Freedman Rachel A, Foster Jared C, Seisler Drew K, Lafky Jacqueline M, Muss Hyman B, Cohen Harvey J, Mandelblatt Jeanne, Winer Eric P, Hudis Clifford A, Partridge Ann H, Carey Lisa A, Cirrincione Constance, Moreno-Aspitia Alvaro, Kimmick Gretchen, Jatoi Aminah, Hurria Arti
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.
J Clin Oncol. 2017 Feb;35(4):421-431. doi: 10.1200/JCO.2016.69.4182. Epub 2016 Dec 19.
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.
目的 尽管对入组挑战的认识不断提高，但老年患者参与乳腺癌治疗试验的情况是否有所改善尚不清楚。方法 我们研究了1985年至2012年期间老年患者参与肿瘤临床试验联盟系统治疗乳腺癌试验的情况，并比较了老年（年龄≥65岁和≥70岁）与年轻（年龄<65岁和<70岁）参与者的疾病特征和治疗停止原因。为了研究入组趋势，我们使用逻辑回归将年龄建模为时间的函数。结果 总体而言，17%的研究参与者年龄≥65岁。辅助、新辅助和转移性试验中分别约有15%、24%和24%的参与者年龄≥65岁，7%、15%和13%的参与者年龄≥70岁。在辅助试验中，年龄≥65岁患者入组的几率随时间显著增加（每年的优势比[OR]为1.04；95%置信区间[CI]为1.04至1.05），但在新辅助和转移性试验中显著降低（OR为0.62；95%CI为0.58至0.67，OR为0.98，95%CI为0.97至1.00）。年龄≥70岁的患者也有类似趋势，但仅在辅助和新辅助试验中具有统计学意义（OR为1.05，95%CI为1.04至1.07；OR为0.57，95%CI为0.52至0.62）。一般来说，辅助研究中年龄≥65岁（与<65岁相比）的患者平均受累淋巴结数量更多，激素受体阴性肿瘤更多，尽管肿瘤大小相似。在所有试验中，年龄≥65岁的患者（50%）比<65岁的患者（35.9%）更早停止方案治疗也更常见。结论 在合作组治疗试验中，老年乳腺癌患者的代表性仍然很低。我们观察到辅助试验的入组情况有所改善，但新辅助/转移性试验的入组情况恶化。增加老年患者入组的新策略对于有意义地改变这一不断增长的患者群体的证据基础至关重要。
