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

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.

Long‐term trajectories of self‐reported cognitive function in a cohort of older survivors of breast cancer: CALGB 369901 (Alliance)

“…Prior reports included earlier subsets of enrollees and/or shorter‐term follow‐up 24, 25, 26, 27. To the best of our knowledge, the current study is the first report using the final cohort and their complete follow‐up data.…”

“…Prior reports included earlier subsets of enrollees and/or shorter-term follow-up. [24][25][26][27] To the best of our knowledge, the current study is the first report using the final cohort and their complete follow-up data. Eligible participants were aged 65 years; diagnosed with invasive, nonmetastatic breast cancer; spoke English or Spanish; passed an entry cognitive screen using the Blessed Orientation-Memory-Concentration test 28 ; and were within 20 weeks of surgery.…”

Frailty and long-term mortality of older breast cancer patients: CALGB 369901 (Alliance)

“…Prior reports included earlier subsets of patients and/or shorter-term follow-up. 21,25-27 Eligible patients were 65 years or older, were diagnosed with primary invasive non-metastatic breast cancer, spoke English or Spanish, passed an entry cognitive screen using the Blessed Orientation, Memory and Concentration test, 28 and were within 20 weeks of definitive surgery.…”

Bridging the Age Gap in breast cancer: Impact of chemotherapy on quality of life in older women with early breast cancer

“…The CALGB 49907 study documented better QoL for patients aged ≥65 receiving capecitabine versus standard regimens, but no QoL differences persisted at 1 year [ 9 ]. Patients receiving chemotherapy within clinical trials had better QoL improvements compared with those treated off study [ 10 ]. Nonetheless, prospective data on QoL for older patients with early breast cancer (EBC) receiving standard chemotherapy are lacking.…”