TY - JOUR
T1 - Older-Patient-Specific Cancer Trials
T2 - A Pooled Analysis of 2,277 Patients (A151715)
AU - Dao, Dyda
AU - Zemla, Tyler
AU - Jatoi, Aminah
AU - Freedman, Rachel A.
AU - Hurria, Arti
AU - Muss, Hyman
AU - Cohen, Harvey Jay
AU - Shulman, Lawrence N.
AU - Citron, Marc
AU - Budman, Daniel
AU - McMurray, Ryan
AU - Partridge, Ann
AU - Carey, Lisa
AU - Sedrak, Mina S.
AU - Lafky, Jacqueline M.
AU - Le-Rademacher, Jennifer G.
N1 - Funding Information:
This work was supported by the National Cancer Institute of the National Institutes of Health [UG1CA189823 (Alliance for Clinical Trials in Oncology NCORP Grant), P30CA033572, U10CA180790, U10CA180838, U10CA180857, U10CA180867, and UG1CA189850]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Funding Information:
Mina Sedrak: Novartis, The Hope Foundation, National Institutes of Health (RF). The other authors indicated no financial relationships.
Publisher Copyright:
© AlphaMed Press 2019
PY - 2019/6
Y1 - 2019/6
N2 - Background: Less than 3% of older patients with cancer are enrolled in clinical trials. To reverse this underrepresentation, we compared older patients enrolled with older-patient-specific trials, defined as those designed for older patients with cancer, with those enrolled in age-unspecified trials. Materials and Methods: We focused on individual patient data from those ≥65 years (younger patients excluded) and included all Alliance phase III adjuvant breast cancer trials from 1985–2012. Results: Among 2,277 patients, 1,014 had been enrolled to older-patient-specific and 1,263 to age-unspecified trials. The median age (range) in the older-patient-specific trials was 72 (65–89) years compared with 68 (65–84) years in the cohort of older patients in age-unspecified trials; p <.0001. A greater percentage of patients 75 years or older had enrolled in older-patient-specific trials compared with the cohort of age-unspecified trials: 26% versus 6% (p <.0001). Median overall survival (OS) was 12.8 years (95% confidence interval [CI], 11.9–13.7) and 13.5 years (95% CI, 12.9–14.1) for older-patient-specific and age-unspecified trials, respectively. OS was comparable (hazard ratio [HR], 1.08; 95% CI, 0.92–1.28; p =.34; referent: age-unspecified trials), after adjusting for age, estrogen receptor status, tumor size, and lymph node status. Similar findings were reached for recurrence-free survival. A lower rate of grade 3–5 adverse events (hematologic and nonhematologic) was reported in older-patient-specific trials (43% vs. 58%; p <.0001). Sensitivity analysis with chemotherapy only trials and subset analysis, adjusted for performance score, yielded similar OS results. Conclusion: Older-patient-specific trials appear to address this underrepresentation of older patients with ostensibly comparable outcomes. Clinical trial identification numbers. NCT00003088 (CALGB 9741); NCT00024102 (CALGB 49907); NCT00068601 (CALGB 40401); NCT00005970 (NCCTG N9831). Implications for Practice: This work underscores the importance of clinical trials that focus on the recruitment of older patients with cancer.
AB - Background: Less than 3% of older patients with cancer are enrolled in clinical trials. To reverse this underrepresentation, we compared older patients enrolled with older-patient-specific trials, defined as those designed for older patients with cancer, with those enrolled in age-unspecified trials. Materials and Methods: We focused on individual patient data from those ≥65 years (younger patients excluded) and included all Alliance phase III adjuvant breast cancer trials from 1985–2012. Results: Among 2,277 patients, 1,014 had been enrolled to older-patient-specific and 1,263 to age-unspecified trials. The median age (range) in the older-patient-specific trials was 72 (65–89) years compared with 68 (65–84) years in the cohort of older patients in age-unspecified trials; p <.0001. A greater percentage of patients 75 years or older had enrolled in older-patient-specific trials compared with the cohort of age-unspecified trials: 26% versus 6% (p <.0001). Median overall survival (OS) was 12.8 years (95% confidence interval [CI], 11.9–13.7) and 13.5 years (95% CI, 12.9–14.1) for older-patient-specific and age-unspecified trials, respectively. OS was comparable (hazard ratio [HR], 1.08; 95% CI, 0.92–1.28; p =.34; referent: age-unspecified trials), after adjusting for age, estrogen receptor status, tumor size, and lymph node status. Similar findings were reached for recurrence-free survival. A lower rate of grade 3–5 adverse events (hematologic and nonhematologic) was reported in older-patient-specific trials (43% vs. 58%; p <.0001). Sensitivity analysis with chemotherapy only trials and subset analysis, adjusted for performance score, yielded similar OS results. Conclusion: Older-patient-specific trials appear to address this underrepresentation of older patients with ostensibly comparable outcomes. Clinical trial identification numbers. NCT00003088 (CALGB 9741); NCT00024102 (CALGB 49907); NCT00068601 (CALGB 40401); NCT00005970 (NCCTG N9831). Implications for Practice: This work underscores the importance of clinical trials that focus on the recruitment of older patients with cancer.
KW - Accrual
KW - Adjuvant
KW - Breast cancer
KW - Clinical trials
KW - Older patients
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U2 - 10.1634/theoncologist.2018-0803
DO - 10.1634/theoncologist.2018-0803
M3 - Article
C2 - 30975921
AN - SCOPUS:85064547737
SN - 1083-7159
VL - 24
SP - e284-e291
JO - Oncologist
JF - Oncologist
IS - 6
ER -