Comparative Age-Based Prospective Multi-Institutional Observations of 12,367 Patients Enrolled to the American College of Surgeons Oncology Group (ACOSOG) Z901101 Trials (Alliance)
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The risk of surgery, particularly for older cancer patients with serious, extensive comorbidities, can make this otherwise curative modality precarious. Leveraging data from the American College of Surgeons Oncology Group, this study sought to characterize age-based comparative demographics, adverse event rates, and study completion rates to define how best to conduct research in older cancer patients.
This study relied on clinical data from 21 completed studies to assess whether older patients experienced more grade 3 or worse adverse events and were more likely to discontinue study participation prematurely than their younger counterparts.
The study enrolled 12,367 patients. The median age was 60 years, and 36% of the patients were 65 years of age or older. Among 4008 patients with adverse event data, 1067 (27%) had experienced a grade 3 or worse event. The patients 65 years or older had higher rates of grade 3 or worse adverse events compared to younger patients [32% vs. 24%; odds ratio (OR), 1.5; 95% confidence interval (CI), 1.3–1.7; p < 0.0001]. This association was not observed in multivariate analyses. The study protocol was completed by 97% of the patients. No association was observed between age and trial completion (OR 0.8; 95% CI 0.7–1.1; p = 0.14). Only the older gastrointestinal cancer trial patients were less likely to complete their studies compared to younger patients (OR 0.50; 95% CI 0.30–0.70; p < 0.0001).
Despite higher rates of adverse events, the older patients typically completed the study protocol, thereby contributing relevant data on how best to render care to older cancer patients and affirming the important role of enrolling these patients to surgical trials.
The research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under award numbers U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology), U10CA180833, U10CA180836, U10CA180858, UG1CA189823, and P30CA033572. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
- 7.Detillon DDEMA, Veen EJ. Postoperative outcome after pulmonary surgery for non-small cell lung cancer in elderly patients. Ann Thorac Surg. 2018;105:287–93.Google Scholar
- 12.Darling GE, Allen MS, Decker PA, et al. Randomized trial of mediastinal lymph node sampling versus complete lymphadenectomy during pulmonary resection in the patient with N0 or N1 (less than hilar) non-small cell carcinoma: results of the American College of Surgery Oncology Group Z0030 Trial.Google Scholar
- 18.Ellis MJ, Suman VJ, Hoog J, et al. Randomized phase 2 neoadjuvant comparison between letrozole, anastrazole, and exemestane for postmenopausal women with estrogen receptive-rich stage 2 to 3 breast cancer: clinical and biomarker outcomes and predictive value of the baseline PAM50-based intrinsic subtype: ACOSOG Z1031. J Clin Oncol. 2011;29:2342–9.CrossRefGoogle Scholar
- 19.Buzdar AU, Suman VJ, Meric-Berstam F, et al. Fluorouracil, epirubicin, and cyclophosphamide (FEC-75) followed by paclitaxel plus trastuzumab versus paclitaxel plus trastuzumab followed by FEC-75 plus trastuzumab as neoadjuvant treatment for patients with HER2-positive breast cancer (Z1041): a randomized, controlled, phase 3 trial. Lancet Oncol. 2013;14:1317–25.CrossRefGoogle Scholar
- 20.Boughey JC, Suman VJ, Mittendorf EA, et al. Sentinal lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer. The ACOSOG (Alliance) Clinical Trial. JAMA. 2013;310:1455–61.Google Scholar
- 21.Grogan EL, Deppen SA, Ballman KV, et al. Accuracy of fluorodeoxyglucose-positron emission tomography within the clinical practice of the American College of Surgeons Oncology Group Z4031 trial to diagnose clinical stage 1 non-small cell lung cancer. Ann Thorac Surg. 2014;97:1142–8.CrossRefGoogle Scholar
- 24.Garcia-Aguilar J, Renfro LA, Chow OS, et al. Organ preservation for clinical T2N0 distal rectal cancer using neoadjuvant chemoradiotherapy and local excision (ACOSOG Z6041): results of an open-label, single-arm, multi-institutional, phase 2 trial. Lancet Oncol. 2015;16:1537–46.CrossRefGoogle Scholar