Table 1.
Compliance with modernized eligibility criteria pre- and postrelease of American Society of Clinical Oncology, Friends of Cancer Research, and US Food and Drug Administration guidelines in late 2017a
| Eligibility criteria | Pre (n = 86, 43.4%) n/N (%) |
Post (n = 112, 56.6%) n/N (%) |
P |
|---|---|---|---|
| Performance status of 2 allowed | 27/74 (36.5) | 38/105 (36.2) | 1.000 |
| HIV+ allowed | 5/58 (8.6) | 49/112 (43.8) | <.0001 |
| Renal function compliant (use of creatinine clearance (CrCl) only) | 6/62 (9.7) | 7/73 (9.6) | 1.000 |
| Reference ranges used for labs assessing organ function | 57/59 (96.6) | 72/75 (96.0) | 1.000 |
| Classification system used for assessing heart failure | 26/49 (53.1) | 35/61 (57.4) | .702 |
| Cardiac abnormalities specified | 59/86 (68.6) | 67/112 (59.8) | .234 |
| QTc compliant | 70/74 (94.6) | 106/109 (97.2) | .443 |
| Prior malignancy >24 mo ago allowed | 49/86 (57.0) | 81/112 (72.3) | .034 |
| Concurrent malignancy allowed if stable and off treatment | 1/47 (2.1) | 23/74 (31.1) | <.0001 |
| Prior therapy allowed + exclusions must be specified | 56/56 (100) | 71/75 (94.7) | .135 |
| Time-based washout period used | 33/55 (60.0) | 41/77 (53.2) | .480 |
| Mentions recovery from prior adverse events | 25/55 (45.5) | 29/77 (37.7) | .377 |
| Brain metastases allowed if stable >4 wk | 21/41 (51.2) | 25/37 (67.6) | .171 |
a
Denominators vary based on availability of data; missing or unknown values were not included in determining the proportion of trials that were compliant. Allowance of brain metastases, if stable for >4 weeks, was assessed only for trials that included patients with metastatic disease.