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105 results on '"Turci, D."'

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

Author

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

Published
2021
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2. Phase III trial comparing 3–6 months of adjuvant FOLFOX4/XELOX in stage II–III colon cancer: safety and compliance in the TOSCA trial

Author

Bilancia, D., Rosati, G., Montesarchio, V., Iaffaioli, R.V., Nasti, G., Daniele, B., Zagonel, V., Lonardi, S., Pella, N., Aprile, G., Pasini, F., Marchetti, P., Romiti, A., Ciuffreda, L., Ferrari, D., Foa, P., Zaniboni, A., Labianca, R., Mosconi, S., Sobrero, A., Bidoli, P., Cazzaniga, M., Beretta, G.D., Corsi, D.C., Cortesi, E., Barni, S., Petrelli, F., Cantore, M., Maiello, E., Cinieri, S., Banzi, M., Santoro, A., Artioli, F., Mattioli, R., Amoroso, D., Amadori, D., Frassineti, L., Turci, D., Ravaioli, A., Bajetta, E., Di Bartolomeo, M., Gianni, L., Ronzoni, M., Ionta, M.T., Massidda, B., Scartozzi, M., Zampino, M.G., Bochicchio, A., Ciarlo, A., Di Leo, A., De Placido, S., Carlomagno, C., Adamo, V., Natale, D., Rulli, E., Galli, F., Poli, D., Torri, V., and Rimassa, L.

Published
2016
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4. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

Floriani, I., Rulli, E., Cropalato Di Tullio, M., Poli, D., Galli, F., Biagioli, E., De Simone, I., Mangano, S., Tonato, M., Zucca, E., Valsecchi, M.G., Bajetta, E., Di Bartolomeo, M., Labianca, R., Amadori, D., Falcone, A., Di Costanzo, F., Daniele, B., Pinto, C., Comella, G., Nitti, D., Mini, E., De Placido, S., Marchet, A., Catena, L., Schiavo, M., Pinotti, G., Proserpio, I., Rosati, G., Bordonaro, R., Cordio, S., Burrafato, G., Bochicchio, A.M., Aieta, M., Fazio, N., Spada, F., Amoroso, V., Marini, G., Soto Parra, H., Novello, G., Massidda, B., Ionta, M.T., Comandè, M., Venezia, R., Bertolini, A., Menatti, E., Zanlorenzi, L., Colombo, A., Iop, A., Bonura, S., Mazza, E., Viganò, M., Ardizzoia, A., Dell'Oro, S., Lo Re, G., Santeufemia, D., Buonadonna, A., Luisi, D., Ucci, G., Di Lucca, G., Bonetti, A., Bergamo, F., Alù, M., Vastola, F., Marchetti, P., Corsi, D.C., Massa, E., Di Pinto, G., Duro, M., Oliani, C., Franchini, M., Inzoli, A., Gebbia, N., Repetto, L., Rota, S., Frontini, L., Mosconi, S., Quadri, A., De Grossi, S., Bidoli, P., Cazzaniga, M.E., Villa, F., Foa, P., Ferrari, D., Aitini, E., Rabbi, C., Barni, S., Petrelli, F., Giordano, M., Luchena, G., Pirovano, M., Nasisi, A., Catalano, V., Giordani, P., Zaniboni, A., Leone, F., Ferrario, S., Beretta, G.D., Menichetti, E.T., Conte, D., Mari, D., Giannicola, R., Pierantoni, C., Luporini, A.G., Ravaioli, A., Tassinari, D., Nicolini, M., Frassineti, G.L., Turci, D., Zumaglini, F., Tamberi, S., Piancastelli, A., Cruciani, G., Landi, L., Minuti, G., Cantore, M., Orlandi, M., Mambrini, A., Ciarlo, A., Cavaciocchi, D., Del Monte, F., Ricci, S., Brunetti, M.I., Lencioni, M., Sisani, M., Sozzi, P., Granetto, C., Chiara, S., Galetto, A.S., Ribecco, A.S., DeCensi, A., Ciuffreda, L., Baldini, E.E., Camisa, R., Todeschini, R., Santoro, A., Rimassa, L., Carnaghi, C., Pressiani, T., Boni, C., Rondini, E., Gnoni, R., Gasperoni, S., Cavanna, L., Palladino, M.A., Mattioli, R., Laici, G., Pucci, F., Alessio, M.D., Bernardini, I., Tomasello, G., Baldino, G., Rossetti, R., Giaquinta, S., Di Fabio, F., Rijas Llimpe, F.L., Brandes, A.A., Marzola, M., Montesarchio, V., Rea, A., Genua, G., Casaretti, R., Silvestro, L., Montano, M., Sarobba, M.G., Sanna, G., Filippelli, G., Dima, G., Greco, E., Roselli, M., Natale, D., Condemi, G., Fumi, G., Tafuto, S., Masullo, P., Tiberio, G., de Manzoni, G., Fiorentini, G., Mazzanti, R., Carlomagno, C., De Stefano, A., Cartenì, G., and Otero, M.

Published
2014
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6. 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

7. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

Bajetta, E., Floriani, I., Di Bartolomeo, M., Labianca, R., Falcone, A., Di Costanzo, F., Comella, G., Amadori, D., Pinto, C., Carlomagno, C., Nitti, D., Daniele, B., Mini, E., Poli, D., Santoro, A., Mosconi, S., Casaretti, R., Boni, C., Pinotti, G., Bidoli, P., Landi, L., Rosati, G., Ravaioli, A., Cantore, M., Di Fabio, F., Aitini, E., Marchet, A., Floriani, I., Rulli, E., Cropalato Di Tullio, M., Poli, D., Galli, F., Biagioli, E., De Simone, I., Poli, D., Mangano, S., Tonato, M., Zucca, E., Valsecchi, MG., Floriani, I., Bajetta, E., Di Bartolomeo, M., Labianca, R., Amadori, D., Falcone, A., Di Costanzo, F., Daniele, B., Pinto, C., Comella, G., Nitti, D., Mini, E., De Placido, S., Marchet, A., Bajetta, E., Di Bartolomeo, M., Catena, L., Schiavo, M., Pinotti, G., Proserpio, I., Rosati, G., Bordonaro, R., Cordio, S., Burrafato, G., Bochicchio, A.M., Aieta, M., Fazio, N., Spada, F., Amoroso, V., Marini, G., Soto Parra, H., Novello, G., Massidda, B., Ionta, M.T., Comandè, M., Venezia, R., Bertolini, A., Menatti, E., Zanlorenzi, L., Colombo, A., Iop, A., Bonura, S., Mazza, E., Viganò, M., Ardizzoia, A., DellʼOro, S., Lo Re, G., Santeufemia, D., Buonadonna, A., Luisi, D., Ucci, G., Di Lucca, G., Bonetti, A., Bergamo, F., Alù, M., Vastola, F., Marchetti, P., Corsi, D.C., Massa, E., Di Pinto, G., Duro, M., Oliani, C., Franchini, M., Inzoli, A., Gebbia, N., Repetto, L., Rota, S., Frontini, L., Labianca, R., Mosconi, S., Quadri, A., De Grossi, S., Bidoli, P., Cazzaniga, M.E., Villa, F., Foa, P., Ferrari, D., Aitini, E., Rabbi, C., Barni, S., Petrelli, F., Giordano, M., Luchena, G., Pirovano, M., Nasisi, A., Catalano, V., Giordani, P., Zaniboni, A., Leone, F., Ferrario, S., Beretta, G.D., Menichetti, E.T., Conte, D., Mari, D., Giannicola, R., Pierantoni, C., Luporini, A.G., Ravaioli, A., Tassinari, D., Nicolini, M., Amadori, D., Frassineti, G.L., Turci, D., Zumaglini, F., Tamberi, S., Piancastelli, A., Cruciani, G., Falcone, A., Landi, L., Minuti, G., Cantore, M., Orlandi, M., Mambrini, A., Ciarlo, A., Cavaciocchi, D., Del Monte, F., Ricci, S., Brunetti, M.I., Lencioni, M., Sisani, M., Sozzi, P., Granetto, C., Chiara, S., Galetto, A.S., Ribecco, A.S., DeCensi, A., Ciuffreda, L., Baldini, E.E., Camisa, R., Todeschini, R., Santoro, A., Rimassa, L., Carnaghi, C., Pressiani, T., Boni, C., Rondini, E., Gnoni, R., Di Costanzo, F., Gasperoni, S., Cavanna, L., Palladino, M.A., Mattioli, R., Laici, G., Pucci, F., Alessio, M.D., Bernardini, I., Tomasello, G., Baldino, G., Rossetti, R., Giaquinta, S., Pinto, C., Di Fabio, F., Rijas Llimpe, F.L., Brandes, A.A., Marzola, M., Montesarchio, V., Rea, A., Daniele, B., Genua, G., Casaretti, R., Silvestro, L., Montano, M., Sarobba, M.G., Sanna, G., Filippelli, G., Dima, G., Greco, E., Roselli, M., Natale, D., Condemi, G., Fumi, G., Tafuto, S., Masullo, P., Nitti, D., Marchet, A., Tiberio, G., de Manzoni, G., Fiorentini, G., Mazzanti, R., Carlomagno, C., De Stefano, A., Cartenì, G., and Otero, M.

Published
2014
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20. 53P - Immune-related adverse events correlate with clinical outcomes in non-small cell lung cancer (NSCLC) patients treated with nivolumab in the Italian expanded access programme

Author

Baldini, E., Lunghi, A., Cortesi, E., Turci, D., Garassino, M.C., Stati, V., Ardizzoni, A., Ricciuti, B., Frassoldati, A., Romano, G., Illiano, A., Verderame, F., Fasola, G., Marchetti, P., Pinto, C., Carteni, G., Scotti, V., Tibaldi, C., Fioretto, L., and Giannarelli, D.

Published
2018
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22. Intermittent versus continuous chemotherapy in advanced colorectal cancer: a randomised 'GISCAD' trial

Author

Labianca, R, Sobrero, A, Isa, L, Cortesi, E, Barni, S, Nicolella, D, Aglietta, M, Lonardi, S, Corsi, D, Turci, D, Beretta, Gd, Fornarini, G, Dapretto, E, Floriani, I, Zaniboni, A, Pessi, A, Mosconi, S, Aitini, E, Carlo, Ao, Astorre, P, Cabiddu, M, Mandala', M, Petrelli, F, Cassata, A, Ucci, G, Catalano, V, Clerico, M, D'Andrea, M, Gambi, A, Frontini, L, Gardani, G, Vaghi, M, Gridelli, C, Gottardi, O, Jirillo, A, Martignoni, G, Piazza, E, Tabiadon, D, Zagonel, V, Meriggi, F, Bolzoni, P, and Naso, G. Italian Group for the Study of Gastrointestinal Cancer-GISCAD.

Subjects
Adult, Male, medicine.medical_specialty, medicine.medical_treatment, metastatic colorectal cancer, intermittent chemotherapy, folfiri, colorectal cancer, FOLFIRI, Kaplan-Meier Estimate, Irinotecan, Gastroenterology, Disease-Free Survival, Bolus (medicine), Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, Aged, Chemotherapy, Levoleucovorin, business.industry, Hazard ratio, Hematology, Drug holiday, Middle Aged, Oxaliplatin, Surgery, Regimen, Treatment Outcome, Oncology, Toxicity, Camptothecin, Female, Fluorouracil, business, Colorectal Neoplasms, medicine.drug
Abstract

In advanced colorectal cancer, chemotherapy is usually administered without pauses and until progression but patients can experience cumulative toxicity and cannot tolerate a heavy therapeutic charge.The aim of the present trial was to evaluate whether an intermittent chemotherapy with levo-leucovorin + 5-fluorouracil (5-FU) + irinotecan (CPT-11) was at least as effective as the same regimen given continuously, both administered until progression, in patients affected with advanced colorectal cancer and not previously exposed to chemotherapy for metastatic disease.A total of 337 patients from 27 institutions were randomised between levo-leucovorin, 100/mg/m(2) i.v. + 5-FU; 400 mg/m(2) i.v. bolus + 5-FU; 600 mg/m(2) 22-h continuous infusion, days 1 and 2 + CPT-11; 180 mg/m(2) day 1, administered every 2 weeks 2 months on and 2 months off (arm A) and the same regimen administered continuously (arm B), until progression in both arms. The main end point was overall survival (OS), the secondary progression-free survival (PFS) and toxicity.At a median follow-up of 41 months, OS was 18 months in arm A and 17 months in arm B [hazard ratio (HR), 0.88]. Also PFS was comparable in the two groups (6 months in both, with HR, 1.03), and even grades 3-4 toxicity (mainly myelosuppression, fever and diarrhoea) was similar. Second-line oxaliplatin-based treatment was administered in a similar percentage (66%) in the two arms. The median chemotherapy-free period (drug holiday) in arm A was 3.5 months.Reducing the charge of therapy in this population did not diminish the efficacy of treatment. Further studies with this strategy, including biologicals, are warranted.

Published
2011

26. A3 - Germline variants and clinical outcomes of high-risk stage II and stage III colon cancer patients treated with oxaliplatin and fluoropyrimidines adjuvant chemotherapy: a pharmacogenetic ancillary study to TOSCA trial

Author

Ruzzo, A., Galli, F., Rulli, E., Lonardi, S., Zagonel, V., Ronzoni, M., Ionta, M.T., Pella, N., Mucciarini, C., Labianca, R., Veltri, E., Sozzi, P., Barni, S., Nicolini, M., Biondi, E., Bramati, A., Turci, D., Buscaglia, M., Magnani, M., and Graziano, F.

Published
2017
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31. 887P - Negative prognostic factors and resulting clinical outcome in patients (pts) with metastatic renal cell carcinoma (mRCC) included in the Italian nivolumab expanded access program (EAP)

Author

Bracarda, S., Galli, L., Maruzzo, M., Lo Re, G., Buti, S., Favaretto, A., Costanzo, F.D., Sacco, C., Merlano, M., Mucciarini, C., Zafarana, E., Romito, S., Maestri, A., Giannitto Giorgio, C., Ionta, M.T., Turci, D., De Giorgi, U., Procopio, G., Cortesi, E., and Porta, C.

Published
2017
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32. Locoregional therapy for liver metastases from colorectal cancer: The possibilities of intraarterial chemotherapy, and new hepatic-directed modalities

Author

Fiorentini, G., Poddie, D. B., cantore maurizio, Giovanis, P., Guadagni, S., Giorgi, U., Cariello, A., Dazzi, C., and Turci, D.

Subjects
Radiation, Hepatology, Medicine (all), Gastroenterology, Cryosurgery, Chemoembolization, Ethanol injection, Hypoxic flow-stop perfusion, Hypoxic isolated liver perfusion, Intraarterial chemotherapy, Liver metastases from colorectal cancer, Liver surgery, Radiofrequency
Published
2001

33. 1079P - Efficacy and safety of nivolumab in elderly patients (pts) with advanced squamous non small cell lung cancer (Sq-NSCLC) participating in the expanded access programme (EAP) in Italy

Author

Grossi, F., Crinò, L., Misino, A., Bidoli, P., Delmonte, A., Gelsomino, F., Proto, C., Mancini, M., Landi, L., Turci, D., Quadrini, S., Antonelli, P., Marchetti, P., Toschi, L., Giusti, S., Di Costanzo, F., Rastelli, F., Sandri, P., Scotti, V., and de Marinis, F.

Published
2016
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37. Role of biological markers in the clinical outcome of colon cancer.

Author

Nanni, O., Volpi, A., Frassineti, G L, De Paola, F, Granato, A M, Dubini, A, Zoli, W, Scarpi, E, Turci, D, Oliverio, G, Gambi, A, and Amadori, D

Subjects
BIOMARKERS, COLON cancer, THERAPEUTIC use of antineoplastic agents, ADENOCARCINOMA, COLON tumors, SURVIVAL, ADJUVANT chemotherapy, RESEARCH, CLINICAL trials, GROWTH factors, ENDOTHELIAL growth factors, PROGNOSIS, EVALUATION research, LYMPHOCYTES, LYMPHOKINES, TREATMENT effectiveness, TUMOR classification, COMPARATIVE studies, RANDOMIZED controlled trials, TRANSFERASES, VASCULAR endothelial growth factors
Abstract

We investigated a number of biological markers, evaluated under strict intralaboratory quality control conditions, in terms of their role in predicting clinical outcome of patients with colon cancer treated with 5-FU-containing regimens. Colon cancer tissue from 263 patients enrolled onto two randomised clinical trials were studied for their cytofluorimetrically determined DNA content and their immunohistochemically evaluated microvessel density, vascular endothelial growth factor expression, thymidylate synthase expression and tumour lymphocyte infiltration. Disease-free survival and overall survival of patients were analysed as a function of the different variables. At a median follow up of 57 months, age, gender and Dukes' stage showed an impact on disease-free survival, whereas no biological marker emerged as an indicator of better or worse disease-free survival. Only histological grade and Dukes' stage were found to influence overall survival. The different biological variables, studied with particular attention for determination reliability, proved to have no impact on the clinical outcome of patients with colon cancer. Therefore, other markers must be identified to complement clinico-pathological variables in the management of this disease. [ABSTRACT FROM AUTHOR]

Published
2002
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38. 5-fluorouracil modulated by leucovorin, methotrexate and mitomycin: highly effective, low-cost chemotherapy for advanced colorectal cancer.

Author

Sobrero, A, Guglielmi, A, Cirillo, M, Recaldin, E, Frassineti, G L, Aschele, C, Ravaioli, A, Testore, P, Caroti, C, Gallo, L, Pessi, M A, Cortesi, E, Turci, D, Grossi, F, and Labianca, R

Subjects
FLUOROURACIL, COLON cancer
Abstract

We have reported that an alternating regimen of bolus and continuous infusion 5-fluorouracil (FU) was superior to bolus FU in terms of response rate and progression-free survival in advanced colorectal cancer. Biochemical modulation was an essential part of this regimen and it was selective for the schedule of FU administration: bolus FU was in fact modulated by methotrexate (MTX) while continuous infusion FU was potentiated by 6-s-leucovorin (LV). Considering the low cost and the favourable report on the activity of mitomycin C (mito) added to CI FU, we have incorporated this agent in the infusional part of our treatment programme. 105 patients with untreated, advanced, measurable colorectal cancer were accrued from 13 Italian centres and treated with the following regimen. 2 biweekly cycles of FU bolus (600 mg/m[SUP2]), modulated by MTX (24 h earlier, 200 mg/m[SUP2]) were alternated with a 3-week continuous infusion of FU (200 mg/m[SUP2] daily), modulated by LV (20 mg/m[SUP2] weekly bolus). Mito, 7 mg/m[SUP2], was given on the first day of the infusional period. After a 1 week rest, the whole cycle (8 weeks) was repeated, if indicated. 5 complete and 34 partial responses were obtained (response rate, 37% on the intention to treat basis; 95% confidence limits, 28-46%). After a median follow-up time of 26 months, 37 patients are still alive. The median progression-free survival is 7.7 months with an overall survival of 18.8 months and a 2-year survival rate of 30%. The regimen was very well tolerated with fewer than 13% of patients experiencing WHO grade III-IV toxicity. These results are consistent with those obtained by our group in 3 previous trials of schedule specific biochemical modulation of FU. They also indicate a highly active, little toxic, inexpensive regimen of old drugs to be used (a) as an alternative to the more expensive combinations including CPT-11 or oxaliplatin or (b) as the basis for combination programmes with these agents. [ABSTRACT FROM AUTHOR]

Published
2001
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40. Randomized phase II noncomparative trial of oral and intravenous doxifluridine plus levo-leucovorin in untreated patients with advanced colorectal carcinoma.

Author

Bajetta, Emilio, Di Bartolomeo, Maria, Somma, Luisa, Moreschi, Monica, Comella, Giuseppe, Turci, Daniele, Gebbia, Vittorio, Scanni, Alberto, Bordogna, Gianni, Stampino, Corrado Gallo, Bajetta, E, Di Bartolomeo, M, Somma, L, Moreschi, M, Comella, G, Turci, D, Gebbia, V, Scanni, A, Bordogna, G, and Stampino, C G

Published
1996
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42. 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

44. Efficacy of nivolumab in pre-treated non-small-cell lung cancer patients harbouring KRAS mutations

Author

Angelo Delmonte, Francesco Passiglia, Diana Giannarelli, Paolo Bidoli, Lorenzo Livi, G. Puppo, Francesco Gelsomino, Giovanna Finocchiaro, Domenico Galetta, Olga Martelli, Oscar Alabiso, Rita Chiari, Daniele Turci, Enrico Ricevuto, Guido Francini, Alfonso Illiano, Elisa Roca, Anna Cecilia Bettini, Clara Natoli, Federico Cappuzzo, Monica Giordano, C. Defferrari, Passiglia, F, Cappuzzo, F, Alabiso, O, Bettini, A, Bidoli, P, Chiari, R, Defferrari, C, Delmonte, A, Finocchiaro, G, Francini, G, Gelsomino, F, Giannarelli, D, Giordano, M, Illiano, A, Livi, L, Martelli, O, Natoli, C, Puppo, G, Ricevuto, E, Roca, E, Turci, D, and Galetta, D

Subjects
Oncology, Adult, Male, medicine.medical_specialty, Cancer Research, medicine.disease_cause, Predictive markers, Article, Proto-Oncogene Proteins p21(ras), 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Carcinoma, Non-Small-Cell Lung, medicine, Carcinoma, 80 and over, Humans, Progression-free survival, Lung cancer, Non-Small-Cell Lung, neoplasms, Aged, Aged, 80 and over, business.industry, Cancer, Common Terminology Criteria for Adverse Events, Middle Aged, medicine.disease, digestive system diseases, Progression-Free Survival, respiratory tract diseases, Nivolumab, Female, Mutation, Immunotherapy, 030220 oncology & carcinogenesis, Expanded access, KRAS, business, Non-small-cell lung cancer
Abstract

Background: The present study investigated the efficacy and safety of nivolumab in pre-treated patients with advanced NSCLC harbouring KRAS mutations. Methods: Clinical data and KRAS mutational status were analysed in patients treated with nivolumab within the Italian Expanded Access Program. Objective response rate, progression-free survival and overall survival were evaluated. Patients were monitored for adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events. Results: Among 530 patients evaluated for KRAS mutations, 206 (39%) were positive while 324 (61%) were KRAS wild-type mutations. KRAS status did not influence nivolumab efficacy in terms of ORR (20% vs 17%, P = 0.39) and DCR (47% vs 41%, P = 0.23). The median PFS and OS were 4 vs 3 months (P = 0.5) and 11.2 vs 10 months (P = 0.8) in the KRAS-positive vs the KRAS-negative group. The 3-months PFS rate was significantly higher in the KRAS-positive group as compared to the KRAS-negative group (53% vs 42%, P = 0.01). The percentage of any grade and grade 3–4 AEs were 45% vs 33% (P = 0.003) and 11% vs 6% (P = 0.03) in KRAS-positive and KRAS-negative groups, respectively. Conclusions: Nivolumab is an effective and safe treatment option for patients with previously treated, advanced non-squamous NSCLC regardless of KRAS mutations.

Published
2019

45. Italian Nivolumab Expanded Access Program in Nonsquamous Non–Small Cell Lung Cancer Patients: Results in Never-Smokers and EGFR-Mutant Patients

Author

Silvia Quadrini, Editta Baldini, Enrico Vasile, Francesco Grossi, Enrico Mini, Hector Soto Parra, Daniele Turci, Giovanni Luca Ceresoli, Marina Chiara Garassino, Stefano Cascinu, Carmelo Bengala, Gianpiero Fasola, Livio Blasi, Alain Gelibter, Carmine Pinto, Filippo de Marinis, Marianna Macerelli, Domenico Galetta, Rita Chiari, Diana Giannarelli, Francesco Cognetti, Paola Antonelli, Giuseppe Lo Russo, Garassino, M. C., Gelibter, A. J., Grossi, F., Chiari, R., Soto Parra, H., Cascinu, S., Cognetti, F., Turci, D., Blasi, L., Bengala, C., Mini, E., Baldini, E., Quadrini, S., Ceresoli, G. L., Antonelli, P., Vasile, E., Pinto, C., Fasola, G., Galetta, D., Macerelli, M., Giannarelli, D., Lo Russo, G., and de Marinis, F.

Subjects
Adult, Male, 0301 basic medicine, Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, EGFR positive, Lung Neoplasms, Expanded access program, Never-smokers, Nonsquamous non–small cell lung cancer, nivolumab, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung, ErbB Receptors, Female, Humans, Italy, Middle Aged, Nivolumab, Non-Smokers, Mutation, Gene mutation, Efficacy, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, 80 and over, Medicine, Non-Small-Cell Lung, Lung cancer, Survival rate, Cancer staging, business.industry, Carcinoma, medicine.disease, Rash, respiratory tract diseases, 030104 developmental biology, 030220 oncology & carcinogenesis, Expanded access, medicine.symptom, business
Abstract

Introduction Nivolumab is the first checkpoint inhibitor approved for the treatment of nonsquamous NSCLC. We report results from the nivolumab Italian expanded access program focusing on never-smokers and patients with EGFR-mutant nonsqamous NSCLC. Methods Nivolumab (3 mg/kg intravenously every 2 weeks) was administered upon physicians' request to patients who had relapsed after one or more prior systemic treatments for stage IIIB/IV nonsquamous NSCLC. Efficacy and safety were evaluated in patients who received at least one dose of nivolumab. Results Of 1588 patients with nonsquamous NSCLC, 305 (19.2%) were never-smokers. EGFR status was available for 1395 patients. Of the 102 patients (6.4%) with EGFR mutation–positive tumors, 51 (50%) were never-smokers. The objective response rate was significantly higher in patients with wild-type EGFR than patients with EGFR-mutant tumors (19.6% versus 8.8% [p = 0.007]), in former and current smokers than in never-smokers (21.5% versus 9.2% [p = 0.0001]), and in never-smokers with wild-type EGFR than in never-smokers with mutant EGFR (11.0% versus 1.9% [p = 0.04]). There was no significant difference in objective response rate between smokers with wild-type EGFR and smokers with mutant EGFR (22.0% versus 20.6%). There was no statistically significant difference in median progression-free survival or in median overall survival. The median overall survival times were 11 months in patients with EGFR wild-type tumors versus 8.3 months in patients with EGFR-mutant tumors, 11.6 months in smokers versus 10.0 months in never-smokers, 11.0 months in never-smokers with EGFR wild-type tumors versus 5.6 months in never-smokers with EGFR-mutant tumors, and 14.1 months in smokers with EGFR-mutant tumors versus 11.3 months in smokers with EGFR wild-type tumors. Conclusions The data on the Italian expanded access program in populations with nonsquamous NSCLC suggest that subgroups of patients could benefit differently from nivolumab according to their EGFR mutational status and smoking habits. These results warrant further investigation.

Published
2018

46. 'Italian cohort of nivolumab Expanded Access Programme (EAP): Preliminary data from a real-world population.'

Author

Francesca Sperandi, Paola Antonelli, Diana Giannarelli, Filippo de Marinis, Silvia Quadrini, Paolo Bidoli, Daniele Turci, Milena Vitali, Luana Calabrò, Irene Prediletto, Anna Manzo, Angelo Delmonte, Marcello Tiseo, Lucio Crinò, Gabriele Minuti, Hector Soto Parra, Fabiana Vitiello, Francesco Grossi, Domenico Galetta, Simone Scagnoli, and Crinò L, Bidoli P, Delmonte A, Grossi F, De Marinis F, Sperandi F, Vitiello F, Vitali M, Soto Parra HJ, Scagnoli S, Minuti G, Calabrò L, Tiseo M, Turci D, Quadrini S, Antonelli P, Manzo A, Prediletto I, Giannarelli D, Galetta D.

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Pediatrics, business.industry, Immune checkpoint inhibitors, respiratory tract diseases, 03 medical and health sciences, 0302 clinical medicine, Survival benefit, 030220 oncology & carcinogenesis, Expanded access, Internal medicine, Cohort, medicine, Squamous non-small cell lung cancer, Nivolumab, business, Nivolumab, non small cell lung cancer, immunotherapy, expanded access program, 030215 immunology
Abstract

3067Background: Nivolumab is the first checkpoint inhibitor approved for the treatment of squamous non small cell lung cancer (Sq-NSCLC) to show a survival benefit in a randomised phase III trial. ...

Published
2016

47. Italian cohort of nivolumab Expanded Access Programme (EAP): efficacy and safety data from a real-world population

Author

Simone Scagnoli, P. Bidoli, Daniele Turci, F. De Marinis, Paola Antonelli, H. Soto Parra, Gabriele Minuti, Silvia Quadrini, I. Prediletto, Domenico Galetta, Francesca Sperandi, Francovito Piantedosi, M. Tiseo, L. Crinò, Diana Giannarelli, Anna Manzo, Angelo Delmonte, Milena Vitali, Francesco Grossi, Luana Calabrò, and Crino’ L, Bidoli P, Delmonte A, Grossi F, De Marinis F, Sperandi F, Piantedosi F, Vitali M, Soto Parra H, Scagnoli S, Minuti G, Calabro’ L, Tiseo M, Turci D, Quadrini S, Antonelli P, Manzo A, Prediletto I, Giannarelli D, Galetta D.

Subjects
0301 basic medicine, medicine.medical_specialty, business.industry, Hematology, World population, Nivolumab, non small cell lung cancer, immunotherapy, NO, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Oncology, Nursing, 030220 oncology & carcinogenesis, Family medicine, Expanded access, Cohort, Medicine, Nivolumab, business
Published
2016

48. Immune-related adverse events correlate with clinical outcomes in NSCLC patients treated with nivolumab: The Italian NSCLC expanded access program.

Author

Baldini E, Lunghi A, Cortesi E, Turci D, Signorelli D, Stati V, Melotti B, Ricciuti B, Frassoldati A, Romano G, Ceresoli GL, Illiano A, Verderame F, Fasola G, Ricevuto E, Marchetti P, Pinto C, Cartenì G, Scotti V, Tibaldi C, Fioretto L, and Giannarelli D

Subjects
Adenocarcinoma of Lung drug therapy, Adenocarcinoma of Lung pathology, Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung pathology, Carcinoma, Squamous Cell drug therapy, Carcinoma, Squamous Cell pathology, Drug-Related Side Effects and Adverse Reactions etiology, Drug-Related Side Effects and Adverse Reactions pathology, Female, Follow-Up Studies, Humans, Incidence, Italy, Lung Neoplasms drug therapy, Lung Neoplasms pathology, Male, Middle Aged, Neoplasm Metastasis, Prognosis, Prospective Studies, Survival Rate, Adenocarcinoma of Lung mortality, Antineoplastic Agents, Immunological adverse effects, Carcinoma, Non-Small-Cell Lung mortality, Carcinoma, Squamous Cell mortality, Drug-Related Side Effects and Adverse Reactions epidemiology, Lung Neoplasms mortality, Nivolumab adverse effects
Abstract

Objectives: The incidence of any and of severe-grade immune-related adverse events (irAEs) with second-line nivolumab monotherapy is 31-65 % and 2-5 % respectively. While potentially serious and even fatal, in the absence of an appropriate therapy, such events might be indicators of the activation of the immune system and, potentially, of efficacy., Materials and Methods: We collected the records of 1959 non-small-cell lung cancer (NSCLC) patients treated with nivolumab in the Italian expanded access program, and we registered the appearance of any and of severe grade irAEs. We retrospectively searched for correlations between toxicity and efficacy parameters by using Cox's regression analysis., Results: Overall, 342 (17.8%) patients developed an irAE of any grade. We observed that patients developing irAE of any grade achieved a significantly higher response rate (RR 27.2% vs 15.2%; p < 0.0001), disease control rate (DCR 60.5% vs 40.2%; p < 0.0001), median progression-free survival (mPFS 6.0 months [95% CI 4.9-7.1] vs 3.0 [95% CI: 2.8-3.2], p < 0.0001) and median overall survival (mOS 16.7 months [95% CI: 13.5-19.9] vs 9.4 [95% CI: 8.4-10.4], p < 0.00001) compared to patients who did not. At multivariate analysis the development of an irAE remained an independent indicator of nivolumab efficacy (HR 1.44 [95% CI: 1.22-1.71] p < 0.0001)., Conclusions: This report, performed in Caucasian NSCLC patients, showed that the appearance of irAEs correlated with outcome., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Published
2020
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49. Author Correction: Sex-Related Differences in Impact on Safety of Pharmacogenetic Profile for Colon Cancer Patients Treated with FOLFOX-4 or XELOX Adjuvant Chemotherapy.

Author

Ruzzo A, Graziano F, Galli F, Galli F, Rulli E, Lonardi S, Ronzoni M, Massidda B, Zagonel V, Pella N, Mucciarini C, Labianca R, Ionta MT, Bagaloni I, Veltri E, Sozzi P, Barni S, Ricci V, Foltran L, Nicolini M, Biondi E, Bramati A, Turci D, Lazzarelli S, Verusio C, Bergamo F, Sobrero A, Frontini L, and Magnani M

Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020
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50. Real-life results from the overall population and key subgroups within the Italian cohort of nivolumab expanded access program in non-squamous non-small cell lung cancer.

Author

Grossi F, Genova C, Crinò L, Delmonte A, Turci D, Signorelli D, Passaro A, Soto Parra H, Catino A, Landi L, Gelsomino F, Tiseo M, Puppo G, Roila F, Ricciardi S, Tonini G, Cognetti F, Toschi L, Tassinari D, Scoppola A, Giannarelli D, and Cortesi E

Subjects
Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung secondary, Central Nervous System Neoplasms secondary, Cohort Studies, Compassionate Use Trials, Female, Humans, Italy, Liver Neoplasms secondary, Lung Neoplasms pathology, Male, Middle Aged, Progression-Free Survival, Survival Rate, Antineoplastic Agents, Immunological therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Central Nervous System Neoplasms drug therapy, Liver Neoplasms drug therapy, Lung Neoplasms drug therapy, Nivolumab therapeutic use
Abstract

Background: Nivolumab was the first immune checkpoint inhibitor approved for previously treated advanced non-small cell lung cancer (NSCLC). Before its introduction in the market, nivolumab was made available to NSCLC patients through an expanded access program (EAP). Here we present the Italian cohort of patients with non-squamous NSCLC enrolled in a worldwide nivolumab EAP, with subgroup analyses involving elderly patients, patients with central nervous system (CNS) metastases and patients receiving nivolumab beyond progression., Methods: Pretreated patients with advanced non-squamous NSCLC received nivolumab at 3 mg/kg every 2 weeks up to 24 months. Efficacy data (investigator-assessed tumour response, progression date and survival) and safety data were collected., Findings: 1588 patients were treated across 153 Italian centres. Overall response rate and disease control rate were 18% and 44%, respectively; median overall survival (OS) was 11.3 months (95% CI: 10.2-12.4). Elderly patients (≥70 n = 522; ≥75 n = 232) achieved outcomes similar to the global study population; patients with CNS metastases (n = 409) had an OS of 8.6 months (95% CI: 6.4-10.8), and a 1-year OS rate of 43%. Nivolumab was administered beyond progression to 276 patients (26%), 57 of whom achieved subsequent disease control; the median OS of patients receiving nivolumab beyond progression was 16.2 months (95% CI: 14.0-18.4), while 1-year OS rate was 62%., Interpretation: To date, this is the largest clinical experience with nivolumab in a real-world setting. Our data support its use in clinical practice for pretreated non-squamous NSCLC, including patients with older age or CNS metastases., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Published
2019
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