Skip to main content
. Author manuscript; available in PMC: 2020 Jun 3.
Published in final edited form as: JAMA Oncol. 2019 Dec 1;5(12):1769–1773. doi: 10.1001/jamaoncol.2019.2055

Table.

Trial Factors Associated With Age Disparities

Trial Factor No. of Trials Mean DMA (SE), years P Value
All included trials 302 ‒6.49(0.34) <.001a
Industry funding of trial
 Yes 249 ‒6.84(0.38) .002
 No 53 ‒4.72 (0.79)
Cooperative group trial
 Yes 74 ‒6.24(0.73) .34
 No 228 ‒6.57(0.39)
Age restriction enrollment criterionb
 Yes 26 ‒10.20(1.46) .001
 No 276 ‒5.71(0.34)
ECOG PS restriction criterion
 Yes (restricted to PS 0–1) 117 ‒7.40(0.42) .01
 No (not restricted to PS 0–1) 103 ‒5.35(0.66)
Molecular profile restriction criterionc
 Yes 45 ‒9.99(0.60) <.001
 No 257 ‒5.88 (0.38)
  Disease site
  Breast 107 ‒7.76(0.52) .001
  Colorectal 36 ‒6.96(0.57)
  Lung 105 ‒8.98(0.35)
  Prostate 54 2.66(0.48)
 Modality
  Systemic therapy 247 ‒6.89(0.38) .04
  Radiotherapy 7 ‒3.64(1.88)
  Surgery 2 ‒12.10(11.10)
  Supportive care 45 ‒4.76(0.83)
 Systemic therapy subgroup
  Cytotoxic chemotherapy 85 ‒5.30(0.78) .01
  Targeted therapy 162 ‒7.72(0.39)
Trial success (PEP met)
 Yes 130 ‒6.40(0.58) .73
 No 120 ‒6.67 (0.49)

Abbreviations: DMA, difference in median age (trial minus population); ECOG, Eastern Cooperative Oncology Group; PEP, primary end point; PS, performance status.

a

For all included trials (N = 302), the P value provided represents the results of a 1-sample t test comparing the mean DMA for all trials against a hypothetical population average DMA of 0. All other P values provided reflect Mann-Whitney U tests or Kruskal-Wallis tests for each trial factor listed.

b

Trials that included a restriction on the upper limit of enrollees were classified as having an “age restriction” enrollment criterion.

c

“Molecular Profile Restriction” trials were those that included an enrollment criterion that selected for younger patients based on the molecular profile of patients’ tumors; this included trials specifically for patients with triple-negative breast cancer, HER2-overexpressing breast cancer, ALK-rearranged non–small-cell lung cancer, or EGFR-mutant non–small-cell lung cancer, all molecular subtypes of each disease site associated with a younger patient population. Modality addressed the primary intervention as part of the randomization in the trial. Systemic therapy modality trials included those testing chemotherapy, targeted systemic agents, immunotherapy, and others; these trials all used systemic therapies to improve disease-related outcomes such as overall and disease-free survival. Supportive care trials included those where the intervention aimed to decrease or prevent disease-related or treatment-related toxicity as the primary end point (rather than survival/disease-control outcomes as discussed previously). Systemic therapy trials were further subdivided into cytotoxic chemotherapy and targeted therapy; the latter includes monoclonal antibodies, small molecule inhibitors, and similar agents. Fifty-two trials were excluded from analysis of trial success (whether the PEP was met) because the primary end point had not been published for these trials at time of analysis.