title: Accrual of Older Patients With Breast Cancer to Alliance Systemic Therapy Trials Over Time: Protocol A151527.
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.
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Rachel A
authors.initials: RA
authors.lastname: Freedman
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Jared C
authors.initials: JC
authors.lastname: Foster
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Drew K
authors.initials: DK
authors.lastname: Seisler
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Lafky
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Hyman B
authors.initials: HB
authors.lastname: Muss
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Harvey J
authors.initials: HJ
authors.lastname: Cohen
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Jeanne
authors.initials: J
authors.lastname: Mandelblatt
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Eric P
authors.initials: EP
authors.lastname: Winer
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Clifford A
authors.initials: CA
authors.lastname: Hudis
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Ann H
authors.initials: AH
authors.lastname: Partridge
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Carey
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Constance
authors.initials: C
authors.lastname: Cirrincione
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Alvaro
authors.initials: A
authors.lastname: Moreno-Aspitia
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Gretchen
authors.initials: G
authors.lastname: Kimmick
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Aminah
authors.initials: A
authors.lastname: Jatoi
authors.affiliation: Rachel A. Freedman, Eric P. Winer, and Ann H. Partridge, Dana-Farber Cancer Institute, Boston, MA; Jared C. Foster, Drew K. Seisler, Jacqueline M. Lafky, and Aminah Jatoi, Mayo Clinic; Jared C. Foster and Drew K. Seisler, Mayo Cancer Center, Rochester, MN; Hyman B. Muss and Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Harvey J. Cohen, Constance Cirrincione, and Gretchen Kimmick, Duke University, Durham, NC; Jeanne Mandelblatt, Georgetown University, Washington, DC; Clifford A. Hudis, Memorial Sloan-Kettering Cancer Center, New York, NY; Alvaro Moreno-Aspitia, Mayo Clinic, Jacksonville, FL; and Arti Hurria, City of Hope, Duarte, CA.
authors.forename: Arti
authors.initials: A
authors.lastname: Hurria
mesh_terms: D000367:Age Factors; D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy / Q000628:therapy*; D017024:Chemotherapy, Adjuvant / Q000706:statistics & numerical data; D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D004608:Eligibility Determination; D005260:Female; D006801:Humans; D018579:Patient Selection