103 results on '"Carnio, S"'
Search Results
2. MA07.09 Adapted Physical Activity (AMAti) Program for Lung Cancer Patients Realized by WALCE (Women Against Lung Cancer in Europe)
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Vallone, S., primary, Carnio, S., additional, Mirandola, D., additional, Pilotto, S., additional, Avancini, A., additional, Garbo, E., additional, Bernardi, G., additional, Destro, C., additional, Torri, S., additional, Collevecchio, A., additional, Riccardi, R., additional, Mariotti, S., additional, Scotti, V., additional, Olmetto, E., additional, Galetta, D., additional, Catino, A., additional, Longo, V., additional, Bafunno, D., additional, Pacchiana Parravicini, M.V., additional, and Novello, S., additional
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- 2023
- Full Text
- View/download PDF
3. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study
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Celio, L, Cortinovis, D, Cogoni, A, Cavanna, L, Martelli, O, Carnio, S, Collovà, E, Bertolini, F, Petrelli, F, Cassano, A, Chiari, R, Zanelli, F, Pisconti, S, Vittimberga, I, Letizia, A, Misino, A, Gernone, A, Bonizzoni, E, Pilotto, S, De Placido, S, Bria, E, Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E, Celio, L, Cortinovis, D, Cogoni, A, Cavanna, L, Martelli, O, Carnio, S, Collovà, E, Bertolini, F, Petrelli, F, Cassano, A, Chiari, R, Zanelli, F, Pisconti, S, Vittimberga, I, Letizia, A, Misino, A, Gernone, A, Bonizzoni, E, Pilotto, S, De Placido, S, Bria, E, Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, and Bria E
- Abstract
Background: The non-inferiority of dexamethasone (DEX) on day 1, with or without low-dose DEX on days 2 and 3, combined with oral NEPA (netupitant/palonosetron), compared with the guideline-consistent use of DEX was demonstrated in cisplatin. Here, we complete the analysis by assessing the impact of emesis on daily lives of patients receiving DEX-sparing regimens using the Functional Living Index-Emesis (FLIE). Methods: Chemotherapy-naïve patients undergoing cisplatin (≥70 mg/m2), were given NEPA and DEX (12 mg) on day 1 and randomized to receive either 1) no further DEX (DEX1), 2) oral DEX (4 mg daily) on days 2–3 (DEX3), or 3) DEX (4 mg twice daily) on days 2–4 (DEX4; control). Patients completed the FLIE questionnaire on day 6 of cycle 1. Endpoints included the FLIE nausea domain, vomiting domain, and overall combined domain scores, as well as the proportion of patients with no impact on daily life (NIDL; overall score > 108). This was a protocol-planned analysis. Results: In the DEX1 group, no significant differences were observed in the FLIE nausea score (48.9 [±1.8; SE] vs. 53.7 [±1.5]), vomiting score (56.6 [±1.4] vs. 58.7 [±0.8]) and overall score (105.6 [±2.8] vs.112.4 [±1.9]) versus DEX4 control; similar results were observed in the DEX3 group for nausea score (49.6 [±1.7]), vomiting score (58.2 [±1]) and overall score (107.8 [±2.4]) versus control. There were no significant between-group differences in the proportion of patients reporting NIDL. Conclusion: Reducing DEX, when administered with NEPA, does not seem to adversely impact the daily functioning in patients undergoing cisplatin. Trial registration: ClinicalTrials.govNCT04201769. Registration date: 17/12/2019 - Retrospectively registered.
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- 2022
4. Chemotherapy-induced nausea and vomiting (CINV) in patients with advanced lung cancer during the first-line treatment: assessment by physicians, nurses, and patients from an Italian multicenter survey
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Carnio, S., Galetta, D., Scotti, V., Cortinovis, D. L., Antonuzzo, A., Pisconti, S., Rossi, A., Martelli, O., Cecere, F. L., Lunghi, A., Del Conte, A., Montagna, E. S., Topulli, J., Pelizzoni, D., Rapetti, S. G., Gianetta, M., Pacchiana, M. V., Pegoraro, V., Cataldo, N., Bria, E., and Novello, S.
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- 2018
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5. Fatigue in lung cancer patients: symptom burden and management of challenges
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Carnio S, Di Stefano RF, and Novello S
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fatigue ,lung cancer ,symptom cluster ,quality of life ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Simona Carnio, Rosario Francesco Di Stefano, Silvia Novello Oncology Department, University of Turin, AOU San Luigi, Orbassano, Italy Abstract: Lung cancer (LC) remains the most common cause of cancer death in several countries across the world. Fatigue is the most frequently reported symptom in LC patients throughout the entire course of disease, and all international guidelines recommend early screening for cancer-related fatigue (CRF) and symptoms that can affect patients' quality of life. In patients with LC, fatigue belongs to the symptom cluster of pain, depression, and insomnia, which are commonly observed simultaneously, but are typically treated as separate although they may have common biological mechanisms. The treatment of CRF remains one of the difficult areas in the oncology field: scarce evidence supports pharmacological therapies, while some interesting data arising indicates alternative remedies and physical exercise seem to be one of the most effective approaches for CRF at any stage of LC. Keywords: fatigue, lung cancer, symptom cluster, quality of life
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- 2016
6. Dexamethasone-Sparing Regimens with Oral Netupitant and Palonosetron for the Prevention of Emesis Caused by High-Dose Cisplatin: A Randomized Noninferiority Study
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Celio, L, Cortinovis, D, Cogoni, A, Cavanna, L, Martelli, O, Carnio, S, Collovà, E, Bertolini, F, Petrelli, F, Cassano, A, Chiari, R, Zanelli, F, Pisconti, S, Vittimberga, I, Letizia, A, Misino, A, Gernone, A, Bonizzoni, E, Pilotto, S, De Placido, S, Bria, E, Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, Bria E, Celio, L, Cortinovis, D, Cogoni, A, Cavanna, L, Martelli, O, Carnio, S, Collovà, E, Bertolini, F, Petrelli, F, Cassano, A, Chiari, R, Zanelli, F, Pisconti, S, Vittimberga, I, Letizia, A, Misino, A, Gernone, A, Bonizzoni, E, Pilotto, S, De Placido, S, Bria, E, Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, and Bria E
- Abstract
Background: To reduce the overall exposure to dexamethasone (DEX) in patients receiving cisplatin-based chemotherapy, we evaluated the noninferiority of DEX on day 1, with or without low-dose DEX on days 2 and 3, combined with an oral fixed-dose combination of netupitant and palonosetron (NEPA), compared with the guideline-consistent use of 4-day DEX. Patients and Methods: In this open-label, multicenter study, chemotherapy-naïve patients undergoing high-dose cisplatin (≥70 mg/m2), were given NEPA and DEX (12 mg) on day 1 and randomized (1:1:1 ratio) to receive either (a) no further DEX (DEX1), (b) oral DEX (4 mg daily) on days 2–3 (DEX3), or (c) DEX (4 mg twice daily) on days 2–4 (DEX4). The primary efficacy endpoint was complete response (CR: no emesis and no rescue medication) during the 5-day overall phase. The noninferiority margin was set at −15% difference (DEX1 or DEX3 minus DEX4). Secondary efficacy endpoints included complete protection (CP: CR and none or mild nausea). Results: Two-hundred twenty-eight patients, 76 in each arm, were assessable. Noninferiority was met for both DEX-sparing regimens and the reference arm, with overall phase CR rates of 76.3% in each of the DEX1 and DEX3 arms and 75.0% in the DEX4 arm (95% confidence interval, −12.3% to 15% for each comparison). During the overall phase, CP rates were similar between groups. Conclusion: A simplified regimen of NEPA plus single-dose DEX offers comparable chemotherapy-induced nausea and vomiting prevention throughout 5 days post-chemotherapy with the advantage of sparing patients additional doses of DEX in the high–emetic-risk setting of cisplatin-based chemotherapy. Implications for Practice: Dexamethasone (DEX) has traditionally played an integral role in the management of chemotherapy-induced emesis. Although generally considered safe, even short-term DEX use is associated with various side effects, and some evidence suggests that concurrent steroids may reduce the efficacy of immunotherapi
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- 2021
7. Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50
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Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, Porzio G., Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, and Porzio G.
- Abstract
Background: Single-agent pembrolizumab represents the standard first-line option for metastatic non-small-cell lung cancer (NSCLC) patients with a PD-L1 (programmed death-ligand 1) expression of ≥ 50%. Methods: We conducted a multicenter retrospective study aimed at evaluating the clinicopathologic correlates of pembrolizumab effectiveness in patients with treatment-naïve NSCLC and a PD-L1 expression of ≥ 50%. Results: One thousand and twenty-six consecutive patients were included. The objective response rate (ORR) was 44.5% (95% CI 40.2–49.1), while the median progression free survival (PFS) and overall survival (OS) were 7.9 months (95% CI 6.9–9.5; 599 events) and 17.2 months (95% CI 15.3–22.3; 598 censored patients), respectively. ECOG-PS ≥ 2 (p < 0.0001) and bone metastases (p = 0.0003) were confirmed to be independent predictors of a worse ORR. Former smokers (p = 0.0002), but not current smokers (p = 0.0532) were confirmed to have a significantly prolonged PFS compared to never smokers at multivariate analysis. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a worse PFS. Previous palliative RT was significantly related to a shortened OS (p = 0.0104), while previous non-palliative RT was significantly related to a prolonged OS (p = 0.0033). Former smokers (p = 0.0131), but not current smokers (p = 0.3433) were confirmed to have a significantly prolonged OS compared to never smokers. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a shortened OS. A PD-L1 expression of ≥ 90%, as assessed by recursive partitioning, was associated with significantly higher ORR (p = 0.0204), and longer and OS (p = 0.0346) at multivariable analysis. Conclusion: Pembrolizumab was effective in a large cohort of NSCLC patients treated outside of clinical trials. Questions regarding the effe
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- 2020
8. Prognostic nutritional index (pni) in oncogene addicted advanced non-small cell lung cancer (ansclc) patients (pts): an Italian experience
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Capizzi, I., primary, Morelli, A.M., additional, Carnio, S., additional, Paratore, C., additional, Bungaro, M., additional, Alemanni, A., additional, Tinivella, M., additional, Tiozzo, E., additional, Pedrazzoli, P., additional, Caccialanza, R., additional, Bertaglia, V., additional, Capelletto, E., additional, Reale, M.L., additional, Tampellini, M., additional, and Novello, S., additional
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- 2021
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9. Evaluation of dexamethasone (DEX)-sparing regimens, administered with NEPA, a fixed combination of netupitant and palonosetron, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in older patients receiving high-dose cisplatin
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Celio, L., primary, Cortinovis, D., additional, Cogoni, A.A., additional, Cavanna, L., additional, Martelli, O., additional, Carnio, S., additional, Collovà, E., additional, Bertolini, F., additional, Petrelli, F., additional, Cassano, A., additional, Chiari, R., additional, Zanelli, F., additional, Pisconti, S., additional, Vittimberga, I., additional, Letizia, A., additional, Misino, A., additional, Gernone, A., additional, Bonizzoni, E., additional, Pilotto, S., additional, De Placido, S., additional, and Bria, E., additional
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- 2021
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10. 1676P Nutritional assessment in the era of targeted therapies in advanced non-small cell lung cancer (aNSCLC) oncogene-addicted patients
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Morelli, A.M., primary, Capizzi, I., additional, Pisano, C., additional, De Filippis, M., additional, Carnio, S., additional, Alemanni, A., additional, Tinivella, M., additional, Pedrazzoli, P., additional, Caccialanza, R., additional, Bertaglia, V., additional, Capelletto, E., additional, Bironzo, P., additional, Reale, M.L., additional, Tampellini, M., additional, and Novello, S., additional
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- 2021
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11. 1783P Multi-parametric T cells profiling in broncho-alveolar lavage fluid (BAL) and blood from advanced lung cancer patients
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Mariniello, A., primary, Tabbò, F., additional, Indellicati, D., additional, Geuna, M., additional, Tesauro, M., additional, Rezmives, N.A., additional, Di Maio, M., additional, Bironzo, P., additional, Reale, M.L., additional, Passiglia, F., additional, Listi, A., additional, Capelletto, E., additional, Carnio, S., additional, Bertaglia, V., additional, Mecca, C., additional, Consito, L.T., additional, De Filippis, M., additional, Bungaro, M., additional, Paratore, C., additional, and Novello, S., additional
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- 2021
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12. 2128P exerCise discussion with Oncologist duriNg caNcEr ConsultaTion: The CONNECT study
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Pilotto, S., Belluomini, L., Tregnago, D., Trestini, I., Sposito, M., Insolda, J., Landi, L., Carnio, S., Vallone, S., Longo, V., Bafunno, D., Galetta, D., Ricciardi, S., Migliorino, M.R., Mariotti, S., Milella, M., Novello, S., and Avancini, A.
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- 2023
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13. 104P Fast progression in high PD-L1 NSCLC treated with pembrolizumab in first-line: A prognostic scoring system based on clinical features
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Passaro, A., primary, Giannarelli, D., additional, Bria, E., additional, Novello, S., additional, Galetta, D., additional, Gelibter, A.J., additional, Reale, M.L., additional, Carnio, S., additional, Vita, E., additional, Stefani, A., additional, Pizzutilo, P., additional, Stati, V., additional, Attili, I., additional, and de Marinis, F., additional
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- 2021
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14. Retrospective multicenter study of post-operative stenosis after stapled colorectal anastomosis
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Sartori A, De Luca M, Fiscon V, Frego M, Vigna S, Mazzeo A, Coco D, Agresta F, Finotti E, Antoniutti M, Carnio S, Elio A, Brunelli M, Ruffo G, Bertocchi E, Parini D, Losacco L, Poli F, Santoro G, Massani M, Ruffolo C, Cian E, Zanatta L, Genna M, Ballarin A, Rebonato M, Fontana M, Moretto G, Impellizzeri H, Merenda R, Margani G, Merigliano S, Baldan N, Ubiali P, Braini A, Balani A, Kosuta M, Infantino A, Giacomel G, Armatura G, Patauner S, de Manzini N, Palmisano S, Sorrentino M, Brizzolari M, Belluco C, Olivieri M, Lauro E, Scudo G, Valduga P, Brolese A, Pignata G, Andreucetti J, Caruso A, Zappalà F, Portale G ., Sartori, A, De Luca, M, Fiscon, V, Frego, M, Vigna, S, Mazzeo, A, Coco, D, Agresta, F, Finotti, E, Antoniutti, M, Carnio, S, Elio, A, Brunelli, M, Ruffo, G, Bertocchi, E, Parini, D, Losacco, L, Poli, F, Santoro, G, Massani, M, Ruffolo, C, Cian, E, Zanatta, L, Genna, M, Ballarin, A, Rebonato, M, Fontana, M, Moretto, G, Impellizzeri, H, Merenda, R, Margani, G, Merigliano, S, Baldan, N, Ubiali, P, Braini, A, Balani, A, Kosuta, M, Infantino, A, Giacomel, G, Armatura, G, Patauner, S, de Manzini, N, Palmisano, S, Sorrentino, M, Brizzolari, M, Belluco, C, Olivieri, M, Lauro, E, Scudo, G, Valduga, P, Brolese, A, Pignata, G, Andreucetti, J, Caruso, A, Zappalà, F, and Portale G, .
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Male ,medicine.medical_specialty ,Colorectal anastomosis ,Constriction, Pathologic ,Anastomosis ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Risk Factors ,Surgical Stapling ,Prevalence ,medicine ,Humans ,Colorectal anastomosi ,Retrospective Studies ,Stenosis ,business.industry ,Stapled anastomosis ,Anastomosis, Surgical ,Retrospective cohort study ,Endoscopic dilatation ,medicine.disease ,Colorectal surgery ,Surgery ,Italy ,Multicenter study ,030220 oncology & carcinogenesis ,030211 gastroenterology & hepatology ,Colorectal Neoplasms ,business ,Complication ,Stapled anastomosi - Abstract
Anastomotic stenosis after colorectal surgery is usually considered low-rate complication and often is under-reported in most studies. Few data are available on management strategies. The aim of the study was to assess the prevalence of stenosis after stapled colorectal anastomosis, performed either in elective or emergent setting, for benign or malignant disease, and to evaluate treatment profiles. This retrospective study was a survey conducted in a large Italian North-Eastern area including three regions (Triveneto), over a 12-month period (January–December 2015). Patients’ characteristics and surgical technique details were recorded, along with data on the prevalence of stenosis and its treatment. Patients with mid or low rectal resection and/or neoadjuvant chemo-radio therapy and/or diverting stoma were excluded. The study was promoted by the Italian Association of Hospital Surgeons (ACOI) and the Society of Surgeons of the Triveneto Region. Twenty-eight surgical units were enrolled in the survey, accounting for over 1400 patients studied. Fifty percent of the units performed laparoscopically > 70% of the colorectal resections and 7.5% of the procedures were emergent. Less than 60% of the units planned regular endoscopic follow-up after colorectal resection. Anastomotic stricture was recorded in 2% of the patients; 88% of the stenoses were diagnosed within 6 months from surgery. Only one anastomotic stricture required re-do surgery. The CANSAS study confirms that colorectal anastomotic stenosis is low-rate—but still present—complication. Treatment strategies vary according to surgeons’ and endoscopists’ preferences. Commonly endoscopic dilatation is preferred, but re-do surgery is required in some cases.
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- 2019
15. Chemotherapy-induced nausea and vomiting (CINV) in patients with advanced lung cancer during the first-line treatment: assessment by physicians, nurses, and patients from an Italian multicenter survey
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Carnio, S, Galetta, D, Scotti, V, Cortinovis, D, Antonuzzo, A, Pisconti, S, Rossi, A, Martelli, O, Cecere, F, Lunghi, A, Del Conte, A, Montagna, E, Topulli, J, Pelizzoni, D, Rapetti, S, Gianetta, M, Pacchiana, M, Pegoraro, V, Cataldo, N, Bria, E, Novello, S, Carnio S, Galetta D, Scotti V, Cortinovis D, Antonuzzo A, Pisconti S, Rossi A, Martelli O, Cecere FL, Lunghi A, Del Conte A, Montagna ES, Topulli J, Pelizzoni D, Rapetti SG, Gianetta M, Pacchiana MV, Pegoraro V, Cataldo N, Bria E, Novello S., Carnio, S, Galetta, D, Scotti, V, Cortinovis, D, Antonuzzo, A, Pisconti, S, Rossi, A, Martelli, O, Cecere, F, Lunghi, A, Del Conte, A, Montagna, E, Topulli, J, Pelizzoni, D, Rapetti, S, Gianetta, M, Pacchiana, M, Pegoraro, V, Cataldo, N, Bria, E, Novello, S, Carnio S, Galetta D, Scotti V, Cortinovis D, Antonuzzo A, Pisconti S, Rossi A, Martelli O, Cecere FL, Lunghi A, Del Conte A, Montagna ES, Topulli J, Pelizzoni D, Rapetti SG, Gianetta M, Pacchiana MV, Pegoraro V, Cataldo N, Bria E, and Novello S.
- Abstract
Purpose: Chemotherapy-induced nausea and vomiting (CINV) still represents a common side-effect of chemotherapy, and often, its perception differs between patients and healthcare professionals. The aim of this study was to evaluate the agreement on the perception of CINV and other items among clinicians, patients, and nurses. Methods: This observational prospective study was part of an evaluation program promoted by the Women Against Lung Cancer in Europe (WALCE) Onlus. From August 2015 to February 2016, a survey was administered in 11 oncologic institutions to 188 stage IV lung cancer patients and to their oncologists and nurses during first-line chemotherapy. Our survey investigated 11 aspects: anxiety, mood, weakness, appetite, nausea, vomiting, pain, drowsiness, breath, general condition, and trust in treatments. These items were assessed through Numerical Rating Scale at four consecutive evaluations: at T0 (immediately prior to the first cycle), at T1 (immediately prior to the second cycle), at T2 (immediately prior to the third cycle), and at T3 (immediately prior to the fourth cycle). Clinician versus patient (CvP), nurse versus patient (NvP), and clinician versus nurse (CvN) agreements were estimated applying Weighted Cohen’s kappa. A multivariate logistic model and generalized equation estimates were applied to evaluate factors possibly influencing CINV development. Results: The incidence of patients reporting CINV varied from 40% at T0 to 71% at T3. Both CvP and NvP agreement on the investigated items were mainly moderate, slightly increasing over time, and becoming substantial for some items, in particular for NvP. Pre-chemotherapy anxiety in its mild, moderate, and severe manifestations, as well as mild, moderate, and severe anxiety experienced after chemotherapy start, exposed patients to a higher risk of anticipatory and acute/delayed CINV, respectively. Conclusions: Despite clinical staff awareness of patients’ status and perceptions, CINV still repres
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- 2018
16. 1815MO Two simplified dexamethasone (DEX)-sparing regimens with NEPA for the prevention of emesis caused by cisplatin (DDP): A phase III, controlled, non-inferiority trial
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Celio, L., primary, Cortinovis, D., additional, Cogoni, A., additional, Cavanna, L., additional, Martelli, O., additional, Carnio, S., additional, Collovà, E., additional, Bertolini, F., additional, Petrelli, F., additional, Cassano, A., additional, Chiari, R., additional, Zanelli, F., additional, Vittimberga, I., additional, Letizia, A., additional, Misino, A., additional, Silvestris, F., additional, Bonizzoni, E., additional, Pilotto, S., additional, De Placido, S., additional, and Bria, E., additional
- Published
- 2020
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17. A systematic review and meta-analysis of trials assessing activity of PD-1/PD-L1 immune checkpoint inhibitors (ICIs) for pre-treated advanced malignant mesothelioma (aMM)
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Tagliamento, M., primary, Bironzo, P., additional, De Luca, E., additional, Pignataro, D., additional, Rapetti, S.G., additional, Audisio, M., additional, Bertaglia, V., additional, Paratore, C., additional, Bungaro, M., additional, Olmetto, E., additional, Artusio, E., additional, Reale, M.L., additional, Zichi, C., additional, Capelletto, E., additional, Carnio, S., additional, Buffoni, L., additional, Passiglia, F., additional, Novello, S., additional, and Di Maio, M., additional
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- 2019
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18. P2.04-15 Association Between Opioids and Outcome of 1st Line Immunotherapy in Advanced NSCLC Patients: A Retrospective Evaluation
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Bironzo, P., primary, Pignataro, D., additional, Audisio, M., additional, Tagliamento, M., additional, Paratore, C., additional, Tabbò, F., additional, Bungaro, M., additional, Zichi, C., additional, De Filippis, M., additional, Rapetti, S., additional, Cetoretta, V., additional, Carnio, S., additional, Mariniello, A., additional, Buffoni, L., additional, Lacidogna, G., additional, Di Maio, M., additional, and Novello, S., additional
- Published
- 2019
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19. MA07.02 Early Change of dNLR Is Correlated with Outcomes in Advanced NSCLC Patients Treated with Immunotherapy
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Mezquita, L., primary, Preeshagul, I., additional, Auclin, E., additional, Saravia, D., additional, Hendriks, L., additional, Rizvi, H., additional, Planchard, D., additional, Park, W., additional, Nadal, E., additional, Ruffinelli, J.C., additional, Ponce, S., additional, Audigier-Valette, C., additional, Carnio, S., additional, Novello, S., additional, Zalcman, G., additional, Majem, M., additional, Mariniello, A., additional, Dingemans, A.M., additional, Lopes, G., additional, Rossoni, C., additional, Pignon, J., additional, Chaput, N., additional, Hellmann, M., additional, Arbour, K., additional, and Besse, B., additional
- Published
- 2019
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20. P1.04-45 Immune-Oncology Gene Expression Profiles Allow Lung Cancer Patients’ Stratification and Identification of Responders to Immunotherapy
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Tabbò, F., primary, Annaratone, L., additional, Nocifora, A., additional, Vignale, C., additional, Carnio, S., additional, Metovic, J., additional, Veneziano, F., additional, Scodes, S., additional, Russo, A., additional, Franchina, T., additional, Sini, C., additional, Coco, S., additional, Garlatti, P., additional, Vieri, S., additional, Adamo, V., additional, Boccardo, S., additional, Grossi, F., additional, Cappuzzo, F., additional, Papotti, M., additional, Righi, L., additional, Passiglia, F., additional, and Novello, S., additional
- Published
- 2019
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- View/download PDF
21. P2.04-14 NLR, dNLR and PLR as Possible Predictive Markers in Patients with NSCLC Treated with ICI
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Carnio, S., primary, Mariniello, A., additional, Pizzutilo, P., additional, Numico, G., additional, Borra, G., additional, Lunghi, A., additional, Parra, H. Soto, additional, Buosi, R., additional, Vavalà, T., additional, Stura, I., additional, Genestroni, S., additional, Alemanni, A., additional, Arizio, F., additional, Catino, A., additional, Montrone, M., additional, Galetta, D., additional, Migliaretti, G., additional, and Novello, S., additional
- Published
- 2019
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22. Patients' Attitudes and Physicians' Perceptions Toward Maintenance Therapy for Advanced Non-Small-cell Lung Cancer: A Multicenter Italian Survey
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Pacchiana, M, Capelletto, E, Carnio, S, Gridelli, C, Rossi, A, Galetta, D, Montagna, E, Bordi, P, Ceribelli, A, Cortinovis, D, Scotti, V, Martelli, O, Valmadre, G, Del Conte, A, Miccianza, A, Morena, R, Rosetti, F, Di Maio, M, Ostacoli, L, Novello, S, Pacchiana MV, Capelletto E, Carnio S, Gridelli C, Rossi A, Galetta D, Montagna ES, Bordi P, Ceribelli A, Cortinovis D, Scotti V, Martelli O, Valmadre G, Del Conte A, Miccianza A, Morena R, Rosetti F, Di Maio M, Ostacoli L, Novello S., Pacchiana, M, Capelletto, E, Carnio, S, Gridelli, C, Rossi, A, Galetta, D, Montagna, E, Bordi, P, Ceribelli, A, Cortinovis, D, Scotti, V, Martelli, O, Valmadre, G, Del Conte, A, Miccianza, A, Morena, R, Rosetti, F, Di Maio, M, Ostacoli, L, Novello, S, Pacchiana MV, Capelletto E, Carnio S, Gridelli C, Rossi A, Galetta D, Montagna ES, Bordi P, Ceribelli A, Cortinovis D, Scotti V, Martelli O, Valmadre G, Del Conte A, Miccianza A, Morena R, Rosetti F, Di Maio M, Ostacoli L, and Novello S.
- Abstract
One question is how long patients with advanced non–small-cell lung cancer wish to receive therapy. The perceptions of > 100 patients and physicians were analyzed to compare different prognostic conditions. The patients' attitudes were generally positive and not directly linked to the expected benefits, suggesting that other factors in conjunction with the clinical assessment, such as the doctor–patient relationship, should be considered to understand patients' motivations. Introduction Pemetrexed maintenance therapy (MT) after induction with platinum-based chemotherapy has recently become a common treatment strategy for advanced nonsquamous non–small-cell lung cancer (NSCLC). However, the benefits of MT should be weighed with consideration of the patients' perceptions and preferences. The aim of the present study was to evaluate patients' attitudes toward MT and to describe physicians' awareness of their patients' inclinations. Materials and Methods We administered a 12-question anonymous survey and the Distress Thermometer Questionnaire to patients with advanced or recurrent nonsquamous NSCLC. The survey was also distributed to the referring physicians. Results From December 2014 to July 2015, 92 patients and 37 physicians were enrolled. All 92 patients completed the questionnaire at T0 (before starting chemotherapy) and 56.5% also did so at T1 (after completion of induction). The physicians completed the survey only at T0. Most patients had a positive attitude toward MT at both T0 (78.9%) and T1 (86.5%), and 100% of the physicians thought their patients would be in favor of MT. The physicians believed that their patients' attitudes toward MT would decrease proportionally with the reduction in the magnitude of the overall survival increase and expected benefits. The decrease expected by the physicians was much greater than that reported by the patients. This was especially true for an overall survival increase as small as 1 month (51.9% of patients accepting MT
- Published
- 2017
23. Striated anal sphincter electromyography in idiopathic fecal incontinence
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Infantino, A., Melega, E., Negrin, P., Masin, Lessandra, Carnio, S., and Lise, M.
- Published
- 1995
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24. P1.01-68 Correlation of the Lung Immune Prognostic Index (LIPI) and PDL1 Status with Outcomes for Immune Checkpoint Inhibitors in Advanced NSCLC Patients
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Mezquita, L., primary, Park, W., additional, Arbour, K., additional, Auclin, E., additional, Hendriks, L., additional, Planchard, D., additional, Saravia, D., additional, Ponce Aix, S., additional, Nadal, E., additional, Audigier-Valette, C., additional, Carnio, S., additional, Adam, J., additional, Ruffinelli, J.C., additional, Zalcman, G., additional, Numico, G., additional, Sullivan, I., additional, Paz-Ares, L., additional, Dingemans, A., additional, Novello, S., additional, Hellmann, M., additional, Lopes, G., additional, and Besse, B., additional
- Published
- 2018
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- View/download PDF
25. SIOG2021-0013* - Evaluation of dexamethasone (DEX)-sparing regimens, administered with NEPA, a fixed combination of netupitant and palonosetron, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in older patients receiving high-dose cisplatin
- Author
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Celio, L., Cortinovis, D., Cogoni, A.A., Cavanna, L., Martelli, O., Carnio, S., Collovà, E., Bertolini, F., Petrelli, F., Cassano, A., Chiari, R., Zanelli, F., Pisconti, S., Vittimberga, I., Letizia, A., Misino, A., Gernone, A., Bonizzoni, E., Pilotto, S., De Placido, S., and Bria, E.
- Published
- 2021
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- View/download PDF
26. Chemotherapy-induced nausea and vomiting (CINV) in patients with advanced lung cancer during the first-line treatment: assessment by physicians, nurses, and patients from an Italian multicenter survey
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Carnio, S., primary, Galetta, D., additional, Scotti, V., additional, Cortinovis, D. L., additional, Antonuzzo, A., additional, Pisconti, S., additional, Rossi, A., additional, Martelli, O., additional, Cecere, F. L., additional, Lunghi, A., additional, Del Conte, A., additional, Montagna, E. S., additional, Topulli, J., additional, Pelizzoni, D., additional, Rapetti, S. G., additional, Gianetta, M., additional, Pacchiana, M. V., additional, Pegoraro, V., additional, Cataldo, N., additional, Bria, E., additional, and Novello, S., additional
- Published
- 2017
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- View/download PDF
27. The close link between anxiety and cluster symptoms in lung cancer patients during first-line chemotherapy: further data from a dedicated WALCE (Women Against Lung Cancer in Europe) survey
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Carnio, S., primary, Galetta, D., additional, Scotti, V., additional, Cortinovis, D.L., additional, Antonuzzo, A., additional, Pisconti, S., additional, Rossi, A., additional, Martelli, O., additional, Cecere, F.L., additional, Lunghi, A., additional, Del Conte, A., additional, Montagna, E.S., additional, Topulli, J., additional, Pelizzoni, D., additional, Rapetti, S.G., additional, Gianetta, M., additional, Pacchiana, M.V., additional, Pegoraro, V., additional, Cataldo, N., additional, Bria, E., additional, and Novello, S., additional
- Published
- 2017
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- View/download PDF
28. MITOCHONDRIA AND OXIDATIVE STRESS IN AGE-RELATED MUSCLE LOSS (SARCOPENIA)
- Author
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LO VERSO, Francesca, CARNIO, S, BARAIBAR, M, LONGA, M, MAFFEI, M, CANEPARI, M, FRIGUET, B, BOTTINELLI, R, and SANDRI, M
- Abstract
Muscle wasting is due to an excessive activation of degradative pathways. It occurs in different pathologies such as cancer, AIDS, diabetes but inevitably it occurs in everybody’s life during aging. Sarcopenia is the degenerative loss of skeletal muscle mass and strength associated with aging. The ability to activate compensatory mechanisms in response to environmental stress and physiological changing is an important factor for survival and maintenance of cellular functions. A system that is often activated both in short and prolonged stress conditions is autophagy. Autophagy is required to clear the cell from dysfunctional organelles and altered proteins and is reported to decline during ageing. This reduction might contribute to age-related organ dysfunction and, in general, to ageing. Here we report that specific autophagy inhibition in muscle has a major impact on this tissue that ultimately affect life span of animals. Inhibition of autophagy exacerbates the aging-related features of muscle such as atrophy, mitochondrial dysfunction, oxidative stress and profound weakness. Mitochondrial dysfunction and oxidative stress directly affect acto-myosin interaction and force generation. These results demonstrate that aging-related muscle dysfunction is mainly caused by a failure of the autophagy system. It has been reported that lifestyle adaptations, such as caloric restriction and physical exercise are able to ameliorate several features during ageing process, moreover physical activity has been recently documented to play a fundamental physiological role in the regulation of autophagy in several tissues. Here we address also the role of autophagy during exercise. We reveal that autophagy is critical for the preservation of mitochondrial function during damaging muscle contraction. We establish that basal oxidative stress plays a crucial role in mitochondrial maintenance during normal physical activity. Therefore, autophagy is an adaptive response to exercise that ensures effective mitochondria-quality control during damaging physical activity., Journal of International Society of Antioxidants in Nutrition & Health, Vol 3, No 3 (2016)
- Published
- 2016
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29. 78P - A systematic review and meta-analysis of trials assessing activity of PD-1/PD-L1 immune checkpoint inhibitors (ICIs) for pre-treated advanced malignant mesothelioma (aMM)
- Author
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Tagliamento, M., Bironzo, P., De Luca, E., Pignataro, D., Rapetti, S.G., Audisio, M., Bertaglia, V., Paratore, C., Bungaro, M., Olmetto, E., Artusio, E., Reale, M.L., Zichi, C., Capelletto, E., Carnio, S., Buffoni, L., Passiglia, F., Novello, S., and Di Maio, M.
- Published
- 2019
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- View/download PDF
30. Chemotherapy-induced nausea and vomiting (CINV) in patients with stage III/IV lung cancer during the first-line treatment: assessment by physician, nurse and patient. Preliminary results from an Italian multicenter survey
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Carnio, S., primary, Galetta, D., additional, Scotti, V., additional, Cortinovis, D.L., additional, Antonuzzo, A., additional, Pisconti, S., additional, Rossi, A., additional, Martelli, O., additional, Cecere, F.L., additional, Bria, E., additional, Del Conte, A., additional, Pegoraro, V., additional, Montagna, E.S., additional, Topulli, J., additional, Pelizzoni, D., additional, Rapetti, S.G., additional, Gianetta, M., additional, and Novello, S., additional
- Published
- 2016
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- View/download PDF
31. E11 - The close link between anxiety and cluster symptoms in lung cancer patients during first-line chemotherapy: further data from a dedicated WALCE (Women Against Lung Cancer in Europe) survey
- Author
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Carnio, S., Galetta, D., Scotti, V., Cortinovis, D.L., Antonuzzo, A., Pisconti, S., Rossi, A., Martelli, O., Cecere, F.L., Lunghi, A., Del Conte, A., Montagna, E.S., Topulli, J., Pelizzoni, D., Rapetti, S.G., Gianetta, M., Pacchiana, M.V., Pegoraro, V., Cataldo, N., Bria, E., and Novello, S.
- Published
- 2017
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- View/download PDF
32. A21 - Chemotherapy-induced nausea and vomiting (CINV) in patients with stage III/IV lung cancer during the first-line treatment: assessment by physician, nurse and patient. Preliminary results from an Italian multicenter survey
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Carnio, S., Galetta, D., Scotti, V., Cortinovis, D.L., Antonuzzo, A., Pisconti, S., Rossi, A., Martelli, O., Cecere, F.L., Bria, E., Del Conte, A., Pegoraro, V., Montagna, E.S., Topulli, J., Pelizzoni, D., Rapetti, S.G., Gianetta, M., and Novello, S.
- Published
- 2016
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33. IL-6 blood level is associated with circulating CEA and prognosis in patients with colorectal cancer
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Belluco, C., Frantz, M, Carnio, S, Plebani, Mario, Nitti, Donato, Lise, M, and Jessup, J. M.
- Published
- 1999
34. Psychological Distress and Quality of Life Evaluation in Head and Neck Cancer: the Role of Family Caregiver
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Ostellino, O., primary, Airoldi, M., additional, Garzaro, M., additional, Raimondo, L., additional, Riva, G., additional, Bartoli, C., additional, Carnio, S., additional, Fora, G., additional, Giordano, C., additional, and Pecorari, G., additional
- Published
- 2012
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35. Cisplatin + Vinorelbine (DDP + VNB) Administered in 60 Cases of Recurrent/Metastatic Salivary Gland Malignancies (RMSGM): Final Report
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Ostellino, O., primary, Airoldi, M., additional, Garzaro, M., additional, Pedani, F., additional, Raimondo, L., additional, Riva, G., additional, Carnio, S., additional, Pecorari, G., additional, Fora, G., additional, and Giordano, C., additional
- Published
- 2012
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36. Second line therapy with cetuximab in NSCLC
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Buosi, R., primary, Gatti, A., additional, Carnio, S., additional, Sponghini, A., additional, Olympios, C., additional, and Alabiso, O., additional
- Published
- 2006
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37. 1843P Safety of immunotherapy in cancer patients with comorbidities: Results of the phase IV Italian immuno-special trial.
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Smussi, D., Carpani, M., Vetrugno, S., Catapano, C., Stucchi, E., Alberti, A., Lorini, L., Carnio, S., Berruti, A., Cortinovis, D.L., Di Pede, P., Citarella, F., Galli, L., Stragliotto, S., Ermacora, P., Roila, F., Zustovich, F., Velutti, L.E., De Feo, G., and Bossi, P.
- Subjects
- *
CANCER patients , *IMMUNOTHERAPY , *COMORBIDITY , *SAFETY - Published
- 2024
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38. Exploratory analysis of the effect of a dexamethasone-sparing regimen for prophylaxis of cisplatin-induced emesis on food intake (LUNG-NEPA study).
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Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, and Bria E
- Subjects
- Humans, Cisplatin therapeutic use, Palonosetron, Vomiting chemically induced, Nausea chemically induced, Dexamethasone therapeutic use, Eating, Lung, Antiemetics, Antineoplastic Agents therapeutic use
- Abstract
We demonstrated the non-inferiority of a dexamethasone (DEX)-sparing (single-dose) regimen with NEPA, a netupitant/palonosetron fixed combination, for preventing chemotherapy-induced nausea and vomiting (CINV) caused by cisplatin. This pre-planned exploratory analysis assessed the effect of the DEX-sparing regimen on a patient's food intake. Chemotherapy-naïve patients undergoing cisplatin (≥ 70 mg/m
2 ) were given NEPA and DEX (12 mg) on day 1 and randomized to receive either no further DEX (DEX1), or oral DEX (4 mg BID) on days 2-4 (DEX4). Patient-reported endpoint maintenance of usual daily food intake was assessed during the 5-days post-chemotherapy. The relationship between usual daily food intake and CINV control, pre-chemotherapy self-rated food intake and BMI-adjusted weight loss (WL) were evaluated. One-hundred fifty-two patients (76/group) were assessable. The proportion of patients reporting maintenance of usual daily food intake was similar in both groups: 69.7% (95% CI, 58.6-78.9) for DEX1 vs. 72.4% (95% CI, 61.4-81.2) for DEX4. Only CINV control was significantly associated with maintenance of usual daily food intake (P ≤ 0.001) during the overall phase. The DEX-sparing regimen does not adversely affect patient-reported daily food intake post-chemotherapy. The current analysis adds further insights into antiemetic efficacy of DEX sparing beyond day 1 in the challenging setting of cisplatin.Trial registration: The parent study was registered on ClinicalTrials.gov (NCT04201769)., (© 2023. The Author(s).)- Published
- 2023
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39. Squamous cell histological transformation in a lung adenocarcinoma patient (hyper) progressing upon immunotherapy.
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Mariniello A, Righi L, Morrone A, Carnio S, and Bironzo P
- Subjects
- Male, Mice, Animals, Humans, Epithelial Cells, Immunotherapy, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms therapy, Adenocarcinoma of Lung therapy, Carcinoma, Squamous Cell therapy
- Abstract
Introduction: In non-small cell lung cancer (NSCLC) histologic transformation upon immune checkpoint inhibitors (ICI) is rare., Case Presentation: We described the case of a patient with early-stage lung adenocarcinoma who relapsed after surgery. At the time of relapse, he received chemo-radiotherapy, followed by consolidation immunotherapy. After 3 cycles the patient experienced disease hyperprogression for onset of a new lung mass, which resulted in squamous cell carcinoma. The preservation of an atypical mutation in the v-raf murine sarcoma viral oncogene homolog B1 (BRAF) gene in both the primary adenocarcinoma and the new squamous carcinoma suggests histological transformation, likely ICI-related., Discussion: We reviewed similar cases in literature, highlighting common patterns and substantial differences. For a deeper insight into inherent biological mechanisms, re-biopsy in case of atypical ICI response should be encouraged.
- Published
- 2022
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40. Multicentre, randomised, open-label, parallel-group, clinical phase II study to evaluate immunonutrition in improving efficacy of immunotherapy in patients with metastatic non-small cell lung cancer, undergoing systematic nutritional counseling.
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Caccialanza R, Cereda E, Agustoni F, Klersy C, Casirati A, Montagna E, Carnio S, Novello S, Milella M, Pilotto S, Trestini I, Buffoni L, Ferrari A, and Pedrazzoli P
- Subjects
- Humans, Quality of Life, Pilot Projects, Dietary Supplements, Counseling, Immunotherapy, Carcinoma, Non-Small-Cell Lung therapy, Lung Neoplasms therapy
- Abstract
Background: Nutritional support, including nutritional counseling and oral nutritional supplements (ONS), has been recommended as a first-line strategy in patients with non-small cell lung cancer (NSCLC). Evidence on the efficacy of immunonutrition during immunotherapy in these patients is positive, but still limited some secondary endpoints, such as treatment toxicity and tolerance. We hypothesize that early systematic provision of ONS with a high-protein-high calorie mixture containing immunonutrients (Impact®) in addition to nutritional counseling, compared to nutritional counseling alone, is beneficial to patients with NSCLC receiving immunotherapy with or without chemotherapy. We designed the present study to evaluate the efficacy of early systematic provision of ONS enriched with immunonutrients compared to nutritional counseling alone, in patients with NSCLC undergoing immunotherapy. Study endpoints were: treatment response (primary endpoint: progression-free survival), treatment tolerance and toxicity, body weight, body composition, protein-calorie intake, quality of life, fatigue, muscle strength and immunological profile., Methods: This is a pragmatic, multicentre, randomized (1:1), parallel-group, open label, controlled, pilot clinical trial (N = 180)., Discussion: The improvement of efficacy of nutritional support in oncology still deserves many efforts. Immunonutrition represents a promising approach also in patients with NSCLC, but evidence on its efficacy on clinical outcomes during immunotherapy is still inconclusive. The present pilot study, which guarantees early high-quality nutritional care (assessment and treatment) to all patients in agreement with current guidelines and recommendations, could represent one of the first proofs of efficacy of early oral immunonutrition in patients with cancer undergoing immunotherapy. Further large randomized trials addressing the improvement of supportive care could be hypothesized, accordingly., Trial Registration: This study is registered on ClinicalTrials.gov Identifier: NCT05384873., (© 2022. The Author(s).)
- Published
- 2022
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41. Comparing T Cell Subsets in Broncho-Alveolar Lavage (BAL) and Peripheral Blood in Patients with Advanced Lung Cancer.
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Mariniello A, Tabbò F, Indellicati D, Tesauro M, Rezmives NA, Reale ML, Listì A, Capelletto E, Carnio S, Bertaglia V, Mecca C, Consito L, De Filippis M, Bungaro M, Paratore C, Di Maio M, Passiglia F, Righi L, Sangiolo D, Novello S, Geuna M, and Bironzo P
- Subjects
- Humans, B7-H1 Antigen metabolism, Bronchoalveolar Lavage Fluid, Interferon-gamma metabolism, Programmed Cell Death 1 Receptor metabolism, Lung Neoplasms immunology, T-Lymphocyte Subsets immunology
- Abstract
Background: Lung cancer (LC) tissue for immunological characterization is often scarce. We explored and compared T cell characteristics between broncho-alveolar lavage from tumor affected (t-BAL) and contralateral lung (cl-BAL), with matched peripheral blood (PB)., Methods: BAL and PB were collected during bronchoscopy for diagnostic and/or therapeutic purposes in patients with monolateral primary lesion., Results: Of 33 patients undergoing BAL and PB sampling, 21 had histologically-confirmed LC. Most cases were locally-advanced or metastatic non-small cell LC. T cell characteristics were not significantly different in t-BAL vs. cl-BAL. Compared to PB, CD8 T cells in BAL presented features of immune activation and exhaustion (high PD-1, low IFN-g production). Accordingly, regulatory CD4 T cells were also higher in BAL vs. PB. When dichotomizing T cell density in t-BAL in high and low, we found that PD-L1 expression in LC was associated with T cell density in t-BAL. T-BAL with high T cell density had higher %IFN-g+CD8 T cells and lower %T-regs., Conclusion: In BAL from advanced LC patients, T cells present features of exhaustion. T cells in t-BAL could be the best surrogate of tumor-infiltrating T cell, and future studies should evaluate T cell phenotype and density as potential biomarkers for cancer immunotherapy outcome.
- Published
- 2022
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42. Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study.
- Author
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Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, and Bria E
- Subjects
- Benzeneacetamides, Cisplatin adverse effects, Dexamethasone, Humans, Nausea chemically induced, Palonosetron therapeutic use, Piperazines, Pyridines, Quinuclidines, Vomiting chemically induced, Vomiting drug therapy, Antiemetics, Antineoplastic Agents adverse effects
- Abstract
Background: The non-inferiority of dexamethasone (DEX) on day 1, with or without low-dose DEX on days 2 and 3, combined with oral NEPA (netupitant/palonosetron), compared with the guideline-consistent use of DEX was demonstrated in cisplatin. Here, we complete the analysis by assessing the impact of emesis on daily lives of patients receiving DEX-sparing regimens using the Functional Living Index-Emesis (FLIE)., Methods: Chemotherapy-naïve patients undergoing cisplatin (≥70 mg/m
2 ), were given NEPA and DEX (12 mg) on day 1 and randomized to receive either 1) no further DEX (DEX1), 2) oral DEX (4 mg daily) on days 2-3 (DEX3), or 3) DEX (4 mg twice daily) on days 2-4 (DEX4; control). Patients completed the FLIE questionnaire on day 6 of cycle 1. Endpoints included the FLIE nausea domain, vomiting domain, and overall combined domain scores, as well as the proportion of patients with no impact on daily life (NIDL; overall score > 108). This was a protocol-planned analysis., Results: In the DEX1 group, no significant differences were observed in the FLIE nausea score (48.9 [±1.8; SE] vs. 53.7 [±1.5]), vomiting score (56.6 [±1.4] vs. 58.7 [±0.8]) and overall score (105.6 [±2.8] vs.112.4 [±1.9]) versus DEX4 control; similar results were observed in the DEX3 group for nausea score (49.6 [±1.7]), vomiting score (58.2 [±1]) and overall score (107.8 [±2.4]) versus control. There were no significant between-group differences in the proportion of patients reporting NIDL., Conclusion: Reducing DEX, when administered with NEPA, does not seem to adversely impact the daily functioning in patients undergoing cisplatin., Trial Registration: ClinicalTrials.gov NCT04201769 . Registration date: 17/12/2019 - Retrospectively registered., (© 2022. The Author(s).)- Published
- 2022
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- View/download PDF
43. A systematic review and meta-analysis of trials assessing PD-1/PD-L1 immune checkpoint inhibitors activity in pre-treated advanced stage malignant mesothelioma.
- Author
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Tagliamento M, Bironzo P, Curcio H, De Luca E, Pignataro D, Rapetti SG, Audisio M, Bertaglia V, Paratore C, Bungaro M, Olmetto E, Artusio E, Reale ML, Zichi C, Capelletto E, Carnio S, Buffoni L, Passiglia F, Novello S, Scagliotti GV, and Di Maio M
- Subjects
- B7-H1 Antigen, Humans, Immune Checkpoint Inhibitors pharmacology, Immune Checkpoint Inhibitors therapeutic use, Programmed Cell Death 1 Receptor, Progression-Free Survival, Lung Neoplasms pathology, Mesothelioma, Malignant drug therapy
- Abstract
Introduction: Advanced stage malignant mesothelioma (asMM) patients have poor prognosis. Several trials investigated the role of programmed cell death protein-1 (PD-1) and its ligand 1 (PD-L1) immune checkpoint inhibitors (ICIs) in pre-treated asMM., Methods: A systematic review of the literature of clinical trials testing single-agent anti PD-1/PD-L1 ICIs in pre-treated asMM was performed. Objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) data were extracted. The predictive role of PD-L1 was assessed., Results: We selected 13 studies including 888 patients. ORR and DCR were 18.1% (95% confidence interval [CI] 13.9-22.8%) and 55.4% (95% CI: 48.1-62.5%), respectively. Median PFS and OS ranged from 2.1 to 5.9 and from 6.7 to 20.9 months, respectively. ORR according to PD-L1 was 27.0% (95% CI: 18.7-36.2%)., Conclusions: Anti-PD-(L)1 ICIs might be considered a treatment option for chemotherapy-resistant asMM, even if reliable predictive factors are still lacking., (Copyright © 2022 Elsevier B.V. All rights reserved.)
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- 2022
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44. Black Hairy Tongue After Immune Checkpoint Inhibitors in NSCLC: A Case Report and Review of the Literature.
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Cecchi C, Mariniello A, Carnio S, Delcuratolo MD, and Novello S
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- Aged, Humans, Male, Tongue, Hairy therapy, Carcinoma, Non-Small-Cell Lung drug therapy, Immune Checkpoint Inhibitors adverse effects, Lung Neoplasms drug therapy, Tongue, Hairy chemically induced
- Published
- 2021
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45. Dexamethasone-Sparing Regimens with Oral Netupitant and Palonosetron for the Prevention of Emesis Caused by High-Dose Cisplatin: A Randomized Noninferiority Study.
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Celio L, Cortinovis D, Cogoni AA, Cavanna L, Martelli O, Carnio S, Collovà E, Bertolini F, Petrelli F, Cassano A, Chiari R, Zanelli F, Pisconti S, Vittimberga I, Letizia A, Misino A, Gernone A, Bonizzoni E, Pilotto S, De Placido S, and Bria E
- Subjects
- Antineoplastic Combined Chemotherapy Protocols adverse effects, Dexamethasone, Humans, Palonosetron therapeutic use, Pyridines, Quinuclidines, Vomiting chemically induced, Vomiting drug therapy, Vomiting prevention & control, Antiemetics therapeutic use, Cisplatin adverse effects
- Abstract
Background: To reduce the overall exposure to dexamethasone (DEX) in patients receiving cisplatin-based chemotherapy, we evaluated the noninferiority of DEX on day 1, with or without low-dose DEX on days 2 and 3, combined with an oral fixed-dose combination of netupitant and palonosetron (NEPA), compared with the guideline-consistent use of 4-day DEX., Patients and Methods: In this open-label, multicenter study, chemotherapy-naïve patients undergoing high-dose cisplatin (≥70 mg/m
2 ), were given NEPA and DEX (12 mg) on day 1 and randomized (1:1:1 ratio) to receive either (a) no further DEX (DEX1), (b) oral DEX (4 mg daily) on days 2-3 (DEX3), or (c) DEX (4 mg twice daily) on days 2-4 (DEX4). The primary efficacy endpoint was complete response (CR: no emesis and no rescue medication) during the 5-day overall phase. The noninferiority margin was set at -15% difference (DEX1 or DEX3 minus DEX4). Secondary efficacy endpoints included complete protection (CP: CR and none or mild nausea)., Results: Two-hundred twenty-eight patients, 76 in each arm, were assessable. Noninferiority was met for both DEX-sparing regimens and the reference arm, with overall phase CR rates of 76.3% in each of the DEX1 and DEX3 arms and 75.0% in the DEX4 arm (95% confidence interval, -12.3% to 15% for each comparison). During the overall phase, CP rates were similar between groups., Conclusion: A simplified regimen of NEPA plus single-dose DEX offers comparable chemotherapy-induced nausea and vomiting prevention throughout 5 days post-chemotherapy with the advantage of sparing patients additional doses of DEX in the high-emetic-risk setting of cisplatin-based chemotherapy., Implications for Practice: Dexamethasone (DEX) has traditionally played an integral role in the management of chemotherapy-induced emesis. Although generally considered safe, even short-term DEX use is associated with various side effects, and some evidence suggests that concurrent steroids may reduce the efficacy of immunotherapies. This study demonstrates comparable antiemetic control during the 5 days post-chemotherapy with a simplified regimen of netupitant/palonosetron plus single-dose DEX versus the standard 4-day DEX reference treatment in high-dose cisplatin. This represents a clinically relevant achievement as it not only simplifies antiemetic prophylaxis but also offers an opportunity to appropriately use in patients where caution with corticosteroid use is advised., (© 2021 The Authors. The Oncologist published by Wiley Periodicals LLC on behalf of AlphaMed Press.)- Published
- 2021
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46. Predicting immunotherapy outcomes under therapy in patients with advanced NSCLC using dNLR and its early dynamics.
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Mezquita L, Preeshagul I, Auclin E, Saravia D, Hendriks L, Rizvi H, Park W, Nadal E, Martin-Romano P, Ruffinelli JC, Ponce S, Audigier-Valette C, Carnio S, Blanc-Durand F, Bironzo P, Tabbò F, Reale ML, Novello S, Hellmann MD, Sawan P, Girshman J, Plodkowski AJ, Zalcman G, Majem M, Charrier M, Naigeon M, Rossoni C, Mariniello A, Paz-Ares L, Dingemans AM, Planchard D, Cozic N, Cassard L, Lopes G, Chaput N, Arbour K, and Besse B
- Subjects
- Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung immunology, Carcinoma, Non-Small-Cell Lung mortality, Carcinoma, Non-Small-Cell Lung pathology, Drug Resistance, Neoplasm, Europe, Female, Flow Cytometry, Humans, Immune Checkpoint Inhibitors adverse effects, Immunophenotyping, Leukocyte Count, Lung Neoplasms immunology, Lung Neoplasms mortality, Lung Neoplasms pathology, Male, Middle Aged, Phenotype, Predictive Value of Tests, Prospective Studies, Retrospective Studies, Time Factors, Treatment Outcome, United States, Young Adult, Carcinoma, Non-Small-Cell Lung drug therapy, Immune Checkpoint Inhibitors therapeutic use, Immunotherapy adverse effects, Immunotherapy mortality, Lung Neoplasms drug therapy, Neutrophils immunology
- Abstract
Background: dNLR at the baseline (B), defined by neutrophils/[leucocytes-neutrophils], correlates with immune-checkpoint inhibitor (ICI) outcomes in advanced non-small-cell lung cancer (aNSCLC). However, dNLR is dynamic under therapy and its longitudinal assessment may provide data predicting efficacy. We sought to examine the impact of dNLR dynamics on ICI efficacy and understand its biological significance., Patients and Methods: aNSCLC patients receiving ICI at 17 EU/US centres were included [Feb/13-Jun/18]. As chemotherapy-only group was evaluated (NCT02105168). dNLR was determined at (B) and at cycle2 (C2) [dNLR≤3 = low]. B+C2 dNLR were combined in one score: good = low (B+C2), poor = high (B+C2), intermediate = other situations. In 57 patients, we prospectively explored the immunophenotype of circulating neutrophils, particularly the CD15+CD244-CD16
low cells (immature) by flow cytometry., Results: About 1485 patients treatment with ICI were analysed. In ICI-treated patients, high dNLR (B) (~1/3rd) associated with worse progression-free (PFS)/overall survival (OS) (HR 1.56/HR 2.02, P < 0.0001) but not with chemotherapy alone (N = 173). High dNLR at C2 was associated with worse PFS/OS (HR 1.64/HR 2.15, P < 0.0001). When dNLR at both time points were considered together, those with persistently high dNLR (23%) had poor survival (mOS = 5 months (mo)), compared with high dNLR at one time point (22%; mOS = 9.2mo) and persistently low dNLR (55%; mOS = 18.6mo) (P < 0.0001). The dNLR impact remained significant after PD-L1 adjustment. By cytometry, high rate of immature neutrophils (B) (30/57) correlated with poor PFS/OS (P = 0.04; P = 0.0007), with a 12-week death rate of 49%., Conclusion: The dNLR (B) and its dynamics (C2) under ICI associate with ICI outcomes in aNSCLC. Persistently high dNLR (B+C2) correlated with early ICI failure. Immature neutrophils may be a key subpopulation on ICI resistance., Competing Interests: Conflict of interest statement LM: Sponsored Research: Amgen, Bristol-Myers Squibb, Boehringer Ingelheim. Consulting, advisory role: Roche Diagnostics, Takeda, Roche. Lectures and educational activities: Bristol-Myers Squibb, Tecnofarma, Roche. Travel, Accommodations, Expenses: Bristol-Myers Squibb, Roche. Mentorship program with key opinion leaders: funded by AstraZeneca. IP has served as a consultant for AstraZeneca, Pfizer and BluePrint Medicines. EA: Travel expenses: Mundipharma. Lectures and educational activities: Sanofi Genzymes. DS, HR, JR, SP, SC, FB, FT, MLR, PS, JG, AJP, MC, MN, CR, APM, LC and WPhad nothing to disclose. LH: none related to the current article, outside of the current article: research funding Roche Genentech, Boehringer Ingelheim, AstraZeneca (all institution), advisory board: Boehringer, BMS, Eli Lilly, Roche Genentech, Pfizer, Takeda, MSD, Boehringer Ingelheim, Amgen (all institution), speaker: MSD, travel/conference reimbursement: Roche Genentech (self); mentorship program with key opinion leaders: funded by AstraZeneca; fees for educational webinars: Quadia (self), interview sessions funded by Roche Genentech (institution), local PI of clinical trials: AstraZeneca, Novartis, BMS, MSD/Merck, GSK, Takeda, Blueprint Medicines, Roche Genentech, Janssen Cilag. EN: none related to the current article, outside of the current article: research support from Roche and Pfizer; advisory boards from Bristol Myers Squibb, Merck Sharpe & Dohme, Lilly, Roche, Pfizer, Takeda, Boehringer Ingelheim, Amgen and AstraZeneca. PM: Principal/subinvestigator of Clinical Trials for Abbvie, Adaptimmune, Aduro Biotech, Agios Pharmaceuticals, Amgen, Argen-X Bvba, Arno Therapeutics, Astex Pharmaceuticals, Astra Zeneca Ab, Aveo, Basilea Pharmaceutica International Ltd, Bayer Healthcare Ag, Bbb Technologies Bv, Beigene, Blueprint Medicines, Boehringer Ingelheim, Boston Pharmaceuticals, Bristol Myers Squibb, Ca, Celgene Corporation, Chugai Pharmaceutical Co, Clovis Oncology, Cullinan-Apollo, Daiichi Sankyo, Debiopharm, Eisai, Eisai Limited, Eli Lilly, Exelixis, Forma Tharapeutics, Gamamabs, Genentech, Glaxosmithkline, H3 Biomedicine, Hoffmann La Roche Ag, Imcheck Therapeutics, Innate Pharma, Institut De Recherche Pierre Fabre, Iris Servier, Janssen Cilag, Janssen Research Foundation, Kyowa Kirin Pharm. Dev, Lilly France, Loxo Oncology, Lytix Biopharma As, Medimmune, Menarini Ricerche, Merck Sharp & Dohme Chibret, Merrimack Pharmaceuticals, Merus, Millennium Pharmaceuticals, Molecular Partners Ag, Nanobiotix, Nektar Therapeutics, Novartis Pharma, Octimet Oncology Nv, Oncoethix, Oncopeptides, Orion Pharma, Ose Pharma, Pfizer, Pharma Mar, Pierre Fabre, Medicament, Roche, Sanofi Aventis, Sotio A.S, Syros Pharmaceuticals, Taiho Pharma, Tesaro, Xencor Research Grants from Astrazeneca, BMS, Boehringer Ingelheim, Janssen Cilag, Merck, Novartis, Pfizer, Roche, Sanofi Non-financial support (drug supplied) from Astrazeneca, Bayer, BMS, Boringher Ingelheim, Medimmune, Merck, NH TherAGuiX, Pfizer, Roche. CAV: Personal fees from Roche, AbbVie, MSD, Bristol-Myers Squibb, Novartis, Astra Zeneca, Takeda and Ipsen. PB: Speaker bureau: AstraZeneca, BMS, Roche, MSD. Honoraria: Beigene. SN: Speaker Bureau/Advisor: Amgen, AstraZeneca, Boehringer, Beigene, MSD, Roche, Takeda, Pfizer. MDH receives research support from Bristol-Myers Squibb; has been a compensated consultant for Merck, Bristol-Myers Squibb, AstraZeneca, Genentech/Roche, Nektar, Syndax, Mirati, Shattuck Labs, Immunai, Blueprint Medicines, Achilles and Arcus; received travel support/honoraria from AstraZeneca, Eli Lilly and Bristol-Myers Squibb; has options from Shattuck Labs, Immunai and Arcus; has a patent filed by his institution related to the use of tumour mutation burden to predict response to immunotherapy (PCT/US2015/062,208), which has received licensing fees from PGDx. GZ: Grants and personal fees from BMS, non-financial support from MSD, personal fees from Borhinger, non-financial support from Roche, personal fees from Astra-Zeneca, non-financial support from Abbvie, outside the submitted work. MM: Grants and personal fees from BMS, personal fees and non-financial support from MSD, personal fees and non-financial support from BOEHRINGER INGELHEIM, personal fees, non-financial support and other from ASTRA ZENENCA, personal fees, non-financial support and other from ROCHE, personal fees from KYOWA KYRIN, personal fees from PIERRE FABRE, outside the submitted work. LPA: Honoraria (self): Adacap, Amgen, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Incyte, Ipsen, Merck, Merck Sharp and Dohme, Novartis, Pfizer, Pharmamar, Roche, Sanofi, Servier, Sysmex, Takeda; Leadership role: Altum sequencing; Research grant/Funding (self): AstraZeneca, Bristol-Myers Squibb, Merck Sharp and Dohme, Pfizer; Officer/Board of Directors Genómica. AMD: Consulting, advisory role or lectures: Roche, Eli Lilly, Boehringer Ingelheim, Astra Zeneca, Pfizer, BMS, Amgen, Novartis, MSD, Takeda, Pharmamar. Research support: Amgen, Abbvie, BMS. DP: Consulting, advisory role or lectures: AstraZeneca, Bristol-Myers Squibb, Boehringer; Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Merck, Novartis, Pfizer, prIME Oncology, Peer. CME, Roche. Honoraria: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene. Eli Lilly, Merck, Novartis, Pfizer, prIME Oncology, Peer CME, Roche. Clinical trials research: AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, Pfizer, Roche, Medimmune, Sanofi-Aventis, Taiho Pharma, Novocure, Daiichi Sankyo. Travel, Accommodations, Expenses: AstraZeneca, Roche, Novartis, prIME Oncology, Pfizer. NC: Sponsored Research at Gustave Roussy Cancer Center BMS fondation, GSK, Sanofi, advisory role and lectures: AstraZeneca. These are outside the scope of this work. GL: Research support Merck serono, BMS, Pfizer, AstraZeneca, Blueprint medicines. KA: Consultant for Astrazeneca and Iovance Biotherapeutics. Her institution has received non-monetary research support from Takeda and Novartis on her behalf. BB: Sponsored Research at Gustave Roussy Cancer Center Abbvie, Amgen, AstraZeneca, Biogen, Blueprint Medicines, BMS, Celgene, Eli Lilly, GSK, Ignyta, IPSEN, Merck KGaA, MSD, Nektar, Onxeo, Pfizer, Pharma Mar, Sanofi, Spectrum Pharmaceuticals, Takeda, Tiziana Pharma., (Copyright © 2021 Elsevier Ltd. All rights reserved.)- Published
- 2021
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47. Early Progression in Non-Small Cell Lung Cancer (NSCLC) with High PD-L1 Treated with Pembrolizumab in First-Line Setting: A Prognostic Scoring System Based on Clinical Features.
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Passaro A, Novello S, Giannarelli D, Bria E, Galetta D, Gelibter A, Reale ML, Carnio S, Vita E, Stefani A, Pizzutilo P, Stati V, Attili I, and de Marinis F
- Abstract
Background: Pembrolizumab is approved in monotherapy for the first-line (1L) of advanced or metastatic NSCLC patients with high PD-L1 (≥50%). Despite a proportion of patients achieve long-term survival, about one-third of patients experience detrimental survival outcomes, including early death, hyperprogression, and fast progression. The impact of clinical factors on early progression (EP) development has not been widely explored., Methods: We designed a retrospective, multicenter study involving five Italian centers, in patients with metastatic NSCLC with PD-L1 ≥ 50%, treated with Pembrolizumab in a 1L setting. EP was defined as a progressive disease within three months from pembrolizumab initiation. Baseline clinical factors of patients with and without EP were collected and analyzed. Logistic regression was performed to identify clinical factors associated with EP and an EP prognostic score was developed based on the logistic model., Results: Overall, 321 out of 336 NSCLC patients treated with 1L pembrolizumab provided all the data for the analysis. EP occurred in 137 (42.7%) patients; the median PFS was 3.8 months (95% CI: 2.9-4.7), and median OS was not reached in the entire study population. Sex, Eastern Cooperative Oncology Group (ECOG) performance status (PS), steroids, metastatic sites ≥2, and the presence of liver/pleural metastasis were confirmed as independent factors for EP by multivariate analysis. By combining these factors, we developed an EP prognostic score ranging from 0-13, with three-risk group stratification: 0-2 (good prognosis), 3-6 (intermediate prognosis), and 7-13 (poor prognosis). The area under the curve (AUC) of the model was 0.76 (95% CI: 0.70-0.81)., Conclusions: We identified six clinical factors independently associated with EP. We developed a prognostic score model for EP-risk to potentially improve clinical practice and patient selection for 1L pembrolizumab in NSCLC with high PD-L1, in the real-world clinical setting.
- Published
- 2021
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48. Pericarditis during chemoimmunotherapy for non-small cell lung cancer: an adverse event to prevent and recognise.
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Jacobs F, Carnio S, De Stefanis P, Luciano A, and Novello S
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- Carcinoma, Non-Small-Cell Lung immunology, Carcinoma, Non-Small-Cell Lung secondary, Cardiotoxicity, Glucocorticoids administration & dosage, Humans, Lung Neoplasms immunology, Lung Neoplasms pathology, Male, Middle Aged, Pericarditis diagnosis, Pericarditis drug therapy, Risk Factors, Treatment Outcome, Antibodies, Monoclonal, Humanized adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carcinoma, Non-Small-Cell Lung drug therapy, Immune Checkpoint Inhibitors adverse effects, Lung Neoplasms drug therapy, Pericarditis chemically induced
- Abstract
Competing Interests: Conflict of interest statement The authors F.J., S.C., P.D.S. and A.L. declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The author S.N. is on the speakers' bureau and reports an advisory role for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Roche, Takeda, AbbVie, Pfizer, MSD, Bayer and BMS.
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- 2021
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49. Italian survey on the clinical management of non-small cell lung cancer patients during the COVID-19 pandemic: A lesson for the second wave.
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Bertaglia V, Reale ML, Bironzo P, Palesandro E, Mariniello A, Leone G, Tabbò F, Bungaro M, Audisio M, Rapetti S, Di Stefano RF, Carnio S, Artusio E, Capelletto E, Sperone P, Passiglia F, and Novello S
- Subjects
- Aged, Chemoradiotherapy, Humans, Italy epidemiology, Pandemics, SARS-CoV-2, Surveys and Questionnaires, COVID-19 epidemiology, Carcinoma, Non-Small-Cell Lung diagnosis, Carcinoma, Non-Small-Cell Lung epidemiology, Carcinoma, Non-Small-Cell Lung therapy, Lung Neoplasms diagnosis, Lung Neoplasms epidemiology, Lung Neoplasms therapy
- Abstract
This study investigated the clinical management of non small cell lung cancer (NSCLC) patients during the first wave of coronavirus disease 2019 (COVID-19) outbreak in Italy. A 29-questions survey was sent to 95 Italian thoracic oncologists, with 77 % of them declaring significant changes in the outpatients management and treatment. The results of this survey pointed out a significant delay of lung cancer diagnosis along with a relevant reduction of patients' accrual within clinical trials. Telemedicine emerged as a valid support for patient-healthcare interactions. Therapeutic indications followed the guidelines for adjuvant chemotherapy and concurrent chemo-radiation. Clinical indications to first-line therapies were largely confirmed, while major changes regarded the selection of second line treatment options as well as the management of elderly population. This work may represent a valid source of information to improve the clinical management of NSCLC patients during second wave of COVID-19 pandemic., (Copyright © 2020 Elsevier B.V. All rights reserved.)
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- 2021
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50. Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG.
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Bersanelli M, Giannarelli D, De Giorgi U, Pignata S, Di Maio M, Verzoni E, Clemente A, Guadalupi V, Signorelli D, Tiseo M, Giusti R, Filetti M, Di Napoli M, Calvetti L, Cappetta A, Ermacora P, Zara D, Barbieri F, Baldessari C, Scotti V, Mazzoni F, Veccia A, Guglielmini PF, Maruzzo M, Rossi E, Grossi F, Casadei C, Cortellini A, Verderame F, Montesarchio V, Rizzo M, Mencoboni M, Zustovich F, Fratino L, Cinieri S, Negrini G, Banzi M, Sorarù M, Zucali PA, Lacidogna G, Russo A, Battelli N, Fornarini G, Mucciarini C, Bracarda S, Bonetti A, Pezzuolo D, Longo L, Sartori D, Iannopollo M, Cavanna L, Meriggi F, Tassinari D, Corbo C, Gernone A, Prati V, Carnio S, Giordano P, Dicorato AM, Verusio C, Atzori F, Carrozza F, Gori S, Castro A, Pilotto S, Vaccaro V, Garzoli E, Di Costanzo F, Maiello E, Labianca R, Pinto C, Tognetto M, and Buti S
- Abstract
Background: This prospective, multicentre, observational INVIDIa-2 study is investigating the clinical efficacy of influenza vaccination in advanced-cancer patients receiving immune-checkpoint inhibitors (ICIs), enrolled in 82 Italian centres, from October 2019 to January 2020. The primary endpoint was the incidence of influenza-like illness (ILI) until 30 April 2020. All the ILI episodes, laboratory tests, complications, hospitalizations and pneumonitis were recorded. Therefore, the study prospectively recorded all the COVID-19 ILI events., Patients and Methods: Patients were included in this non-prespecified COVID-19 analysis, if alive on 31 January 2020, when the Italian government declared the national emergency. The prevalence of confirmed COVID-19 cases was detected as ILI episode with laboratory confirmation of SARS-CoV-2. Cases with clinical-radiological diagnosis of COVID-19 (COVID-like ILIs), were also reported., Results: Out of 1257 enrolled patients, 955 matched the inclusion criteria for this unplanned analysis. From 31 January to 30 April 2020, 66 patients had ILI: 9 of 955 cases were confirmed COVID-19 ILIs, with prevalence of 0.9% [95% confidence interval (CI): 0.3-2.4], a hospitalization rate of 100% and a mortality rate of 77.8%. Including 5 COVID-like ILIs, the overall COVID-19 prevalence was 1.5% (95% CI: 0.5-3.1), with 100% hospitalization and 64% mortality. The presence of elderly, males and comorbidities was significantly higher among patients vaccinated against influenza versus unvaccinated ( p = 0.009, p < 0.0001, p < 0.0001). Overall COVID-19 prevalence was 1.2% for vaccinated (six of 482 cases, all confirmed) and 1.7% for unvaccinated (8 of 473, 3 confirmed COVID-19 and 5 COVID-like), p = 0.52. The difference remained non-significant, considering confirmed COVID-19 only ( p = 0.33)., Conclusion: COVID-19 has a meaningful clinical impact on the cancer-patient population receiving ICIs, with high prevalence, hospitalization and an alarming mortality rate among symptomatic cases. Influenza vaccination does not protect from SARS-CoV-2 infection., Competing Interests: Conflict of interest statement: The Federation of Italian Cooperative Oncology Groups (FICOG) received funding for the present study by Seqirus and Roche S.p.A.; the Federation also received funding during the conduct of the present study by Astra Zeneca, Bristol Myers Squibb (BMS), Sanofi. Melissa Bersanelli received funding for the present study by Seqirus and Roche S.p.A. (FICOG as Institution, no personal fees). She also received, outside the present work, research funding from Pfizer and Novartis (Institution), honoraria as speaker at scientific events (personal fees) by Astra Zeneca, Bristol Myers Squibb (BMS), Novartis and Pfizer; as consultant for advisory role (personal fees) by Novartis, BMS and Pfizer. Ugo De Giorgi received honoraria from AstraZeneca, Roche, MSD, Pfizer, GSK, Clovis, Incyte and research funding from Roche, AstraZeneca, MSD, Pfizer. Dr Di Maio reports personal fees from Bristol Myers Squibb, personal fees from Merck Sharp & Dohme, personal fees from AstraZeneca, personal fees from Janssen, personal fees from Astellas, personal fees from Pfizer, personal fees from Eisai, personal fees from Takeda, grants from Tesaro GSK, outside the submitted work. Sebastiano Buti received honoraria as speaker at scientific events and advisory role by BMS, Pfizer; MSD, Ipsen, Roche S.p.A., Eli Lilly, AstraZeneca and Novartis; he also received research funding from Novartis. Marcello Tiseo received honoraria (personal fees) by MSD, BMS, Boehringer (BI), Takeda, AstraZeneca, and research funding by AstraZeneca (Institution). Vieri Scotti participated, with personal fees, to advisory boards and speaker’s bureaus for Roche S.p.A. Dr Cortellini reports grants from AstraZeneca, grants from MSD, grants from BMS, grants from Roche, during the conduct of the study; grants from AstraZeneca, grants from MSD, grants from BMS, grants from Roche, grants from Novartis, outside the submitted work. Saverio Cinieri declared international board for Eli Lilly international. Paolo Andrea Zucali acts in a consultant or advisory role for Sanofi, BMS, Pfizer, MSD, Astellas, Janssen, Ipsen, Novartis, all outside the scope of work. Sergio Bracarda declares to have acted as advisory board member (uncompensated) for: Janssen, Astellas, Pfizer, MSD, BMS, Merck, AstraZeneca, AAA, Ipsen, Bayer, Roche/Genentech. Francesco Carozza declared personal fees from Janssen. Sara Pilotto reports personal fees from AstraZeneca, Eli Lilly, Boehringer Ingelheim, Merk & Co, Roche, outside the submitted work. All remaining authors have declared no conflicts of interest., (© The Author(s), 2020.)
- Published
- 2020
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