{"doi":"10.17615/7sc4-5m23","title":"Older-Patient-Specific Cancer Trials: A Pooled Analysis of 2,277 Patients (A151715)","abstract":"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.","journal":"UNC Libraries","year":2021,"id":229949,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":0.0,"corpus_rank":10062,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":true,"is_dataset_confidence":0.846,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":835583,"name":"M.S. Sedrak","orcid":null,"position":1,"is_corresponding":false},{"id":835584,"name":"T. Zemla","orcid":null,"position":2,"is_corresponding":false},{"id":835585,"name":"M. Citron","orcid":null,"position":3,"is_corresponding":false},{"id":133746,"name":"A. Jatoi","orcid":null,"position":4,"is_corresponding":false},{"id":835586,"name":"H. Muss","orcid":null,"position":5,"is_corresponding":false},{"id":835587,"name":"J.M. Lafky","orcid":null,"position":6,"is_corresponding":false},{"id":835588,"name":"L. Carey","orcid":null,"position":7,"is_corresponding":false},{"id":835589,"name":"L.N. Shulman","orcid":null,"position":8,"is_corresponding":false},{"id":835590,"name":"R. McMurray","orcid":null,"position":9,"is_corresponding":false},{"id":835591,"name":"R.A. Freedman","orcid":null,"position":10,"is_corresponding":false},{"id":835592,"name":"DR Budman","orcid":null,"position":11,"is_corresponding":false},{"id":835593,"name":"J.G. Le-Rademacher","orcid":null,"position":12,"is_corresponding":false},{"id":835594,"name":"A. Partridge","orcid":null,"position":13,"is_corresponding":false},{"id":835595,"name":"H.J. Cohen","orcid":null,"position":14,"is_corresponding":false},{"id":835596,"name":"Dao, D.","orcid":null,"position":15,"is_corresponding":false},{"id":835582,"name":"A. Hurria","orcid":null,"position":0,"is_corresponding":true}],"reference_count":0,"raw_metadata":null,"created_at":"2026-07-18T23:55:01.675482Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}