueller, Jeffrey, Nanda, Rita, Isaacs, Claudine J, Pohlmann, Paula R, Lynce, Filipa, Tousimis, Eleni A, Zeck, Jay C, Lee, M Catherine, Lang, Julie E, Mhawech-Fauceglia, Paulette, Rao, Roshni, Taback, Bret, Goodellas, Constantine, Chen, Margaret, Kalinsky, Kevin M, Hibshoosh, Hanina, Killelea, Brigid, Sanft, Tara, Hirst, Gillian L, Asare, Smita, Matthews, Jeffrey B, Perlmutter, Jane, Esserman, Laura J, and I-SPY2 Investigators

Subjects
I-SPY2 Investigators
Abstract

[This corrects the article DOI: 10.1038/s41523-018-0074-6.].

Published
2019

20. Aqueous skin antisepsis before surgical fixation of open fractures (Aqueous-PREP): a multiple-period, cluster-randomised, crossover trial

Author

Slobogean, Gerard P., Sprague, Sheila, Wells, Jeffrey L., Bhandari, Mohit, Harris, Anthony D., Mullins, C. Daniel, Thabane, Lehana, Wood, Amber, Della Rocca, Gregory J., Hebden, Joan N., Jeray, Kyle J., Marchand, Lucas S., O'Hara, Lyndsay M., Zura, Robert D., Lee, Christopher, Patterson, Joseph T., Gardner, Michael J., Blasman, Jenna, Davies, Jonah, Liang, Stephen, Taljaard, Monica, Devereaux, PJ, Guyatt, Gordon, Heels-Ansdell, Diane, Marvel, Debra, Palmer, Jana E., Friedrich, Jeff, O'Hara, Nathan N., Grissom, Frances, Gitajn, I. Leah, Morshed, Saam, O'Toole, Robert V., Petrisor, Bradley, Mossuto, Franca, Joshi, Manjari G., D'Alleyrand, Jean-Claude G., Fowler, Justin, Rivera, Jessica C., Talbot, Max, Pogorzelski, David, Dodds, Shannon, Li, Silvia, Del Fabbro, Gina, Szasz, Olivia Paige, Bzovsky, Sofia, McKay, Paula, Minea, Alexandra, Murphy, Kevin, Howe, Andrea L., Demyanovich, Haley K., Hoskins, Wayne, Medeiros, Michelle, Polk, Genevieve, Kettering, Eric, Mahal, Nirmen, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Nascone, Jason, Pensy, Raymond, Pollak, Andrew, Sciadini, Marcus, Degani, Yasmin, Phipps, Heather, Hempen, Eric, Johal, Herman, Ristevski, Bill, Williams, Dale, Denkers, Matthew, Rajaratnam, Krishan, Al-Asiri, Jamal, Gallant, Jodi L., Pusztai, Kaitlyn, MacRae, Sarah, Renaud, Sara, Adams, John D., Beckish, Michael L., Bray, Christopher C., Brown, Timothy R., Cross, Andrew W., Dew, Timothy, Faucher, Gregory K., Gurich Jr, Richard W., Lazarus, David E., Millon, S. John, Moody, M. Christian, Palmer, M. Jason, Porter, Scott E., Schaller, Thomas M., Sridhar, Michael S., Sanders, John L., Rudisill Jr, L. Edwin, Garitty, Michael J., Poole, Andrew S., Sims, Michael L., Walker, Clark M., Carlisle, Robert, Hofer, Erin A., Huggins, Brandon, Hunter, Michael, Marshall, William, Ray, Shea B., Smith, Cory, Altman, Kyle M., Pichiotino, Erin R., Quirion, Julia C., Loeffler, Markus F., Cole, Austin A., Maltz, Ethan J., Parker, Wesley, Ramsey, T. Bennett, Burnikel, Alex, Colello, Michael, Stewart, Russell, Wise, Jeremy, Anderson, Matthew, Eskew, Joshua, Judkins, Benjamin, Miller, James M., Tanner, Stephanie L., Snider, Rebecca G., Townsend, Christine E., Pham, Kayla H., Martin, Abigail, Robertson, Emily, Bray, Emily, Sykes, J. Wilson, Yoder, Krystina, Conner, Kelsey, Abbott, Harper, Natoli, Roman M., McKinley, Todd O., Virkus, Walter W., Sorkin, Anthony T., Szatkowski, Jan P., Mullis, Brian H., Jang, Yohan, Lopas, Luke A., Hill, Lauren C., Fentz, Courteney L., Diaz, Maricela M., Brown, Krista, Garst, Katelyn M., Denari, Emma W., Osborn, Patrick, Pierrie, Sarah N., Kessler, Bradley, Herrera, Maria, Miclau, Theodore, Marmor, Meir T., Matityahu, Amir, McClellan, R. Trigg, Shearer, David, Toogood, Paul, Ding, Anthony, Murali, Jothi, El Naga, Ashraf, Tangtiphaiboontana, Jennifer, Belaye, Tigist, Berhaneselase, Eleni, Pokhvashchev, Dmitry, Obremskey, William T., Jahangir, Amir Alex, Sethi, Manish, Boyce, Robert, Stinner, Daniel J., Mitchell, Phillip P., Trochez, Karen, Rodriguez, Elsa, Pritchett, Charles, Hogan, Natalie, Fidel Moreno, A., Hagen, Jennifer E., Patrick, Matthew, Vlasak, Richard, Krupko, Thomas, Talerico, Michael, Horodyski, Marybeth, Pazik, Marissa, Lossada-Soto, Elizabeth, Gary, Joshua L., Warner, Stephen J., Munz, John W., Choo, Andrew M., Achor, Timothy S., Routt, Milton L. “Chip”, Kutzler, Michael, Boutte, Sterling, Warth, Ryan J., Prayson, Michael J., Venkatarayappa, Indresh, Horne, Brandon, Jerele, Jennifer, Clark, Linda, Boulton, Christina, Lowe, Jason, Ruth, John T., Askam, Brad, Seach, Andrea, Cruz, Alejandro, Featherston, Breanna, Carlson, Robin, Romero, Iliana, Zarif, Isaac, Dehghan, Niloofar, McKee, Michael, Jones, Clifford B., Sietsema, Debra L., Williams, Alyse, Dykes, Tayler, Guerra-Farfan, Ernesto, Tomas-Hernandez, Jordi, Teixidor-Serra, Jordi, Molero-Garcia, Vicente, Selga-Marsa, Jordi, Porcel-Vazquez, Juan Antonio, Andres-Peiro, Jose Vicente, Esteban-Feliu, Ignacio, Vidal-Tarrason, Nuria, Serracanta, Jordi, Nuñez-Camarena, Jorge, del Mar Villar-Casares, Maria, Mestre-Torres, Jaume, Lalueza-Broto, Pilar, Moreira-Borim, Felipe, Garcia-Sanchez, Yaiza, Marcano-Fernández, Francesc, Martínez-Carreres, Laia, Martí-Garín, David, Serrano-Sanz, Jorge, Sánchez-Fernández, Joel, Sanz-Molero, Matsuyama, Carballo, Alejandro, Pelfort, Xavier, Acerboni-Flores, Francesc, Alavedra-Massana, Anna, Anglada-Torres, Neus, Berenguer, Alexandre, Cámara-Cabrera, Jaume, Caparros-García, Ariadna, Fillat-Gomà, Ferran, Fuentes-López, Ruben, Garcia-Rodriguez, Ramona, Gimeno-Calavia, Nuria, Martínez-Álvarez, Marta, Martínez-Grau, Patricia, Pellejero-García, Raúl, Ràfols-Perramon, Ona, Peñalver, Juan Manuel, Salomó Domènech, Mònica, Soler-Cano, Albert, Velasco-Barrera, Aldo, Yela-Verdú, Christian, Bueno-Ruiz, Mercedes, Sánchez-Palomino, Estrella, Andriola, Vito, Molina-Corbacho, Matilde, Maldonado-Sotoca, Yeray, Gasset-Teixidor, Alfons, Blasco-Moreu, Jorge, Fernández-Poch, Núria, Rodoreda-Puigdemasa, Josep, Verdaguer-Figuerola, Arnau, Cueva-Sevieri, Heber Enrique, Garcia-Gimenez, Santiago, Viskontas, Darius G., Apostle, Kelly L., Boyer, Dory S., Moola, Farhad O., Perey, Bertrand H., Stone, Trevor B., Lemke, H. Michael, Spicer, Ella, Payne, Kyrsten, Hymes, Robert A., Schwartzbach, Cary C., Schulman, Jeff E., Malekzadeh, A. Stephen, Holzman, Michael A., Gaski, Greg E., Wills, Jonathan, Pilson, Holly, Carroll, Eben A., Halvorson, Jason J., Babcock, Sharon, Goodman, J. Brett, Holden, Martha B., Williams, Wendy, Hill, Taylor, Brotherton, Ariel, Romeo, Nicholas M., Vallier, Heather A., Vergon, Anna, Higgins, Thomas F., Haller, Justin M., Rothberg, David L., Olsen, Zachary M., McGowan, Abby V., Hill, Sophia, Dauk, Morgan K., Bergin, Patrick F., Russell, George V., Graves, Matthew L., Morellato, John, McGee, Sheketha L., Bhanat, Eldrin L., Yener, Ugur, Khanna, Rajinder, Nehete, Priyanka, Potter, David, VanDemark III, Robert, Seabold, Kyle, Staudenmier, Nicholas, Coe, Marcus, Dwyer, Kevin, Mullin, Devin S., Chockbengboun, Theresa A., DePalo Sr., Peter A., Phelps, Kevin, Bosse, Michael, Karunakar, Madhav, Kempton, Laurence, Sims, Stephen, Hsu, Joseph, Seymour, Rachel, Churchill, Christine, Mayfield, Ada, Sweeney, Juliette, Jaeblon, Todd, Beer, Robert, Bauer, Brent, Meredith, Sean, Talwar, Sneh, Domes, Christopher M., Gage, Mark J., Reilly, Rachel M., Paniagua, Ariana, Dupree, JaNell, Weaver, Michael J., von Keudell, Arvind G., Sagona, Abigail E., Mehta, Samir, Donegan, Derek, Horan, Annamarie, Dooley, Mary, Heng, Marilyn, Harris, Mitchel B., Lhowe, David W., Esposito, John G., Alnasser, Ahmad, Shannon, Steven F., Scott, Alesha N., Clinch, Bobbi, Weber, Becky, Beltran, Michael J., Archdeacon, Michael T., Sagi, Henry Claude, Wyrick, John D., Le, Theodore Toan, Laughlin, Richard T., Thomson, Cameron G., Hasselfeld, Kimberly, Lin, Carol A., Vrahas, Mark S., Moon, Charles N., Little, Milton T., Marecek, Geoffrey S., Dubuclet, Denice M., Scolaro, John A., Learned, James R., Lim, Philip K., Demas, Susan, Amirhekmat, Arya, and Dela Cruz, Yan Marco

Published
2022
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21. (In)Visible Power: A Critical Policy Analysis of edTPA

Author

Potter, David

Abstract

In less than a decade, Pearson's distribution of the Teacher Performance Assessment (edTPA) has expanded to hundreds of teacher education preparation programs in the United States. Used in more than forty states, the edTPA has become one of the most prevalent forms of high-stakes evaluation for student teachers, with several states requiring candidates to pass edTPA to gain teacher certification. This article examines the history and policies associated with edTPA in arts education. To do this, I examined emerging literature concerning edTPA, with a particular focus on the policy documents released by the Stanford Center for Assessment, Learning, and Equity in conjunction with Pearson. Findings from the study include inconsistencies within the evaluation of fine arts teacher candidates, the absence of arts educators from the development of edTPA, and marginalization by means of forced compliance.

Published
2021
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22. Music educators' perceptions of portfolio-based teacher evaluations in Tennessee.

Author

Potter, David

Subjects
*PUBLIC school teachers, *MUSIC teachers, *SCHOOL music, *ASSESSMENT of education, *TEACHER evaluation
Abstract

The purpose of this study was to gather and investigate the perceptions of K-12 public school music teachers who have used portfolio-based evaluations in Tennessee. Research questions included: (1) What are the perceptions of music teachers in Tennessee who have used the Tennessee Fine Arts Portfolio Model? (2) Do differences in music teacher perceptions of the Tennessee Fine Arts Portfolio Model exist among a range of backgrounds, and if so, where do those differences exist? Tennessee Music Education Association members (K-12 public school music teachers, N = 98) responded to a researcher-constructed questionnaire. While most respondents scored above or significantly above expectations on the portfolio, their perceptions of the value of the portfolio averaged between neutral (neither agree nor disagree) and negative (disagree). While the most experienced teachers found the portfolio standards harder to implement compared to those who were the least experienced, they also scored higher. Tenured teachers also perceived the standards as significantly harder to implement than those who were not tenured. Finally, those with a bachelor's degree found the portfolio significantly less beneficial, authentic, ideal, and consistent with their goals than their counterparts who earned master's degrees. Recommendations include prioritizing feedback over scoring, localizing portfolio evaluations, and providing tenured teachers with choice in how they are evaluated. [ABSTRACT FROM AUTHOR]

Published
2024
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23. Qualified kidney injury biomarkers demonstrate value during early clinical drug development.

Author

Ravindra, Kodihalli C, Fader, Kelly A, Potter, David, Radi, Zaher A, Friedman, Gary S, Brenneman, Karrie A, Amin, Neeta B, Weiss, Roberta, Danto, Spencer I, Page, Karen, Ramaiah, Shashi K, and Vaidya, Vishal S

Subjects
LIPOCALIN-2, NEPHROTOXICOLOGY, KIDNEY injuries, DRUG development, LUPUS nephritis
Abstract

Drug-induced kidney injury (DIKI) is of significant concern, both during drug development and in clinical practice. We report a patient-centric approach for clinical implementation of the FDA-qualified kidney safety biomarker panel, highlighting Phase 1 and 2 trials for candidate therapeutics in Pfizer's portfolio (PFE-1 and PFE-2, respectively) that induced kidney tubular injury in rat toxicity studies. Clusterin (CLU), cystatin-C (CysC), kidney injury molecule-1 (KIM-1), N -acetyl-beta- d -glucosaminidase (NAG), neutrophil gelatinase-associated lipocalin (NGAL), and osteopontin (OPN) were measured in urine samples from (i) Phase 1 healthy volunteers (HVs; n  = 12) dosed with PFE-1, (ii) Phase 2 rheumatoid arthritis (RA) patients (n  = 266) dosed with PFE-2, (iii) lupus patients on standard-of-care therapies (n  = 121), and (iv) healthy volunteers (n  = 60). The FDA-defined composite measure (CM), calculated as the geometric mean response across the 6 biomarkers, was increased ∼30% in HVs administered 100 mg PFE-1 relative to placebo, providing evidence of DIKI. In contrast, the CM for RA patients dosed with PFE-2 was comparable to placebo controls, helping to de-risk the concern for DIKI at clinically relevant doses. Comparing individual biomarker concentrations across disease states revealed that CLU, KIM-1, NAG, NGAL, and OPN are elevated in the urine of RA and lupus patients (those without severe active proliferative lupus nephritis) relative to HVs. Overall, these case studies demonstrate the value of using the FDA-qualified kidney biomarker panel to guide risk assessment, dose selection, and clinical decision making for novel therapeutics, both in HVs and patient populations. [ABSTRACT FROM AUTHOR]

Published
2024
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24. Roman Holiday

Author

Potter, David

Subjects
Literature/writing
Abstract

ROME AND PERSIA: The Seven Hundred Year Rivalry, by Adrian Goldsworthy PAX: War and Peace in Rome's Golden Age, by Tom Holland The Roman Empire, an enormous multiethnic state that [...]

Published
2023

26. Surgical Standards for Management of the Axilla in Breast Cancer Clinical Trials with Pathological Complete Response Endpoint.

Author

Boughey, Judy C, Alvarado, Michael D, Lancaster, Rachael B, Fraser Symmans, W, Mukhtar, Rita, Wong, Jasmine M, Ewing, Cheryl A, Potter, David A, Tuttle, Todd M, Hieken, Tina J, Carter, Jodi M, Jakub, James W, Kaplan, Henry G, Buchanan, Claire L, Jaskowiak, Nora T, Sattar, Husain A, Mueller, Jeffrey, Nanda, Rita, Isaacs, Claudine J, Pohlmann, Paula R, Lynce, Filipa, Tousimis, Eleni A, Zeck, Jay C, Lee, M Catherine, Lang, Julie E, Mhawech-Fauceglia, Paulette, Rao, Roshni, Taback, Bret, Chen, Margaret, Kalinsky, Kevin M, Hibshoosh, Hanina, Killelea, Brigid, Sanft, Tara, Hirst, Gillian L, Asare, Smita, Matthews, Jeffrey B, Perlmutter, Jane, Esserman, Laura J, and and I-SPY 2 Investigators

Subjects
and I-SPY 2 Investigators, Clinical Trials and Supportive Activities, Clinical Research, Patient Safety, Cancer
Abstract

Advances in the surgical management of the axilla in patients treated with neoadjuvant chemotherapy, especially those with node positive disease at diagnosis, have led to changes in practice and more judicious use of axillary lymph node dissection that may minimize morbidity from surgery. However, there is still significant confusion about how to optimally manage the axilla, resulting in variation among practices. From the viewpoint of drug development, assessment of response to neoadjuvant chemotherapy remains paramount and appropriate assessment of residual disease-the primary endpoint of many drug therapy trials in the neoadjuvant setting-is critical. Therefore decreasing the variability, especially in a multicenter clinical trial setting, and establishing a minimum standard to ensure consistency in clinical trial data, without mandating axillary lymph node dissection, for all patients is necessary. The key elements which include proper staging and identification of nodal involvement at diagnosis, and appropriately targeted management of the axilla at the time of surgical resection are presented. The following protocols have been adopted as standard procedure by the I-SPY2 trial for management of axilla in patients with node positive disease, and present a framework for prospective clinical trials and practice.

Published
2018

44. PRE-ISPY phase I/Ib oncology platform program (PRE-I-SPY-P1).

Author

Pohlmann, Paula R, primary, Potter, David Alexander, additional, Chen, Nan, additional, Mouabbi, Jason A, additional, Rampurwala, Murtuza, additional, Rayani, Shayan, additional, Tan, Antoinette R., additional, Leon-Ferre, Roberto Antonio, additional, Giridhar, Karthik, additional, Boughey, Judy Caroline, additional, Han, Hyo S., additional, Kennedy, Laura Carpin, additional, Walsh, Elaine M., additional, Tripathy, Debashish, additional, Jafari, Shabnam, additional, Eklund, Martin, additional, Nanda, Rita, additional, Meric-Bernstam, Funda, additional, Yee, Douglas, additional, and Esserman, Laura, additional

Published
2024
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45. Embryology of the fat‐tailed dunnart (Sminthopsis crassicaudata): A marsupial model for comparative mammalian developmental and evolutionary biology

Author

Newton, Axel H., primary, Hutchison, Jennifer C., additional, Farley, Ella R., additional, Scicluna, Emily L., additional, Youngson, Neil A., additional, Liu, Jun, additional, Menzies, Brandon R., additional, Hildebrandt, Thomas B., additional, Lawrence, Ben M., additional, Sutherland, Angus H. W., additional, Potter, David L., additional, Tarulli, Gerard A., additional, Selwood, Lynne, additional, Frankenberg, Stephen, additional, Ord, Sara, additional, and Pask, Andrew J., additional

Published
2024
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48. Contributors

Author

Achenbach, Leonard, primary, Adams, Julie, additional, Adams, Nicholas S., additional, McClees Aldridge, Julian, additional, Altman, Kyle M., additional, Amaro, Emilie J., additional, Antosh, Ivan, additional, Arrington, Edward, additional, Aversano, Francis J., additional, Azimi, Hassan J., additional, Barlow, Jonathan, additional, Berthold, Daniel P., additional, Boe, Chelsea C., additional, Bonazza, Nicholas A., additional, Brogan, David M., additional, Bruni, David F., additional, Calfee, Ryan P., additional, Catalano, Louis W., additional, Christie, Brian, additional, Christopherson, Zachary, additional, Cohen, Joseph B., additional, Cohn, Matthew R., additional, Cole, Brian J., additional, Cole, Peter A., additional, Cornelis, Bert, additional, Cregar, William M., additional, Cvetanovich, Gregory L., additional, Danford, Nicholas C., additional, Dantzker, Nicholas J., additional, DeBaun, Malcolm R., additional, De Wilde, Lieven, additional, Desai, Mihir J., additional, Edwards, Scott G., additional, Eglseder, Andy, additional, Elrick, Bryant P., additional, Evans, Peter J., additional, Faucher, Gregory K., additional, Fernandez, John J., additional, Finley, Zachary J., additional, Fogel, Nathaniel, additional, Foruria, Antonio M., additional, Frantz, Travis L., additional, Fu, Michael C., additional, Gardner, Michael J., additional, Gaston, R. Glenn, additional, Geissler, William B., additional, Gilat, Ron, additional, Gillespie, Robert J., additional, Gillis, Joshua A., additional, Goodnough, L. Henry, additional, Grier, Jordan, additional, Hammert, Warren C., additional, Hatzidakis, Armodios M., additional, Haunschild, Eric D., additional, Hess, Daniel E., additional, Hochreiter, Bettina, additional, Honig, Rachel, additional, Hoyen, Harry A., additional, Huang, Jerry I., additional, Hughes, Thomas B., additional, Jankowski, Jaclyn M., additional, Jeffcoat, Devon, additional, Johnson, Pierce, additional, Jost, Bernhard, additional, Kakar, Sanjeev, additional, Kamal, Robin, additional, Kaufmann, Robert A., additional, Kennedy, June, additional, Kremen, Thomas J., additional, Kuhn, John E., additional, Lafosse, Laurent, additional, Lafosse, Thibault, additional, Langhammer, Chris, additional, Liporace, Frank A., additional, London, Daniel A., additional, Maheshwer, Bhargavi, additional, Maslow, Jed I., additional, Maziak, Nina, additional, Mazzocca, Augustus D., additional, McKee, Michael, additional, Mengers, Sunita, additional, Millett, Peter J., additional, Moody, M. Christian, additional, Morrey, Mark E., additional, Nakashian, Michael N., additional, Neviaser, Andrew, additional, Nicholson, Gregory, additional, Nicholson, Luke T., additional, Nolte, Philip C., additional, O’Brien, Michael J., additional, O’Donnell, Marc J., additional, Omid, Reza, additional, Orbay, Jorge L., additional, O’Shaughnessy, Maureen, additional, Osterman, A. Lee, additional, Mayo, Belén Pardos, additional, Piper, Christine C., additional, Pitcher, Austin A., additional, Potter, David, additional, Rasuli, Kevin, additional, Reichel, Lee M., additional, Riboh, Jonathan C., additional, Ring, David, additional, Rizzo, Marco, additional, Ruch, David, additional, Russo, Frank A., additional, Sabbag, Casey, additional, Sanchez-Sotelo, Joaquin, additional, Savoie, Felix H., additional, Scheibel, Markus, additional, Schroder, BSME, Lisa K., additional, Sears, Benjamin W., additional, Singh, Anshu, additional, Spross, Christian, additional, Srinivasan, Ramesh C., additional, Steinmann, Scott, additional, Tabeayo, Eloy, additional, Tarr, Ryan, additional, Tauro, Tracy, additional, Tavakolian, Paul A., additional, Tokish, John M., additional, Tosti, Rick, additional, Tu, Leigh-Anne, additional, Uyeki, Colin L., additional, Van Tongel, Alexander, additional, Veltre, David R., additional, Verma, Nikhil N., additional, Walker, J. Brock, additional, Watts, Adam C., additional, Williams, Brady T., additional, Williams, Joel C., additional, Wilson, David, additional, Wolfson, Theodore S., additional, Wysocki, Robert W., additional, Yao, Jeffrey, additional, and Yoon, Richard S., additional

Published
2022
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50. Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

Author

Slobogean, Gerard P., Bhandari, Mohit, Sprague, Sheila, D'Alleyrand, Jean-Claude, Harris, Anthony D., Mullins, Daniel C., Thabane, Lehana, Wells, Jeffrey, Wood, Amber, Della Rocca, Gregory J., Hebden, Joan, Jeray, Kyle J., Marchand, Lucas, O'Hara, Lyndsay M., Zura, Robert, Gardner, Michael J., Blasman, Jenna, Davies, Jonah, Liang, Stephen, Taljaard, Monica, Devereaux, P.J., Guyatt, Gordon H., Heels-Ansdell, Diane, Marvel, Debra, Palmer, Jana, Friedrich, Jeff, O'Hara, Nathan N., Grissom, Ms Frances, Gitajn, I. Leah, Morshed, Saam, O'Toole, Robert V., Petrisor, Bradley A., Camara, Megan, Mossuto, Franca, Joshi, Manjari G., Fowler, Justin, Rivera, Jessica, Talbot, Max, Dodds, Shannon, Garibaldi, Alisha, Li, Silvia, Nguyen, Uyen, Pogorzelski, David, Rojas, Alejandra, Scott, Taryn, Del Fabbro, Gina, Szasz, Olivia Paige, McKay, Paula, Howe, Andrea, Rudnicki, Joshua, Demyanovich, Haley, Little, Kelly, Mullins, C. Daniel, Medeiros, Michelle, Kettering, Eric, Hale, Diamond, Petrisor, Brad A., Johal, Herman, Ristevski, Bill, Williams, Dale, Denkers, Matthew, Rajaratnam, Krishan, Al-Asiri, Jamal, Leonard, Jordan, Marcano-Fernández, Francesc A., Gallant, Jodi, Persico, Federico, Gjorgjievski, Marko, George, Annie, Natoli, Roman M., Gaski, Greg E., McKinley, Todd O., Virkus, Walter W., Sorkin, Anthony T., Szatkowski, Jan P., Baele, Joseph R., Mullis, Brian H., Hill, Lauren C., Hudgins, Andrea, Osborn, Patrick, Pierrie, Sarah, Martinez, Eric, Kimmel, Joseph, Adams, John D., Beckish, Michael L., Bray, Christopher C., Brown, Timothy R., Cross, Andrew W., Dew, Timothy, Faucher, Gregory K., Gurich, Richard W., Jr., Lazarus, David E., Millon, S. John, Palmer, M. Jason, Porter, Scott E., Schaller, Thomas M., Sridhar, Michael S., Sanders, John L., Rudisill, L. Edwin, Jr., Garitty, Michael J., Poole, Andrew S., Sims, Michael L., Walker, Clark M., Carlisle, Robert M., II, Hofer, Erin Adams, Huggins, Brandon S., Hunter, Michael D., Marshall, William A., Ray, Shea Bielby, Smith, Cory D., Altman, Kyle M., Bedard, Julia C., Loeffler, Markus F., Pichiotino, Erin R., Cole, Austin A., Maltz, Ethan J., Parker, Wesley, Ramsey, T. Bennett, Burnikel, Alex, Colello, Michael, Stewart, Russell, Wise, Jeremy, Moody, M. Christian, Tanner, Stephanie L., Snider, Rebecca G., Townsend, Christine E., Pham, Kayla H., Martin, Abigail, Robertson, Emily, Miclau, Theodore, Kandemir, Utku, Marmor, Meir, Matityahu, Amir, McClellan, R. Trigg, Meinberg, Eric, Shearer, David, Toogood, Paul, Ding, Anthony, Donohoe, Erin, Murali, Jothi, Belaye, Tigist, Berhaneselase, Eleni, Paul, Alexandra, Garg, Kartik, Gary, Joshua L., Warner, Stephen J., Munz, John W., Choo, Andrew M., Achor, Timothy S., “Chip” Routt, Milton L., Rao, Mayank, Pechero, Guillermo, Miller, Adam, Hagen, Jennifer E., Patrick, Matthew, Vlasak, Richard, Krupko, Thomas, Sadasivan, Kalia, Koenig, Chris, Bailey, Daniel, Wentworth, Daniel, Van, Chi, Schwartz, Justin, Dehghan, Niloofar, Jones, Clifford B., Tracy Watson, J., McKee, Michael, Karim, Ammar, Talerico, Michael, Sietsema, Debra L., Williams, Alyse, Dykes, Tayler, Obremskey, William T., Jahangir, Amir Alex, Sethi, Manish, Boyce, Robert, Stinner, Daniel J., Mitchell, Phillip, Trochez, Karen, Rodriguez, Andres, Gajari, Vamshi, Rodriguez, Elsa, Pritchett, Charles, Boulton, Christina, Lowe, Jason, Wild, Jason, Ruth, John T., Taylor, Michel, Seach, Andrea, Saeed, Sabina, Culbert, Hunter, Cruz, Alejandro, Knapp, Thomas, Hurkett, Colin, Lowney, Maya, Prayson, Michael, Venkatarayappa, Indresh, Horne, Brandon, Jerele, Jennifer, Clark, Linda, Marcano-Fernández, Francesc, Jornet-Gibert, Montsant, Martínez-Carreres, Laia, Martí-Garín, David, Serrano-Sanz, Jorge, Sánchez-Fernández, Joel, Sanz-Molero, Matsuyama, Carballo, Alejandro, Pelfort, Xavier, Acerboni-Flores, Francesc, Alavedra-Massana, Anna, Anglada-Torres, Neus, Berenguer, Alexandre, Cámara-Cabrera, Jaume, Caparros-García, Ariadna, Fillat-Gomà, Ferran, Fuentes-López, Ruben, Garcia-Rodriguez, Ramona, Gimeno-Calavia, Nuria, Graells-Alonso, Guillem, Martínez-Álvarez, Marta, Martínez-Grau, Patricia, Pellejero-García, Raúl, Ràfols-Perramon, Ona, Peñalver, Juan Manuel, Domènech, Mònica Salomó, Soler-Cano, Albert, Velasco-Barrera, Aldo, Yela-Verdú, Christian, Bueno-Ruiz, Mercedes, Sánchez-Palomino, Estrella, Guerra-Farfan, Ernesto, Tomas-Hernandez, Jordi, Teixidor-Serra, Jordi, Molero-Garcia, Vicente, Selga-Marsa, Jordi, Porcel-Vasquez, Juan Antonio, Andres-Peiro, Jose Vicente, Minguell-Monyart, Joan, Garcia-Sanchez, Yaiza, Nuñez-Camarena, Jorge, Tauste-Rubio, Eladia, Gonzalez-Amigo, Marta, Romeo, Nicholas M., Vallier, Heather A., Breslin, Mary A., Fraifogl, Joanne, Wilson, Eleanor S., Wadenpfuhl, Leanne K., Halliday, Paul G., Viskontas, Darius G., Apostle, Kelly L., Boyer, Dory S., Moola, Farhad O., Perey, Bertrand H., Stone, Trevor B., Lemke, H. Michael, Zomar, Mauri, Spicer, Ella, Fan, Chen “Brenda”, Payne, Kyrsten, Phelps, Kevin, Bosse, Michael, Karunakar, Madhav, Kempton, Laurence, Sims, Stephen, Hsu, Joseph, Seymour, Rachel, Churchill, Christine, Bartel, Claire, Mayberry, Robert Miles, Brownrigg, Maggie, Girardi, Cara, Mayfield, Ada, Hymes, Robert A., Schwartzbach, Cary C., Schulman, Jeff E., Malekzadeh, A. Stephen, Holzman, Michael A., Ramsey, Lolita, Ahn, James S., Panjshiri, Farhanaz, Das, Sharmistha, English, Antoinisha D., Haaser, Sharon M., Cuff, Jaslynn A.N., Pilson, Holly, Carroll, Eben A., Halvorson, Jason J., Babcock, Sharon, Goodman, J. Brett, Holden, Martha B., Bullard, Debra, Williams, Wendy, Higgins, Thomas F., Haller, Justin M., Rothberg, David L., Marchand, Lucas S., Neese, Ashley, Russell, Mark, Olsen, Zachary M., Coe, Marcus, Dwyer, Kevin, Mullin, Devin S., Reilly, Clifford A., DePalo, Peter, Hall, Amy E., Heng, Marilyn, Harris, Mitchel B., Smith, R. Malcolm, Lhowe, David W., Esposito, John G., Bansal, Mira, Bergin, Patrick F., Russell, George V., Graves, Matthew L., Morellato, John, Champion, Heather K., Johnson, Leslie N., McGee, Sheketha L., Bhanat, Eldrin L., Mehta, Samir, Donegan, Derek, Ahn, Jaimo, Horan, Annamarie, Dooley, Mary, Kuczinski, Ashley, Iwu, Ashley, Potter, David, VanDemark, Robert, III, Pfaff, Branden, Hollinsworth, Troy, Weaver, Michael J., von Keudell, Arvind G., McTague, Michael F., Allen, Elizabeth M., Jaeblon, Todd, Beer, Robert, Demyanovich, Haley K., Gage, Mark J., Reilly, Rachel M., Sparrow, Cindy, Pechero, Guillermo, Jr., Holden, Martha, Wells, Jeff, Eglseder, Andrew, Johnson, Aaron, Langhammer, Christopher, Lebrun, Christopher, Manson, Theodore, Nascone, Jason, Paryavi, Ebrahim, Pensy, Raymond, Pollak, Andrew, Sciadini, Marcus, Degani, Yasmin, and Joseph, Katherine

Published
2021
Full Text
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