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Association details:
Evidence:
Evidence Level:
Sensitive: B - Late Trials
Title:

Novartis radioligand therapy Lutathera® demonstrated statistically significant and clinically meaningful progression-free survival in first line advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

Published date:
09/25/2023
Excerpt:
Novartis announced the Phase III NETTER-2 trial with Lutathera® (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) met its primary endpoint. First line treatment with Lutathera in combination with long-acting octreotide demonstrated a significant improvement in progression-free survival (PFS) in patients with newly diagnosed somatostatin receptor (SSTR)-positive...
Evidence Level:
Sensitive: B - Late Trials
Title:

O-2 Overall survival and long-term safety data from the NETTER-1 trial: 177-Lu-Dotatate vs. high-dose octreotide in patients with progressive midgut NETs

Published date:
07/04/2021
Excerpt:
...in patients with advanced, progressive, well-differentiated, somatostatin receptor-positive midgut neuroendocrine tumors (NETs)….Median OS was 11.7 months longer with 177Lu-DOTATATE compared to high-dose octreotide in the NETTER-1 trial (48 vs. 36.3 months).
DOI:
https://doi.org/10.1016/j.annonc.2021.05.006
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

Final overall survival in the phase 3 NETTER-1 study of lutetium-177-DOTATATE in patients with midgut neuroendocrine tumors.

Published date:
05/19/2021
Excerpt:
Median OS was 48.0 months in the 177Lu-DOTATATE arm of the NETTER-1 trial and 36.3 months in the control arm. This difference was not statistically significant, potentially impacted by a high rate (36%) of cross-over of patients in the control arm to radioligand therapy after progression. In overall conclusion, the NETTER-1 study demonstrated that 177Lu-DOTATATE yielded a clinically and statistically significant improvement in PFS as a primary endpoint (HR: 0.18, p< 0.0001) as well as a clinically meaningful trend towards improvement in median OS of 11.7 months.
DOI:
10.1200/JCO.2021.39.15_suppl.4112
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

LUTATHERA Injection General Use Result Survey

Excerpt:
...Somatostatin receptor-positive neuroendocrine tumor Patients who started to receive this drug before the contract for this study will also be included in the study population and it will be allowed to register them after the contract so that all patients who receive this drug will be included in this study....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Trial of Lu-177 DOTATATE (Lutathera®) in Unlicensed Indications

Excerpt:
...Presence of unresectable or metastatic, well differentiated, somatostatin receptor positive non gastroenteropancreatic neuroendocrine tumours....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs

Excerpt:
...- Patients must be diagnosed with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic-neuroendocrine tumour (GEP-NET)....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Post-Authorization Long-Term Safety Study of LUTATHERA

Excerpt:
...- with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Using Novel Imaging to More Safely Treat Neuroendocrine Tumors

Excerpt:
...- Candidates for 177Lu-DOTATATE (Lutathera) treatment for somatostatin receptor-positive neuroendocrine tumor...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea

Excerpt:
...- somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults....
Trial ID: