A planned, prospective comparison of short-term quality of life outcomes among older patients with breast cancer treated with standard chemotherapy in a randomized clinical trial vs. an observational study: CALGB #49907 and #369901.
OBJECTIVE
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.


CONCLUSIONS
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.
Department of Oncology, Georgetown University Medical Center and Lombardi Cancer Center, Cancer Prevention and Control Program, Washington, DC, USA. Electronic address: mandelbj@georgetown.edu.
Jeanne S
JS
Mandelblatt
Department of Oncology, Georgetown University Medical Center and Lombardi Cancer Center, Cancer Prevention and Control Program, Washington, DC, USA.
Solomon B
SB
Makgoeng
Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center and Lombardi Cancer Center, Washington, DC, USA.
Gheorghe
G
Luta
Department of Medical Oncology & Therapeutics Research, City of Hope, LA, CA, USA.
Arti
A
Hurria
Department of Medicine, Division of Medical Oncology, Duke University Medical Center, Durham, NC, USA.
Gretchen
G
Kimmick
Department of Medicine, Georgetown University School of Medicine and Lombardi Cancer Center, Breast Cancer Program, Washington, DC, USA.
Claudine
C
Isaacs
Department of Oncology, Georgetown University Medical Center and Lombardi Cancer Center, Cancer Prevention and Control Program, Washington, DC, USA.
Michelle
M
Tallarico
Department of Biostatistics and Bioinformatics, Duke University Medical Center, and Cancer and Leukemia Group B Statistical Center, Durham, NC, USA.
William T
WT
Barry
Department of Biostatistics and Bioinformatics, Duke University Medical Center, and Cancer and Leukemia Group B Statistical Center, Durham, NC, USA.
Brandy
B
Pitcher
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Eric P
EP
Winer
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
Clifford
C
Hudis
Department of Medicine and Center for the Study of Aging and Human Development, Duke University, Durham, NC, USA.
Harvey J
HJ
Cohen
Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.
Hyman B
HB
Muss
D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D000367:Age Factors; D018943:Anthracyclines / Q000009:adverse effects / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy / Q000523:psychology; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D016032:Randomized Controlled Trials as Topic; D064887:Observational Studies as Topic
D018943:Anthracyclines
Breast cancer; Chemotherapy; Observational studies; Older patients; Quality of life; Randomized clinical trials