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Impact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with Lu-177-Dotatate : an analysis of the NETTER-1 study
- Source :
- European Journal of Nuclear Medicine and Molecular Imaging, European Journal of Nuclear Medicine and Molecular Imaging, Springer Verlag (Germany), 2020, ⟨10.1007/s00259-020-04709-x⟩, Dipòsit Digital de la UB, Universidad de Barcelona, European journal of nuclear medicine and molecular imaging, vol 47, iss 10, European Journal of Nuclear Medicine and Molecular Imaging, 47(10), 2372-2382. Springer-Verlag
- Publication Year :
- 2020
- Publisher :
- Uppsala universitet, Endokrin tumörbiologi, 2020.
-
Abstract
- Purpose To assess the impact of baseline liver tumour burden, alkaline phosphatase (ALP) elevation, and target lesion size on treatment outcomes with 177Lu-Dotatate. Methods In the phase 3 NETTER-1 trial, patients with advanced, progressive midgut neuroendocrine tumours (NET) were randomised to 177Lu-Dotatate (every 8 weeks, four cycles) plus octreotide long-acting release (LAR) or to octreotide LAR 60 mg. Primary endpoint was progression-free survival (PFS). Analyses of PFS by baseline factors, including liver tumour burden, ALP elevation, and target lesion size, were performed using Kaplan-Meier estimates; hazard ratios (HRs) with corresponding 95% CIs were estimated using Cox regression. Results Significantly prolonged median PFS occurred with 177Lu-Dotatate versus octreotide LAR 60 mg in patients with low ( 50%) liver tumour burden (HR 0.187, 0.216, 0.145), and normal or elevated ALP (HR 0.153, 0.177), and in the presence or absence of a large target lesion (diameter > 30 mm; HR, 0.213, 0.063). Within the 177Lu-Dotatate arm, no significant difference in PFS was observed amongst patients with low/moderate/high liver tumour burden (P = 0.7225) or with normal/elevated baseline ALP (P = 0.3532), but absence of a large target lesion was associated with improved PFS (P = 0.0222). Grade 3 and 4 liver function abnormalities were rare and did not appear to be associated with high baseline liver tumour burden. Conclusions 177Lu-Dotatate demonstrated significant prolongation in PFS versus high-dose octreotide LAR in patients with advanced, progressive midgut NET, regardless of baseline liver tumour burden, elevated ALP, or the presence of a large target lesion. Clinicaltrials.gov: NCT01578239, EudraCT: 2011-005049-11
- Subjects :
- Target lesion
177Lu-Dotatate
NETTER-1 study group
Phases of clinical research
Octreotide
Lu-177-Dotatate
Liver tumour burden
NETTER-1
Neuroendocrine tumour
Gastroenterology
0302 clinical medicine
Medicine
ComputingMilieux_MISCELLANEOUS
Cancer
Liver Neoplasms
Hazard ratio
General Medicine
Other Physical Sciences
Nuclear Medicine & Medical Imaging
Neuroendocrine Tumors
Treatment Outcome
030220 oncology & carcinogenesis
Original Article
medicine.symptom
Liver cancer
medicine.drug
Radiology, Nuclear Medicine and Medical Imaging
medicine.medical_specialty
Liver tumor
Clinical Trials and Supportive Activities
Clinical Sciences
030209 endocrinology & metabolism
NO
Càncer de fetge
Lesion
03 medical and health sciences
Clinical Research
Internal medicine
Organometallic Compounds
Humans
Radiology, Nuclear Medicine and imaging
Progression-free survival
Tumors
Cancer och onkologi
business.industry
Alkaline Phosphatase
medicine.disease
Cancer and Oncology
Liver function
Radiologi och bildbehandling
Digestive Diseases
business
[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Subjects
Details
- Language :
- English
- ISSN :
- 16197070 and 16197089
- Database :
- OpenAIRE
- Journal :
- European Journal of Nuclear Medicine and Molecular Imaging, European Journal of Nuclear Medicine and Molecular Imaging, Springer Verlag (Germany), 2020, ⟨10.1007/s00259-020-04709-x⟩, Dipòsit Digital de la UB, Universidad de Barcelona, European journal of nuclear medicine and molecular imaging, vol 47, iss 10, European Journal of Nuclear Medicine and Molecular Imaging, 47(10), 2372-2382. Springer-Verlag
- Accession number :
- edsair.doi.dedup.....051673575094bb68869f1194f244874a