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1. Effect of Primary Tumor Side on Survival Outcomes in Untreated Patients With Metastatic Colorectal Cancer When Selective Internal Radiation Therapy Is Added to Chemotherapy: Combined Analysis of Two Randomized Controlled Studies

Author

Brown, Michael, Burge, Matthew, Cardaci, Giuseppe, Clarke, Stephen, Eliadis, Paul, Ferguson, Tom, Ganju, Vinod, Gibbs, Peter, van Hazel, Guy, James, Philip, Karapetis, Chris, Liauw, Winston, Marx, Gavin, Matos, Marco, Nott, Louise, Pavlakis, Nick, Powell, Alex, Price, Timothy, Ransom, David, Segelov, Eva, Shannon, Jenny, Singhal, Nimit, Strickland, Andrew, Walpole, Euan, Craninx, Michel, Delaunoit, Thierry, Deleporte, Amélie, Ferrante, Michel, Geboes, Karen, Hendlisz, Alain, Hendrickx, Koen, De Man, Marc, Monsaert, Els, Moons, Veerle, Peeters, Marc, Polus, Marc, Boucher, Eveline, Balosso, Jacques, Chevallier, Patrick, Louafi, Samy, Pracht, Marc, Rebischung, Christine, Smith, Denis, Taieb, Julien, Terrebonne, Eric, Bruch, Harald-Robert, Gehbauer, Gerald, Heinemann, Volker, Helmberger, Thomas, Ko, Yon-Dschun, Kröning, Hendrik, Lammert, Frank, Nusch, Arnd, Pluntke, Stefan, Ridwelski, Karsten, Riera-Knorrenschild, Jorge, Riess, Hanno, Riera, Jorge Ramon, Ricke, Jens, Sauerbruch, Tilmann, Scheidhauer, Klemens, Stötzer, Oliver, Tatsch, Klaus, Vehling-Kaiser, Ursula, Vogl, Thomas, Beny, Alex, Geva, Ravit, Shacham-Shmueli, Einat, Stemmer, Salomon, Tichler, Thomas, Wolf, Ido, Angelelli, Bruna, Martoni, Andrea, Findlay, Michael P.N., Isaacs, Richard, O’Donnell, Anne, Perez, David, Robinson, Bridget A., Rodríguez, Javier, Vera-Garcia, Ruth, Amin, Pradip, Bloomgarden, Daniel, Bui, James, Carlisle, James, Chai, Seungjean, Chen, Yi-Jen, Chuong, Michael, Coveler, Andrew, Facchini, Francis, Frenette, Gary, Frick, Jacob, Garofalo, Michael, George, Benjamin, Gordon, Michael, Gulec, Seza, Hannigan, James, Holtzman, Matthew, Kaubisch, Andreas, Kaiser, Adeel, Kooy, Todd, Limentani, Steven, Margolis, Jeffrey, Martin, Robert, Ozer, Howard, Padia, Siddarth, Rilling, William, Savin, Michael, Schneiderman, Elyse, Seeger, Grant, Sharma, Navesh, Shibata, Stephen, Smith, Randall, Wang, Eric, Whiting, Samuel, Aghmesheh, Morteza, Burge, Mathew, Cooray, Prasad, Feeney, Kynan, Lim, Lionel, Singh, Madhu, Underhill, Craig, Deleporte, Amelie, Durand, Aurelie, Faivre, Sandrine, Ferru, Aurelie, Hammel, Pascal, Bremer, Christoph, De Wit, Maike, Ayala, Hubert, Heching, Norman, Shani, Adi, Granetto, Cristina, Masi, Gianluca, Mosconi, Stefania, Numico, Gianmauro, Trogu, Antonio, Kim, Yeul Hong, Sae-Won, Han, Jackson, Chris, O'Donnell, Anne, Fragoso, Maria, Tan, Iain, Casado, Ana Ruiz, Liang, Jin Tung, Liu, Jin Hwang, Ades, Steven, Auber, Miklos, Boland, Patrick, Bowers, Charles, Crain, Martin, Dowling, Kyran, Iyer, Renuka, Ratner, Lynn, Sanchez, Federico, Stoltzfus, Patricia, Westcott, Mark, Sharma, Navesh K., Findlay, Michael, Robinson, Bridget, Jackson, Christopher, Gebski, Val, Van Buskirk, Mark, and Zhao, Huaqing

Published
2018
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2. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials

Author

Adams, Richard, Bateman, Andrew, Blesing, Claire, Brown, Ewan, Chau, Ian, Cummins, Sebastian, Cunningham, David, Falk, Stephen, Hadaki, Maher, Hall, Marcia, Hickish, Tamas, Hornbuckle, Joanne, Lofts, Fiona, Lowndes, Sarah, Mayer, Astrid, Metcalfe, Matthew, Middleton, Gary, Mills, Jamie, Montazeri, Amir, Muirhead, Rebecca, Polychronis, Andreas, Purcell, Colin, Ross, Paul, Sharma, Ricky A, Sherwin, Liz, Smith, David, Soomal, Rubin, Swinson, Daniel, Walther, Axel, Wasan, Harpreet, Weaver, Andrew, Wilson, Charles, Wilson, Greg, Amin, Pradip, Angelelli, Bruna, Balosso, Jacques, Beny, Alex, Bloomgarden, Daniel, Boucher, Evelyn, Brown, Michael, Bruch, Harald-Robert, Bui, James, Burge, Matthew, Cardaci, Giuseppe, Carlisle, James, Chai, Seungjean, Chen, Yi-Jen, Chevallier, Patrick, Chuong, Michael, Clarke, Stephen, Coveler, Andrew, Craninx, Michael, Delanoit, Thierry, Deleporte, Amélie, Eliadis, Paul, Facchini, Francis, Ferguson, Thomas, Ferrante, Michel, Findlay, Michael, Frenette, Gary, Frick, Jacob, Ganju, Vinod, Garofalo, Michael, Geboes, Karen, Gehbauer, Gerald, George, Benjamin, Geva, Ravit, Gibbs, Peter, Gordon, Michael, Gregory, Kate, Gulec, Seza, Hannigan, James, van Hazel, Guy, Heching, Norman, Heinemann, Volker, Helmberger, Thomas, Hendlisz, Alain, Hendrickx, Koen, Holtzman, Matthew, Isaacs, Richard, Jackson, Christopher, James, Philip, Kaiser, Adeel, Karapetis, Chris, Kaubisch, Andreas, Ko, Yon-Dschun, Kröning, Hendrik, Lammert, Frank, Liauw, Winston, Limentani, Steven, Louafi, Samy, de Man, Marc, Margolis, Jeffrey, Martin, Robert, Martoni, Andrea, Marx, Gavin, Matos, Marco, Monsaert, Els, Moons, Veerle, Nott, Louise, Nusch, Arnd, O'Donnell, Anne, Ozer, Howard, Padia, Siddarth, Pavlakis, Nick, Peeters, Marc, Perez, David, Pluntke, Stefan, Polus, Marc, Powell, Alex, Pracht, Marc, Price, Timothy, Ransom, David, Rebischung, Christine, Ricke, Jens, Ridwelski, Karsten, Riera-Knorrenschild, Jorge, Riess, Hanno, Rilling, William, Robinson, Bridget, Rodríguez, Javier, Sanchez, Federico, Sauerbruch, Tilmann, Savin, Michael, Scheidhauer, Klemens, Schneiderman, Elyse, Seeger, Grant, Segelov, Eva, Schmueli, Einat Shaham, Shani, Adi, Shannon, Jenny, Sharma, Navesh, Shibata, Stephen, Singhal, Nimit, Smith, Denis, Smith, Randall, Stemmer, Salomon, Stötzer, Oliver, Strickland, Andrew, Taieb, Julien, Tatsch, Klaus, Terrebonne, Eric, Tichler, Thomas, Vehling-Kaiser, Ursula, Vera-Garcia, Ruth, Vogl, Thomas, Walpole, Euan, Wang, Eric, Whiting, Samuel, Wolf, Ido, Ades, Steven, Aghmesheh, Morteza, Auber, Miklos, Ayala, Hubert, Boland, Patrick, Bouche, Eveline, Bowers, Charles, Bremer, Christoph, Burge, Mathew, Casado, Ana Ruiz, Cooray, Prasad, Crain, Martin, De Wit, Maike, Dowling, Kyran, Durand, Aurelie, Faivre, Sandrine, Feeney, Kynan, Ferguson, Tom, Ferru, Aurelie, Fragoso, Maria, Granetto, Cristina, Hammel, Pascal, Issacs, Richard, Iyer, Renuka, Kim, Yeul Hong, Liang, Jin Tung, Lim, Lionel, Liu, Jin Hwang, Masi, Gianluca, Mosconi, Stefania, Numico, Gianmauro, Ratner, Lynn, Sae-Won, Han, Singh, Madhu, Stoltzfus, Patricia, Tan, Iain, Trogu, Antonio, Underhill, Craig, Westcott, Mark, Wasan, Harpreet S, Sharma, Navesh K, Francis, Anne, Moschandreas, Joanna, Virdee, Pradeep S, Dutton, Peter, Love, Sharon, Gebski, Val, and Gray, Alastair

Published
2017
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6. Effect of Primary Tumor Side on Survival Outcomes in Untreated Patients With Metastatic Colorectal Cancer When Selective Internal Radiation Therapy Is Added to Chemotherapy: Combined Analysis of Two Randomized Controlled Studies

Author

Gibbs, Peter, primary, Heinemann, Volker, additional, Sharma, Navesh K., additional, Taieb, Julien, additional, Ricke, Jens, additional, Peeters, Marc, additional, Findlay, Michael, additional, Robinson, Bridget, additional, Jackson, Christopher, additional, Strickland, Andrew, additional, Gebski, Val, additional, Van Buskirk, Mark, additional, Zhao, Huaqing, additional, van Hazel, Guy, additional, Brown, Michael, additional, Burge, Matthew, additional, Cardaci, Giuseppe, additional, Clarke, Stephen, additional, Eliadis, Paul, additional, Ferguson, Tom, additional, Ganju, Vinod, additional, Gibbs, Peter, additional, James, Philip, additional, Karapetis, Chris, additional, Liauw, Winston, additional, Marx, Gavin, additional, Matos, Marco, additional, Nott, Louise, additional, Pavlakis, Nick, additional, Powell, Alex, additional, Price, Timothy, additional, Ransom, David, additional, Segelov, Eva, additional, Shannon, Jenny, additional, Singhal, Nimit, additional, Walpole, Euan, additional, Craninx, Michel, additional, Delaunoit, Thierry, additional, Deleporte, Amélie, additional, Ferrante, Michel, additional, Geboes, Karen, additional, Hendlisz, Alain, additional, Hendrickx, Koen, additional, De Man, Marc, additional, Monsaert, Els, additional, Moons, Veerle, additional, Polus, Marc, additional, Boucher, Eveline, additional, Balosso, Jacques, additional, Chevallier, Patrick, additional, Louafi, Samy, additional, Pracht, Marc, additional, Rebischung, Christine, additional, Smith, Denis, additional, Terrebonne, Eric, additional, Bruch, Harald-Robert, additional, Gehbauer, Gerald, additional, Helmberger, Thomas, additional, Ko, Yon-Dschun, additional, Kröning, Hendrik, additional, Lammert, Frank, additional, Nusch, Arnd, additional, Pluntke, Stefan, additional, Ridwelski, Karsten, additional, Riera-Knorrenschild, Jorge, additional, Riess, Hanno, additional, Riera, Jorge Ramon, additional, Sauerbruch, Tilmann, additional, Scheidhauer, Klemens, additional, Stötzer, Oliver, additional, Tatsch, Klaus, additional, Vehling-Kaiser, Ursula, additional, Vogl, Thomas, additional, Beny, Alex, additional, Geva, Ravit, additional, Shacham-Shmueli, Einat, additional, Stemmer, Salomon, additional, Tichler, Thomas, additional, Wolf, Ido, additional, Angelelli, Bruna, additional, Martoni, Andrea, additional, Findlay, Michael P.N., additional, Isaacs, Richard, additional, O’Donnell, Anne, additional, Perez, David, additional, Robinson, Bridget A., additional, Rodríguez, Javier, additional, Vera-Garcia, Ruth, additional, Amin, Pradip, additional, Bloomgarden, Daniel, additional, Bui, James, additional, Carlisle, James, additional, Chai, Seungjean, additional, Chen, Yi-Jen, additional, Chuong, Michael, additional, Coveler, Andrew, additional, Facchini, Francis, additional, Frenette, Gary, additional, Frick, Jacob, additional, Garofalo, Michael, additional, George, Benjamin, additional, Gordon, Michael, additional, Gulec, Seza, additional, Hannigan, James, additional, Holtzman, Matthew, additional, Kaubisch, Andreas, additional, Kaiser, Adeel, additional, Kooy, Todd, additional, Limentani, Steven, additional, Margolis, Jeffrey, additional, Martin, Robert, additional, Ozer, Howard, additional, Padia, Siddarth, additional, Rilling, William, additional, Savin, Michael, additional, Schneiderman, Elyse, additional, Seeger, Grant, additional, Sharma, Navesh, additional, Shibata, Stephen, additional, Smith, Randall, additional, Wang, Eric, additional, Whiting, Samuel, additional, Aghmesheh, Morteza, additional, Burge, Mathew, additional, Cooray, Prasad, additional, Feeney, Kynan, additional, Lim, Lionel, additional, Singh, Madhu, additional, Underhill, Craig, additional, Deleporte, Amelie, additional, Durand, Aurelie, additional, Faivre, Sandrine, additional, Ferru, Aurelie, additional, Hammel, Pascal, additional, Bremer, Christoph, additional, De Wit, Maike, additional, Ayala, Hubert, additional, Heching, Norman, additional, Shani, Adi, additional, Granetto, Cristina, additional, Masi, Gianluca, additional, Mosconi, Stefania, additional, Numico, Gianmauro, additional, Trogu, Antonio, additional, Kim, Yeul Hong, additional, Sae-Won, Han, additional, Jackson, Chris, additional, O'Donnell, Anne, additional, Fragoso, Maria, additional, Tan, Iain, additional, Casado, Ana Ruiz, additional, Liang, Jin Tung, additional, Liu, Jin Hwang, additional, Ades, Steven, additional, Auber, Miklos, additional, Boland, Patrick, additional, Bowers, Charles, additional, Crain, Martin, additional, Dowling, Kyran, additional, Iyer, Renuka, additional, Ratner, Lynn, additional, Sanchez, Federico, additional, Stoltzfus, Patricia, additional, and Westcott, Mark, additional

Published
2018
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7. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials

Author

Wasan, Harpreet S, Gibbs, Peter, Sharma, Navesh K, Taieb, Julien, Heinemann, Volker, Ricke, Jens, Peeters, Marc, Findlay, Michael, Weaver, Andrew, Mills, Jamie, Wilson, Charles, Adams, Richard, Francis, Anne, Moschandreas, Joanna, Virdee, Pradeep S, Dutton, Peter, Love, Sharon, Gebski, Val, Gray, Alastair, Bateman, Andrew, Blesing, Claire, Brown, Ewan, Chau, Ian, Cummins, Sebastian, Cunningham, David, Falk, Stephen, Hadaki, Maher, Hall, Marcia, Hickish, Tamas, Hornbuckle, Joanne, Lofts, Fiona, Lowndes, Sarah, Mayer, Astrid, Metcalfe, Matthew, Middleton, Gary, Montazeri, Amir, Muirhead, Rebecca, Polychronis, Andreas, Purcell, Colin, Ross, Paul, Sharma, Ricky A, Sherwin, Liz, Smith, David, Soomal, Rubin, Swinson, Daniel, Walther, Axel, Wasan, Harpreet, Wilson, Greg, Amin, Pradip, Angelelli, Bruna, Balosso, Jacques, Beny, Alex, Bloomgarden, Daniel, Boucher, Evelyn, Brown, Michael, Bruch, Harald-Robert, Bui, James, Burge, Matthew, Cardaci, Giuseppe, Carlisle, James, Chai, Seungjean, Chen, Yi-Jen, Chevallier, Patrick, Chuong, Michael, Clarke, Stephen, Coveler, Andrew, Craninx, Michael, Delanoit, Thierry, Deleporte, Amã©lie, Eliadis, Paul, Facchini, Francis, Ferguson, Thomas, Ferrante, Michel, Frenette, Gary, Frick, Jacob, Ganju, Vinod, Garofalo, Michael, Geboes, Karen, Gehbauer, Gerald, George, Benjamin, Geva, Ravit, Gordon, Michael, Gregory, Kate, Gulec, Seza, Hannigan, James, van Hazel, Guy, Heching, Norman, Helmberger, Thomas, Hendlisz, Alain, Hendrickx, Koen, Holtzman, Matthew, Isaacs, Richard, Jackson, Christopher, MORRISON JR, PHILIP JAMES, Kaiser, Adeel, Karapetis, Chris, Kaubisch, Andreas, Yon-Dschun, Ko, Krã¶ning, Hendrik, Lammert, Frank, Liauw, Winston, Limentani, Steven, Louafi, Samy, de Man, Marc, Margolis, Jeffrey, Martin, Robert, Martoni, Andrea, Marx, Gavin, Matos, Marco, Monsaert, Els, Moons, Veerle, Nott, Louise, Nusch, Arnd, O'Donnell, Anne, Ozer, Howard, Padia, Siddarth, Pavlakis, Nick, Perez, David, Pluntke, Stefan, Polus, Marc, Powell, Alex, Pracht, Marc, Price, Timothy, Ransom, David, Rebischung, Christine, Ridwelski, Karsten, Riera-Knorrenschild, Jorge, Riess, Hanno, Rilling, William, Robinson, Bridget, Rodrã­guez, Javier, Sanchez, Federico, Sauerbruch, Tilmann, Savin, Michael, Scheidhauer, Klemens, Schneiderman, Elyse, Seeger, Grant, Segelov, Eva, Schmueli, Einat Shaham, Shani, Adi, Shannon, Jenny, Sharma, Navesh, Shibata, Stephen, Singhal, Nimit, Smith, Denis, Smith, Randall, Stemmer, Salomon, Stã¶tzer, Oliver, Strickland, Andrew, Tatsch, Klaus, Terrebonne, Eric, Tichler, Thomas, Vehling-Kaiser, Ursula, Vera-Garcia, Ruth, Vogl, Thomas, Walpole, Euan, Wang, Eric, Whiting, Samuel, Wolf, Ido, Ades, Steven, Aghmesheh, Morteza, Auber, Miklos, Ayala, Hubert, Boland, Patrick, Bouche, Eveline, Bowers, Charles, Bremer, Christoph, Burge, Mathew, Casado, Ana Ruiz, Cooray, Prasad, Crain, Martin, De Wit, Maike, Deleporte, Amelie, Dowling, Kyran, Durand, Aurelie, Faivre, Sandrine, Feeney, Kynan, Ferguson, Tom, Ferru, Aurelie, Fragoso, Maria, Granetto, Cristina, Hammel, Pascal, Issacs, Richard, Iyer, Renuka, Kim, Yeul Hong, Liang, Jin Tung, Lim, Lionel, Liu, Jin Hwang, Masi, Gianluca, Mosconi, Stefania, Numico, Gianmauro, Ratner, Lynn, Sae-Won, Han, Singh, Madhu, Stoltzfus, Patricia, Tan, Iain, Trogu, Antonio, Underhill, Craig, Westcott, Mark, FOXFIRE Trial Investigators, SIRFLOX Trial Investigators, and FOXFIRE-Global Trial Investigators

Subjects
Aged, 80 and over, Adult, Male, Radiotherapy, Brachytherapy, Liver Neoplasms, Aged, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Colorectal Neoplasms, Disease-Free Survival, Female, Humans, Middle Aged, Radiotherapy, Adjuvant, Treatment Outcome, Oncology, Articles, digestive system diseases, Editorial, Colonic Neoplasms, 80 and over, Human medicine, Adjuvant
Abstract

Background Data suggest selective internal radiotherapy (SIRT) in third-line or subsequent therapy for metastatic colorectal cancer has clinical benefit in patients with colorectal liver metastases with liver-dominant disease after chemotherapy. The FOXFIRE, SIRFLOX, and FOXFIRE-Global randomised studies evaluated the efficacy of combining first-line chemotherapy with SIRT using yttrium-90 resin microspheres in patients with metastatic colorectal cancer with liver metastases. The studies were designed for combined analysis of overall survival. Methods FOXFIRE, SIRFLOX, and FOXFIRE-Global were randomised, phase 3 trials done in hospitals and specialist liver centres in 14 countries worldwide (Australia, Belgium, France, Germany, Israel, Italy, New Zealand, Portugal, South Korea, Singapore, Spain, Taiwan, the UK, and the USA). Chemotherapy-naive patients with metastatic colorectal cancer (WHO performance status 0 or 1) with liver metastases not suitable for curative resection or ablation were randomly assigned (1: 1) to either oxaliplatin-based chemotherapy (FOLFOX: leucovorin, fluorouracil, and oxaliplatin) or FOLFOX plus single treatment SIRT concurrent with cycle 1 or 2 of chemotherapy. In FOXFIRE, FOLFOX chemotherapy was OxMdG (oxaliplatin modified de Gramont chemotherapy; 85 mg/m(2) oxaliplatin infusion over 2 h, L-leucovorin 175 mg or D,L-leucovorin 350 mg infusion over 2 h, and 400 mg/m(2) bolus fluorouracil followed by a 2400 mg/m(2) continuous fluorouracil infusion over 46 h). In SIRFLOX and FOXFIRE-Global, FOLFOX chemotherapy was modified FOLFOX6 (85 mg/m(2) oxaliplatin infusion over 2 h, 200 mg leucovorin, and 400 mg/m(2) bolus fluorouracil followed by a 2400 mg/m(2) continuous fluorouracil infusion over 46 h). Randomisation was done by central minimisation with four factors: presence of extrahepatic metastases, tumour involvement of the liver, planned use of a biological agent, and investigational centre. Participants and investigators were not masked to treatment. The primary endpoint was overall survival, analysed in the intention-to-treat population, using a two-stage meta-analysis of pooled individual patient data. All three trials have completed 2 years of follow-up. FOXFIRE is registered with the ISRCTN registry, number ISRCTN83867919. SIRFLOX and FOXFIRE-Global are registered with ClinicalTrials.gov, numbers NCT00724503 (SIRFLOX) and NCT01721954 (FOXFIRE-Global). Findings Between Oct 11, 2006, and Dec 23, 2014, 549 patients were randomly assigned to FOLFOX alone and 554 patients were assigned FOLFOX plus SIRT. Median follow-up was 43.3 months (IQR 31.6-58.4). There were 411 (75%) deaths in 549 patients in the FOLFOX alone group and 433 (78%) deaths in 554 patients in the FOLFOX plus SIRT group. There was no difference in overall survival (hazard ratio [HR] 1.04, 95% CI 0.90-1.19; p=0.61). The median survival time in the FOLFOX plus SIRT group was 22.6 months (95% CI 21.0-24.5) compared with 23.3 months (21.8-24.7) in the FOLFOX alone group. In the safety population containing patients who received at least one dose of study treatment, as treated, the most common grade 3-4 adverse event was neutropenia (137 [24%] of 571 patients receiving FOLFOX alone vs 186 (37%) of 507 patients receiving FOLFOX plus SIRT). Serious adverse events of any grade occurred in 244 (43%) of 571 patients receiving FOLFOX alone and 274 (54%) of 507 patients receiving FOLFOX plus SIRT. 10 patients in the FOLFOX plus SIRT group and 11 patients in the FOLFOX alone group died due to an adverse event; eight treatment-related deaths occurred in the FOLFOX plus SIRT group and three treatment-related deaths occurred in the FOLFOX alone group. Interpretation Addition of SIRT to first-line FOLFOX chemotherapy for patients with liver-only and liver-dominant metastatic colorectal cancer did not improve overall survival compared with that for FOLFOX alone. Therefore, early use of SIRT in combination with chemotherapy in unselected patients with metastatic colorectal cancer cannot be recommended. To further define the role of SIRT in metastatic colorectal cancer, careful patient selection and studies investigating the role of SIRT as consolidation therapy after chemotherapy are needed. Copyright (C) The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license.

Published
2017

10. Prospective Cohort Study of Nephrogenic Systemic Fibrosis in Patients With Stage 3–5 Chronic Kidney Disease Undergoing MRI With Injected Gadobenate Dimeglumine or Gadoteridol

Author

Soulez, Gilles, primary, Bloomgarden, Daniel C., additional, Rofsky, Neil M., additional, Smith, Martin P., additional, Abujudeh, Hani H., additional, Morgan, Desiree E., additional, Lichtenstein, Richard J., additional, Schiebler, Mark L., additional, Wippold, Franz J., additional, Russo, Craig, additional, Kuhn, Matthew J., additional, Mennitt, Kevin W., additional, Maki, Jeffrey H., additional, Stolpen, Alan, additional, Liou, Johnson, additional, Semelka, Richard C., additional, Kirchin, Miles A., additional, Shen, Ningyan, additional, Pirovano, Gianpaolo, additional, and Spinazzi, Alberto, additional

Published
2015
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11. DETERMINING THE RISKS OF MAGNETIC RESONANCE IMAGING AT 1.5 TESLA FOR PATIENTS WITH PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS: THE MAGNASAFE REGISTRY

Author

Russo, Robert J., primary, Costa, Heather, additional, Kabra, Ashish, additional, Doud, Debra, additional, Uretsky, Seth, additional, Wolff, Steven, additional, Martin, Edward, additional, Machado, Christian, additional, Higgins, Steven, additional, Tominaga, Gail, additional, Florin, Todd, additional, Bloomgarden, Daniel, additional, Birgersdotter-Green, Ulrika, additional, Ponce, George, additional, Schaerf, Raymond, additional, Lampert, Rachel, additional, Shah, Dipan, additional, Arshad, Aysha, additional, Anderson, Jeffrey, additional, Tonkin, Allison, additional, Rivard, Andrew, additional, Fyke, Frazier, additional, and Biederman, Robert, additional

Published
2013
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12. REPEAT MRI FOR PATIENTS WITH IMPLANTED CARDIAC DEVICES DOES NOT INCREASE THE RISK OF CLINICAL EVENTS OR PARAMETER CHANGES: PRELIMINARY RESULTS FROM THE MAGNASAFE REGISTRY

Author

Russo, Robert J., primary, Costa, Heather, additional, Doud, Debra, additional, Birgersdotter-Green, Ulrika, additional, Bloomgarden, Daniel, additional, Florin, Todd, additional, Lampert, Rachel, additional, Machado, Christian, additional, Martin, Edward, additional, Ponce, George, additional, Porter, Michael, additional, Schaerf, Raymond, additional, Tominaga, Gail, additional, Uretsky, Seth, additional, and Wolff, Steven, additional

Published
2012
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15. Quantification of left ventricular mechanical function from magnetic resonance images

Author

Bloomgarden, Daniel Caleb and Bloomgarden, Daniel Caleb

Abstract

Cardiovascular disease is one of the leading causes of morbidity and mortality in the United States of America. One of the most common endpoints of cardiovascular disease is heart failure, or mechanical failure of the heart pump. Much is known about the pathophysiological processes underlying the progression of heart disease, however, relatively little is known about the quantitative relationship between microscopic damage to muscle cells and the resulting changes in the mechanical function of the heart. More information may help doctors to predict the outcomes of measurable damage, or help scientist increase their understanding of cardiac function. This quantitative data is currently limited because of the complexity of the microstructure of the myocardium, the multitude of interrelated physiological compensatory response mechanisms of the heart to disease, and the relatively complex geometry and structure of the left ventricle. The goals of this work included the development and validation of methods for quantitatively studying cardiac mechanical function using magnetic resonance imaging. Specifically, methods were optimized for acquiring fast, high contrast and low artifact images. Tools were developed for visualizing images, extracting features, and calculating quantitative function parameters. Methods for modeling the three-dimensional geometry and deformation of the left ventricle were refined and characterized. Additionally, specific experimental methods were developed for measuring the 3D strains using MR tagging and 3D finite element modeling in the normal canine left ventricle. Three-dimensional left ventricular strains from all regions of the left ventricle were analyzed and the strains were examined for regional differences as well as variation with alteration in the hemodynamics. The strains were referred to a cardiac coordinate system and to an anatomical coordinate system related to the direction of the myocardial fibers. Although there were relativel

Published
1996

26. Prospective Cohort Study of Nephrogenic Systemic Fibrosis in Patients With Stage 3-5 Chronic Kidney Disease Undergoing MRI With Injected Gadobenate Dimeglumine or Gadoteridol.

Author

Soulez G, Bloomgarden DC, Rofsky NM, Smith MP, Abujudeh HH, Morgan DE, Lichtenstein RJ, Schiebler ML, Wippold FJ 2nd, Russo C, Kuhn MJ, Mennitt KW, Maki JH, Stolpen A, Liou J, Semelka RC, Kirchin MA, Shen N, Pirovano G, and Spinazzi A

Subjects
Adolescent, Adult, Aged, Female, Gadolinium adverse effects, Humans, Kidney Function Tests, Male, Meglumine adverse effects, Middle Aged, Nephrogenic Fibrosing Dermopathy epidemiology, Product Surveillance, Postmarketing, Prospective Studies, Risk Factors, Contrast Media adverse effects, Heterocyclic Compounds adverse effects, Kidney Failure, Chronic complications, Magnetic Resonance Imaging, Meglumine analogs & derivatives, Nephrogenic Fibrosing Dermopathy chemically induced, Organometallic Compounds adverse effects
Abstract

Objective: The purpose of this study was to determine the incidence of nephrogenic systemic fibrosis (NSF) in patients with chronic kidney disease (CKD) and moderate-to-severe impairment of kidney function who had not previously been exposed to gadolinium-based contrast agents (GBCAs) or referred to undergo contrast-enhanced MRI with gadobenate dimeglumine or gadoteridol., Subjects and Methods: Two multicenter prospective cohort studies evaluated the incidence of unconfounded NSF in patients with stage 3 CKD (estimated glomerular filtration rate [eGFR] in cohort 1, 30-59 mL/min/1.73 m(2)) or stage 4 or 5 CKD (eGFR in cohort 2, < 30 mL/min/1.73 m(2)) after injection of gadobenate dimeglumine (study A) or gadoteridol (study B). A third study (study C) determined the incidence of NSF in patients with stage 4 or 5 CKD who had not received a GBCA in the 10 years before enrollment. Monitoring for signs and symptoms suggestive of NSF was performed via telephone at 1, 3, 6, and 18 months, with clinic visits occurring at 1 and 2 years., Results: For studies A and B, the populations evaluated for NSF comprised 363 and 171 patients, respectively, with 318 and 159 patients in cohort 1 of each study, respectively, and with 45 and 12 patients in cohort 2, respectively. No signs or symptoms of NSF were reported or detected during the 2 years of patient monitoring. Likewise, no cases of NSF were reported for any of the 405 subjects enrolled in study C., Conclusion: To our knowledge, and consistent with reports in the literature, no association of gadobenate dimeglumine or gadoteridol with unconfounded cases of NSF has yet been established. Study data confirm that both gadoteridol and gadobenate dimeglumine properly belong to the class of GBCAs considered to be associated with the lowest risk of NSF.

Published
2015
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