Heidi D Klepin1, Ellen Ritchie2, Brittny Major-Elechi3, Jennifer Le-Rademacher3, Drew Seisler3, Libby Storrick3, Ben L Sanford4, Guido Marcucci5, Weiqiang Zhao6, Susan A Geyer7, Karla V Ballman2, Bayard L Powell8, Maria R Baer9, Wendy Stock10, Harvey Jay Cohen11, Richard M Stone12, Richard A Larson10, Geoffrey L Uy13. 1. Wake Forest University Health Sciences, Winston-Salem, NC, United States of America. Electronic address: hklepin@wakehealth.edu. 2. Weill Medical College of Cornell University, New York, NY, United States of America. 3. Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, United States of America. 4. Alliance Statistics and Data Center, Duke University, Durham, NC, United States of America. 5. City of Hope Comprehensive Cancer Center, Duarte, CA, United States of America. 6. The Ohio State University Cancer Center, Columbus, OH, United States of America. 7. Alliance Statistics and Data Center, The Ohio State University Medical Center, Columbus, OH, United States of America. 8. Wake Forest University Health Sciences, Winston-Salem, NC, United States of America. 9. Greenebaum Cancer Center, University of Maryland, Baltimore, MD, United States of America. 10. University of Chicago Comprehensive Cancer Center, Chicago, IL, United States of America. 11. Duke Cancer Institute, Duke University, Durham, NC, United States of America. 12. Dana-Farber/Partners CancerCare, Boston, MA, United States of America. 13. Washington University School of Medicine, St. Louis, MO, United States of America.
Abstract
OBJECTIVE: To demonstrate feasibility of performing geriatric assessment (GA) in the National Clinical Trials Network (NCTN) and to explore the utility of GA to characterize treatment tolerance. MATERIALS AND METHODS: We conducted a multisite companion study (CALGB 361006) to CALGB 11001, a phase 2 trial of adults ≥60 years old with newly diagnosed FLT3- mutated AML, testing the efficacy of adding sorafenib to intensive chemotherapy. On 361006, a GA was administered prior to induction and prior to post-remission therapy. The GA is divided into items requiring administration by a health care professional (HCP) and patient self-administered questionnaires. Feasibility outcomes were recruitment rate, time to GA completion, difficulty with GA administration, percent of patients requiring assistance, and satisfaction. Change in GA measures pre- and post-induction were compared using Wilcoxon signed rank test and McNemar's tests. RESULTS: The recruitment rate was 80% (N = 43, median age 68 years). Median completion time of the GA was 30 min; (10 and 21 min for HCP and patients, respectively). HCP reported no difficulty completing assessments (100%). Most patients completed questionnaires without assistance (77%), and were satisfied with the length (89%). Self-reported physical function, mental health, social activity and nutritional parameters worsened after induction. CONCLUSION: GA is feasible to administer in the setting of intensive induction for older adults with AML in the NCTN and provides evidence of the impact of induction therapy on physical and emotional health.
OBJECTIVE: To demonstrate feasibility of performing geriatric assessment (GA) in the National Clinical Trials Network (NCTN) and to explore the utility of GA to characterize treatment tolerance. MATERIALS AND METHODS: We conducted a multisite companion study (CALGB 361006) to CALGB 11001, a phase 2 trial of adults ≥60 years old with newly diagnosed FLT3- mutated AML, testing the efficacy of adding sorafenib to intensive chemotherapy. On 361006, a GA was administered prior to induction and prior to post-remission therapy. The GA is divided into items requiring administration by a health care professional (HCP) and patient self-administered questionnaires. Feasibility outcomes were recruitment rate, time to GA completion, difficulty with GA administration, percent of patients requiring assistance, and satisfaction. Change in GA measures pre- and post-induction were compared using Wilcoxon signed rank test and McNemar's tests. RESULTS: The recruitment rate was 80% (N = 43, median age 68 years). Median completion time of the GA was 30 min; (10 and 21 min for HCP and patients, respectively). HCP reported no difficulty completing assessments (100%). Most patients completed questionnaires without assistance (77%), and were satisfied with the length (89%). Self-reported physical function, mental health, social activity and nutritional parameters worsened after induction. CONCLUSION: GA is feasible to administer in the setting of intensive induction for older adults with AML in the NCTN and provides evidence of the impact of induction therapy on physical and emotional health.
Authors: Arti Hurria; Supriya Gupta; Marjorie Zauderer; Enid L Zuckerman; Harvey J Cohen; Hyman Muss; Miriam Rodin; Katherine S Panageas; Jimmie C Holland; Leonard Saltz; Mark G Kris; Ariela Noy; Jorge Gomez; Ann Jakubowski; Clifford Hudis; Alice B Kornblith Journal: Cancer Date: 2005-11-01 Impact factor: 6.860
Authors: Gail J Roboz; Sumithra J Mandrekar; Pinkal Desai; Kristina Laumann; Alison R Walker; Eunice S Wang; Jonathan E Kolitz; Bayard L Powell; Eyal C Attar; Wendy Stock; Clara D Bloomfield; Jessica Kohlschmidt; Krzysztof Mrózek; Duane C Hassane; Levi Garraway; Judit Jané-Valbuena; Michele Baltay; Adam Tracy; Guido Marcucci; Richard M Stone; Richard A Larson Journal: Blood Adv Date: 2018-12-26
Authors: Kathleen Elliot; Janet A Tooze; Rachel Geller; Bayard L Powell; Timothy S Pardee; Ellen Ritchie; LeAnne Kennedy; Kathryn E Callahan; Heidi D Klepin Journal: Leuk Res Date: 2014-07-07 Impact factor: 3.156
Authors: Heidi D Klepin; Ann M Geiger; Janet A Tooze; Stephen B Kritchevsky; Jeff D Williamson; Leslie R Ellis; Denise Levitan; Timothy S Pardee; Scott Isom; Bayard L Powell Journal: J Am Geriatr Soc Date: 2011-09-13 Impact factor: 5.562
Authors: Bob Löwenberg; Gert J Ossenkoppele; Wim van Putten; Harry C Schouten; Carlos Graux; Augustin Ferrant; Pieter Sonneveld; Johan Maertens; Mojca Jongen-Lavrencic; Marie von Lilienfeld-Toal; Bart J Biemond; Edo Vellenga; Marinus van Marwijk Kooy; Leo F Verdonck; Joachim Beck; Hartmut Döhner; Alois Gratwohl; Thomas Pabst; Gregor Verhoef Journal: N Engl J Med Date: 2009-09-24 Impact factor: 91.245
Authors: Shabbir M H Alibhai; Marc Leach; Vikas Gupta; George A Tomlinson; Joseph M Brandwein; Fernando Suarez Saiz; Mark D Minden Journal: Crit Rev Oncol Hematol Date: 2008-09-07 Impact factor: 6.312
Authors: Shabbir M H Alibhai; Sara O'Neill; Karla Fisher-Schlombs; Henriette Breunis; Narhari Timilshina; Joseph M Brandwein; Mark D Minden; George A Tomlinson; S Nicole Culos-Reed Journal: Support Care Cancer Date: 2013-11-16 Impact factor: 3.603
Authors: Isabela M Bumanlag; Joseph Abi Jaoude; Michael K Rooney; Cullen M Taniguchi; Ethan B Ludmir Journal: Semin Radiat Oncol Date: 2022-04 Impact factor: 5.934
Authors: Mohammed Saad; Kah Poh Loh; Janet A Tooze; Timothy S Pardee; Leslie R Ellis; Bayard L Powell; Rupali Roy Bhave; Ann M Geiger; Jeff D Williamson; Stephen Kritchevsky; Heidi D Klepin Journal: Blood Date: 2020-12-03 Impact factor: 25.476
Authors: Justin D Woods; Joshua F Zeidner; Hendrik W Van Deventer; Katarzyna Jamieson; Melissa Matson; Jack Zhang; William Pulley; Tucker Brenizer; Hyman Muss; Kirsten A Nyrop; Sanah N Vohra; Allison M Deal; Anastasia Ivanova; Matthew C Foster Journal: J Geriatr Oncol Date: 2021-12-23 Impact factor: 3.929
Authors: Ellen R M Scheepers; Ariel M Vondeling; Noortje Thielen; René van der Griend; Reinhard Stauder; Marije E Hamaker Journal: Haematologica Date: 2020-05-07 Impact factor: 9.941
Authors: Marie A Flannery; Eva Culakova; Beverly E Canin; Luke Peppone; Erika Ramsdale; Supriya G Mohile Journal: J Clin Oncol Date: 2021-05-27 Impact factor: 44.544