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2. Radioligand therapies in cancer: mapping the educational landscape in Europe

Author

Bugani, Valentina, Battistelli, Luca, Sansovini, Maddalena, Monti, Manuela, Paganelli, Giovanni, Gich, Ignasi, Flotats, Albert, Erba, Paola Anna, Blay, Jean-Yves, la Fougère, Christian, Van Poppel, Hendrik, Charalambous, Andreas, Herrmann, Ken, Giordano, Alessandro, Györke, Tamás, Deroose, Christophe, Matteucci, Federica, and Carrió, Ignasi

Published
2023
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4. Impact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with 177Lu-Dotatate: an analysis of the NETTER-1 study

Author

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, 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, and Krenning, Eric

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Digestive Diseases, Clinical Research, Clinical Trials and Supportive Activities, Cancer, Alkaline Phosphatase, Humans, Liver Neoplasms, Neuroendocrine Tumors, Octreotide, Organometallic Compounds, Treatment Outcome, NETTER-1 study group, 177Lu-Dotatate, Liver tumour burden, NETTER-1, Neuroendocrine tumour, Other Physical Sciences, Clinical Sciences, Nuclear Medicine & Medical Imaging, Clinical sciences
Abstract

PurposeTo assess the impact of baseline liver tumour burden, alkaline phosphatase (ALP) elevation, and target lesion size on treatment outcomes with 177Lu-Dotatate.MethodsIn 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.ResultsSignificantly 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.Conclusions177Lu-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.

Published
2020

5. Neuroendocrine Tumors: Therapy with Radiolabeled Peptides

Author

Bodei, Lisa, Jayaprakasam, Vetri Sudar, Kidd, Mark, Gilardi, Laura, Volterrani, Duccio, Paganelli, Giovanni, Grana, Chiara M., Modlin, Irvin M., Volterrani, Duccio, editor, Erba, Paola A., editor, Strauss, H. William, editor, Mariani, Giuliano, editor, and Larson, Steven M., editor

Published
2022
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7. Correlation of [68Ga]Ga-PSMA PET/CT response and PSA decline in first-line enzalutamide for metastatic castration-resistant prostate cancer patients.

Author

Giunta, Emilio Francesco, Caroli, Paola, Scarpi, Emanuela, Altavilla, Amelia, Rossetti, Virginia, Marini, Irene, Celli, Monica, Casadei, Chiara, Lolli, Cristian, Schepisi, Giuseppe, Bleve, Sara, Brighi, Nicole, Cursano, Maria Concetta, Paganelli, Giovanni, Matteucci, Federica, and De Giorgi, Ugo

Abstract

Purpose: to assess the utility of response monitoring to enzalutamide by using [68Ga]Ga-PSMA PET in mCRPC patients treated with enzalutamide as first-line therapy. Methods: patients underwent [68Ga]Ga-PSMA PET less than 8 weeks before and 3 months after starting enzalutamide. On the basis of EAU/EANM criteria, patients were categorized as PSMA responders (PET-R) or PSMA non-responders (PET-NR), whilst, based on PSA, they were classified as biochemical responders (PSA-R) or non-responders (PSA-NR). Survival analysis was performed using the Cox regression hazard model and the Kaplan-Meier method. Results: 69 patients were considered fully evaluable. We observed 47.8% of concordance between [68Ga]Ga-PSMA PET and PSA monitoring at 3 months after starting enzalutamide. For discordant cases, the PSA reduction has a weak impact on PFS and a significant impact on OS in PET-NR patients, whilst this change has no impact either for PFS and OS in PET-R ones. Conclusions: [68Ga]Ga-PSMA PET could be a useful imaging tool for monitoring response to enzalutamide in mCRPC patients, being more informative than PSA in this setting, and possibly better guiding clinicians in therapeutic decisions. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Circulating androgen receptor gene amplification and resistance to 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer: results of a Phase 2 trial

Author

De Giorgi, Ugo, Sansovini, Maddalena, Severi, Stefano, Nicolini, Silvia, Monti, Manuela, Gurioli, Giorgia, Foca, Flavia, Casadei, Chiara, Conteduca, Vincenza, Celli, Monica, Di Iorio, Valentina, Calistri, Daniele, Matteucci, Federica, von Eyben, Finn Edler, Attard, Gerhardt, and Paganelli, Giovanni

Published
2021
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16. Plasma tumour DNA as an early indicator of treatment response in metastatic castration-resistant prostate cancer

Author

Conteduca, Vincenza, Wetterskog, Daniel, Scarpi, Emanuela, Romanel, Alessandro, Gurioli, Giorgia, Jayaram, Anuradha, Lolli, Cristian, Tandefelt, Delila Gasi, Schepisi, Giuseppe, Casadei, Chiara, Wingate, Anna, Matteucci, Federica, Paganelli, Giovanni, Gonzalez-Billalabeitia, Enrique, Demichelis, Francesca, De Giorgi, Ugo, and Attard, Gerhardt

Published
2020
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25. Interim analysis of the REASSURE (Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation) study: patient characteristics and safety according to prior use of chemotherapy in routine clinical practice

Author

Dizdarevic, Sabina, Petersen, Peter Meidahl, Essler, Markus, Versari, Annibale, Bourre, Jean-Cyril, la Fougère, Christian, Valdagni, Riccardo, Paganelli, Giovanni, Ezziddin, Samer, Kalinovský, Ján, Bayh, Inga, and Du, Yong

Published
2019
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26. Circulating hsa-miR-5096 predicts 18F-FDG PET/CT positivity and modulates somatostatin receptor 2 expression: a novel miR-based assay for pancreatic neuroendocrine tumors

Author

Bocchini, Martine, Tazzari, Marcella, Ravaioli, Sara, Piccinini, Filippo, Foca, Flavia, Tebaldi, Michela, Nicolini, Fabio, Grassi, Ilaria, Severi, Stefano, Calogero, Raffaele Adolfo, Arigoni, Maddalena, Schrader, Joerg, Mazza, Massimiliano, Paganelli, Giovanni, Bocchini, Martine, Tazzari, Marcella, Ravaioli, Sara, Piccinini, Filippo, Foca, Flavia, Tebaldi, Michela, Nicolini, Fabio, Grassi, Ilaria, Severi, Stefano, Calogero, Raffaele Adolfo, Arigoni, Maddalena, Schrader, Joerg, Mazza, Massimiliano, and Paganelli, Giovanni

Subjects
Cancer Research, pancreatic neuroendocrine tumors, PRRT (peptide receptor radionuclide therapy), miRNA – microRNA, functional imaging (positron-emission tomography), SSTR2, Oncology
Abstract

Gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs) are rare diseases encompassing pancreatic (PanNETs) and ileal NETs (SINETs), characterized by heterogeneous somatostatin receptors (SSTRs) expression. Treatments for inoperable GEP-NETs are limited, and SSTR-targeted Peptide Receptor Radionuclide Therapy (PRRT) achieves variable responses. Prognostic biomarkers for the management of GEP-NET patients are required. 18F-FDG uptake is a prognostic indicator of aggressiveness in GEP-NETs. This study aims to identify circulating and measurable prognostic miRNAs associated with 18F-FDG-PET/CT status, higher risk and lower response to PRRT.MethodsWhole miRNOme NGS profiling was conducted on plasma samples obtained from well-differentiated advanced, metastatic, inoperable G1, G2 and G3 GEP-NET patients enrolled in the non-randomized LUX (NCT02736500) and LUNET (NCT02489604) clinical trials prior to PRRT (screening set, n= 24). Differential expression analysis was performed between 18F-FDG positive (n=12) and negative (n=12) patients. Validation was conducted by Real Time quantitative PCR in two distinct well-differentiated GEP-NET validation cohorts, considering the primary site of origin (PanNETs n=38 and SINETs n=30). The Cox regression was applied to assess independent clinical parameters and imaging for progression-free survival (PFS) in PanNETs. In situ RNA hybridization combined with immunohistochemistry was performed to simultaneously detect miR and protein expression in the same tissue specimens. This novel semi-automated miR-protein protocol was applied in PanNET FFPE specimens (n=9). In vitro functional experiments were performed in PanNET models.ResultsWhile no miRNAs emerged to be deregulated in SINETs, hsa-miR-5096, hsa-let-7i-3p and hsa-miR-4311 were found to correlate with 18F-FDG-PET/CT in PanNETs (p-value:18F-FDG-PET/CT positive PanNETs with worse prognosis after PRRT (p-value:68Gallium-DOTATOC captation values (p-value:SSTR2 when ectopically expressed in PanNET cells (p-value:Conclusionshsa-miR-5096 well performs as a biomarker for 18F-FDG-PET/CT and as independent predictor of PFS. Moreover, exosome-mediated delivery of hsa-miR-5096 may promote SSTR2 heterogeneity and thus resistance to PRRT.

Published
2023
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27. POSTER: MM-602 Role of the Combination of FDG-PET Plus Whole Body MRI for Staging Patients With High-Risk Smoldering Myeloma: A Prospective Trial

Author

Cerchione, Claudio, primary, Nappi, Davide, additional, Marchesini, Matteo, additional, Feliciani, Giacomo, additional, Iamurri, Andrea Prochowski, additional, Ronconi, Sonia, additional, Cangini, Delia, additional, Ceccolini, Michela, additional, Matuozzo, Claudia, additional, Mammoli, Fabiana, additional, Frabetti, Federica, additional, Paganelli, Giovanni, additional, Matteucci, Federica, additional, Pallotti, Caterina, additional, Scarpi, Emanuela, additional, Pazzi, Chiara, additional, Barone, Domenico, additional, Romeo, Antonino, additional, Simonetti, Giorgia, additional, Musuraca, Gerardo, additional, Martinelli, Giovanni, additional, and Rossi, Alice, additional

Published
2023
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28. MM-602 Role of the Combination of FDG-PET Plus Whole Body MRI for Staging Patients With High-Risk Smoldering Myeloma: A Prospective Trial

Author

Cerchione, Claudio, primary, Nappi, Davide, additional, Marchesini, Matteo, additional, Feliciani, Giacomo, additional, Iamurri, Andrea Prochowski, additional, Ronconi, Sonia, additional, Cangini, Delia, additional, Ceccolini, Michela, additional, Matuozzo, Claudia, additional, Mammoli, Fabiana, additional, Frabetti, Federica, additional, Paganelli, Giovanni, additional, Matteucci, Federica, additional, Pallotti, Caterina, additional, Scarpi, Emanuela, additional, Pazzi, Chiara, additional, Barone, Domenico, additional, Romeo, Antonino, additional, Simonetti, Giorgia, additional, Musuraca, Gerardo, additional, Martinelli, Giovanni, additional, and Rossi, Alice, additional

Published
2023
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29. P953: ROLE OF THE COMBINATION OF FDG PET PLUS WHOLE BODY MRI FOR STAGING NEWLY DIAGNOSED AND RELAPSED/REFRACTORY MULTIPLE MYELOMA: A PROSPECTIVE TRIAL

Author

Cerchione, Claudio, primary, Nappi, Davide, additional, Marchesini, Matteo, additional, Feliciani, Giacomo, additional, Prochowski Iamurri, Andrea, additional, Ronconi, Sonia, additional, Cangini, Delia, additional, Ceccolini, Michela, additional, Matuozzo, Claudia, additional, Mammoli, Fabiana, additional, Frabetti, Federica, additional, Paganelli, Giovanni, additional, Matteucci, Federica, additional, Pallotti, Caterina, additional, Scarpi, Emanuela, additional, Pazzi, Chiara, additional, Barone, Domenico, additional, Romeo, Antonino, additional, Simonetti, Giorgia, additional, Musuraca, Gerardo, additional, Martinelli, Giovanni, additional, and Rossi, Alice, additional

Published
2023
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30. P918: ROLE OF THE COMBINATION OF FDG PET PLUS WHOLE BODY MRI FOR STAGING PATIENTS IN HIGH RISK SMOLDERING MYELOMA: A PROSPECTIVE TRIAL

Author

Cerchione, Claudio, primary, Nappi, Davide, additional, Marchesini, Matteo, additional, Ronconi, Sonia, additional, Cangini, Delia, additional, Ceccolini, Michela, additional, Feliciani, Giacomo, additional, Prochowski Iamurri, Andrea, additional, Matuozzo, Claudia, additional, Mammoli, Fabiana, additional, Frabetti, Federica, additional, Paganelli, Giovanni, additional, Matteucci, Federica, additional, Pallotti, Caterina, additional, Scarpi, Emanuela, additional, Pazzi, Chiara, additional, Barone, Domenico, additional, Romeo, Antonino, additional, Simonetti, Giorgia, additional, Musuraca, Gerardo, additional, Martinelli, Giovanni, additional, and Rossi, Alice, additional

Published
2023
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37. Radioligand therapies in cancer: mapping the educational landscape in Europe

Author

Bugani, V, Battistelli, L, Sansovini, M, Monti, M, Paganelli, G, Gich, I, Flotats, A, Erba, P, Blay, J, la Fougère, C, Van Poppel, H, Charalambous, A, Herrmann, K, Giordano, A, Györke, T, Deroose, C, Matteucci, F, Carrió, I, Bugani, Valentina, Battistelli, Luca, Sansovini, Maddalena, Monti, Manuela, Paganelli, Giovanni, Gich, Ignasi, Flotats, Albert, Erba, Paola Anna, Blay, Jean-Yves, la Fougère, Christian, Van Poppel, Hendrik, Charalambous, Andreas, Herrmann, Ken, Giordano, Alessandro, Györke, Tamás, Deroose, Christophe, Matteucci, Federica, Carrió, Ignasi, Bugani, V, Battistelli, L, Sansovini, M, Monti, M, Paganelli, G, Gich, I, Flotats, A, Erba, P, Blay, J, la Fougère, C, Van Poppel, H, Charalambous, A, Herrmann, K, Giordano, A, Györke, T, Deroose, C, Matteucci, F, Carrió, I, Bugani, Valentina, Battistelli, Luca, Sansovini, Maddalena, Monti, Manuela, Paganelli, Giovanni, Gich, Ignasi, Flotats, Albert, Erba, Paola Anna, Blay, Jean-Yves, la Fougère, Christian, Van Poppel, Hendrik, Charalambous, Andreas, Herrmann, Ken, Giordano, Alessandro, Györke, Tamás, Deroose, Christophe, Matteucci, Federica, and Carrió, Ignasi

Abstract

Aim: We performed a systematic survey to assess the existing gaps in Europe in multidisciplinary education for integration of radioligand therapy (RLT) into cancer care and to obtain detailed information on the current limitations and key contents relevant. Methods: A high-quality questionnaire, with emphasis on survey scales, formulation, and validity of the different items, was designed. An expert validation process was undertaken. The survey was circulated among medical specialties involved in cancer treatment, universities, and nursing organizations. Questionnaires (156) were distributed, and 95 responses received. Results: Sevety-eight percent of medical societies indicated that training in RLT was very important and 12% important. Eighty-eight percent indicated that their specialty training program included RLT. Twenty-six percent were satisfied with the existing structure of training in RLTs. Ninety-four percent indicated that the existing training is based on theory and hands-on experience. Main identified limitations were lack of centers ready to train and of personnel available for teaching. Sixty-five percent indicated that national programs could be expanded. Fifty percent of consulted universities indicated partial or scarce presence of RLT contents in their teaching programs. In 26% of the cases, the students do not have the chance to visit a RLT facility. A large majority of the universities are interested in further expansion of RLT contents in their curriculums. Nursing organizations almost never (44.4%) or occasionally (33.3%) include RLT contents in the education of nurses and technologists. Hands-on experience is almost never (38%) and sometimes (38%) offered. However, 67% of centers indicated high interest in expanding RLT contents. Conclusion: Centers involved recognize the importance of the training and indicate a need for inclusion of additional clinical content, imaging analysis, and interpretation as well as extended hands-on training. A co

Published
2023

43. In Vivo Models for the Performance and Safety of BAT-90, a Novel 90-Yttrium-based Internal Radiotherapy Platform

Author

AMATO, ANTONINO, MCVIE, GORDON, PAGANELLI, GIOVANNI, CARRIERO, PIER LUIGI, CIANNI, ROBERTO, and ETTORRE, GIUSEPPE MARIA

Subjects
Pharmacology, Cancer Research, General Biochemistry, Genetics and Molecular Biology, Research Article
Abstract

Background/Aim: BAT-90 is an innovative active implantable device designed for the irradiation of unresectable tumors (e.g., liver cancer) or surgical tumor beds, based on the combination of Yttrium-90 beta-emitting microspheres and a tissue adhesive hydrogel, currently used in cardio-vascular surgery. The rationale behind BAT-90 is to localize the Yttrium-90 activity on the administration site, while minimizing its body dispersion. Materials and Methods: The effective induction of necrosis in the target injection area was tested in a pig liver model, whereas the safety of BAT-90 was assessed and demonstrated in biocompatibility tests for acute systemic toxicity, intracutaneous reactivity, delayed hypersensitivity and subcutaneous implantation. Results: BAT-90 administration induced necrosis into the target site, while the safety experiments in the treated animals highlighted results very similar to the controls. Conclusion: BAT-90 could be considered as a safe and innovative treatment option for inoperable solid tumors of the liver.

Published
2022
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49. Neuroendocrine Tumors

Author

Bodei, Lisa, Boni, Giuseppe, Paganelli, Giovanni, Volterrani, Duccio, Strauss, H. William, editor, Mariani, Giuliano, editor, Volterrani, Duccio, editor, and Larson, Steven M., editor

Published
2013
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50. Dosimetry Using SPECT-CT

Author

Basile, Chiara, Botta, Francesca, Cremonesi, Marta, De Cicco, Concetta, Di Dia, Amalia, Mango, Lucio, Pacilio, Massimiliano, Paganelli, Giovanni, Fanti, Stefano, Farsad, Mohsen, and Mansi, Luigi

Published
2011
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