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1. Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real-world results from an expanded access programme

Author

De Giorgi, U, Carteni, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, Cn, Procopio, G, Falcone, A, Roila, F, Cascinu, S, Tirelli, U, Giustini, L, Sobrero, A, Cappuzzo, F, Tortora, G, Tassinari, D, Passalacqua, R, Pazzola, A, Surico, G, Maio, M, Benedetti, G, Barone, C, Adamo, V, Ricevuto, E, De Censi, A, Spada, M, Tonini, G, Pinto, C, Ciuffreda, L, Ruggeri, Em, Bengala, C, Scotti, V, Fagnani, D, Bonetti, A, Mitterer, M, Castiglione, F, Bidoli, P, Ferrau, F, Crino, L, Frassoldati, A, Marchetti, P, Mini, E, Scoppola, A, Verusio, C, Favaretto, A, Di Costanzo, F, Fasola, G, Merlano, M, Artioli, F, Di Leo, A, Romito, S, Maestri, A, Giorgio, Cg, Ionta, Mt, Verderame, F, Zampa, G, Numico, G, Minelli, M, Tagliaferri, P, Foa, P, Palmiotti, G, De Placido, S, Mattioli, R, Iuliano, F, Defraia, E, Siena, S, Clerico, M, Salvagno, L, Ceresoli, Gl, Bernardo, A, Di Lieto, M, Moroni, M, Maisano, M, Scartozzi, M, Scagliotti, G, Soraru, M, Pepe, S, Scaltriti, A, Gebbia, V, Testa, E, Lorusso, V, Bordonaro, R, De Signoribus, G, Tedde, N, Santoro, A, Francini, G, Aondio, G, De Giorgi, U., Carteni, G., Giannarelli, D., Basso, U., Galli, L., Cortesi, E., Caserta, C., Pignata, S., Sabbatini, R., Bearz, A., Buti, S., Lo Re, G., Berruti, A., Bracarda, S., Cognetti, F., Rastelli, F., Fornarini, G., Porta, C., Turci, D., Sternberg, C. N., Procopio, G., Falcone, A., Roila, F., Cascinu, S., Tirelli, U., Giustini, L., Sobrero, A., Cappuzzo, F., Tassinari, D., Passalacqua, R., Pazzola, A., Surico, G., Maio, M., Benedetti, G., Barone, C., Adamo, V., Ricevuto, E., De Censi, A., Spada, M., Tonini, G., Pinto, C., Ciuffreda, L., Ruggeri, E. M., Bengala, C., Scotti, V., Fagnani, D., Bonetti, A., Mitterer, M., Castiglione, F., Bidoli, P., Ferrau, F., Crino, L., Frassoldati, A., Marchetti, P., Mini, E., Scoppola, A., Verusio, C., Favaretto, A., Di Costanzo, F., Fasola, G., Merlano, M., Artioli, F., Di Leo, A., Romito, S., Maestri, A., Giannitto Giorgio, C., Ionta, M. T., Verderame, F., Zampa, G., Numico, G., Minelli, M., Tagliaferri, P., Foa, P., Palmiotti, G., De Placido, S., Mattioli, R., Iuliano, F., Defraia, E., Siena, S., Clerico, M., Salvagno, L., Ceresoli, G. L., Bernardo, A., Di Lieto, M., Moroni, M., Maisano, M., Scartozzi, M., Scagliotti, G., Soraru, M., Pepe, S., Scaltriti, A., Gebbia, V., Testa, E., Lorusso, V., Bordonaro, R., De Signoribus, G., Tedde, N., Santoro, A., Francini, G., Aondio, G., De Giorgi, U, Cartenì, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, C, Procopio, G, and Bidoli, P

Subjects
0301 basic medicine, Male, expanded access programme, nivolumab, real-world experience, renal cell cancer, Antineoplastic Agent, 0302 clinical medicine, Antineoplastic Agents, Immunological, 80 and over, Sunitinib, Medicine, Urology, Aged, 80 and over, Sulfonamides, Brain Neoplasms, Kidney Neoplasm, Common Terminology Criteria for Adverse Events, Middle Aged, Kidney Neoplasms, Progression-Free Survival, Survival Rate, Everolimu, Immunological, Response Evaluation Criteria in Solid Tumors, 030220 oncology & carcinogenesis, Retreatment, Female, Nivolumab, medicine.drug, Human, Adult, medicine.medical_specialty, Indazoles, metastatic renal cancer, Response Evaluation Criteria in Solid Tumor, Antineoplastic Agents, Bone Neoplasms, Bone Neoplasm, expanded access programme, nivolumab, real-world experience, renal cell cancer, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Antineoplastic Agents, Immunological, Bone Neoplasms, Brain Neoplasms, Carcinoma, Renal Cell, Everolimus, Female, Humans, Kidney Neoplasms, Male, Middle Aged, Nivolumab, Progression-Free Survival, Pyrimidines, Response Evaluation Criteria in Solid Tumors, Retreatment, Sulfonamides, Sunitinib, Survival Rate, Sulfonamide, Pazopanib, Brain Neoplasm, 03 medical and health sciences, Aged, Carcinoma, Renal Cell, Everolimus, Humans, Pyrimidines, Internal medicine, Progression-free survival, Survival rate, business.industry, Carcinoma, Renal Cell, 030104 developmental biology, Pyrimidine, Expanded access, business
Abstract

Objective: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Expanded Access Programme. Patients and Methods: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Results: A total of 389 patients were enrolled between July 2015 and April 2016, of whom 18% were aged ≥75 years, 6.7% had non-clear cell RCC, 49.6% had bone and 8.2% brain metastases, and 79% had received ≥2 previous lines of therapy. The most common any-grade treatment-related AEs were fatigue (13%) and rash (9%). Twenty-two patients (5.7%) discontinued treatment because of AEs. There were no treatment-related deaths. The objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% confidence interval 3.7–6.2) and the 12-month overall survival rate was 63%. Similar survival rates were reported among patients with non-clear-cell histology, elderly patients, those with bone and/or brain metastases, and those who had received prior first-line sunitinib or pazopanib, or prior everolimus. Conclusion: The safety and efficacy observed were consistent with those reported in the pivotal Checkmate 025 trial. Results in patients with non-clear-cell mRCC who were elderly, pretreated with everolimus, and had bone and/or brain metastases encourage the use of nivolumab in these categories of patients. © 2018 The Authors BJU International

Published
2019

2. Incidence of neuroepithelial primary brain tumors among adult population of Emilia-Romagna Region, Italy

Author

Baldin, Elisa, Testoni, Stefania, de Pasqua, Silvia, Ferro, Salvatore, Albani, Fiorenzo, Baruzzi, Agostino, D’alessandro, Roberto, On behalf of PERNO study group, Null, Baruzzi, A., Albani, F., Calbucci, F., D’alessandro, R., Michelucci, R., Brandes, A., Eusebi, V., Ceruti, Stefano, Fainardi, Enrico, Tamarozzi, R., Emiliani, E., Cavallo, Michele Alessandro, Franceschi, E., Tosoni, A., Cavallo, M., Fiorica, F., Valentini, A., Depenni, R., Mucciarini, C., Crisi, G., Sasso, E., Biasini, C., Cavanna, L., Guidetti, D., Marcello, N., Pisanello, A., Cremonini, A. M., Guiducci, G., de Pasqua, S., Testoni, S., Agati, R., Ambrosetto, G., Bacci, A., Baldin, E., Baldrati, A., Barbieri, E., Bartolini, S., Bellavista, E., Bisulli, F., Bonora, E., Bunkheila, F., Carelli, V., Crisci, M., Dall’occa, P., Ferro, S., Franceschi, C., Frezza, G., Grasso, V., Leonardi, M., Mostacci, B., Palandri, G., Pasini, E., Pastore Trossello, M., Poggi, R., Riguzzi, P., Rinaldi, R., Rizzi, S., Romeo, G., Spagnolli, F., Tinuper, P., Trocino, C., Dall’agata, M., Faedi, M., Frattarelli, M., Gentili, G., Giovannini, A., Iorio, P., Pasquini, U., Galletti, G., Guidi, C., Neri, W., Patuelli, A., Strumia, S., Casmiro, M., Gamboni, A., Rasi, F., Cruciani, G., Cenni, P., Dazzi, C., Guidi, A. R., Zumaglini, F., Amadori, A., Pasini, G., Pasquinelli, M., Pasquini, E., Polselli, A., Ravasio, A., Viti, B., Sintini, M., Ariatti, A., Bertolini, F., Bigliardi, G., Carpeggiani, P., Cavalleri, F., Meletti, S., Nichelli, P., Pettorelli, E., Pinna, G., Zunarelli, E., Artioli, F., Bernardini, I., Costa, M., Greco, G., Guerzoni, R., Stucchi, C., Iaccarino, C., Ragazzi, M., Rizzi, R., Zuccoli, G., Api, P., Cartei, F., Fallica, Elisa, Granieri, Enrico Gavino Giuseppe, Latini, Francesco, Lelli, G., Monetti, C., Saletti, A., Schivalocchi, Roberta, Seraceni, S., Tola, Maria Rosaria, Urbini, B., Giorgi, C., Montanari, E., Cerasti, D., Crafa, P., Dascola, I., Florindo, I., Giombelli, E., Mazza, S., Ramponi, Vania, Servadei, F., Silini, E. M., Torelli, P., Immovilli, P., Morelli, N., Vanzo, C., Nobile, C., Baldin, Elisa, Testoni, Stefania, De Pasqua, Silvia, Ferro, Salvatore, Albani, Fiorenzo, Baruzzi, Agostino, D'Alessandro, Roberto, On behalf of PERNO study group, Baruzzi, A., Albani, F., Calbucci, F., D'Alessandro, R., Michelucci, R., Brandes, A., Eusebi, V., Ceruti, S., Fainardi, E., Tamarozzi, R., Emiliani, E., Cavallo, M., Franceschi, E., Tosoni, A., Fiorica, F., Valentini, A., Depenni, R., Mucciarini, C., Crisi, G., Sasso, E., Biasini, C., Cavanna, L., Guidetti, D., Marcello, N., Pisanello, A., Cremonini, A. M., Guiducci, G., de Pasqua, S., Testoni, S., Agati, R., Ambrosetto, G., Bacci, A., Baldin, E., Baldrati, A., Barbieri, E., Bartolini, S., Bellavista, E., Bisulli, F., Bonora, E., Bunkheila, F., Carelli, V., Crisci, M., Dall'Occa, P., Ferro, S., Franceschi, C., Frezza, G., Grasso, V., Leonardi, M., Mostacci, B., Palandri, G., Pasini, E., Pastore Trossello, M., Poggi, R., Riguzzi, P., Rinaldi, R., Rizzi, S., Romeo, G., Spagnolli, F., Tinuper, P., Trocino, C., Dall'Agata, M., Faedi, M., Frattarelli, M., Gentili, G., Giovannini, A., Iorio, P., Pasquini, U., Galletti, G., Guidi, C., Neri, W., Patuelli, A., Strumia, S., Casmiro, M., Gamboni, A., Rasi, F., Cruciani, G., Cenni, P., Dazzi, C., Guidi, A. R., Zumaglini, F., Amadori, A., Pasini, G., Pasquinelli, M., Pasquini, E., Polselli, A., Ravasio, A., Viti, B., Sintini, M., Ariatti, A., Bertolini, F., Bigliardi, G., Carpeggiani, P., Cavalleri, F., Meletti, S., Nichelli, P., Pettorelli, E., Pinna, G., Zunarelli, E., Artioli, F., Bernardini, I., Costa, M., Greco, G., Guerzoni, R., Stucchi, C., Iaccarino, C., Ragazzi, M., Rizzi, R., Zuccoli, G., Api, P., Cartei, F., Fallica, E., Granieri, E., Latini, F., Lelli, G., Monetti, C., Saletti, A., Schivalocchi, R., Seraceni, S., Tola, M. R., Urbini, B., Giorgi, C., Montanari, E., Cerasti, D., Crafa, P., Dascola, I., Florindo, I., Giombelli, E., Mazza, S., Ramponi, V., Servadei, F., Silini, E. M., Torelli, P., Immovilli, P., Morelli, N., Vanzo, C., and Nobile, C.

Subjects
Registrie, Male, Pediatrics, Neurology, Survival, Epidemiology, medicine.medical_treatment, Primary brain tumors, 0302 clinical medicine, Neoplasms, 80 and over, Medicine, Oligodendroglial Tumor, Registries, Neuroradiology, Aged, 80 and over, education.field_of_study, Brain Neoplasms, Incidence (epidemiology), Incidence, General Medicine, Middle Aged, Neoplasms, Neuroepithelial, Glioblastoma, Incidence rate, Adult, Aged, Female, Humans, Italy, 2708, Neurology (clinical), Psychiatry and Mental Health, 030220 oncology & carcinogenesis, Neurosurgery, Human, medicine.medical_specialty, Population, Neuroepithelial, Dermatology, Primary brain tumor, NO, Brain Neoplasm, 03 medical and health sciences, education, business.industry, Radiation therapy, business, 030217 neurology & neurosurgery
Abstract

Incidence of neuroepithelial Primary Brain Tumors (nPBT) varies, ranging from 7.3 to 11.6 cases/100,000/year across Europe. We present incidence and survival of nPBT in the Emilia-Romagna region (ER), Italy. This study is the largest in Southern Europe. Specialists in neurosurgery, neurology, neuroradiology, oncology, radiotherapy, genetics, and pathology of ER notified all suspected nPBT adult cases residing in ER (4,337,966 inhabitants) observed during 2009. Furthermore, through ICD-9 discharge codes, we identified and reviewed all possible cases. Neuroepithelial PBT diagnosis was based on histological or radiological findings. We included 400 incident nPBT cases, of which 102 (25%) were retrospectively identified. These latter were significantly older. The standardized incidence was 10.5/100,000/year (95% CI 9.4–11.5), higher for men. It was 9.2/100,000/year (95% CI 8.3–10.2) for astrocytic tumors, 0.6/100,000/year (95% CI 0.4–0.9) for oligodendroglial tumors, and 7.1 (95% CI 6.3–8.0) for glioblastoma (GBM). Among GBM patients, median survival was 249 days if prospectively identified vs. 132 days when identified through ICD-9 codes (pÂ

Published
2017

3. Which elderly newly diagnosed glioblastoma patients can benefit from radiotherapy and temozolomide? A PERNO prospective study

Author

Franceschi, Enrico, Depenni, R., Paccapelo, Alexandro, Ermani, Mario, Faedi, M., Sturiale, Carmelo, Michiara, Maria, Servadei, F., Pavesi, Giacomo, Urbini, B., Pisanello, A., Crisi, G., Cavallo, Michele A., Dazzi, C., Biasini, C., Bertolini, F., Mucciarini, C., Pasini, G., Baruzzi, Agostino, Brandes, Alba A, Albani, F., Calbucci, F., D’Alessandro, R., Michelucci, R., de Pasqua, S., Testoni, S., Brandes, A., Franceschi, E., Tosoni, A., Eusebi, V., Ceruti, S., Fainardi, E., Tamarozzi, R., Emiliani, E., Cavallo, M., Fiorica, F., Sasso, E., Cavanna, L., Guidetti, D., Marcello, N., Cremonini, A. M., Guiducci, G., Agati, R., Ambrosetto, G., Bacci, A., Baldin, E., Baldrati, A., Barbieri, E., Bartolini, S., Bellavista, E., Bisulli, F., Bonora, E., Bunkheila, F., Carelli, V., Crisci, M., Dall’Occa, P., de Biase, D., Ferro, S., Franceschi, C., Frezza, G., Grasso, V., Leonardi, M., Marucci, G., Morandi, L., Mostacci, B., Palandri, G., Pasini, E., Pastore Trossello, M., Pession, A., Poggi, R., Riguzzi, P., Rinaldi, R., Rizzi, S., Romeo, G., Spagnolli, F., Tinuper, P., Trocino, C., Dall’Agata, M., Frattarelli, M., Gentili, G., Giovannini, A., Iorio, P., Pasquini, U., Galletti, G., Guidi, C., Neri, W., Patuelli, A., Strumia, S., Casmiro, M., Gamboni, A., Rasi, F., Cruciani, G., Cenni, P., Guidi, A. R., Zumaglini, F., Amadori, A., Pasquinelli, M., Pasquini, E., Polselli, A., Ravasio, A., Viti, B., Sintini, M., Ariatti, A., Bigliardi, G., Carpeggiani, P., Cavalleri, F., Meletti, Stefano, Nichelli, Paolo Frigio, Pettorelli, E., Pinna, G., Zunarelli, E., Artioli, F., Bernardini, I., Costa, M., Greco, G., Guerzoni, R., Stucchi, C., Iaccarino, C., Ragazzi, M., Rizzi, R., Zuccoli, G., Api, P., Cartei, F., Colella, M., Fallica, E., Farneti, M., Frassoldati, A., Granieri, E., Latini, F., Monetti, C., Saletti, A., Schivalocchi, R., Sarubbo, S., Seraceni, S., Tola, M. R., Zini, G., Giorgi, C., Montanari, E., Cerasti, D., Crafa, P., Dascola, I., Florindo, I., Giombelli, E., Mazza, S., Ramponi, V., Silini, E. M., Torelli, P., Immovilli, P., Morelli, N., Vanzo, C., Nobile, C., Franceschi, E., Depenni, R., Paccapelo, Alexandro, Ermani, Mario, Faedi, M., Sturiale, Carmelo, Michiara, Maria, Servadei, F., Pavesi, Giacomo, Urbini, B., Pisanello, A., Crisi, G., Cavallo, Michele A., Dazzi, C., Biasini, C., Bertolini, F., Mucciarini, C., Pasini, G., Baruzzi, Agostino, Brandes, Alba A., Albani, F., Calbucci, F., D’Alessandro, R., Michelucci, R., de Pasqua, S., Testoni, S., Brandes, A., Tosoni, A., Eusebi, V., Ceruti, S., Fainardi, E., Tamarozzi, R., Emiliani, E., Cavallo, M., Fiorica, F., Sasso, E., Cavanna, L., Guidetti, D., Marcello, N., Cremonini, A.M., Guiducci, G., Agati, R., Ambrosetto, G., Bacci, A., Baldin, E., Baldrati, A., Barbieri, E., Bartolini, S., Bellavista, E., Bisulli, F., Bonora, E., Bunkheila, F., Carelli, V., Crisci, M., Dall’Occa, P., de Biase, D., Ferro, S., Franceschi, C., Frezza, G., Grasso, V., Leonardi, M., Marucci, G., Morandi, L., Mostacci, B., Palandri, G., Pasini, E., Pastore Trossello, M., Pession, A., Poggi, R., Riguzzi, P., Rinaldi, R., Rizzi, S., Romeo, G., Spagnolli, F., Tinuper, P., Trocino, C., Dall’Agata, M., Frattarelli, M., Gentili, G., Giovannini, A., Iorio, P., Pasquini, U., Galletti, G., Guidi, C., Neri, W., Patuelli, A., Strumia, S., Casmiro, M., Gamboni, A., Rasi, F., Cruciani, G., Cenni, P., Guidi, A.R., Zumaglini, F., Amadori, A., Pasquinelli, M., Pasquini, E., Polselli, A., Ravasio, A., Viti, B., Sintini, M., Ariatti, A., Bigliardi, G., Carpeggiani, P., Cavalleri, F., Meletti, S., Nichelli, P., Pettorelli, E., Pinna, G., Zunarelli, E., Artioli, F., Bernardini, I., Costa, M., Greco, G., Guerzoni, R., Stucchi, C., Iaccarino, C., Ragazzi, M., Rizzi, R., Zuccoli, G., Api, P., Cartei, F., Colella, M., Fallica, E., Farneti, M., Frassoldati, A., Granieri, E., Latini, F., Monetti, C., Saletti, A., Schivalocchi, R., Sarubbo, S., Seraceni, S., Tola, M.R., Zini, G., Giorgi, C., Montanari, E., Cerasti, D., Crafa, P., Dascola, I., Florindo, I., Giombelli, E., Mazza, S., Ramponi, V., Silini, E.M., Torelli, P., Immovilli, P., Morelli, N., Vanzo, C., and Nobile, C.

Subjects
Oncology, medicine.medical_specialty, Cancer Research, medicine.medical_treatment, Dacarbazine, Population, Context (language use), NO, 03 medical and health sciences, 0302 clinical medicine, Elderly, Internal medicine, medicine, Temozolomide, Humans, MGMT methylation, Prospective Studies, Prospective cohort study, education, Promoter Regions, Genetic, Antineoplastic Agents, Alkylating, DNA Modification Methylases, Survival analysis, Aged, Aged, 80 and over, education.field_of_study, Radiotherapy, business.industry, Brain Neoplasms, Tumor Suppressor Proteins, Glioblastoma, Neurology (clinical), Neurology, DNA Methylation, Survival Analysis, Surgery, Radiation therapy, DNA Repair Enzymes, 030220 oncology & carcinogenesis, Concomitant, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

The role of temozolomide concurrent with and adjuvant to radiotherapy (RT/TMZ) in elderly patients with glioblastoma (GBM) remains unclear. We evaluated the outcome of patients >70 years in the context of the Project of Emilia-Romagna Region in Neuro-Oncology (PERNO), the first Italian prospective observational population-based study in neuro-oncology. For this analysis the criteria for selecting patients enrolled in the PERNO study were: age >70 years; PS 0–3; histologically confirmed GBM; postoperative radiotherapy (RT) after surgery with or without concomitant temozolomide (TMZ) or postsurgical TMZ alone. Between January 2009 and December 2010, 76 GBM elderly patients were identified in the prospective PERNO study. Twenty-three patients did not receive any treatment after surgery, and 53 patients received postsurgical treatments (25 patients received RT alone and 28 patients RT/TMZ). Median survival was 11.1 months (95 % CI 8.8–13.5), adding temozolomide concomitant and adjuvant to radiotherapy it was 11.6 months (95 % CI 8.6–14.6), and 9.3 months (95 % CI 8.1–10.6) in patients treated with RT alone (P = 0.164). However, patients with MGMT methylated treated with RT/TMZ obtained a better survival (17.2 months, 95 % CI 11.5–22.9) (P = 0.042). No difference in terms of survival were observed if patients with MGMT unmethylated tumor received RT alone, or RT/TMZ or, in MGMT methylated tumor, if patients received radiotherapy alone. In elderly patients RT/TMZ represent a widely used approach but it is effective with methylated MGMT tumors only.

Published
2016

4. Incidence of breast cancer in Italy: mastectomies and quadrantectomies performed between 2000 and 2005

Author

Piscitelli, P, Santoriello, A, Buonaguro, Fm, DI MAIO, M, Iolascon, G, Gimigliano, F, Marinelli, A, Distante, Alessandro, Serravezza, G, Sordi, E, Cagossi, K, Artioli, F, Santangelo, M, Fucito, A, Gimigliano, R, Brandi, Ml, Crespi, M, Giordano, A, Crom, HUMAN HEALTH FOUNDATION STUDY GROUP, Piscitelli, P, Santoriello, A, Buonaguro, Fm, DI MAIO, M, Iolascon, Giovanni, Gimigliano, Francesca, Marinelli, Alessandra, Distante, A, Serravezza, G, Sordi, E, Cagossi, K, Artioli, F, Santangelo, M, Fucito, A, Gimigliano, Raffaele, Brandi, Ml, Crespi, M, Giordano, A, Crom, HUMAN HEALTH FOUNDATION STUDY, Group, Prisco, Piscitelli, Antonio, Santoriello, Franco M., Buonaguro, Massimo, Dimaio, Giovanni, Iolascon, Francesca, Gimigliano, Alessandra, Marinelli, Alessandro, Distante, Giuseppe, Serravezza, Emiliano, Sordi, Katia, Cagossi, Fabrizio, Artioli, Santangelo, Michele, Alfredo, Fucito, Raffaele, Gimigliano, Maria Luisa, Brandi, Massimo, Crespi, and Antonio, Giordano

Subjects
Adult, medicine.medical_specialty, Cancer Research, Time Factors, Databases, Factual, Time Factor, medicine.medical_treatment, Breast surgery, Breast Neoplasms, Mastectomy, Segmental, lcsh:RC254-282, Young Adult, Breast cancer, Age groups, medicine, Humans, Young adult, Aged, Mastectomy, Simple, Gynecology, business.industry, Obstetrics, Incidence (epidemiology), Research, Incidence, Middle Aged, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Italy, Oncology, Christian ministry, Female, Databases, Factual, Mastectomy, Segmental, Simple, business, Breast Neoplasm, Human
Abstract

Objectives: We aimed to determine the incidence of women's breast cancer in Italy without using statistical approximations. Methods: We analyzed the national hospitalizations database at the Ministry of Health to calculate the number of major surgeries in Italian women (mastectomies and quadrantectomies) due to breast cancer between 2000 and 2005, overall and by age groups (= 75 years old). Results: Over the six years examined, an overall number of 100,745 mastectomies and 168,147 quadrantectomies were performed. A total of 41,608 major surgeries due to breast cancer were performed in the year 2000 and this number rose to 47,200 in 2005, with a 13.4% increase over six years. Conclusion: by analyzing the hospitalizations database concerning major breast surgery, incidence of breast cancer in Italy was found to be 26.5% higher than the official estimations which have been computed using statistical models (namely 47,200 vs. 37,300 cases in year 2005). Objectives. We aimed to determine the incidence of women's breast cancer in Italy without using statistical approximations. Methods. We analyzed the national hospitalizations database at the Ministry of Health to calculate the number of major surgeries in Italian women (mastectomies and quadrantectomies) due to breast cancer between 2000 and 2005, overall and by age groups (

Published
2009

5. Expression of 19 microRNAs in glioblastoma and comparison with other brain neoplasia of grades I-III

Author

Visani, M, de Biase, D, Marucci, G, Cerasoli, S, Nigrisoli, E, Bacchi Reggiani ML, Albani, F, Baruzzi, A, Pession, A, Calbucci, F, D'Alessandro, R, Michelucci, R, Brandes, A, Eusebi, V, Ceruti, S, Fainardi, E, Tamarozzi, R, Emiliani, E, Cavallo, M, Franceschi, E, Tosoni, A, Fiorica, F, Valentini, A, Depenni, R, Mucciarini, C, Crisi, G, Sasso, E, Biasini, C, Cavanna, L, Guidetti, D, Marcello, N, Pisanello, A, Cremonini, Am, Guiducci, G, Agati, R, Ambrosetto, G, Bacci, A, Baldin, E, Baldrati, A, Barbieri, E, Bartolini, S, Bellavista, E, Bisulli, F, Bonora, E, Bunkheila, F, Carelli, V, Crisci, M, Dall'Occa, P, Ferro, S, Franceschi, C, Frezza, G, Grasso, V, Leonardi, M, Morandi, L, Mostacci, B, Palandri, G, Pasini, E, Pastore Trossello, M, Poggi, R, Riguzzi, P, Rinaldi, R, Rizzi, S, Romeo, G, Spagnolli, F, Tinuper, P, Trocino, C, Dall'Agata, M, Frattarelli, M, Gentili, G, Giovannini, A, Iorio, P, Pasquini, U, Galletti, G, Guidi, C, Neri, W, Patuelli, A, Strumia, S, Faedi, M, Casmiro, M, Gamboni, A, Rasi, F, Cruciani, G, Cenni, P, Dazzi, C, Guidi, Ar, Zumaglini, F, Amadori, A, Pasini, G, Pasquinelli, M, Pasquini, E, Polselli, A, Ravasio, A, Viti, B, Sintini, M, Ariatti, A, Bertolini, F, Bigliardi, G, Carpeggiani, P, Cavalleri, F, Meletti, S, Nichelli, P, Pettorelli, E, Pinna, G, Zunarelli, E, Artioli, F, Bernardini, I, Costa, M, Greco, G, Guerzoni, R, Stucchi, C, Iaccarino, C, Ragazzi, M, Rizzi, R, Zuccoli, G, Api, P, Cartei, F, Fallica, E, Granieri, E, Latini, F, Lelli, G, Monetti, C, Saletti, A, Schivalocchi, R, Seraceni, S, Tola, Mr, Urbini, B, Giorgi, C, Montanari, E, Cerasti, D, Crafa, P, Dascola, I, Florindo, I, Giombelli, E, Mazza, S, Ramponi, V, Servadei, F, Silini, Em, Torelli, P, Immovilli, P, Morelli, N, Vanzo, C, Nobile, C, Michela Visani, Dario de Biase, Gianluca Marucci, Serenella Cerasoli, Evandro Nigrisoli, Maria Letizia Bacchi Reggiani, Fiorenzo Albani, Agostino Baruzzi, Annalisa Pession, the PERNO study group [, Elena Bonora, and ]

Subjects
Adult, Male, Cancer Research, Low-grade brain tumor, Brain neoplasia, Glioblastoma, Low-grade brain tumors, MicroRNA, Real-time PCR, Aged, Brain Neoplasms, Female, Gene Expression Profiling, Humans, MicroRNAs, Middle Aged, Neoplasm Grading, RNA, Neoplasm, Gene Expression Regulation, Neoplastic, Genetics, Molecular Medicine, Biology, Bioinformatics, medicine.disease_cause, NO, Brain Neoplasm, Genetic, microRNA, medicine, Locked nucleic acid, MicroRNA, Glioblastoma, Brain neoplasia, Low-grade brain tumors, Real-time PCR, Cancer, General Medicine, medicine.disease, Molecular medicine, Fold change, Gene expression profiling, Real-time polymerase chain reaction, Oncology, Cancer research, Carcinogenesis, Corrigendum, Human
Abstract

Several biomarkers have been proposed as useful parameters to better specify the prognosis or to delineate new target therapy strategies for glioblastoma patients. MicroRNAs could represent putative target molecules, considering their role in tumorigenesis, cancer progression and their specific tissue expression. Although several studies have tried to identify microRNA signature for glioblastoma, a microRNA profile is still far from being well-defined. In this work the expression of 19 microRNAs (miR-7, miR-9, miR-9∗, miR-10a, miR-10b, miR-17, miR-20a, miR-21, miR-26a, miR-27a, miR-31, miR-34a, miR-101, miR-137, miR-182, miR-221, miR-222, miR-330, miR-519d) was evaluated in sixty formalin-fixed and paraffin-embedded glioblastoma samples using a locked nucleic acid real-time PCR. Moreover, a comparison of miRNA expressions was performed between primary brain neoplasias of different grades (grades IV-I). The analysis of 14 validated miRNA expression in the 60 glioblastomas, using three different non-neoplastic references as controls, revealed a putative miRNA signature: mir-10b and miR-21 were up-regulated, while miR-7, miR-31, miR-101, miR-137, miR-222 and miR-330 were down-regulated in glioblastomas. Comparing miRNA expression between glioblastoma group and gliomas of grades I-III, 3 miRNAs (miR-10b, mir-34a and miR-101) showed different regulation statuses between high-grade and low-grade tumors. miR-10b was up-regulated in high grade and significantly down-regulated in low-grade gliomas, suggesting that could be a candidate for a GBM target therapy. This study provides further data for the identification of a miRNA profile for glioblastoma and suggests that different-grade neoplasia could be characterized by different expression of specific miRNAs.

Published
2014

6. Definition of miRNAs Expression Profile in Glioblastoma Samples: The Relevance of Non-Neoplastic Brain Reference

Author

Visani, Michela, De Biase, Dario, Marucci, Gianluca, Taccioli, Cristian, Baruzzi, Agostino, Pession, Annalisa, Baruzzi, A., Albani, F., Calbucci, F., D'alessandro, R., Michelucci, R., Brandes, A., Eusebieusebi, V., Ceruti, S., Fainardi, E., Tamarozzi, R., Emiliani, E., Cavallo, M., Franceschi, E., Tosoni, A., Fiorica, F., Valentini, A., Depenni, R., Mucciarini, C., Crisi, G., Sasso, E., Biasini, C., Cavanna, L., Guidetti, D., Marcello, N., Pisanello, A., Cremonini, A. M., Guiducci, G., De Pasqua, S., Testoni, S., Agati, R., Ambrosetto, G., Bacci, A., Baldin, E., Baldrati, A., Barbieri, E., Bartolini, S., Bellavista, E., Bisulli, F., Bonora, E., Bunkheila, F., Carelli, V., Crisci, M., Dall'occa, P., Ferro, S., Franceschi, C., Frezza, G., Grasso, V., Leonardi, M., Mostacci, B., Palandri, G., Pasini, E., Pastore Trossello, M., Poggi, R., Riguzzi, P., Rinaldi, R., Rizzi, S., Romeo, G., Spagnolli, F., Tinuper, P., Trocino, C., Cerasoli, S., Dall'agata, M., Faedi, M., Frattarelli, M., Gentili, G., Giovannini, A., Iorio, P., Pasquini, U., Galletti, G., Guidi, C., Neri, W., Patuelli, A., Strumia, S., Casmiro, M., Gamboni, A., Rasi, F., Cruciani, G., Cenni, P., Dazzi, C., Guidi, A. R., Zumaglini, F., Amadori, A., Pasini, G., Pasquinelli, M., Pasquini, E., Polselli, A., Ravasio, A., Viti, B., Sintini, M., Ariatti, A., Bertolini, F., Bigliardi, G., Carpeggiani, P., Cavalleri, F., Meletti, S., Nichelli, P., Pettorelli, E., Pinna, G., Zunarelli, E., Artioli, F., Bernardini, I., Costa, M., Greco, G., Guerzoni, R., Stucchi, C., Iaccarino, C., Ragazzi, M., Rizzi, R., Zuccoli, G., Api, P., Cartei, F., Fallica, E., Granieri, E., Latini, F., Lelli, G., Monetti, C., Saletti, A., Schivalocchi, R., Seraceni, S., Tola, M. R., Urbini, B., Giorgi, C., Montanari, E., Cerasti, D., Crafa, P., Dascola, I., Florindo, I., Giombelli, E., Mazza, S., Ramponi, V., Servadei, F., Silini, E. M., Torelli, P., Immovilli, P., Morelli, N., Vanzo, C., Nobile, C., M. Visani, D. de Biase, G. Marucci, C. Taccioli, A. Baruzzi, A. Pession, Perno Study Group, F. Albani, V. Eusebi, F. Bisulli, V. Carelli, M. Leonardi, B. Mostacci, P. Tinuper, the PERNO Study group [, E. Bonora, and ]

Subjects
Male, Genetics and Molecular Biology (all), Adult, Aged, Brain, Female, Gene Expression Profiling, Gene Expression Regulation, Neoplastic, Glioblastoma, Humans, MicroRNAs, Middle Aged, Real-Time Polymerase Chain Reaction, Reference Values, Statistics, Nonparametric, Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), Gene Expression, Bioinformatics, Biochemistry, Surgical oncology, Nucleic Acids, metabolism, Female, Gene Expression Profiling, Molecular Cell Biology, Basic Cancer Research, Gene expression, normal adjacent the tumor, Neurological Tumors, methods, Gene Expression Regulation, brain tumors, glioblastoma, miRNAs, Multidisciplinary, Cancer Risk Factors, Medicine (all), Statistics, non-neoplastic brain, Real-time polymerase chain reaction, Oncology, miRNAs, Medicine, DNA microarray, brain RNA commercial reference, Research Article, Adult, Aged, Brain, Neoplastic, genetics/physiology, Glioblastoma, metabolism, Humans, Male, MicroRNAs, metabolism, Middle Aged, Real-Time Polymerase Chain Reaction, Reference Values, Statistics, Nonparametric, Science, Brain tumor, Biology, NO, Molecular Genetics, epileptic tissue, Text mining, microRNA, medicine, miRNA, business.industry, Computational Biology, Cancers and Neoplasms, medicine.disease, Gene expression profiling, Gene Expression Regulation, Cancer research, RNA, brain tumors, metabolism, Middle Aged, Real-Time Polymerase Chain Reaction, Reference Values, Statistic, business, metabolism, Humans, Male, MicroRNA, Glioblastoma Multiforme
Abstract

Glioblastoma is the most aggressive brain tumor that may occur in adults. Regardless of the huge improvements in surgery and molecular therapy, the outcome of neoplasia remains poor. MicroRNAs are small molecules involved in several cellular processes, and their expression is altered in the vast majority of tumors. Several studies reported the expression of different miRNAs in glioblastoma, but one of the most critical point in understanding glioblastoma miRNAs profile is the comparison of these studies. In this paper, we focused our attention on the non-neoplastic references used for determining miRNAs expression. The aim of this study was to investigate if using three different non-neoplastic brain references (normal adjacent the tumor, commercial total RNA, and epileptic specimens) could provide discrepant results. The analysis of 19 miRNAs was performed using Real-Time PCR, starting from the set of samples described above and the expression values compared. Moreover, the three different normal RNAs were used to determine the miRNAs profile in 30 glioblastomas. The data showed that different non-neoplastic controls could lead to different results and emphasize the importance of comparing miRNAs profiles obtained using the same experimental condition.

Published
2013

7. Carpal tunnel syndrome and musculoskeletal symptoms in postmenopausal women with early breast cancer treated with exemestane or tamoxifen after 2-3 years of tamoxifen: a retrospective analysis of the Intergroup Exemestane Study

Author

Mieog, Js, Morden, Jp, Bliss, Jm, Coombes, Rc, van de Velde CJ, IES Steering Committee: Delozier, T, Veronesi, A, Vrdoljak, E, Monnier, A, Coombes, C, Nagykalnai, T, Roumen, Rm, Utracka Hutka, B, Pluzanska, A, Porpiglia, M, Genta, F, Benedetto, Chiara, Sozzani, P, Steiner, M, Rubinov, R, Leviov, M, Semiglazov, V, Fox, J, Mayordomo, Ji, Cervek, J, Sleeboom, Hp, Jassem, J, Hinton, Cp, Paulsen, Th, Guleng, Rj, Fein, L, Gutulescu, N, Florián, J, Rosso, R, Rutgers, Ej, Krzakowski, M, Pienkowski, T, Krajina, Z, Siffnerova, H, Pawlicki, M, Drosik, K, Wagnerowa, M, Brunt, M, Vukelja, S, Mitrowic, L, Cataliotti, L, Karnicka Mlodkowska, H, Bonnefoi, H, Tilch, G, Chollet, P, Patel, A, Kamby, C, Giustini, L, Acito, L, Mouridsen, H, Roche, H, De Lafontan, B, Tomczak, P, Petruzelka, L, Lortholary, A, Pacquola, Mg, Skene, A, Rici, S, Michelotti, A, Ghilezan, N, Stewart, A, Beauduin, M, Andersen, J, Vassilaros, S, Celio, L, Bajetta, E, Bastús, R, Marsland, T, Paridaens, R, Tzekova, V, Lichtenegger, W, Piersma, H, Jones, S, Holmberg, S, Verhoeven, D, Hill, A, Porcile, G, Bruno, Mf, Chernozemski, I, Coleman, R, Jadeja, J, Cohn, A, Merlano, M, Perroni, D, Di Costanzo, F, Van Bochove, A, Gerrits, Ma, Malec, V, Balil, A, Mendiola, C, Dodwell, D, Knox, R, Horgan, K, Joannides, T, Leonard, Rc, Cawthorn, Sj, Ghosh, C, Cantrell, J, Campos, D, Orti, R, Diedrich, K, Aas, H, Barnadas, A, Vila, Mm, Makris, A, Anderson, T, Chittor, S, Michel, J, Philip, P, Redmond, P, Mastboom, Wj, Nordenskjöld, B, Simmonds, P, Grieve, Rj, Tomova, A, Piot, G, Borea, G, Ucci, G, Einarsson, E, Nicholson, S, Gardiol, Ea, Kerger, J, Schlosser, J, Namer, M, Pinotti, G, Rutten, Ht, Iversen, T, Nejim, A, Dudov, A, Grundtvig, P, Lang, I, Massidda, B, Van De Velde CH, Gervasio, Mh, Tengrup, I, Tennvall, L, Goodman, S, Modgill, Vk, Vorobiof, Da, Mickiewicz, E, Chirgwin, J, Focan, C, Albin, N, Contu, Aa, Svensson, Jh, Borghede, G, Källström, Ac, Forbes, Jf, Hurtz, Hj, Tubiana Hulin, M, Viens, P, Scanni, A, Arnoldi, E, Nastasi, G, Bottini, A, Alquati, P, Muscat, V, Brincat, S, Holmen, K, Amaral, N, Moreno, I, Trask, C, Robinson, A, Mcintyre, K, Otsuka, A, Hohaus, B, Hoefig, G, Georgoulias, V, Salvagni, S, Bidin, L, Artioli, F, Engan, T, Benedikstsson, Kp, Campbell, I, Harvey, V, Zimbler, H, Mrsic Krmpotic, Z, Canon, Jl, Tchilingirov, Pv, Buser, K, Bolanca, A, Reztke, U, Rhein, U, Jouve, M, Mullins, G, Vesentini, L, Gallo, L, Merlini, L, Decensi, A, Carreca, I, Van Tienhoven, G, Börjesson, B, Hansen, J, Koza, I, Arcusa, A, Inoriza, A, Pelegri, A, Eremin, O, Modiano, Mr, Anthony, S, Donat, D, Richardet, E, Kochli, O, Zeißig, P, Gauch, G, Aabo, K, Fumoleau, P, Erdkamp, Fl, Lovén, L, Jönsson, Pe, Perren, T, Stuart, N, Galindo, E, Marek, Bj, Salmon, Jp, Dohollou, N, Thompson, R, Folco, U, Rosa, A, Tonato, M, Heijmans, Gj, Koralewski, P, Bång, H, Lescure, Ar, Carrato, A, Martin, M, Neave, F, Howell, T, Savin, M, Loesch, D, Hannois, A, Mohr, A, Laube, T, Omar, S, Bonneterre, J, Servent, V, Danese, S, Sertoli, Mr, Butzelaar, Rm, Steller, Ep, Gomez, H, Skoog, P, Alvarez, I, Aguilar, Ea, Giner, Jl, Yosef, Hm, Barrett Lee, P, Buzdar, Au, George, T, Olivaires, J, Vsianska, M, Köhler, U, Lindeløv, B, Toftdahl, Db, Nielsen, Eb, Veyret, C, Castera, D, Kerbrat, P, Vassilaros, P, Yeo, W, Boni, C, Aitini, E, Luporini, G, Herben, Mg, Espelid, H, Dahl, S, Ingvar, C, Meana, A, Pico, C, Garcia, Am, Agrawal, Rk, Gruenberg, D, Nunez de Pierro, A, Gill, G, Nogaret, Jm, Honhon, B, Wassenaar, H, Nielander, R, Warnier, P, Sessa, C, Padrik, P, Guastalla, Jp, Serin, D, Jaubert, D, Dank, M, Given, Fh, Mascia, V, De Fraia, E, Silingardi, V, Conte, Pf, Labianca, R, Tondini, C, Bagnulo, A, Gardani, G, Wils, J, Liem, G, Nuytinck, Jk, Formoe, E, Ambré, T, Alés, J, Aramburo, P, Mansi, J, Graham, J, Joffe, J, Sainsbury, J, Stone, J, Good, Rh, Cartwright, T, Werner, Id, Murray, E, Beith, J, Tigges, Fj, Bojko, P, Sandberg, E, Jensen, B, Lotz, Jp, Carney, D, Shapira, J, Neumann, A, Goldhirsch, A, Dicato, M, de Graaf, H, Maartense, E, Burghouts, J, Cassinello, J, Jones, A, Gaffney, C, Blum, R, Abdi, E, Becquart, D, Dirix, L, Janssens, J, Nmarschner, N, Blaska Jaulerry, B, Prevot, G, Mirah Lev, L, Shani, A, Baruch, Nb, Peretz, T, Gips, M, Cognetti, F, Carlini, P, Nortier, Jw, Huinink D, ten B., Roussel, Jg, Unneberg, K, Kylberg, F, Hovind, H, Nestvold, T, Fogelkvist, R, Due, J, Muller, S, Gilligan, D, Russel, S, Mcaleer, J, Yiangou, C, Foote, L, Schottstaedt, M, Holmes, Fa, Wainstein, R, Contreras, O, Martinez, J, Della Fiorentina, S, Beslija, S, Vermorken, Jb, Thirion, M, Fraikin, J, Castiglione, M, Jäger, W, Fasching, P, Fabriz, H, Neis, K, Kirschbaum, M, Labat, Jp, Dupuis, O, Bernard, J, Datchary, J, Provencal, J, Allain, P, Clerico, M, Lopez, M, Nalli, G, Aspevik, R, Fràguas, A, Curescu, S, Cuevas, Jm, Oltra, A, Bradley, C, Kapoor, R, Akbain, S, Croghan, Mk, Modiano, M, Taetle, R, Beale, P, Gobert, P, Bondue, H, Böhm, R, Møller, Ka, Brettes, Jp, Netter, G, Grogan, L, Klein, B, Botta, M, Barni, S, Van Meerwijk, I, Kåresen, R, Godes, J, Aramburo, A, Jara, C, Zanger, B, Fleagle, Jt, Greenspan, A, Marschke, R, Medgyesy, Dc, Garbo, L., CCA -Cancer Center Amsterdam, and Radiotherapy

Subjects
medicine.medical_specialty, Population, Breast Neoplasms, Disease-Free Survival, chemistry.chemical_compound, Breast cancer, Exemestane, Internal medicine, Surveys and Questionnaires, medicine, Clinical endpoint, Humans, Carpal tunnel syndrome, education, Aged, Retrospective Studies, Aged, 80 and over, education.field_of_study, business.industry, Aromatase Inhibitors, Hazard ratio, Middle Aged, medicine.disease, Carpal Tunnel Syndrome, Surgery, Musculoskeletal Abnormalities, Androstadienes, Postmenopause, Tamoxifen, Treatment Outcome, Oncology, chemistry, Hormonal therapy, Female, business, medicine.drug
Abstract

BACKGROUND: Aromatase inhibitors are more effective than is tamoxifen in prevention of breast-cancer recurrence, but at the expense of increased musculoskeletal side-effects, such as carpal tunnel syndrome. The aim of this study was to assess risk factors and the prognostic value of musculoskeletal symptoms during treatment with the steroidal aromatase inhibitor exemestane or with tamoxifen after 2-3 years of tamoxifen. METHODS: In the Intergroup Exemestane Study, postmenopausal women treated for early invasive breast cancer who remained disease free and on treatment after 2-3 years of tamoxifen were randomised to switch to exemestane or to continue tamoxifen for the remainder of the 5-year period of endocrine treatment. The primary endpoint for this retrospective analysis was occurrence of carpal tunnel syndrome and any musculoskeletal events, analysed in the safety population, which consisted of all patients who had received any trial treatment. As well as case-report forms, questionnaires were distributed retrospectively to gain more details of cases of carpal tunnel syndrome. The relation between musculoskeletal symptoms reported by 6 months from randomisation and survival from 9 months onwards was assessed by Cox proportional hazards models. The trial is registered, number ISRCTN11883920. It has completed accrual and follow-up is continuing for enrolled participants. FINDINGS: After a median follow-up of 91·0 months (IQR 83·0-99·2), carpal tunnel syndrome had been reported for 66 (2·8%) of 2319 patients in the exemestane group compared with 13 (0·6%) of 2338 in the tamoxifen group (odds ratio [OR] 5·23, 99% CI 2·39-11·49; p

Published
2012

8. Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial

Author

Gerardo Rosati, Sara Lonardi, Fabio Galli, Maria Di Bartolomeo, Monica Ronzoni, Maria G. Zampino, Maria Banzi, Alberto Zaniboni, Felice Pasini, Silvia Bozzarelli, Silvio K. Garattini, Daris Ferrari, Vincenzo Montesarchio, Andrea Mambrini, Libero Ciuffreda, Francesca Galli, Valeria Pusceddu, Chiara Carlomagno, Paolo Bidoli, Domenico Amoroso, Anna M. Bochicchio, Luca Frassineti, Domenico Corsi, Domenico Bilancia, Alessandro Pastorino, Alfonso De Stefano, Roberto Labianca, D. Bilancia, G. Rosati, V. Montesarchio, R.V. Iaffaioli, G. Nasti, B. Daniele, V. Zagonel, S. Lonardi, N. Pella, G. Aprile, F. Pasini, Roma P. Marchetti, A. Romiti, L. Ciuffreda, D. Ferrari, P. Foa, A. Zaniboni, R. Labianca, S. Mosconi, A. Sobrero, P. Bidoli, M. Cazzaniga, G.D. Beretta, D.C. Corsi, E. Cortesi, S. Barni, F. Petrelli, P. Allione, A.M. D'Arco, G. Valmadre, E. Piazza, E. Veltri, G. Vietti Ramus, L. Giustini, S. Tumulo, S. Cascinu, C. Granetto, F. Testore, M. Giordano, M. Moroni, M. Di Seri, A. Nuzzo, L. Angelelli, S. Gori, G. Farina, M. Aglietta, R. Franchi, M. Comandé, P. Giordani, G. Tonini, E. Bucci, A. Ballestrero, M. Benasso, C. Graiff, S. Bravi, O. Caffo, R.R. Silva, L. Frontini, S. Rota, L. Cozzi, M. Cantore, E. Maiello, S. Cinieri, N. Silvestris, S. Romito, V. Gebbia, M. Banzi, A. Santoro, F. Artioli, R. Mattioli, A. Contu, F. Di Costanzo, F. Leonardi, L. Cavanna, R. Passalacqua, D. Amoroso, P. Sozzi, M. D'Amico, D. Amadori, L. Frassineti, D. Turci, A. Ravaioli, E. Pasquini, A. Gambi, M. Faedi, G. Cruciani, E. Bajetta, M. Di Bartolomeo, L. Gianni, M. Ronzoni, M.T. Ionta, B. Massidda, M. Scartozzi, M.G. Zampino, A.M. Bochicchio, A. Ciarlo, A. Di Leo, S. Frustaci, G. Rangoni, A. Arizzoia, L. Pavesi, C. Verusio, G. Pinotti, A. Iop, S. De Placido, C. Carlomagno, V. Adamo, C. Ficorella, D. Natale, E. Greco, E. Rulli, F. Galli, D. Poli, L. Porcu, V. Torri, Rosati, G, Lonardi, S, Galli, F, Di Bartolomeo, M, Ronzoni, M, Zampino, M, Banzi, M, Zaniboni, A, Pasini, F, Bozzarelli, S, Garattini, S, Ferrari, D, Montesarchio, V, Mambrini, A, Ciuffreda, L, Pusceddu, V, Carlomagno, C, Bidoli, P, Amoroso, D, Bochicchio, A, Frassineti, L, Corsi, D, Bilancia, D, Pastorino, A, De Stefano, A, Labianca, R, Iaffaioli, R, Nasti, G, Daniele, B, Zagonel, V, Pella, N, Aprile, G, Marchetti, R, Romiti, A, Foa, P, Mosconi, S, Sobrero, A, Cazzaniga, M, Beretta, G, Cortesi, E, Barni, S, Petrelli, F, Allione, P, D'Arco, A, Valmadre, G, Piazza, E, Veltri, E, Ramus, G, Giustini, L, Tumulo, S, Cascinu, S, Granetto, C, Testore, F, Giordano, M, Moroni, M, Di Seri, M, Nuzzo, A, Angelelli, L, Gori, S, Farina, G, Aglietta, M, Franchi, R, Comande, M, Giordani, P, Tonini, G, Bucci, E, Ballestrero, A, Benasso, M, Graiff, C, Bravi, S, Caffo, O, Silva, R, Frontini, L, Rota, S, Cozzi, L, Cantore, M, Maiello, E, Cinieri, S, Silvestris, N, Romito, S, Gebbia, V, Santoro, A, Artioli, F, Mattioli, R, Contu, A, Di Costanzo, F, Leonardi, F, Cavanna, L, Passalacqua, R, Sozzi, P, D'Amico, M, Amadori, D, Turci, D, Ravaioli, A, Pasquini, E, Gambi, A, Faedi, M, Cruciani, G, Bajetta, E, Gianni, L, Ionta, M, Massidda, B, Scartozzi, M, Ciarlo, A, Di Leo, A, Frustaci, S, Rangoni, G, Arizzoia, A, Pavesi, L, Verusio, C, Pinotti, G, Iop, A, De Placido, S, Adamo, V, Ficorella, C, Natale, D, Greco, E, Rulli, E, Poli, D, Porcu, L, Torri, V, Rosati, G., Lonardi, S., Galli, F., Di Bartolomeo, M., Ronzoni, M., Zampino, M. G., Banzi, M., Zaniboni, A., Pasini, F., Bozzarelli, S., Garattini, S. K., Ferrari, D., Montesarchio, V., Mambrini, A., Ciuffreda, L., Pusceddu, V., Carlomagno, C., Bidoli, P., Amoroso, D., Bochicchio, A. M., Frassineti, L., Corsi, D., Bilancia, D., Pastorino, A., De Stefano, A., Labianca, R., Iaffaioli, R. V., Nasti, G., Daniele, B., Zagonel, V., Pella, N., Aprile, G., Marchetti, R. P., Romiti, A., Foa, P., Mosconi, S., Sobrero, A., Cazzaniga, M., Beretta, G. D., Cortesi, E., Barni, S., Petrelli, F., Allione, P., D'Arco, A. M., Valmadre, G., Piazza, E., Veltri, E., Ramus, G. V., Giustini, L., Tumulo, S., Cascinu, S., Granetto, C., Testore, F., Giordano, M., Moroni, M., Di Seri, M., Nuzzo, A., Angelelli, L., Gori, S., Farina, G., Aglietta, M., Franchi, R., Comande, M., Giordani, P., Tonini, G., Bucci, E., Ballestrero, A., Benasso, M., Graiff, C., Bravi, S., Caffo, O., Silva, R. R., Frontini, L., Rota, S., Cozzi, L., Cantore, M., Maiello, E., Cinieri, S., Silvestris, N., Romito, S., Gebbia, V., Santoro, A., Artioli, F., Mattioli, R., Contu, A., Di Costanzo, F., Leonardi, F., Cavanna, L., Passalacqua, R., Sozzi, P., D'Amico, M., Amadori, D., Turci, D., Ravaioli, A., Pasquini, E., Gambi, A., Faedi, M., Cruciani, G., Bajetta, E., Gianni, L., Ionta, M. T., Massidda, B., Scartozzi, M., Ciarlo, A., Di Leo, A., Frustaci, S., Rangoni, G., Arizzoia, A., Pavesi, L., Verusio, C., Pinotti, G., Iop, A., De Placido, S., Adamo, V., Ficorella, C., Natale, D., Greco, E., Rulli, E., Poli, D., Porcu, L., Torri, V., and Corsi, D. C.

Subjects
0301 basic medicine, Oncology, Male, Cancer Research, Colorectal cancer, Leucovorin, Efficacy, Older patient, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Stage (cooking), Aged, 80 and over, Colonic Neoplasm, Prognostic factor, Middle Aged, Prognosis, Colon cancer, Survival Rate, Oxaliplatin, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Colonic Neoplasms, Female, Fluorouracil, medicine.drug, Human, Compliance, Adult, medicine.medical_specialty, Prognosi, Adjuvant chemotherapy, Older patients, Prognostic factors, Subgroup analysis, Follow-Up Studie, 03 medical and health sciences, Internal medicine, Post-hoc analysis, medicine, Adjuvant therapy, Humans, Capecitabine, Cancer staging, Aged, Antineoplastic Combined Chemotherapy Protocol, business.industry, medicine.disease, 030104 developmental biology, Neoplasm Recurrence, Local, business, Follow-Up Studies
Abstract

Background: Previous studies on oxaliplatin and fluoropyrimidines as adjuvant therapy in older patients with stage III colon cancer (CC) produced conflicting results. Patients and methods: We assessed the impact of age on time to tumour recurrence (TTR), disease-free survival (DFS), cancer-specific survival (CSS), and overall survival (OS) in 2360 patients with stage III CC (1667 aged

Published
2021

9. Fighting cancer in coronavirus disease era: organization of work in medical oncology departments in Emilia Romagna region of Italy

Author

Luigi Cavanna, Enrico Franceschi, Giovanni Luca Frassineti, Antonio Frassoldati, Federico Cappuzzo, Giuseppe Longo, Vincenzo Di Nunno, Davide Tassinari, Fabrizio Artioli, Francesco Leonardi, Andrea Ardizzoni, Antonio Maestri, Carmine Pinto, Alba A. Brandes, Brandes A.A., Ardizzoni A., Artioli F., Cappuzzo F., Cavanna L., Frassineti G.L., Frassoldati A., Leonardi F., Longo G., Maestri A., Tassinari D., Franceschi E., Nunno V.D., and Pinto C.

Subjects
Oncology, Cancer Research, Nurses, Social Workers, Disease, medicine.disease_cause, patients, 0302 clinical medicine, Neoplasms, Surveys and Questionnaires, Health care, 030212 general & internal medicine, oncological centresoncological patient, risk reduction, Coronavirus, High rate, Social Worker, General Medicine, cancer, coronavirus disease, COVID-19, Emilia Romagna, healthcare workers, medical oncology departments, patients, risk reduction, survey, humanities, Emilia Romagna, Work (electrical), coronavirus disease, Italy, 030220 oncology & carcinogenesis, oncological centresoncological patients, Coronavirus Infections, Human, Research Article, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Pneumonia, Viral, NO, 03 medical and health sciences, Betacoronavirus, healthcare worker, Internal medicine, Physicians, medicine, cancer, Humans, survey, Pandemics, Infection Control, Betacoronaviru, Pandemic, business.industry, Coronavirus Infection, Nurse, healthcare workers, SARS-CoV-2, Cancer, COVID-19, medicine.disease, Clinical trial, medical oncology department, Physician, Neoplasm, business, medical oncology departments
Abstract

Aim: To assess the measures applied to reduce the spread of coronavirus disease (COVID-19) and the timing of their application in medical oncology departments. Materials & methods: We surveyed all medical oncology departments from the Italian Emilia Romagna region via a multidomain questionnaire. The questions covered items on patients, healthcare workers, risk reduction measure and clinical trials. Results: A total of 12 centers involving 861 healthcare members joined the survey. The measures applied to patients and health workers partially converged in all the departments while major divergences were found in the clinical trials domain. High rate of COVID-19 infection occurred among medical doctors (21/208, 10.1%) and social care workers (13/110, 11.8%). Rate of infection among nurses was 5.7% (24/418). Conclusion: All measures able to reduce risk of COVID-19 infection must be applied in medical oncology departments. Early introduction of risk reduction measures may be a critical issue.

Published
2020

10. Sharing real-world experiences to optimize the management of olaparib toxicities: a practical guidance from an Italian expert panel

Author

Giulia Tasca, Clelia Casartelli, Giusy Scandurra, Valentina Guarneri, Claudia Marchetti, Elena Maccaroni, Rocco De Vivo, Claudio Zamagni, Emanuele Baldo Gisone, Emanuele Naglieri, Marilena Di Napoli, Giovanna Scarfone, Vera Loizzi, Ilaria Spagnoletti, Vanda Salutari, Veronica Parolin, Giorgia Mangili, Fabrizio Artioli, G. Ronzino, Germana Tognon, Francesca Martella, Domenica Lorusso, Giusy Ricciardi, Elisabetta De Matteis, Valentina Arcangeli, Rossella Lauria, Cinzia Cardalesi, Sabrina Chiara Cecere, Mariangela Bella, Alberto Andrea Lissoni, Alessandra Bologna, Simona Secondino, Giusi Blanco, Lorusso, D, Bologna, A, Cecere, S, De Matteis, E, Scandurra, G, Zamagni, C, Arcangeli, V, Artioli, F, Bella, M, Blanco, G, Cardalesi, C, Casartelli, C, De Vivo, R, Di Napoli, M, Gisone, E, Lauria, R, Lissoni, A, Loizzi, V, Maccaroni, E, Mangili, G, Marchetti, C, Martella, F, Naglieri, E, Parolin, V, Ricciardi, G, Ronzino, G, Salutari, V, Scarfone, G, Secondino, S, Spagnoletti, I, Tasca, G, Tognon, G, and Guarneri, V

Subjects
Psychological intervention, Clinical practice, Piperazines, Poly(ADP-ribose) Polymerase Inhibitor, Antineoplastic Agent, chemistry.chemical_compound, 0302 clinical medicine, Olaparib, Maintenance therapy, 030212 general & internal medicine, Fatigue, Phthalazine, Ovarian Neoplasms, BRCA1 Protein, Nursing research, Adherence, Recurrent ovarian cancer, Toxicities, Transition, Anemia, Antineoplastic Agents, BRCA2 Protein, Female, Humans, Italy, Mutation, Nausea, Neoplasm Recurrence, Local, Phthalazines, Poly(ADP-ribose) Polymerase Inhibitors, Vomiting, Local, Oncology, 030220 oncology & carcinogenesis, medicine.symptom, Human, medicine.medical_specialty, Psycho-oncology, 03 medical and health sciences, medicine, Intensive care medicine, Piperazine, Settore MED/06 - ONCOLOGIA MEDICA, business.industry, Ovarian Neoplasm, BRCA mutation, Neoplasm Recurrence, Settore MED/40 - GINECOLOGIA E OSTETRICIA, Toxicitie, chemistry, business
Abstract

Olaparib is the first poly(ADP-ribose) polymerase inhibitor approved as maintenance therapy of recurrent ovarian cancer (OC) patients with a BRCA mutation. To achieve the maximum clinical benefit, adherence to olaparib must be persistent. However, in clinical practice, this is challenged by the frequent suboptimal management of toxicities. In view of the expanding use of olaparib also in Italy, physicians must learn how to adequately and promptly manage drug toxicities not to unnecessarily interrupt or reduce the dose. The experts agreed that nausea,vomiting, anemia, and fatigue are the most frequent events experienced by OC patients on olaparib, and that these toxicities usually develop early during treatment, are mainly of grade 1-2 and transient and can be managed with simple non-pharmacological interventions. By sharing their real-world experiences, the panel prepared, for each toxicity, an algorithm organized by grade and besides the procedures indicated in the local label, included supportive care interventions based also on nutritional and lifestyle modifications and psycho-oncology consultation. Moreover, in view of the tablet entry into the Italian market, the full and reduced dosages of capsules and tablets were compared. This practical guidance is intended to be a tool to support especially less-experienced physicians in the management of these complex patients, with the aim to help preventing the worsening of patients' conditions and the unnecessary interruption/reduction of olaparib dosage, which may jeopardize treatment efficacy.

Published
2020

11. Endoscopic exclusive transcanal approach to the tympanic cavity cholesteatoma in pediatric patients: Our experience

Author

Daniele Marchioni, Livio Presutti, Elisabetta Genovese, Franca Laura Artioli, Domenico Villari, Alessia Rubini, Davide Soloperto, Marchioni D., Soloperto D., Rubini A., Villari D., Genovese E., Artioli F., and Presutti L.

Subjects
Male, medicine.medical_specialty, Neoplasm, Residual, Adolescent, medicine.medical_treatment, Kaplan-Meier Estimate, Endoscopic ear surgery, Ossicular prosthesis, Mastoid, Tympanoplasty, Chart review, medicine, otorhinolaryngologic diseases, Middle Ear Cholesteatoma, Humans, Tympanic cavity, Endoscopic approach, Ossiculoplasty, Pediatric cholesteatoma, Surgical outcomes, Child, Ear Ossicles, Retrospective Studies, Ossicular chain, Surgical outcome, Cholesteatoma, Middle Ear, business.industry, Cholesteatoma, Endoscopy, General Medicine, Plastic Surgery Procedures, medicine.disease, Surgery, Ossicular Prosthesis, medicine.anatomical_structure, Ossicular Replacement, Treatment Outcome, Otorhinolaryngology, Child, Preschool, Pediatrics, Perinatology and Child Health, Female, business
Abstract

Objectives The aim of the present study is to describe our experience in the management of tympanic cavity cholesteatoma in pediatric patients, treated with endoscopic exclusive transcanal approach. Methods A chart review of clinical data and videos from the operations of 54 pediatric patients, undergoing surgery between January 2007 and December 2013, was made. Patients presenting with cholesteatoma involving the tympanic cavity (mesotympanum, epitympanum, protympanum and/or hypotympanum), with no mastoid involvement, were included in the first group and underwent an exclusive transcanalar endoscopic approach (TEA). In case of mastoid extension of the pathology, patients were included in the control group and underwent a canal wall up microscopic technique (CWU). Results In this study, 34 males and 20 females, including 5 bilateral cases, giving a total of 59 ears, were reviewed. Median age was 9.6 years (range 4–16 years). 31 cholesteatomas underwent a TEA approach, while 28 underwent a CWU approach, based on inclusion criteria. No differences from congenital vs acquired form was made, due to the difficult to correctly distinguish always the two forms. The ossicular chain was preserved in 26.6% of patients (16 ears): 42% of patients (13 ears) undergoing a transcanal endoscopic approach and 10% of patients undergoing a canal wall up microscopic approach (3 ears) ( P = 0.006). Second look surgery was executed in 41.6% of patients (25 ears). In partial ossicular prosthesis reconstructions, the mean preoperative pure-tone average was 29.4 dB, while the mean postoperative pure-tone average was 27.1 dB, with a mean increase of 2.3 dB. In total ossicular prosthesis reconstructions, the mean preoperative pure-tone average was 47.8 dB, while the mean postoperative pure-tone average was 26.5 dB, with a mean increase of 21.3 dB. Recurrence rate was 12.9% (4 ears) for the transcanal endoscopic approach group and 17.2% (5 ears) for the canal wall up microscopic approach. Residual disease was present in 26.6%: 19.3% (6 ears) for the transcanal endoscopic approach group and 34.4% (10 ears) for the canal wall up microscopic approach. The mean follow up was 36 months (range 8–88). Kaplan–Meier analysis at 36 months showed a lower recurrence risk for the transcanal endoscopic approach compared with the canal wall up microscopic approach, but this data was not statistically significant ( P = 0.58). Conclusion The transcanal endoscopic approach represents a feasible, minimally invasive and conservative technique for the management of pediatric middle ear cholesteatoma.

Published
2015

12. Multicentre randomised phase III study comparing the same dose and schedule of cisplatin plus the same schedule of vinorelbine or gemcitabine in advanced non-small cell lung cancer

Author

Francesca Sperandi, L. Mantovani, Barbara Melotti, P. Preti, Andrea Martoni, V. Picece, F. Di Fabio, S. Giaquinta, A. Petralia, A. Marino, Monica Guaraldi, F. Artioli, G. Palomba, Antonio Farris, Martoni, A, Marino, A, Sperandi, F, Giaquinta, S, Di Fabio, F, Melotti, B, Guaraldi, M, Palomba, G, Preti, P, Petraia, A, Artioli, F, Picece, V, Farris, A, and Mantovani, L

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, medicine.drug_class, Cost-Benefit Analysis, Neutropenia, Vinblastine, NSCLC, Vinorelbine, Deoxycytidine, Antimetabolite, Gastroenterology, Bolus (medicine), Carcinoma, Non-Small-Cell Lung, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Humans, Medicine, Lung cancer, Aged, business.industry, Middle Aged, medicine.disease, Gemcitabine, Surgery, Regimen, Oncology, Toxicity, Disease Progression, Female, Cisplatin, business, medicine.drug
Abstract

This study compares two cytotoxic regimens comprising the same dose and schedule of cisplatin (CP) plus vinorelbine (VNR) or gemcitabine (GEM) administered under the same schedule to patients with advanced non-small cell lung cancers (NSCLC). From April 1998 to February 2003, 285 patients were randomised to receive either VNR 25 mg/m 2 on days 1 and 8 as an intravenous (i.v.) bolus plus CP 75 mg/m 2 on day 1 (regimen A) or GEM 1200 mg/m 2 on days 1 and 8 as an i.v. 30-min infusion plus CP 75 mg/m 2 on day 1 (regimen B). Both treatments were recycled every 21 days. If no progression had occurred after six cycles, the patients continued to receive VNR or GEM monochemotherapy weekly. Cross-over of the two single agents was considered if disease progression occurred. Objective response (OR), time to progression (TTP) and overall survival (OS) were analysed according to the intention-to-treat principle. 272 patients were ultimately eligible (137 on A and 135 on B). Their main characteristics were: male/female ratio 214/58; median age 63 (range 32-77) years; median Karnofsky Performance Status (PS) 80 (range 70-100); stage IIIB 34%, stage IV 61%, recurrent disease 5%; histology - epidermoid 29%, adenocarcinoma 53%, other NSCLC 18%. The characteristics of the patients in the two arms were well matched. The following response rates were observed in regimens A and B, respectively: complete response (CR) 0.7% and 3.7%, partial response (PR) 31.9% and 22.2% (P = 0.321). Median CR + PR duration was 8 months in both arms. Clinical benefit represented by an improvement in symptoms was evident in 25.7% and 28.1%, respectively. Median TTP was 5 months in both arms and median OS 11 months in both arms. Grade III-IV neutropenia occurred in 30.7% and 17.7% of the patients in arms A and B, respectively (P = 0.017); thrombocytopenia occurred in 0% and 9.3% (P = 0.004), respectively. No difference in the incidence of anaemia was observed. Non-haematological toxicity was generally mild: a higher incidence of grade 1-2 peripheral neurotoxicity and grade 1-2 local toxicity with regimen A and grade 1-2 liver toxicity with regimen B was reported. A pharmaco-economic comparison showed a difference between the two doublets, principally due to the different costs of VNR and GEM. Under the study conditions the combination of VNR or GEM with the same dose and schedule of CP produced similar OR, clinical benefits, TTP and OS in advanced NSCLC, and only mild toxicological differences were observed. Pharmaco-economic evaluation favoured the CP + VNR doublet. © 2004 Elsevier Ltd. All rights reserved.

Published
2005

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