Table 1.
Major and Minor Eligibility Criteria for Z4032 Trial
| Criterion | SR* (n = 114) |
SRB* (n = 108) |
||
|---|---|---|---|---|
| No. of Patients | % | No. of Patients | % | |
| Major criteria | ||||
| FEV1 ≤ 50% predicted | 67 | 58.8 | 49 | 45.4 |
| DLCO ≤ 50% predicted | 72 | 63.2 | 74 | 68.5 |
| Minor criteria | ||||
| Age ≥ 75 years | 43 | 37.7 | 42 | 38.9 |
| FEV1 51% to 60% predicted | 18 | 15.8 | 25 | 23.1 |
| DLCO 51% to 60% predicted | 19 | 16.7 | 19 | 17.6 |
| Pulmonary hypertension (defined as a pulmonary artery systolic pressure > 40 mmHg) as estimated by echocardiography or right heart catheterization | 4 | 3.5 | 1 | 0.9 |
| Poor left ventricular function (defined as an ejection fraction of ≤ 40%) | 9 | 7.9 | 3 | 2.8 |
| Resting or exercise arterial Po2 ≤ 55 mmHg or Spo2 ≤ 88% | 5 | 4.4 | 6 | 5.6 |
| Pco2 > 45 mmHg | 3 | 2.6 | 3 | 2.8 |
| Modified Medical Research Council Dyspnea Scale ≥ 3 | 31 | 27.2 | 17 | 15.7 |
NOTE. Eligible patients must have met either one major or two minor criteria.
Abbreviations: DLCO, diffusing capacity of the lung for carbon monoxide; FEV1, forced expiratory volume in 1 second; Pco2, partial pressure of carbon dioxide; Po2, partial pressure of oxygen; Spo2, saturation of peripheral oxygen; SR, sublobar resection; SRB, sublobar resection with brachytherapy.
*
Patients may have multiple criteria.