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
| العنوان: | 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 |
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| المؤلفون: | Strosberg, Jonathan, Kunz, Pamela L., Hendifar, Andrew, Yao, James, Bushnell, David, Kulke, Matthew H., Baum, Richard P., Caplin, Martyn, Ruszniewski, Philippe, Delpassand, Ebrahim, Hobday, Timothy, Verslype, Chris, Benson, Al, Srirajaskanthan, Rajaventhan, Pavel, Marianne, Mora Salvador, Jaume, Berlin, Jordan, Grande, Enrique, Reed, Nicholas, Seregni, Ettore, Paganelli, Giovanni, Severi, Stefano, Morse, Michael, Metz, David C., Ansquer, Catherine, Courbon, Frédéric, Al-Nahhas, Adil, Baudin, Eric, Giammarile, Francesco, Taïeb, David, Mittra, Erik, Wolin, Edward, O’Dorisio, Thomas M., Lebtahi, Rachida, Deroose, Christophe M., Grana, Chiara M., Bodei, Lisa, Öberg, Kjell, Polack, Berna Degirmenci, He, Beilei, Mariani, Maurizio F., Gericke, Germo, Santoro, Paola, Erion, Jack L., Ravasi, Laura, Krenning, Eric, Netter-1 Study Group |
| المساهمون: | Service de médecine nucléaire [Marseille], Université de la Méditerranée - Aix-Marseille 2-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Radiology & Nuclear Medicine |
| المصدر: | 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 |
| بيانات النشر: | Uppsala universitet, Endokrin tumörbiologi, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | 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 |
| الوصف: | 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 |
| وصف الملف: | application/pdf; Print-Electronic |
| اللغة: | English |
| تدمد: | 1619-7070 1619-7089 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::051673575094bb68869f1194f244874aTest http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-423870Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....051673575094bb68869f1194f244874a |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 16197070 16197089 |
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