Table 1.
Drug-related grade 3 or 4 adverse events with ≥ 1% incidence in phase III trials of [177Lu]Lu-DOTA-TATE, everolimus, and sunitinib in the treatment of pancreatic and gastrointestinal neuroendocrine tumours (PanNETs and GI-NETs, respectively) [9–11, 13]
| Adverse event, n (%) | [177Lu]Lu-DOTA-TATE (n = 111) [13]a | Everolimus [9, 10] | Sunitinib [11] | |
|---|---|---|---|---|
| PanNETs (n = 204) | GI-NETs (n = 202)b | PanNETs (n = 83) | ||
| Abdominal pain | 3 (3) | – | – | 4 (5) |
| Anaemia | – | 12 (6) | 8 (4) | – |
| Anorexia/decreased appetite | – | – | 1 (< 1) | 2 (2) |
| Diarrhoea | 3 (3) | 7 (3) | 15 (7) | 4 (5) |
| Dyspnoea | – | – | 2 (1) | – |
| Epistaxis | – | – | – | 1 (1) |
| Fatigue or asthenia | 2 (2) | – | – | 8 (10) |
| Fatigue | – | 5 (2) | 7 (3) | 4 (5) |
| Asthenia | – | 2 (1) | 3 (1) | 4 (5) |
| Flushing | 1 (1) | – | – | – |
| Hair colour changes | – | – | – | 1 (1) |
| Hyperglycaemia | – | 11 (5) | 7 (3) | – |
| Hypertension | – | – | – | 8 (10) |
| Infectionsc | – | 5 (2) | 14 (7) | – |
| Leucopenia | 1 (1) | – | – | – |
| Lymphopenia | 10 (9) | – | – | – |
| Mucosal inflammation | – | – | – | 1 (1) |
| Musculoskeletal pain | 2 (2) | – | – | – |
| Nausead | 4 (4) | 5 (2) | 3 (1) | 1 (1) |
| Neutropenia | 1 (1) | – | – | 10 (12) |
| Palmar-plantar erythrodysesthesia | – | – | – | 5 (6) |
| Peripheral oedema | – | 1 (< 1) | 4 (2) | – |
| Pneumonitise | – | 5 (2) | 3 (1) | – |
| Pyrexia | – | – | 4 (2) | – |
| Stomatitisf | – | 14 (7) | 18 (9) | 3 (4) |
| Thrombocytopenia | 2 (2) | 8 (4) | – | 3 (4) |
| Vomitingd | 8 (7) | – | – | – |
| Weight loss | – | – | – | 1 (1) |
All data are expressed as n (%)
aDue to the lack of detailed information on grade 3 or 4 adverse events in patients with PanNETs receiving [177Lu]Lu-DOTA-TATE, data obtained in patients with GI-NETs (from the NETTER-1 trial [13]) were extrapolated to patients with PanNETs
bData are from the RADIANT-4 trial [9], which included patients with lung NETs as well as GI-NETs
cAll types of infections are included
dEpisodes caused by co-administration of amino acid infusion are excluded
eIncludes interstitial lung disease, lung infiltration, and pulmonary fibrosis
fIncludes aphthous stomatitis, mouth ulceration, and tongue ulceration
GI-NET gastrointestinal neuroendocrine tumours, PanNET pancreatic neuroendocrine tumour