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DOI: 10.1200/JCO.23.00871 Journal of Clinical Oncology - published online before print September 1, 2023
PMID: 37656930
ABSTRACT
Successful completion of chemotherapy is critical to improve breast cancer outcomes. Relative dose intensity (RDI), defined as the ratio of chemotherapy delivered to prescribed, is a measure of chemotherapy completion and is associated with cancer mortality. The effect of exercise and eating a healthy diet on RDI is unknown. We conducted a randomized trial of an exercise and nutrition intervention on RDI and pathologic complete response (pCR) in women diagnosed with breast cancer initiating chemotherapy.
One hundred seventy-three women with stage I-III breast cancer were randomly assigned to usual care (UC; n = 86) or a home-based exercise and nutrition intervention with counseling sessions delivered by oncology-certified registered dietitians (n = 87). Chemotherapy dose adjustments and delays and pCR were abstracted from electronic medical records. T-tests and chi-square tests were used to examine the effect of the intervention versus UC on RDI and pCR.
Participants randomly assigned to intervention had greater improvements in exercise and diet quality compared with UC (P < .05). RDI was 92.9% ± 12.1% and 93.6% ± 11.1% for intervention and UC, respectively (P = .69); the proportion of patients in the intervention versus UC who achieved ≥85% RDI was 81% and 85%, respectively (P = .44). The proportion of patients who had at least one dose reduction and/or delay was 38% intervention and 36% UC (P = .80). Among 72 women who received neoadjuvant chemotherapy, women randomly assigned to intervention were more likely to have a pCR than those randomly assigned to UC (53% v 28%; P = .037).
Presented in part at the 2022 ASCO annual meeting, Chicago, IL, June 3-7, 2022.
All individual participant data collected during the trial, after deidentification, will be shared. In addition, the study Protocol, statistical analysis plan, informed consent form, and analytic code will also be shared. These data will be shared immediately after publication with no end date.
Conception and design: Tara Sanft, Maura Harrigan, Brenda Cartmel, Fang-Yong Li, Dawn L. Hershman, Karen Basen-Engquist, Beth A. Jones, Jennifer A. Ligibel, Melinda L. Irwin
Financial support: Melinda L. Irwin
Administrative support: Michelle Zupa
Provision of study materials or patients: Maura Harrigan, Courtney McGowan, Michelle Zupa, Anees B. Chagpar, Jennifer A. Ligibel, Melinda L. Irwin
Collection and assembly of data: Tara Sanft, Maura Harrigan, Courtney McGowan, Brenda Cartmel, Michelle Zupa, Fang-Yong Li, Thai Hien Nguyen, Dawn L. Hershman, Anees B. Chagpar, Anna Tanasijevic, Jennifer A. Ligibel, Melinda L. Irwin
Data analysis and interpretation: Tara Sanft, Maura Harrigan, Courtney McGowan, Brenda Cartmel, Fang-Yong Li, Leah M. Ferrucci, Leah Puklin, Anlan Cao, Marian L. Neuhouser, Dawn L. Hershman, Beth A. Jones, Tish Knobf, Andrea Silber, Melinda L. Irwin
Manuscript writing: All authors
Final approval of manuscript: All authors
Accountable for all aspects of the work: All authors
The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.
Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).
Tara Sanft
Speakers' Bureau: Hologic/Biotheranostics
Brenda Cartmel
Stock and Other Ownership Interests: Pfizer
Fang-Yong Li
Consulting or Advisory Role: Yiviva
Dawn L. Hershman
Consulting or Advisory Role: AIM Specialty Health
Anees B. Chagpar
Leadership: Protean Biodiagnostics
Consulting or Advisory Role: Sanofi/Aventis, Guardant Health, Novartis/Pfizer
Speakers' Bureau: Merck
Andrea Silber
Honoraria: AstraZeneca/Daiichi Sankyo
Consulting or Advisory Role: AstraZeneca/Daiichi Sankyo
No other potential conflicts of interest were reported.
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