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1. Inter-center agreement of mRECIST in transplanted patients for hepatocellular carcinoma

Author

Vicentin, I, Mosconi, C, Garanzini, E, Sposito, C, Serenari, M, Buscemi, V, Verna, M, Spreafico, C, Golfieri, R, Mazzaferro, V, De Carlis, L, Cescon, M, Ercolani, G, Vanzulli, A, Cucchetti, A, Vicentin I., Mosconi C., Garanzini E., Sposito C., Serenari M., Buscemi V., Verna M., Spreafico C., Golfieri R., Mazzaferro V., De Carlis L., Cescon M., Ercolani G., Vanzulli A., Cucchetti A., Vicentin, I, Mosconi, C, Garanzini, E, Sposito, C, Serenari, M, Buscemi, V, Verna, M, Spreafico, C, Golfieri, R, Mazzaferro, V, De Carlis, L, Cescon, M, Ercolani, G, Vanzulli, A, Cucchetti, A, Vicentin I., Mosconi C., Garanzini E., Sposito C., Serenari M., Buscemi V., Verna M., Spreafico C., Golfieri R., Mazzaferro V., De Carlis L., Cescon M., Ercolani G., Vanzulli A., and Cucchetti A.

Abstract

Objectives: To evaluate the inter-observer reliability of modified Response Evaluation Criteria In Solid Tumours (mRECIST) of patients with hepatocellular carcinoma (HCC) undergoing neo-adjuvant treatments before liver transplant (LT). The agreement of tumor number, size, transplant criteria, and the radiological-pathological concordance were also assessed. Methods: A total of 180 radiological studies before/after neo-adjuvant therapies performed on 90 patients prior to LT were reviewed from three expert centers. Kappa-statistic and intraclass correlation (ICC) were evaluated on mRECIST and on tumoral features. Complete radiological response (CR) was compared with complete pathological response (CPR). Results: Before neo-adjuvant therapies, the agreement on tumor number, size, and transplant criteria ranged from moderate (defined as ICC of 0.41–0.60) to almost perfect (ICC of 0.81–0.99), being higher with magnetic resonance imaging (MRI) than CT (0.657–0.899 and 0.422–0.776, respectively). After neo-adjuvant therapies, the agreement decreased, as ICCs ranged between 0.518 and 0.663 with MRI and between 0.508 and 0.677 with CT. Concordant mRECIST pairs were 201 of 270 reviews (76.3%) with a kappa of 0.648 indicating substantial agreement. When the three observers completely agreed on CR, the positive predictive value for CPR was 51.6%. The negative predictive value was 94.2% with a kappa of 0.512 indicating fair agreement between radiology and pathology. Conclusions: mRECIST agreement was substantial among the three observers involved. The agreement on tumor number, size, and transplant criteria ranged from moderate to almost perfect, with the highest ICCs obtained with MRI before neo-adjuvant therapies. Finally, the predictive value of mRECIST in the diagnosis of CPR was only fair. Key Points: • The review of 180 radiological exams of patients with hepatocellular carcinoma before and after neo-adjuvant therapies showed that the concordance among three different rate

Published
2021

2. Targeted treatments in advanced renal cell carcinoma: focus on axitinib

Author

Verzoni E, Grassi P, Testa I, Iacovelli R, Biondani P, Garanzini E, De Braud F, and Procopio G

Subjects
Therapeutics. Pharmacology, RM1-950
Abstract

Elena Verzoni, Paolo Grassi, Isabella Testa, Roberto Iacovelli, Pamela Biondani, Enrico Garanzini , Filippo De Braud, Giuseppe ProcopioDepartment of Medical Oncology 1, Fondazione IRCCS Istituto Nazionale Tumori, Milan, ItalyAbstract: Antiangiogenesis options have evolved rapidly in the last few years, with an increasing number of agents currently approved by the US Food and Drug Administration and European Medicines Agency. Angiogenesis inhibitors have been shown to be very effective for the treatment of metastatic renal cancer cell. Axitinib is a third-generation inhibitor of vascular endothelial growth factor receptor and is currently being developed for the treatment of various malignancies. The pharmacokinetic properties of axitinib may have a selective therapeutic effect, with minimal adverse reactions and enhanced safety. In a large Phase III study of previously treated patients with metastatic renal cell carcinoma, axitinib achieved a longer progression-free survival than sorafenib with an acceptable safety profile and good quality of life. This review focuses on the pharmacology, pharmacokinetics, and clinical activity of axitinib in the current treatment of renal cell carcinoma. The role of axitinib in the adjuvant and/or neoadjuvant setting needs to be evaluated in further clinical trials.Keywords: axitinib, renal cell carcinoma, vascular endothelial growth factor receptor, angiogenesis

Published
2014

4. 1105P Predictive factors of adverse events onset in GEPNET patients treated with PRRT

Author

Scalorbi, F., primary, Argiroffi, G., additional, Lorenzoni, A., additional, Baccini, M., additional, Gherardini, L., additional, Fuoco, V., additional, Prinzi, N., additional, Pusceddu, S., additional, Calareso, G., additional, Garanzini, E., additional, Centonze, G., additional, Milione, M., additional, Chiesa, C., additional, Seregni, E., additional, and Maccauro, M., additional

Published
2021
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5. Including mRECIST in the Metroticket 2.0 criteria improves prediction of hepatocellular carcinoma-related death after liver transplant

Author

Cucchetti, A, Serenari, M, Sposito, C, Di Sandro, S, Mosconi, C, Vicentin, I, Garanzini, E, Mazzaferro, V, De Carlis, L, Golfieri, R, Spreafico, C, Vanzulli, A, Buscemi, V, Ravaioli, M, Ercolani, G, Pinna, A, Cescon, M, Cucchetti, Alessandro, Serenari, Matteo, Sposito, Carlo, Di Sandro, Stefano, Mosconi, Cristina, Vicentin, Ilaria, Garanzini, Enrico, Mazzaferro, Vincenzo, De Carlis, Luciano, Golfieri, Rita, Spreafico, Carlo, Vanzulli, Angelo, Buscemi, Vincenzo, Ravaioli, Matteo, Ercolani, Giorgio, Pinna, Antonio Daniele, Cescon, Matteo, Cucchetti, A, Serenari, M, Sposito, C, Di Sandro, S, Mosconi, C, Vicentin, I, Garanzini, E, Mazzaferro, V, De Carlis, L, Golfieri, R, Spreafico, C, Vanzulli, A, Buscemi, V, Ravaioli, M, Ercolani, G, Pinna, A, Cescon, M, Cucchetti, Alessandro, Serenari, Matteo, Sposito, Carlo, Di Sandro, Stefano, Mosconi, Cristina, Vicentin, Ilaria, Garanzini, Enrico, Mazzaferro, Vincenzo, De Carlis, Luciano, Golfieri, Rita, Spreafico, Carlo, Vanzulli, Angelo, Buscemi, Vincenzo, Ravaioli, Matteo, Ercolani, Giorgio, Pinna, Antonio Daniele, and Cescon, Matteo

Abstract

Background & Aims: In the context of liver transplantation (LT) for hepatocellular carcinoma (HCC), prediction models are used to ensure that the risk of post-LT recurrence is acceptably low. However, the weighting that ‘response to neoadjuvant therapies’ should have in such models remains unclear. Herein, we aimed to incorporate radiological response into the Metroticket 2.0 model for post-LT prediction of “HCC-related death”, to improve its clinical utility. Methods: Data from 859 transplanted patients (2000-2015) who received neoadjuvant therapies were included. The last radiological assessment before LT was reviewed according to the modified RECIST criteria. Competing-risk analysis was applied. The added value of including radiological response into the Metroticket 2.0 was explored through category-based net reclassification improvement (NRI) analysis. Results: At last radiological assessment prior to LT, complete response (CR) was diagnosed in 41.3%, partial response/stable disease (PR/SD) in 24.9% and progressive disease (PD) in 33.8% of patients. The 5-year rates of “HCC-related death” were 3.1%, 9.6% and 13.4% in those with CR, PR/SD, or PD, respectively (p <0.001). Log10AFP (p <0.001) and the sum of number and diameter of the tumour/s (p <0.05) were determinants of “HCC-related death” for PR/SD and PD patients. To maintain the post-LT 5-year incidence of “HCC-related death” <30%, the Metroticket 2.0 criteria were restricted in some cases of PR/SD and in all cases with PD, correctly reclassifying 9.4% of patients with “HCC-related death”, at the expense of 3.5% of patients who did not have the event. The overall/net NRI was 5.8. Conclusion: Incorporating the modified RECIST criteria into the Metroticket 2.0 framework can improve its predictive ability. The additional information provided can be used to better judge the suitability of candidates for LT following neoadjuvant therapies. Lay summary: In the context of liver transplantation for pa

Published
2020

6. 1183P Sequential PRRT and SIRT: Evaluation of safety, toxicity and best sequence treatment in liver dominant GEPNETs

Author

Scalorbi, F., primary, Lorenzoni, A., additional, Mazzaglia, S., additional, Garanzini, E., additional, Chiesa, C., additional, Aliberti, G., additional, Argiroffi, G., additional, Pusceddu, S., additional, Prinzi, N., additional, Spreafico, C., additional, Centonze, G., additional, Coppa, J., additional, Marchianò, A., additional, Milione, M., additional, Mazzaferro, V., additional, Seregni, E., additional, and Maccauro, M., additional

Published
2020
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7. Surgical Resection Does Not Improve Survival in Patients with Renal Metastases to the Pancreas in the Era of Tyrosine Kinase Inhibitors

Author

Santoni, M, Conti, A, Partelli, S, Porta, C, Sternberg, Cn, Procopio, G, Bracarda, S, Basso, U, De Giorgi, U, Derosa, L, Rizzo, M, Ortega, C, Massari, F, Iacovelli, Roberto, Milella, M, Di Lorenzo, G, Buti, S, Cerbone, L, Burattini, L, Montironi, R, Santini, D, Falconi, M, Cascinu, S, Iacovelli, R, Albiges, L, Loriot, Y, Massard, C, Fizazi, K, Escudier, B, Pietrantonio, F, Di Bartolomeo, M, de Braud, F, Verzoni, E, Braud, Fd, Testa, I, Grassi, P, Galli, G, De Braud, F, Saravia, D, Salvioni, R, Farcomeni, Alessio, Maggi, C, Palazzo, A, Ricchini, F, Porcu, L, Torri, V, Masini, C, Atzori, F, Pagano, M, De Vivo, R, Mosca, A, Rossi, M, Paglino, C, Muzzonigro, G, Fanetti, G, Deraco, M, Perrone, F, Baratti, D, Kusamura, S, Tamborini, E, Castano, A, Consonni, Pv, Bossi, I, Gavazzi, C, Milione, M, Pelosi, G, Orlando, V, Cortesi, E, Biondani, P, Garanzini, E, Facciorusso, Mg, Testi, A, Miceli, R, Leone, G, de Braud, F., Santoni, Matteo, Conti, Alessandro, Porta, Camillo, Sternberg Cora, N., Procopio, Giuseppe, Bracarda, Sergio, Basso, Umberto, De Giorgi, Ugo, Derosa, Lisa, Rizzo, Mimma, Ortega, Cinzia, Massari, Francesco, Iacovelli, Roberto, Milella, Michele, Di Lorenzo, Giuseppe, Buti, Sebastiano, Cerbone, Linda, Burattini, Luciano, Montironi, Rodolfo, Santini, Daniele, Falconi, Massimo, Cascinu, Stefano, and Partelli, Stefano

Subjects
Oncology, Male, medicine.medical_treatment, urologic and male genital diseases, Gastroenterology, Nephrectomy, Metastasis, Surgical oncology, Renal cell carcinoma, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Medicine, Aged, 80 and over, Middle Aged, Protein-Tyrosine Kinases, Prognosis, Combined Modality Therapy, female genital diseases and pregnancy complications, Kidney Neoplasms, Survival Rate, Local, Lymphatic Metastasis, Female, Adult, medicine.medical_specialty, Internal medicine, Carcinoma, Humans, Neoplasm Invasiveness, Survival rate, Carcinoma, Renal Cell, Protein Kinase Inhibitors, Aged, Neoplasm Staging, Retrospective Studies, business.industry, Renal Cell, Cancer, medicine.disease, not applicable, Pancreatic Neoplasms, Neoplasm Recurrence, Concomitant, Surgery, Neoplasm Recurrence, Local, business, Follow-Up Studies
Abstract

The aim of this study was to compare survival of resected and unresected patients in a large cohort of patients with metastases to the pancreas from renal cell carcinoma (PM-RCC). Data from 16 Italian centers involved in the treatment of metastatic RCC were retrospectively collected. The Kaplan–Meier and log-rank test methods were used to evaluate overall survival (OS). Clinical variables considered were sex, age, concomitant metastasis to other sites, surgical resection of PM-RCC, and time to PM-RCC occurrence. Overall, 103 consecutive patients with radically resected primary tumors were enrolled in the analysis. PM-RCCs were synchronous in only three patients (3 %). In 56 patients (54 %), the pancreas was the only metastatic site, whereas in the other 47 patients, lung (57 %), lymph nodes (28 %), and liver (21 %) were the most common concomitant metastatic sites. Median time for PM-RCC occurrence was 9.6 years (range 0–24 years) after nephrectomy. Surgical resection of PM-RCC was performed in 44 patients (median OS 103 months), while 59 patients were treated with tyrosine kinase inhibitors (TKIs; median OS 86 months) (p = 0.201). At multivariate analysis, Memorial Sloan Kettering Cancer Center risk group was the only independent prognostic factor. None of the other clinical variables, such as age, sex, pancreatic surgery, or the presence of concomitant metastases, were significantly associated with outcome in PM-RCC patients. The presence of PM-RCC is associated with a long survival, and surgical resection does not improve survival in comparison with TKI therapy. However, surgical resection leads to a percentage of disease-free PM-RCC patients.

Published
2014

11. Treatment of collecting duct carcinoma: Current status and future perspectives

Author

Procopio, G., Testa, I., Roberto Iacovelli, Grassi, P., Verzoni, E., Garanzini, E., Colecchia, M., Torelli, T., Braud, F., Procopio, G, Testa, I, Iacovelli, R, Grassi, P, Verzoni, E, Garanzini, E, Colecchia, M, Torelli, T, and De Braud, F

Subjects
Adult, Aged, 80 and over, Niacinamide, Sirolimus, Sulfonamides, Indazoles, Neovascularization, Pathologic, Phenylurea Compounds, Angiogenesis Inhibitors, Antineoplastic Agents, Middle Aged, Sorafenib, Kidney Neoplasms, Cohort Studies, Pyrimidines, Humans, Carcinoma, Renal Cell, Aged
Abstract

Chemotherapy for collecting duct carcinoma (CDC) has demonstrated only limited efficacy in the advanced setting. The present study evaluated the activity of targeted therapies in metastatic CDC.We evaluated a cohort of 384 consecutive patients with metastatic renal cell carcinoma (mRCC). The characteristics of patients with CDC were compared against those of the remaining cohort. All patients with CDC were treated with targeted therapies.Thirteen patients with advanced CDC were referred to our Center (incidence: 3.4% of all mRCC). Median age was 57 and 62 years in the CDC and non-CDC groups, respectively. The overall disease control in the CDC population was 23%, and median overall survival was 4 (95% confidence interval(CI)=2.4-5.6) months. Three patients obtained a satisfying response (disease control lasting 6-33 months).CDC has a poor prognosis compared to non-CDC renal cell carcinoma. Treatment for CDC represents a future challenge and targeted therapies may play a role in selected cases.

12. Stability of Multi-Parametric Prostate MRI Radiomic Features to Variations in Segmentation.

Author

Thulasi Seetha S, Garanzini E, Tenconi C, Marenghi C, Avuzzi B, Catanzaro M, Stagni S, Villa S, Chiorda BN, Badenchini F, Bertocchi E, Sanduleanu S, Pignoli E, Procopio G, Valdagni R, Rancati T, Nicolai N, and Messina A

Abstract

Stability analysis remains a fundamental step in developing a successful imaging biomarker to personalize oncological strategies. This study proposes an in silico contour generation method for simulating segmentation variations to identify stable radiomic features. Ground-truth annotation provided for the whole prostate gland on the multi-parametric MRI sequences (T2w, ADC, and SUB-DCE) were perturbed to mimic segmentation differences observed among human annotators. In total, we generated 15 synthetic contours for a given image-segmentation pair. One thousand two hundred twenty-four unfiltered/filtered radiomic features were extracted applying Pyradiomics, followed by stability assessment using ICC(1,1). Stable features identified in the internal population were then compared with an external population to discover and report robust features. Finally, we also investigated the impact of a wide range of filtering strategies on the stability of features. The percentage of unfiltered (filtered) features that remained robust subjected to segmentation variations were T2w-36% (81%), ADC-36% (94%), and SUB-43% (93%). Our findings suggest that segmentation variations can significantly impact radiomic feature stability but can be mitigated by including pre-filtering strategies as part of the feature extraction pipeline.

Published
2023
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13. Somatostatin analogs in association with peptide receptor radionucleotide therapy in advanced well-differentiated NETs.

Author

Prinzi N, Raimondi A, Maccauro M, Milione M, Garanzini E, Torchio M, Corti F, Nichetti F, Lo Russo G, Giacomelli L, Mazzaferro V, Di Bartolomeo M, Seregni E, de Braud F, and Pusceddu S

Subjects
Adult, Aged, Aged, 80 and over, Female, Humans, Intestinal Neoplasms metabolism, Intestinal Neoplasms mortality, Kaplan-Meier Estimate, Male, Middle Aged, Neoplasm Grading, Neoplasm Metastasis, Neoplasm Staging, Neuroendocrine Tumors metabolism, Neuroendocrine Tumors mortality, Pancreatic Neoplasms metabolism, Pancreatic Neoplasms mortality, Prognosis, Proportional Hazards Models, Receptors, Peptide metabolism, Retrospective Studies, Somatostatin analogs & derivatives, Somatostatin chemistry, Stomach Neoplasms metabolism, Stomach Neoplasms mortality, Treatment Outcome, Intestinal Neoplasms pathology, Intestinal Neoplasms therapy, Isotope Labeling, Neuroendocrine Tumors pathology, Neuroendocrine Tumors therapy, Nucleotides chemistry, Pancreatic Neoplasms pathology, Pancreatic Neoplasms therapy, Somatostatin therapeutic use, Stomach Neoplasms pathology, Stomach Neoplasms therapy
Abstract

Aim: Data from 69 well-differentiated gastroenteropancreatic neuroendocrine tumors treated with peptide receptor radionucleotide therapy + somatostatin analogs (SSAs) after SSA treatment failure were evaluated. Methods: We identified two groups: S1 - patients who kept the same SSA treatment beyond progression; S2 - patients who switched the SSA with another SSA after progression. Results: Median progression-free survival was 53 and 127 months in S1 and S2, respectively (p = 0.001; hazard ratio: 0.31; 95% CI: 0.15-0.63). Median overall survival was 69 versus 150 months in S1 and S2, respectively (p = 0.004; hazard ratio: 0.32; 95% CI: 0.14-0.71). Conclusion: In patients with advanced well-differentiated gastroenteropancreatic neuroendocrine tumors treated with peptide receptor radionucleotide therapy plus SSA after SSA failure, the 'switch' strategy of SSA after progression improve progression-free survival and overall survival.

Published
2019
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14. Treatment of collecting duct carcinoma: current status and future perspectives.

Author

Procopio G, Testa I, Iacovelli R, Grassi P, Verzoni E, Garanzini E, Colecchia M, Torelli T, and De Braud F

Subjects
Adult, Aged, Aged, 80 and over, Cohort Studies, Humans, Indazoles, Middle Aged, Neovascularization, Pathologic drug therapy, Niacinamide analogs & derivatives, Niacinamide therapeutic use, Phenylurea Compounds therapeutic use, Pyrimidines therapeutic use, Sirolimus analogs & derivatives, Sirolimus therapeutic use, Sorafenib, Sulfonamides therapeutic use, Angiogenesis Inhibitors therapeutic use, Antineoplastic Agents therapeutic use, Carcinoma, Renal Cell blood supply, Carcinoma, Renal Cell drug therapy, Kidney Neoplasms blood supply, Kidney Neoplasms drug therapy
Abstract

Background: Chemotherapy for collecting duct carcinoma (CDC) has demonstrated only limited efficacy in the advanced setting. The present study evaluated the activity of targeted therapies in metastatic CDC., Patients and Methods: We evaluated a cohort of 384 consecutive patients with metastatic renal cell carcinoma (mRCC). The characteristics of patients with CDC were compared against those of the remaining cohort. All patients with CDC were treated with targeted therapies., Results: Thirteen patients with advanced CDC were referred to our Center (incidence: 3.4% of all mRCC). Median age was 57 and 62 years in the CDC and non-CDC groups, respectively. The overall disease control in the CDC population was 23%, and median overall survival was 4 (95% confidence interval(CI)=2.4-5.6) months. Three patients obtained a satisfying response (disease control lasting 6-33 months)., Conclusion: CDC has a poor prognosis compared to non-CDC renal cell carcinoma. Treatment for CDC represents a future challenge and targeted therapies may play a role in selected cases.

Published
2014

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