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Older-Patient-Specific Cancer Trials: A Pooled Analysis of 2,277 Patients (A151715)

Dyda Dao1, Tyler Zemla2, Aminah Jatoi1

  • 1Mayo Clinic, Rochester, Minnesota, USA.

The Oncologist
|April 13, 2019
PubMed
Abstract

Insights

Older patients with cancer enrolled in trials specifically designed for them showed similar survival outcomes but fewer adverse events compared to those in general trials. These findings highlight the value of age-specific clinical trials for older cancer patients.

Area of Science:

  • Geriatric Oncology
  • Clinical Trial Design
  • Cancer Research

Background:

  • Older adults (≥65 years) are underrepresented in cancer clinical trials, with less than 3% enrollment.
  • This study addresses the underrepresentation by comparing older patients in age-specific trials versus age-unspecified trials.

Purpose of the Study:

  • To evaluate the impact of older-patient-specific clinical trials on enrollment, outcomes, and adverse events in older cancer patients.
  • To determine if trials designed for older adults yield comparable survival results to general trials.

Main Methods:

  • Analysis of individual patient data from Alliance phase III adjuvant breast cancer trials (1985-2012) for patients aged 65 and older.
  • Comparison of enrollment demographics, overall survival (OS), recurrence-free survival (RFS), and adverse events between older-patient-specific and age-unspecified trials.

Main Results:

  • Older-patient-specific trials enrolled a higher percentage of patients aged 75 and older (26% vs. 6%).
  • Overall survival (OS) and recurrence-free survival (RFS) were comparable between the two trial types (OS HR: 1.08, 95% CI: 0.92-1.28).
  • Older-patient-specific trials reported significantly lower rates of grade 3-5 adverse events (43% vs. 58%).

Conclusions:

  • Older-patient-specific trials effectively increase the enrollment of older adults with cancer.
  • These specialized trials demonstrate comparable survival outcomes to age-unspecified trials.
  • Focusing on age-specific trials is crucial for improving the inclusion and care of older cancer patients in research.
Keywords:
AccrualAdjuvantBreast cancerClinical trialsOlder patients

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