{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,25]],"date-time":"2026-02-25T05:18:36Z","timestamp":1771996716534,"version":"3.50.1"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2019,4,12]],"date-time":"2019-04-12T00:00:00Z","timestamp":1555027200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute of the National Institutes of Health","doi-asserted-by":"publisher","award":["UG1CA189823"],"award-info":[{"award-number":["UG1CA189823"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute of the National Institutes of Health","doi-asserted-by":"publisher","award":["P30CA033572"],"award-info":[{"award-number":["P30CA033572"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute of the National Institutes of Health","doi-asserted-by":"publisher","award":["U10CA180790"],"award-info":[{"award-number":["U10CA180790"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute of the National Institutes of Health","doi-asserted-by":"publisher","award":["U10CA180838"],"award-info":[{"award-number":["U10CA180838"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute of the National Institutes of Health","doi-asserted-by":"publisher","award":["U10CA180857"],"award-info":[{"award-number":["U10CA180857"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute of the National Institutes of Health","doi-asserted-by":"publisher","award":["U10CA180867"],"award-info":[{"award-number":["U10CA180867"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute of the National Institutes of Health","doi-asserted-by":"publisher","award":["UG1CA189850"],"award-info":[{"award-number":["UG1CA189850"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,6,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Materials and Methods<\/jats:title>\n                  <jats:p>We focused on individual patient data from those \u226565 years (younger patients excluded) and included all Alliance phase III adjuvant breast cancer trials from 1985\u20132012.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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\u201389) years compared with 68 (65\u201384) years in the cohort of older patients in age-unspecified trials; p &amp;lt; .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 &amp;lt; .0001). Median overall survival (OS) was 12.8 years (95% confidence interval [CI], 11.9\u201313.7) and 13.5 years (95% CI, 12.9\u201314.1) for older-patient-specific and age-unspecified trials, respectively. OS was comparable (hazard ratio [HR], 1.08; 95% CI, 0.92\u20131.28; 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\u20135 adverse events (hematologic and nonhematologic) was reported in older-patient-specific trials (43% vs. 58%; p &amp;lt; .0001). Sensitivity analysis with chemotherapy only trials and subset analysis, adjusted for performance score, yielded similar OS results.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>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)<\/jats:p>\n               <\/jats:sec>","DOI":"10.1634\/theoncologist.2018-0803","type":"journal-article","created":{"date-parts":[[2019,4,11]],"date-time":"2019-04-11T18:26:46Z","timestamp":1555007206000},"page":"e284-e291","source":"Crossref","is-referenced-by-count":6,"title":["Older-Patient-Specific Cancer Trials: A Pooled Analysis of 2,277 Patients (A151715)"],"prefix":"10.1093","volume":"24","author":[{"given":"Dyda","family":"Dao","sequence":"first","affiliation":[{"name":"Mayo Clinic, Rochester, Minnesota, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tyler","family":"Zemla","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aminah","family":"Jatoi","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Rochester, Minnesota, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rachel A.","family":"Freedman","sequence":"additional","affiliation":[{"name":"Dana-Farber\/Partners CancerCare, Boston, Massachusetts, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arti","family":"Hurria","sequence":"additional","affiliation":[{"name":"City of Hope Comprehensive Cancer Center, Duarte, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hyman","family":"Muss","sequence":"additional","affiliation":[{"name":"Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harvey Jay","family":"Cohen","sequence":"additional","affiliation":[{"name":"Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lawrence 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