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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)

  • Health Services Research and Global Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

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.

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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.

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Authors and Affiliations

  1. MedStar Georgetown University Hospital, Washington, D.C., USA

    Waddah B. Al-Refaie MD

  2. Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA

    Paul A. Decker MS, Heidi Nelson MD, Angelina Tan MD, Jennifer G. Le-Rademacher PhD & Aminah Jatoi MD

  3. Weill Medical College of Cornell University, New York, NY, USA

    Karla V. Ballman PhD

  4. M.D. Anderson Cancer Center, University of Texas, Houston, TX, USA

    Peter W. T. Pisters MD, Kelly K. Hunt MD & Lisa Newman MD

  5. University of Chicago Comprehensive Cancer Center, Chicago, IL, USA

    Mitchell C. Posner MD

  6. Washington University School of Medicine, St. Louis, MO, USA

    Bryan Meyers MD

  7. Baylor College of Medicine, Houston, TX, USA

    Armin D. Weinberg PhD

  8. City of Hope Comprehensive Cancer Center, Duarte, CA, USA

    Arti Hurria MD

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  1. Waddah B. Al-Refaie MD
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  2. Paul A. Decker MS
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  3. Karla V. Ballman PhD
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  4. Peter W. T. Pisters MD
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  13. Arti Hurria MD
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  14. Aminah Jatoi MD
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Correspondence to Aminah Jatoi MD.

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Al-Refaie, W.B., Decker, P.A., Ballman, K.V. et al. Comparative Age-Based Prospective Multi-Institutional Observations of 12,367 Patients Enrolled to the American College of Surgeons Oncology Group (ACOSOG) Z901101 Trials (Alliance). Ann Surg Oncol 26, 4213–4221 (2019). https://doi.org/10.1245/s10434-019-07851-5

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