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