Table 1. Demographic and Baseline Clinical Characteristics of All Patients Who Underwent Randomization*.
| Characteristic | 177Lu-Dotatate Group (N = 116) | Control Group (N = 113) |
|---|---|---|
| Sex — no. (%) | ||
| Male | 63 (54) | 53 (47) |
| Female | 53 (46) | 60 (53) |
| Age — yr | 63±9 | 64±10 |
| Body-mass index† | 25±5 | 26±7 |
| Median time since diagnosis — yr | 3.8 | 4.8 |
| Primary tumor site — no. (%) | ||
| Ileum | 86 (74) | 82 (73) |
| Small intestine, not otherwise specified | 11 (9) | 12 (11) |
| Midgut, not otherwise specified | 9 (8) | 7 (6) |
| Jejunum | 6 (5) | 9 (8) |
| Right colon | 3 (3) | 1 (1) |
| Appendix | 1 (1) | 2 (2) |
| Site of metastasis — no. (%) | ||
| Liver | 97 (84) | 94 (83) |
| Lymph nodes | 77 (66) | 65 (58) |
| Mesentery | 17 (15) | 8 (7) |
| Bone | 13 (11) | 12 (11) |
| Other | 15 (13) | 10 (9) |
| Peritoneum | 7 (6) | 10 (9) |
| Lungs | 11 (9) | 5 (4) |
| Ovaries | 1 (1) | 9 (8) |
| Somatostatin receptor scintigraphy, Krenning scale — no. (%)‡ | ||
| Grade 2 | 11 (9) | 12 (11) |
| Grade 3 | 34 (29) | 34 (30) |
| Grade 4 | 71 (61) | 67 (59) |
*
Plus–minus values are means ±SD. Percentages may not sum to 100 because of rounding.
†
The body-mass index is the weight in kilograms divided by the square of the height in meters.
‡
The Krenning scale ranges from grade 0 (no uptake by tumor) to grade 4 (very intense uptake by tumor), with higher grades indicating a higher level of expression of somatostatin receptors. The highest grade per patient was reported.