Table 1.
Demographic and baseline characteristics of the patients
| Pasireotide LAR n=53 | Octreotide LAR n=57 | |
|---|---|---|
| Age (years), median (range) | 61 (40–80) | 63 (28–86) |
| Sex, n (%) | ||
| Male/female | 29 (55)/24 (45) | 34 (60)/23 (40) |
| Race, n (%) | ||
| Caucasian | 49 (92) | 57 (100) |
| Asian | 1 (2) | 0 |
| Black | 1 (2) | 0 |
| Other | 2 (4) | 0 |
| Karnofsky performance status, n (%) | ||
| 80–100 | 49 (93) | 50 (88) |
| <80 | 3 (6) | 6 (11) |
| Missing | 1 (2) | 1 (2) |
| Primary tumor site, n (%) | ||
| Small intestine | 38 (72) | 46 (81) |
| Colon | 3 (6) | 1 (2) |
| Liver | 3 (6) | 0 |
| Pancreas | 1 (2) | 1 (2) |
| Lung | 0 | 1 (2) |
| Stomach | 0 | 1 (2) |
| Othera | 8 (15) | 7 (12) |
| Histologic grade of tumor, n (%) | ||
| Well differentiated | 41 (77) | 48 (84) |
| Moderately differentiated | 2 (4) | 1 (2) |
| Unknown | 10 (19) | 8 (14) |
| Tumor stage, n (%) | ||
| Stage I | 0 | 1 (2) |
| Stage II | 0 | 1 (2) |
| Stage III | 2 (4) | 1 (2) |
| Stage IV | 46 (87) | 47 (83) |
| Unknown/missing | 0/5 (10) | 1 (2)/6 (11) |
| Time since initial diagnosis (years), n (%) | ||
| 0.5 to <2 | 6 (11) | 14 (25) |
| 2 to <5 | 18 (34) | 13 (23) |
| 5 to <10 | 11 (21) | 18 (32) |
| ≥10 | 7 (13) | 7 (12) |
| Missing | 11 (21) | 5 (9) |
| Previous medications, n (%) | ||
| Chemotherapy | 10 (19) | 12 (21) |
| Immunotherapy | 12 (23) | 14 (25) |
| Targeted therapy | 7 (13) | 8 (14) |
| Other | 14 (26) | 10 (18) |
| Missing | 26 (49) | 24 (42) |
| Previous SSA use, n (%)b | ||
| Octreotide LAR | 45 (85) | 50 (88) |
| Octreotide SC | 11 (21) | 9 (16) |
| Lanreotide autogel | 6 (11) | 13 (23) |
| Lanreotide SR | 3 (6) | 1 (2) |
| No of patients with baseline | 49 | 49 |
| 5-HIAA data | ||
| Elevated baseline 5-HIAA (>ULN), n (%) | 44 (90) | 40 (82) |
| No of patients with baseline CgA datac | 15 | 17 |
| Elevated baseline CgA (>2× ULN), n (%) | 11 (73) | 10 (59) |
Notes:
a
Other sites included distal ilium, cecum, GI primary, recto-sigmoid, unknown primary, mesentery, appendix, head of pancreas;
b
patients might have been taking more than 1 SSA prior to study entry;
c
baseline CgA data were missing for approximately 70% of patients as the CgA assessment was introduced with a protocol amendment issued after 48 patients had been enrolled.
Abbreviations: CgA, chromogranin A; 5-HIAA, 5-hydroxyindoleacetic acid; GI, gastrointestinal; octreotide LAR, octreotide long-acting repeatable; pasireotide LAR, pasireotide long-acting release; SC, subcutaneous; SR, sustained release; SSA, somatostatin analogues; ULN, upper limit of normal.