Table 1.
Entry criteria for enrollment in ACOSOG Z4032. Patients must have either one major or two minor criteria.
Major Criteria | SR** (N=114) |
SRB** (N=108) |
---|---|---|
1. FEV1 ≤ 50% predicted | 67 (58.8%) | 49 (45.4%) |
2. DLCO ≤ 50% predicted | 72 (63.2%) | 74 (68.5%) |
Minor Criteria | ||
1. Age ≥75 | 43 (37.7%) | 42 (38.9%) |
2. FEV1 51–60% predicted | 18 (15.8%) | 25 (23.1%) |
3. DLCO 51–60% predicted | 19 (16.7%) | 19 (17.6%) |
4. Pulmonary hypertension (defined as a pulmonary artery systolic pressure greater than 40mmHg) as estimated by echocardiography or right heart catheterization |
4 (3.5%) | 1 (0.9%) |
5. Poor left ventricular function (defined as an ejection fraction of 40% or less) |
9 (7.9%) | 3 (2.8%) |
6. Resting or Exercise Arterial pO2 ≤ 55 mm Hg or SpO2 ≤ 88% |
5 (4.4%) | 6 (5.6%) |
7. pCO2 > 45 mm Hg | 3 (2.6%) | 3 (2.8%) |
8. Modified Medical Research Council (MMRC) Dyspnea Scale ≥ 3. |
31 (27.2%) | 17 (15.7%) |
One patient may have multiple criteria; all randomized non-excluded patients