LUTATHERA (177 Lutécium oxodotréotide) - TNE intestinales

Key points

Approval of reimbursement only for the treatment of well-differentiated (G1 and G2), progressive, inoperable or metastatic intes-tinal neuroendocrine tumours (NETs) expressing somatostatin receptors in adults.

Therapeutic improvement?

Therapeutic improvement with respect to octreotide.

Role in therapeutic strategy?

The Committee points out that the initiation of LUTATHERA (177Lutecium oxodotreotide) treatment must be discussed within the framework of multidisciplinary review meetings as part of the NET-specific national network, RENATEN, designated by INCa.

The treatment of intestinal NETs consists of tumour syndrome management, along with the management of any potentially associated secretory syndrome, which has a significant impact on patient quality of life and morbidity.

Considering the updated data from the NETTER-1 study, showing no new safety signals of concern, and despite the lack of evidence of a benefit in terms of overall survival, vectorised internal radiotherapy with LUTATHERA remains a 2nd-line treatment, after disease progression with octreotide. This therapy is envisaged as a 1st-line treatment following a multidisciplinary review in specific cases of patients presenting with tumours that are progressive from the outset or with a large liver tumour mass (> 50%).

Failing comparative data, the role of Radio Ligand Therapy (RLT) with respect to everolimus in not known.

LUTATHERA must be co-administered with a hyperosmolar amino acid solution. Due to prolonged serotonin secretion from NETs, capable of damaging heart valves (right heart valve stenosis), co-administering this solution may induce a sudden water/salt overload potentially causing acute decompensation on the damaged heart. For the initial pre-treatment assessment for digestive tract NETs, the TNCD recommends performing echocardiography on patients presenting with carcinoid syndrome or elevated 5HIAA (5-hydroxyindolacetic acid, the main catabolite of serotonin) levels in urine, with a view to analysing heart valve status.

Note that LUTATHERA is a radiopharmaceutical medicinal product requiring compliance with radioprotection rules.

Special recommendations

The Committee recommends that the initiation of LUTATHERA (177Lutecium oxodotreotide) treatment must be discussed within the framework of regional multidisciplinary review meetings as part of the NET-specific national network, RENATEN, designated by INCa.