response to nab-paclitaxel and an additional 3 had stable disease per RECIST criteria, yielding a disease control rate of 50%. Common grade 3 or 4 toxicities across the entire study population included fatigue (12%), neutropenia (9%), febrile neutropenia (9
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Al B. Benson III, Alan P. Venook, Mahmoud M. Al-Hawary, Mustafa A. Arain, Yi-Jen Chen, Kristen K. Ciombor, Stacey A. Cohen, Harry S. Cooper, Dustin A. Deming, Ignacio Garrido-Laguna, Jean L. Grem, Sarah E. Hoffe, Joleen Hubbard, Steven Hunt, Ahmed Kamel, Natalie Kirilcuk, Smitha Krishnamurthi, Wells A. Messersmith, Jeffrey Meyerhardt, Eric D. Miller, Mary F. Mulcahy, Steven Nurkin, Michael J. Overman, Aparna Parikh, Hitendra Patel, Katrina S. Pedersen, Leonard B. Saltz, Charles Schneider, David Shibata, John M. Skibber, Constantinos T. Sofocleous, Elena M. Stoffel, Eden Stotsky-Himelfarb, Christopher G. Willett, Alyse Johnson-Chilla, Kristina M. Gregory, and Lisa A. Gurski
Joseph C. Alvarnas, Patrick A. Brown, Patricia Aoun, Karen Kuhn Ballen, Naresh Bellam, William Blum, Michael W. Boyer, Hetty E. Carraway, Peter F. Coccia, Steven E. Coutre, Jennifer Cultrera, Lloyd E. Damon, Daniel J. DeAngelo, Dan Douer, Haydar Frangoul, Olga Frankfurt, Salil Goorha, Michael M. Millenson, Susan O'Brien, Stephen H. Petersdorf, Arati V. Rao, Stephanie Terezakis, Geoffrey Uy, Meir Wetzler, Andrew D. Zelenetz, Maoko Naganuma, and Kristina M. Gregory
neurotoxicity. The incidence of adverse events such as febrile neutropenia and elevation of liver enzymes was also similar between treatment groups. These initial safety data suggest that nelarabine may be better tolerated in frontline regimens than in the
Al B. Benson III, Alan P. Venook, Lynette Cederquist, Emily Chan, Yi-Jen Chen, Harry S. Cooper, Dustin Deming, Paul F. Engstrom, Peter C. Enzinger, Alessandro Fichera, Jean L. Grem, Axel Grothey, Howard S. Hochster, Sarah Hoffe, Steven Hunt, Ahmed Kamel, Natalie Kirilcuk, Smitha Krishnamurthi, Wells A. Messersmith, Mary F. Mulcahy, James D. Murphy, Steven Nurkin, Leonard Saltz, Sunil Sharma, David Shibata, John M. Skibber, Constantinos T. Sofocleous, Elena M. Stoffel, Eden Stotsky-Himelfarb, Christopher G. Willett, Christina S. Wu, Kristina M. Gregory, and Deborah Freedman-Cass
associated with trifluridine/tipiracil were neutropenia (38%), leukopenia (21%), and febrile neutropenia (4%); one drug-related death occurred. A postmarketing surveillance study did not reveal any unexpected safety signals. 226 The panel added trifluridine
Margaret A. Tempero, J. Pablo Arnoletti, Stephen Behrman, Edgar Ben-Josef, Al B. Benson III, Jordan D. Berlin, John L. Cameron, Ephraim S. Casper, Steven J. Cohen, Michelle Duff, Joshua D.I. Ellenhorn, William G. Hawkins, John P. Hoffman, Boris W. Kuvshinoff II, Mokenge P. Malafa, Peter Muscarella II, Eric K. Nakakura, Aaron R. Sasson, Sarah P. Thayer, Douglas S. Tyler, Robert S. Warren, Samuel Whiting, Christopher Willett, and Robert A. Wolff
concerns exist about the toxicity of the FOLFIRINOX regimen (i.e., approximately one fourth of the patients receiving this regimen experienced grade 3/4 fatigue, 46% experienced grade 3/4 neutropenia, and 5.4% experienced grade 3/4 febrile neutropenia
guidelines and the analytical flowcharts. For instance, the use of granulocyte-colony stimulating factors (G-CSFs) in febrile neutropenia and the day of G-CSF initiation were observed. Conclusions: The consensus method identified a list of ADEs that experts
Patrick Brown, Hiroto Inaba, Colleen Annesley, Jill Beck, Susan Colace, Mari Dallas, Kenneth DeSantes, Kara Kelly, Carrie Kitko, Norman Lacayo, Nicole Larrier, Luke Maese, Kris Mahadeo, Ronica Nanda, Valentina Nardi, Vilmarie Rodriguez, Jenna Rossoff, Laura Schuettpelz, Lewis Silverman, Jessica Sun, Weili Sun, David Teachey, Victor Wong, Gregory Yanik, Alyse Johnson-Chilla, and Ndiya Ogba
such as febrile neutropenia and elevation of liver enzymes was also similar between treatment groups. These initial safety data suggest that nelarabine may be better tolerated in frontline regimens than in the R/R setting. 209 Results from the efficacy
=.001). The high weight group did have an increased rate of febrile neutropenia compared with the medium and low weight groups, but these differences were not significant. Incidences of chemotherapy delay and dose reduction were comparable across the 3
Al B. Benson III, Alan P. Venook, Mahmoud M. Al-Hawary, Mustafa A. Arain, Yi-Jen Chen, Kristen K. Ciombor, Stacey Cohen, Harry S. Cooper, Dustin Deming, Linda Farkas, Ignacio Garrido-Laguna, Jean L. Grem, Andrew Gunn, J. Randolph Hecht, Sarah Hoffe, Joleen Hubbard, Steven Hunt, Kimberly L. Johung, Natalie Kirilcuk, Smitha Krishnamurthi, Wells A. Messersmith, Jeffrey Meyerhardt, Eric D. Miller, Mary F. Mulcahy, Steven Nurkin, Michael J. Overman, Aparna Parikh, Hitendra Patel, Katrina Pedersen, Leonard Saltz, Charles Schneider, David Shibata, John M. Skibber, Constantinos T. Sofocleous, Elena M. Stoffel, Eden Stotsky-Himelfarb, Christopher G. Willett, Kristina M. Gregory, and Lisa A. Gurski
(38%), leukopenia (21%), and febrile neutropenia (4%); one drug-related death occurred. 332 A postmarketing surveillance study did not reveal any unexpected safety signals 334 and a subgroup analysis of the RECOURSE trial reported similar efficacy