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Comparative Age-Based Prospective Multi-Institutional Observations of 12,367 Patients Enrolled to the American College of Surgeons Oncology Group (ACOSOG) Z901101 Trials (Alliance)

  • Waddah B. Al-Refaie
  • Paul A. Decker
  • Karla V. Ballman
  • Peter W. T. Pisters
  • Mitchell C. Posner
  • Kelly K. Hunt
  • Bryan Meyers
  • Armin D. Weinberg
  • Heidi Nelson
  • Lisa Newman
  • Angelina Tan
  • Jennifer G. Le-Rademacher
  • Arti Hurria
  • Aminah JatoiEmail author
Health Services Research and Global Oncology
  • 7 Downloads

Abstract

Background

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.

Methods

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.

Results

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).

Conclusion

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.

Notes

Acknowledgment

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.

Supplementary material

10434_2019_7851_MOESM1_ESM.docx (54 kb)
Supplementary material 1 (DOCX 54 kb)

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Copyright information

© Society of Surgical Oncology 2019

Authors and Affiliations

  • Waddah B. Al-Refaie
    • 1
  • Paul A. Decker
    • 2
  • Karla V. Ballman
    • 3
  • Peter W. T. Pisters
    • 4
  • Mitchell C. Posner
    • 5
  • Kelly K. Hunt
    • 4
  • Bryan Meyers
    • 6
  • Armin D. Weinberg
    • 7
  • Heidi Nelson
    • 2
  • Lisa Newman
    • 4
  • Angelina Tan
    • 2
  • Jennifer G. Le-Rademacher
    • 2
  • Arti Hurria
    • 8
  • Aminah Jatoi
    • 2
    Email author
  1. 1.MedStar Georgetown University HospitalWashington, D.C.USA
  2. 2.Alliance Statistics and Data CenterMayo ClinicRochesterUSA
  3. 3.Weill Medical College of Cornell UniversityNew YorkUSA
  4. 4.M.D. Anderson Cancer CenterUniversity of TexasHoustonUSA
  5. 5.University of Chicago Comprehensive Cancer CenterChicagoUSA
  6. 6.Washington University School of MedicineSt. LouisUSA
  7. 7.Baylor College of MedicineHoustonUSA
  8. 8.City of Hope Comprehensive Cancer CenterDuarteUSA

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