Jeanne S Mandelblatt1, Solomon B Makgoeng2, Gheorghe Luta3, Arti Hurria4, Gretchen Kimmick5, Claudine Isaacs6, Michelle Tallarico2, William T Barry7, Brandy Pitcher7, Eric P Winer8, Clifford Hudis9, Harvey J Cohen10, Hyman B Muss11. 1. Department of Oncology, Georgetown University Medical Center and Lombardi Cancer Center, Cancer Prevention and Control Program, Washington, DC, USA. Electronic address: mandelbj@georgetown.edu. 2. Department of Oncology, Georgetown University Medical Center and Lombardi Cancer Center, Cancer Prevention and Control Program, Washington, DC, USA. 3. Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center and Lombardi Cancer Center, Washington, DC, USA. 4. Department of Medical Oncology & Therapeutics Research, City of Hope, LA, CA, USA. 5. Department of Medicine, Division of Medical Oncology, Duke University Medical Center, Durham, NC, USA. 6. Department of Medicine, Georgetown University School of Medicine and Lombardi Cancer Center, Breast Cancer Program, Washington, DC, USA. 7. Department of Biostatistics and Bioinformatics, Duke University Medical Center, and Cancer and Leukemia Group B Statistical Center, Durham, NC, USA. 8. Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. 9. Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA. 10. Department of Medicine and Center for the Study of Aging and Human Development, Duke University, Durham, NC, USA. 11. Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Abstract
OBJECTIVES:Patients ≥ 65 years old ("older") are often not included in randomized clinical trials (RCT), but when they are, care in an RCT might improve quality of life (QoL). We conducted a prospective comparison of QoL among older women receiving standard chemotherapy from the same cooperative group physicians in an RCT vs. an observational study ("off-trial"). METHODS:Older women with invasive, non-metastatic breast cancer (n=150 RCT; 530 off-trial) were included. Linear mixed-effects models tested associations between chemotherapy on- vs. off-trial and changes in EORTC (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) QoL scores over 24 months, controlling for pre-treatment QoL, age, education, tumor factors, comorbidity, and other covariates. RESULTS:Anthracycline regimens were used by 58% of women treated on-trial vs. 54% of those treated off-trial. Women in the RCT reported an adjusted mean increase of 13.7 points (95% CI 10.2, 17.1) in global QoL at 24 months (vs. mid-treatment), while women treated off-trial had only an adjusted improvement of 7.0 points (95% CI 3.5, 10.4; p=.007 for difference in mean changes). Women in the RCT had significantly greater improvement in emotional function than those treated off-trial, controlling for baseline; they also had greater reductions in therapy side effects and fatigue at 24 months than women off-trial, controlling for covariates. CONCLUSION: There may be different QoL trajectories for older women undergoing breast cancer chemotherapy on- vs. off-trial. If confirmed, the results suggest that the extra monitoring and communication within an RCT could provide the infrastructure for interventions to address symptoms and improve QoL for the growing older cancer population.
RCT Entities:
OBJECTIVES:Patients ≥ 65 years old ("older") are often not included in randomized clinical trials (RCT), but when they are, care in an RCT might improve quality of life (QoL). We conducted a prospective comparison of QoL among older women receiving standard chemotherapy from the same cooperative group physicians in an RCT vs. an observational study ("off-trial"). METHODS: Older women with invasive, non-metastatic breast cancer (n=150 RCT; 530 off-trial) were included. Linear mixed-effects models tested associations between chemotherapy on- vs. off-trial and changes in EORTC (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) QoL scores over 24 months, controlling for pre-treatment QoL, age, education, tumor factors, comorbidity, and other covariates. RESULTS:Anthracycline regimens were used by 58% of women treated on-trial vs. 54% of those treated off-trial. Women in the RCT reported an adjusted mean increase of 13.7 points (95% CI 10.2, 17.1) in global QoL at 24 months (vs. mid-treatment), while women treated off-trial had only an adjusted improvement of 7.0 points (95% CI 3.5, 10.4; p=.007 for difference in mean changes). Women in the RCT had significantly greater improvement in emotional function than those treated off-trial, controlling for baseline; they also had greater reductions in therapy side effects and fatigue at 24 months than women off-trial, controlling for covariates. CONCLUSION: There may be different QoL trajectories for older women undergoing breast cancer chemotherapy on- vs. off-trial. If confirmed, the results suggest that the extra monitoring and communication within an RCT could provide the infrastructure for interventions to address symptoms and improve QoL for the growing older cancer population.
Authors: Jeanne S Mandelblatt; Stephen B Edge; Neal J Meropol; Ruby Senie; Theodore Tsangaris; Luther Grey; Burt Peterson; Yi-Ting Hwang; Jane C Weeks Journal: Cancer Date: 2002-12-15 Impact factor: 6.860
Authors: M A Sprangers; M Groenvold; J I Arraras; J Franklin; A te Velde; M Muller; L Franzini; A Williams; H C de Haes; P Hopwood; A Cull; N K Aaronson Journal: J Clin Oncol Date: 1996-10 Impact factor: 44.544
Authors: Alice B Kornblith; Lan Lan; Laura Archer; Ann Partridge; Gretchen Kimmick; Clifford Hudis; Eric Winer; Rebecca Casey; Samantha Bennett; Harvey Jay Cohen; Hyman B Muss Journal: J Clin Oncol Date: 2011-02-07 Impact factor: 44.544
Authors: S M Miller; S V Hudson; B L Egleston; S Manne; J S Buzaglo; K Devarajan; L Fleisher; J Millard; N Solarino; J Trinastic; N J Meropol Journal: Psychooncology Date: 2012-02-14 Impact factor: 3.894
Authors: Araba Adjei; Jan C Buckner; Elizabeth Cathcart-Rake; Hongbin Chen; Harvey J Cohen; Dyda Dao; Jo-Ellen De Luca; Josephine Feliciano; Rachel A Freedman; Richard M Goldberg; Judith Hopkins; Joleen Hubbard; Aminah Jatoi; Meghan Karuturi; Margaret Kemeny; Gretchen G Kimmick; Heidi D Klepin; Jessica L Krok-Schoen; Jacqueline M Lafky; Jennifer G Le-Rademacher; Daneng Li; Stuart M Lichtman; Ronald Maggiore; Jeanne Mandelblatt; Vicki A Morrison; Hyman B Muss; Michael O Ojelabi; Mina S Sedrak; Niveditha Subbiah; Virginia Sun; Susan Tuttle; Noam VanderWalde; Tanya Wildes; Melisa L Wong; Jennifer Woyach Journal: J Geriatr Oncol Date: 2019-06-11 Impact factor: 3.599
Authors: Hyman B Muss; Mei-Yin C Polley; Donald A Berry; Heshan Liu; Constance T Cirrincione; Maria Theodoulou; Ann M Mauer; Alice B Kornblith; Ann H Partridge; Lynn G Dressler; Harvey J Cohen; Patricia A Kartcheske; Edith A Perez; Antonio C Wolff; Julie R Gralow; Harold J Burstein; Ahmad A Mahmood; Linda M Sutton; Gustav Magrinat; Barbara A Parker; Ronald D Hart; Debjani Grenier; Arti Hurria; Aminah Jatoi; Larry Norton; Clifford A Hudis; Eric P Winer; Lisa Carey Journal: J Clin Oncol Date: 2019-07-24 Impact factor: 44.544
Authors: Surbhi Sidana; Cristine Allmer; Melissa C Larson; Amylou Dueck; Kathleen Yost; Rahma Warsame; Gita Thanarajasingam; James R Cerhan; Jonas Paludo; S Vincent Rajkumar; Thomas M Habermann; Grzegorz S Nowakowski; Yi Lin; Morie A Gertz; Thomas Witzig; Angela Dispenzieri; Wilson I Gonsalves; Stephen M Ansell; Carrie A Thompson; Shaji K Kumar Journal: JCO Oncol Pract Date: 2022-05-17
Authors: Marloes G M Derks; Nienke A de Glas; Esther Bastiaannet; Anton J M de Craen; Johanneke E A Portielje; Cornelis J H van de Velde; Floor E van Leeuwen; Gerrit-Jan Liefers Journal: Oncologist Date: 2016-07-01
Authors: Jeanne S Mandelblatt; Ling Cai; George Luta; Gretchen Kimmick; Jonathan Clapp; Claudine Isaacs; Brandeyln Pitcher; William Barry; Eric Winer; Stephen Sugarman; Clifford Hudis; Hyman Muss; Harvey J Cohen; Arti Hurria Journal: Breast Cancer Res Treat Date: 2017-03-31 Impact factor: 4.872
Authors: Gretchen G Kimmick; Brittny Major; Jonathan Clapp; Jeff Sloan; Brandelyn Pitcher; Karla Ballman; Myra Barginear; Rachel A Freedman; Andrew Artz; Heidi D Klepin; Jacqueline M Lafky; Judith Hopkins; Eric Winer; Clifford Hudis; Hyman Muss; Harvey Cohen; Aminah Jatoi; Arti Hurria; Jeanne Mandelblatt Journal: Breast Cancer Res Treat Date: 2017-03-10 Impact factor: 4.872
Authors: Jeanne S Mandelblatt; Jonathan D Clapp; Gheorghe Luta; Leigh Anne Faul; Michelle D Tallarico; Trina D McClendon; Jessica A Whitley; Ling Cai; Tim A Ahles; Robert A Stern; Paul B Jacobsen; Brent J Small; Brandelyn N Pitcher; Estrella Dura-Fernandis; Hyman B Muss; Arti Hurria; Harvey J Cohen; Claudine Isaacs Journal: Cancer Date: 2016-07-22 Impact factor: 6.860