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4. Anti-Granulocyte–Macrophage Colony–Stimulating Factor Monoclonal Antibody Gimsilumab for COVID-19 Pneumonia: A Randomized, Double-Blind, Placebo-controlled Trial

Author

Criner, Gerard J, Lang, Frederick M, Gottlieb, Robert L, Mathews, Kusum S, Wang, Tisha S, Rice, Todd W, Madduri, Deepu, Bellam, Shashi, Jeanfreau, Robert, Case, Amy H, Glassberg, Marilyn K, Lyon, George Marshall, Ahmad, Kareem, Mendelson, Robert, DiMaio, J Michael, Tran, MaryAnn P, Spak, Cedric W, Abbasi, Jamil A, Davis, Steven G, Ghamande, Shekhar, Shen, Steven, Sherman, Lisa, and Lowry, Simon

Subjects
Patient Safety, Clinical Trials and Supportive Activities, Pneumonia & Influenza, Infectious Diseases, Pneumonia, Clinical Research, Lung, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Good Health and Well Being, Antibodies, Monoclonal, Humanized, Double-Blind Method, Humans, Inflammation, COVID-19 Drug Treatment, gimsilumab, GM-CSF, SARS-CoV-2, COVID-19, acute respiratory distress syndrome, Medical and Health Sciences, Respiratory System
Abstract

Rationale: GM-CSF (granulocyte-macrophage colony-stimulating factor) has emerged as a promising target against the hyperactive host immune response associated with coronavirus disease (COVID-19). Objectives: We sought to investigate the efficacy and safety of gimsilumab, an anti-GM-CSF monoclonal antibody, for the treatment of hospitalized patients with elevated inflammatory markers and hypoxemia secondary to COVID-19. Methods: We conducted a 24-week randomized, double-blind, placebo-controlled trial, BREATHE (Better Respiratory Education and Treatment Help Empower), at 21 locations in the United States. Patients were randomized 1:1 to receive two doses of intravenous gimsilumab or placebo 1 week apart. The primary endpoint was all-cause mortality rate at Day 43. Key secondary outcomes were ventilator-free survival rate, ventilator-free days, and time to hospital discharge. Enrollment was halted early for futility based on an interim analysis. Measurements and Main Results: Of the planned 270 patients, 225 were randomized and dosed; 44.9% of patients were Hispanic or Latino. The gimsilumab and placebo groups experienced an all-cause mortality rate at Day 43 of 28.3% and 23.2%, respectively (adjusted difference = 5% vs. placebo; 95% confidence interval [-6 to 17]; P = 0.377). Overall mortality rates at 24 weeks were similar across the treatment arms. The key secondary endpoints demonstrated no significant differences between groups. Despite the high background use of corticosteroids and anticoagulants, adverse events were generally balanced between treatment groups. Conclusions: Gimsilumab did not improve mortality or other key clinical outcomes in patients with COVID-19 pneumonia and evidence of systemic inflammation. The utility of anti-GM-CSF therapy for COVID-19 remains unclear. Clinical trial registered with www.clinicaltrials.gov (NCT04351243).

Published
2022

6. NCCN Guidelines® Insights: Palliative Care, Version 2.2021.

Author

Dans, Maria, Kutner, Jean S, Agarwal, Rajiv, Baker, Justin N, Bauman, Jessica R, Beck, Anna C, Campbell, Toby C, Carey, Elise C, Case, Amy A, Dalal, Shalini, Doberman, Danielle J, Epstein, Andrew S, Fecher, Leslie, Jones, Joshua, Kapo, Jennifer, Lee, Richard T, Loggers, Elizabeth T, McCammon, Susan, Mitchell, William, Ogunseitan, Adeboye B, Portman, Diane G, Ramchandran, Kavitha, Sutton, Linda, Temel, Jennifer, Teply, Melissa L, Terauchi, Stephanie Y, Thomas, Jane, Walling, Anne M, Zachariah, Finly, Bergman, Mary Anne, Ogba, Ndiya, and Campbell, Mallory

Subjects
Cancer, Chronic Pain, Pain Research, Clinical Research, Management of diseases and conditions, 7.2 End of life care, Good Health and Well Being, Humans, Medical Oncology, Neoplasms, Palliative Care, Quality of Life, Oncology & Carcinogenesis
Abstract

Palliative care has evolved to be an integral part of comprehensive cancer care with the goal of early intervention to improve quality of life and patient outcomes. The NCCN Guidelines for Palliative Care provide recommendations to help the primary oncology team promote the best quality of life possible throughout the illness trajectory for each patient with cancer. The NCCN Palliative Care Panel meets annually to evaluate and update recommendations based on panel members' clinical expertise and emerging scientific data. These NCCN Guidelines Insights summarize the panel's recent discussions and highlights updates on the importance of fostering adaptive coping strategies for patients and families, and on the role of pharmacologic and nonpharmacologic interventions to optimize symptom management.

Published
2021

12. Smartphone-Guided Self-prone Positioning vs Usual Care in Nonintubated Hospital Ward Patients With COVID-19: A Pragmatic Randomized Clinical Trial

Author

Rampon, Garrett, Jia, Shijing, Agrawal, Ritwick, Arnold, Nicholas, Martín-Quirόs, Alejandro, Fischer, Ernest A., Malatack, James, Jagan, Nikhil, Sergew, Amen, Case, Amy Hajari, Miller, Kristin, Tanios, Maged, Doros, Gheorghe, Ross, Craig S., Garcia, Michael A., Gillmeyer, Kari R., Griffiths, Nicholas G., Jandali, Badr, Modzelewski, Katherine L., Rucci, Justin M., Simpson, Steven Q., Walkey, Allan J., and Bosch, Nicholas A.

Published
2022
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13. Cough-Specific Quality of Life Predicts Disease Progression Among Patients With Interstitial Lung Disease: Data From the Pulmonary Fibrosis Foundation Patient Registry

Author

Bascom, Rebecca, Belloli, Elizabeth, Bhatt, Nitin, Bhorade, Sangeeta, Case, Amy, Castriotta, Richard, Criner, Gerard, Danoff, Sonye, De Andrade, Joao, Desai, Alpa, Glassberg, Marilyn, Glazer, Craig, Gulati, Mridu, Gupta, Nishant, Hamblin, Mark, Huie, Tristan, Kaner, Robert, Kass, Daniel, Kim, Hyun, Kreider, Maryl, Lancaster, Lisa, Lasky, Joseph, Limper, Andrew, Montesi, Sydney, Mooney, Joshua, Morrison, Lake, Nambiar, Anoop, Nathan, Steven, Natt, Bhupinder, Paul, Tessy, Perez, Rafael, Podolanczuk, Anna, Raghu, Ganesh, Scholand, Mary Beth, Shifren, Adrian, Strek, Mary, Todd, Nevins, Walia, Rajat, Weight, Stephen, Whelan, Timothy, Wolters, Paul, Lee, Janet, White, Emily, Freiheit, Elizabeth, Strek, Mary E., Podolanczuk, Anna J., and Patel, Nina M.

Published
2022
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22. Disease Severity and Quality of Life in Patients With Idiopathic Pulmonary Fibrosis: A Cross-Sectional Analysis of the IPF-PRO Registry

Author

Asi, Wael, Baker, Albert, Beegle, Scott, Belperio, John A., Condos, Rany, Cordova, Francis, Culver, Daniel A., de Andrade, Joao A.M., Dilling, Daniel, Flaherty, Kevin R., Glassberg, Marilyn, Gulati, Mridu, Guntupalli, Kalpalatha, Gupta, Nishant, Hajari Case, Amy, Hotchkin, David, Huie, Tristan, Kaner, Robert, Kim, Hyun, Kreider, Maryl, Lancaster, Lisa, Lasky, Joseph, Lederer, David, Lee, Doug, Liesching, Timothy, Lipchik, Randolph, Lobo, Jason, Mageto, Yolanda, Menon, Prema, Morrison, Lake, Namen, Andrew, Oldham, Justin, Raj, Rishi, Ramaswamy, Murali, Russell, Tonya, Sachs, Paul, Safdar, Zeenat, Sigal, Barry, Silhan, Leann, Strek, Mary, Suliman, Sally, Tabak, Jeremy, Walia, Rajat, Whelan, Timothy P., O’Brien, Emily C., Hellkamp, Anne S., Neely, Megan L., Swaminathan, Aparna, Bender, Shaun, Snyder, Laurie D., Conoscenti, Craig S., Todd, Jamie L., Palmer, Scott M., and Leonard, Thomas B.

Published
2020
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23. Sustained Clinical Benefits of Spiration Valve System in Severe Emphysema Patients: 24-Month Follow-Up of EMPROVE

Author

Criner, Gerard J, primary, Mallea, Jorge M., additional, Abu-Hijleh, Muhanned, additional, Sachdeva, Ashutosh, additional, Kalhan, Ravi, additional, Hergott, Christopher A, additional, Lazarus, Donald R., additional, Mularski, Richard A, additional, Calero, Karel, additional, Reed, Michael F, additional, Nsiah-Dosu, Stephanie, additional, Himes, David, additional, Kubo, Hiroshi, additional, Kinsey, C. Matthew, additional, Majid, Adnan, additional, Hogarth, D. Kyle, additional, Kaplan, Philip V, additional, Case, Amy Hajari, additional, Makani, Samir S, additional, Chen, Tze-Ming, additional, Delage, Antoine, additional, Zgoda, Michael, additional, and Shepherd, Ray W, additional

Published
2023
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26. Use of a molecular classifier to identify usual interstitial pneumonia in conventional transbronchial lung biopsy samples: a prospective validation study

Author

Raghu, Ganesh, Flaherty, Kevin R, Lederer, David J, Lynch, David A, Colby, Thomas V, Myers, Jeffrey L, Groshong, Steve D, Larsen, Brandon T, Chung, Jonathan H, Steele, Mark P, Benzaquen, Sadia, Calero, Karel, Case, Amy H, Criner, Gerard J, Nathan, Steven D, Rai, Navdeep S, Ramaswamy, Murali, Hagmeyer, Lars, Davis, J Russell, Gauhar, Umair A, Pankratz, Daniel G, Choi, Yoonha, Huang, Jing, Walsh, P Sean, Neville, Hannah, Lofaro, Lori R, Barth, Neil M, Kennedy, Giulia C, Brown, Kevin K, and Martinez, Fernando J

Published
2019
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27. Sustained Clinical Benefits of Spiration Valve System in Patients with Severe Emphysema: 24-Month Follow-Up of EMPROVE.

Author

Criner, Gerard J., Mallea, Jorge M., Abu-Hijleh, Muhanned, Sachdeva, Ashutosh, Kalhan, Ravi, Hergott, Christopher A., Lazarus, Donald R., Mularski, Richard A., Calero, Karel, Reed, Michael F., Nsiah-Dosu, Stephanie, Himes, David, Hiroshi Kubo, Kinsey, C. Matthew, Majid, Adnan, Hogarth, D. Kyle, Kaplan, Philip V., Case, Amy Hajari, Makani, Samir S., and Tze-Ming Chen

Subjects
LUNGS, CHRONIC obstructive pulmonary disease, FORCED expiratory volume, VALVES, RANDOMIZED controlled trials, DISEASE exacerbation
Abstract

Rationale: Follow-up of patients with emphysema treated with endobronchial valves is limited to 3--12 months after treatment in prior reports. To date, no comparative data exist between treatment and control subjects with a longer follow-up. Objectives: To assess the durability of the Spiration Valve System (SVS) in patients with severe heterogeneous emphysema over a 24-month period. Methods: EMPROVE, a multicenter randomized controlled trial, presents a rigorous comparison between treatment and control groups for up to 24 months. Lung function, respiratory symptoms, and quality-of-life (QOL) measures were assessed. Results: A significant improvement in forced expiratory volume in 1 second was maintained at 24 months in the SVS treatment group versus the control group. Similarly, significant improvements were maintained in several QOL measures, including the St. George's Respiratory Questionnaire and the COPD Assessment Test. Patients in the SVS treatment group experienced significantly less dyspnea than those in the control group, as indicated by the modified Medical Research Council dyspnea scale score. Adverse events at 24 months did not significantly differ between the SVS treatment and control groups. Acute chronic obstructive pulmonary disease exacerbation rates in the SVS treatment and control groups were 13.7% (14 of 102) and 15.6% (7 of 45), respectively. Pneumothorax rates in the SVS treatment and control groups were 1.0% (1 of 102) and 0.0% (0 of 45), respectively. Conclusions: SVS treatment resulted in statistically significant and clinically meaningful durable improvements in lung function, respiratory symptoms, and QOL, as well as a statistically significant reduction in dyspnea, for at least 24 months while maintaining an acceptable safety profile. Clinical trial registered with www.clinicaltrials.gov (NCT 01812447). [ABSTRACT FROM AUTHOR]

Published
2024
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28. Breast Cancer

Author

Case, Amy, primary, Edwards, Gwenllian, additional, and Pembroke, Catherine, additional

Published
2020
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32. The Role of Feeling “Heard and Understood” in Promoting and Measuring the Receipt of Goal-Concordant Care in Advanced Cancer (QI131)

Author

Loggers, Elizabeth T., primary, Case, Amy, additional, Chwistek, Marcin, additional, Guay, Marvin Delgado, additional, Grossman, Steven R., additional, Gustin, Jillian, additional, di Ciccone, Barbara Lubrano, additional, Nelson, Judith, additional, Reddy, Akhila, additional, Tulsky, James, additional, Zachariah, Finly, additional, and Landrum, Kristen McNiff, additional

Published
2023
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35. Long-term inhaled treprostinil for PH-ILD: INCREASE open-label extension study

Author

Waxman, Aaron, primary, Restrepo-Jaramillo, Ricardo, additional, Thenappan, Thenappan, additional, Engel, Peter, additional, Bajwa, Abubakr, additional, Ravichandran, Ashwin, additional, Feldman, Jeremy, additional, Hajari Case, Amy, additional, Tapson, Victor, additional, Smith, Peter, additional, Deng, Chunqin, additional, Shen, Eric, additional, and Nathan, Steven D., additional

Published
2023
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36. Postoperative Restrictive Opioid Protocols and Durable Changes in Opioid Prescribing and Chronic Opioid Use

Author

Zsiros, Emese, primary, Ricciuti, Jason, additional, Gallo, Steven, additional, Argentieri, Deanna, additional, Attwood, Kristopher, additional, Ji, Wenyan, additional, Hutson, Alan, additional, Visco, Paul, additional, Coffey, Devon, additional, Riebandt, Grazyna, additional, Mark, Jaron, additional, Varghese, Aaron, additional, Hess, Suzanne M., additional, Furlani, Thomas, additional, Fabiano, Andrew, additional, Hennon, Mark, additional, Yendamuri, Sai, additional, Kauffman, Eric C., additional, Wooten, Kimberly E., additional, Hicks, Wesley L., additional, Young, Jessica, additional, Takabe, Kazuaki, additional, Odunsi, Kunle, additional, Case, Amy A., additional, Segal, Brahm H., additional, Johnson, Candace S., additional, Kuvshinoff, Boris, additional, Nurkin, Steven, additional, Paragh, Gyorgy, additional, and de Leon-Casasola, Oscar, additional

Published
2023
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39. Multinational Association of Supportive Care in Cancer (MASCC) expert opinion/consensus guidance on the use of cannabinoids for gastrointestinal symptoms in patients with cancer

Author

Alderman, Bryony, primary, Hui, David, additional, Mukhopadhyay, Sandip, additional, Bouleuc, Carole, additional, Case, Amy A., additional, Amano, Koji, additional, Crawford, Gregory B., additional, de Feo, Giulia, additional, Sbrana, Andrea, additional, Tanco, Kimberson, additional, To, Josephine, additional, Garsed, Jessica, additional, and Davis, Mellar, additional

Published
2022
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40. Effective Palliative Care: What Is Involved?

Author

Swami, Mehak and Case, Amy Allen

Subjects
Palliative care -- Analysis, Medical care quality -- Analysis, Pain management -- Analysis, Oncologists -- Practice, Cancer treatment -- Analysis, Workers, Cancer, Nurses, Psychologists, Physicians, Social workers, Health
Abstract

It is important for oncologists who provide comprehensive cancer care to be familiar with the principles of primary palliative care and interdisciplinary team-based approaches to palliative care. Palliative care is a medical subspecialty that provides specialized care to individuals with serious illnesses, with a primary focus on providing symptom relief, pain management, and relief from psychosocial distress, regardless of diagnosis or prognosis. Ideally, palliative care is provided by a team of physicians, nurses, social workers, psychologists, and chaplains. The core of palliative care is addressing, in depth, the physical, emotional, and spiritual suffering that a patient can experience. Palliative care is a key component of oncologic care, and we highly recommend that it be integrated into the plan of care for patients with advanced cancer. Early integration of palliative care has been shown to provide improved outcomes in patients with advanced cancer. This article reviews the ways in which palliative care and oncology teams can collaborate to provide high-quality care to patients and their families; it also provides practical tips for oncologists who wish to initiate primary palliative care for their patients. Prior to referral to a specialized interdisciplinary palliative care team, oncologists may start advance-care planning discussions, provide basic pain and non-pain symptom relief, and utilize assessment tools. If a specialized palliative care team is not available, the oncologist will often address additional aspects of palliative care, with assistance from social work departments and other resources in the community., What Is Palliative or Supportive Care? Palliative care is a medical subspecialty that provides care for people with serious illnesses; its primary focus is on providing symptom relief, pain management, [...]

Published
2018

43. Cough-Specific Quality of Life Predicts Disease Progression Among Patients With Interstitial Lung Disease

Author

Lee, Janet, primary, White, Emily, additional, Freiheit, Elizabeth, additional, Scholand, Mary Beth, additional, Strek, Mary E., additional, Podolanczuk, Anna J., additional, Patel, Nina M., additional, Bascom, Rebecca, additional, Belloli, Elizabeth, additional, Bhatt, Nitin, additional, Bhorade, Sangeeta, additional, Case, Amy, additional, Castriotta, Richard, additional, Criner, Gerard, additional, Danoff, Sonye, additional, De Andrade, Joao, additional, Desai, Alpa, additional, Glassberg, Marilyn, additional, Glazer, Craig, additional, Gulati, Mridu, additional, Gupta, Nishant, additional, Hamblin, Mark, additional, Huie, Tristan, additional, Kaner, Robert, additional, Kass, Daniel, additional, Kim, Hyun, additional, Kreider, Maryl, additional, Lancaster, Lisa, additional, Lasky, Joseph, additional, Limper, Andrew, additional, Montesi, Sydney, additional, Mooney, Joshua, additional, Morrison, Lake, additional, Nambiar, Anoop, additional, Nathan, Steven, additional, Natt, Bhupinder, additional, Paul, Tessy, additional, Perez, Rafael, additional, Podolanczuk, Anna, additional, Raghu, Ganesh, additional, Shifren, Adrian, additional, Strek, Mary, additional, Todd, Nevins, additional, Walia, Rajat, additional, Weight, Stephen, additional, Whelan, Timothy, additional, and Wolters, Paul, additional

Published
2022
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46. Disparities in Lung Transplant among Patients with Idiopathic Pulmonary Fibrosis: An Analysis of the IPF-PRO Registry

Author

Swaminathan, Aparna C., primary, Hellkamp, Anne S., additional, Neely, Megan L., additional, Bender, Shaun, additional, Paoletti, Luca, additional, White, Eric S., additional, Palmer, Scott M., additional, Whelan, Timothy P. M., additional, Dilling, Daniel F., additional, Baker, Albert, additional, Beegle, Scott, additional, Belperio, John A., additional, Condos, Rany, additional, Cordova, Francis, additional, Culver, Daniel A., additional, Fitzgerald, John, additional, Flaherty, Kevin R., additional, Gibson, Kevin, additional, Gulati, Mridu, additional, Guntupalli, Kalpalatha, additional, Gupta, Nishant, additional, Case, Amy Hajari, additional, Hotchkin, David, additional, Huie, Tristan J., additional, Kaner, Robert J., additional, Kim, Hyun J., additional, Lancaster, Lisa H., additional, Lasky, Joseph A., additional, Lee, Doug, additional, Liesching, Timothy, additional, Lipchik, Randolph, additional, Lobo, Jason, additional, Luckhardt, Tracy R., additional, Mageto, Yolanda, additional, Menon, Prema, additional, Morrison, Lake, additional, Namen, Andrew, additional, Oldham, Justin M., additional, Paul, Tessy, additional, Zhang, David, additional, Porteous, Mary, additional, Raj, Rishi, additional, Ramaswamy, Murali, additional, Russell, Tonya, additional, Sachs, Paul, additional, Safdar, Zeenat, additional, Shafazand, Shirin, additional, Siddiqi, Ather, additional, Sigal, Barry, additional, Strek, Mary E., additional, Suliman, Sally, additional, Tabak, Jeremy, additional, and Walia, Rajat, additional

Published
2022
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48. The Impact of the Envisia Genomic Classifier in the Diagnosis and Management of Patients with Idiopathic Pulmonary Fibrosis

Author

Lasky, Joseph A., primary, Case, Amy, additional, Unterman, Avraham, additional, Kreuter, Michael, additional, Scholand, Mary Beth, additional, Chaudhary, Sachin, additional, Lofaro, Lori R., additional, Johnson, Marla, additional, Huang, Jing, additional, Bhorade, Sangeeta M., additional, and Kennedy, Giulia C., additional

Published
2022
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