Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527

Rachel A. Freedman, Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, Hyman B. Muss, Harvey J. Cohen, Jeanne Mandelblatt, Eric P. Winer, Clifford A. Hudis, Ann H. Partridge, Lisa A. Carey, Constance Cirrincione, Alvaro Moreno-Aspitia, Gretchen Kimmick, Aminah Jatoi, Arti Hurria

Research output: Contribution to journalArticle

32 Scopus citations

Abstract

Purpose Despite increasing awareness of accrual challenges, it is unknown if accrual of older patients to breast cancer treatment trials is improving. Methods We examined accrual of older patients to Alliance for Clinical Trials in Oncology systemic therapy breast cancer trials during 1985-2012 and compared disease characteristics and reasons for therapy cessation for older (age ≥ 65 years and ≥ 70 years) versus younger (age < 65 years and < 70 years) participants. To examine accrual trends, we modeled age as a function of time, using logistic regression. Results Overall, 17% of study participants were ≥ 65 years of age. Approximately 15%, 24%, and 24% of participants in adjuvant, neoadjuvant, and metastatic trials were age ≥ 65 years, and 7%, 15%, and 13% were age ≥ 70 years, respectively. The odds of a patient age ≥ 65 years enrolling significantly increased over time for adjuvant trials (odds ratio [OR] per year, 1.04; 95% CI, 1.04 to 1.05) but decreased significantly for neoadjuvant and metastatic trials (OR, 0.62; 95% CI, 0.58 to 0.67 and OR, 0.98, 95% CI, 0.97 to 1.00). Similar trends were seen for those age ≥ 70 years but these were statistically significant for adjuvant and neoadjuvant trials only (OR, 1.05, 95% CI, 1.04 to 1.07; and OR, 0.57, 95% CI, 0.52 to 0.62). In general, those age ≥ 65 years ( v those < 65 years) in adjuvant studies had a higher mean number of lymph nodes involved and more hormone receptor-negative tumors, although tumor sizes were similar. Early protocol treatment cessation was also more frequent in those age ≥ 65 years (50%) versus < 65 years (35.9%) across trials. Conclusion Older patients with breast cancer remain largely underrepresented in cooperative group therapeutic trials. We observed some improvement in accrual to adjuvant trials but worsening of accrual for neoadjuvant/metastatic trials. Novel strategies to increase accrual of older patients are critical to meaningfully change the evidence base for this growing patient population.

Original languageEnglish (US)
Pages (from-to)421-431
Number of pages11
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume35
Issue number4
DOIs
StatePublished - Feb 1 2017

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Fingerprint Dive into the research topics of 'Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527'. Together they form a unique fingerprint.

  • Cite this

    Freedman, R. A., Foster, J. C., Seisler, D. K., Lafky, J. M., Muss, H. B., Cohen, H. J., Mandelblatt, J., Winer, E. P., Hudis, C. A., Partridge, A. H., Carey, L. A., Cirrincione, C., Moreno-Aspitia, A., Kimmick, G., Jatoi, A., & Hurria, A. (2017). Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 35(4), 421-431. https://doi.org/10.1200/JCO.2016.69.4182