Table 1: Summary of Clinical Evidence Suggesting Antitumour Activity of Octreotide Monotherapy in Patients with Progressive Gastroenteropancreatic-Neuroendocrine Tumours.
| Study Type | Regimen | Results | Reference |
|---|---|---|---|
| Phase II trial, n=34, patients with advanced functioning (n=21) and not functioning (n=13) carcinoid or islet cell NETs | Octreotide SC 250 µg TID | SD in 50 % of patients for median 5 months (range 2–27 months) | 45 |
| Phase II trial, n=103, metastatic GEP-NETs. 64 functioning and 39 non-functioning | Octreotide SC 200 µg TID | SD in 36.5 % of patients for median 18 months (range 3 to >42 months) | 46 |
| Phase II trial, n=58, patients with histological evidence of carcinoid or other NETs | Octreotide SC 500 µg TID (n=23) versus octreotide SC 1,000 µg TID (n=35) | SD in 47 % for at least 6 months and at least 1 year in 22 %; PR in 3 % | 47 |
| Prospective study, n=35, 18 functional, progressive metastatic NETs | Octreotide acetate LAR SC 100 µg three times daily (max 100 µg 3 times/day ) or lanreotide 30 mg every 14 days (max 30 mg/10 days) | SD in 57 % for median 7 months. PR in 3 % | 48 |
| Phase II trial, n=32, progressive, metastatic, pNETs | Octreotide acetate LAR 30 mg/28 days (n=20) versus lanreotide SR 60 mg/28 days (n=11) | SD in 45.2 % of patients for 6–60 months | 29 |
| Prospective study, n=15, gastric carcinoid tumours type 1 | Octreotide acetate LAR 20–30 mg/month (n=14) or lanreotide 90 mg/monthly (n=1) | At 1 year, 73 % observed complete disappearance of tumours; 20 % had a significant decrease in the number and size of tumour | 11 |
| Prospective study, n=15, advanced progressive metastatic gastrinoma characterised by Zollinger-Ellison syndrome and liver metastases | Octreotide acetate LAR 30 mg/28 days | At 3 months, SD in 47 %. Mean duration of response was 25.0±6.1 months (range 5.5–54.1 months) | 11 |
| Prospective phase IV study (n=21), well-differentiated, non-functioning advanced pNET | Octreotide acetate LAR 30 mg/28 days | SD in 35 % | 49 |
| Phase III study (n=19), progressive NETs of the pancreas and bronchial tract | Octreotide acetate LAR 30 mg/28 days versus chemotherapy (streptozotocin + 5-fluorouracil) | SD in 26 %, PR in 11 % | 31 |
| Phase III study (PROMID), n=85, well-differentiated metastatic NETs of the midgut | Octreotide acetate LAR 30 mg/28 days versus placebo | At 6 months, SD in 66.7 % versus 37.2 % placebo; PR in 2 % | 17 |
| Phase III multinational, randomised, double blind trial RADIANT-2 | Everolimus 10 mg/day + octreotide acetate LAR 30 mg/28 days versus placebo + octreotide acetate LAR 30 mg/28 days | SD 84 % versus 81 % in placebo; PR in 1 % | 28 |
GEP-NETs = gastroenteropancreatic-neuroendocrine tumours; LAR = long-acting release; pNETS = pancreatic NETs; PR = partial response; SC = subcutaneous; SD = stable disease; SR = short release; TID = three times daily.