This is a prospective, open-label, multi-center, non-comparative, non-interventional observational study to assess safety and effectiveness of Lutathera in patients with somatostatin receptor-positive GEP-NET in the real-world setting in Korea.
Study Type
OBSERVATIONAL
Enrollment
89
Prospective observational study. There is no treatment allocation. Patients administered Lutathera by prescription that have started before inclusion of the patient into the study will be enrolled.
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Incidence of Adverse Events
Incidence of Adverse Events (AEs), Serious AE and unexpected AEs.
Time frame: Up to 36 weeks
Incidence of Adverse Drug Reactions
Incidence of Adverse Drug Reactions (ADRs), Serious ADRs and unexpected ADRs.
Time frame: Up to 36 weeks
Effectiveness in terms of Overall Response Rate (ORR)
ORR is defined as the proportion of treated patients who achieve a best overall response of partial response (PR) or complete response (CR) according to RECIST 1.1. Partial Response (PR): At least a 30% decrease from baseline, confirmed at 4 weeks. Complete Response (CR): Disappearance of all known disease, confirmed at 4 weeks, lymph nodes must be less than 10 mm short axis
Time frame: Up to 32 weeks (4 cycles of 8 weeks)
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Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea