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2. Health-related quality of life trajectories in melanoma patients after electrochemotherapy: real-world insights from the InspECT register

Author

Campana L. G., Quaglino P., de Terlizzi F., Mascherini M., Brizio M., Spina R., Bertino G., Kunte C., Odili J., Matteucci P., MacKenzie Ross A., Schepler H., Clover J.A.P., Kis Erika, and Kollaborációs szervezet: InspECT Melanoma and QoL Working Groups

Subjects
Electrochemotherapy (ECT), Infectious Diseases, 03.02. Klinikai orvostan, Dermatology, Melanoma, Health-related quality of life (HRQoL)
Abstract

Background Electrochemotherapy (ECT) effectively controls skin metastases from cutaneous melanoma. Objectives This study aimed to evaluate health-related quality of life (HRQoL) in melanoma patients pre-/post-ECT and its effect on treatment outcome. Methods The analysis included prospective data from the International Network for Sharing Practices of ECT register. Following the Standard Operating Procedures, patients received intravenous or intratumoural bleomycin (15 000 IU/m(2); 1000 IU mL/cm(3)) followed by 100-microsecond, 1000-V/cm electric pulses. Endpoints included response (RECIST v3.0), local progression-free survival (LPFS), toxicity (CTCAE v5.0), and patient-reported HRQoL at baseline, one, two, four, and 10 months (EuroQol [EQ-5D-3L], including 5-item utility score [EQ-5D] and visual analogue scale for self-reported health state [EQ-VAS]). Comparisons within/between subgroups were made for statistical and minimal important differences (MID). HRQoL scores and clinical covariates were analysed to identify predictors of response in multivariate analysis. Results Median tumour size was 2 cm. Complete response rate, G3 toxicity, and one-year LPFS in 378 patients (76% of the melanoma cohort) were 47%, 5%, and 78%, respectively. At baseline, age-paired HRQoL did not differ from the general European population. Following ECT, both EQ-5D and EQ-VAS scores remained within MID boundaries, particularly among complete responders. A subanalysis of the EQ-5D items revealed a statistically significant deterioration in pain/discomfort and mobility (restored within 4 months), and self-care and usual activities (throughout the follow-up) domains. Concomitant checkpoint inhibition correlated with better EQ-5D and EQ-VAS trajectories. Baseline EQ-5D was the exclusive independent predictor for complete response (RR 14.76, P = 0.001). Conclusions HRQoL of ECT melanoma patients parallels the general population and is preserved in complete responders. Transient deterioration in pain/discomfort and mobility and persistent decline in self-care and usual activities may warrant targeted support interventions. Combination with checkpoint inhibitors is associated with better QoL outcomes. Baseline HRQoL provides predictive information, which can help identify patients most likely to respond.

Published
2022

4. Preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study

Author

Joyce O'Shaughnessy, Susana Sousa, Josefina Cruz, Lesley Fallowfield, Päivi Auvinen, Catarina Pulido, Ana Cvetanovic, Sharon Wilks, Leonor Ribeiro, Mauricio Burotto, Dirk Klingbiel, Dimitri Messeri, Ari Alexandrou, Peter Trask, Judy Fredriksson, Zuzana Machackova, Ljiljana Stamatovic, Ernesto Korbenfeld, Jorge Nadal, Helio Pinczowski, Felipe J. Cruz, Gustavo Sousa, Aline C. Goncalves, Gisah Guilgen, Antti Jekunen, Winne Yeo, Chi K. Cheng, Hikmat A. Razeq, Fadi Karak, Fadi Farhat, Servando C. Huerta, Brizio M. Jaime, Juan Feregrino, Omar Castillo-Fernandez, Juan C. Alcedo, Maria Dionisio, Salha Bujassoum, Hatoon Bakhraibah, Alvaro R. Lescure, Camilla Wendt, Sara Margolin, Helena G. Björneklett, Michelina Cairo, Shaker Dakhil, Nguyet Le-Lindqwister, Ling Ma, Kristi J. McIntyre, Joyce O’Shaughnessy, Svetislava J. Vukelja, Donald Richards, and John Wallmark

Subjects
0301 basic medicine, Cancer Research, Receptor, ErbB-2, Phases of clinical research, Gastroenterology, Subcutaneous injection, 0302 clinical medicine, Trastuzumab, Antineoplastic Combined Chemotherapy Protocols, Infusions, Intravenous, Adjuvant, Early breast cancer, Aged, 80 and over, Patient preference, Cross-Over Studies, Subcutaneous, Patient Preference, Fixed dose, Middle Aged, Neoadjuvant Therapy, Drug Combinations, Oncology, Chemotherapy, Adjuvant, Patient Satisfaction, 030220 oncology & carcinogenesis, Female, Pertuzumab, medicine.drug, Adult, Quality of life, medicine.medical_specialty, Injections, Subcutaneous, Fixed-dose combination, Breast Neoplasms, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Young Adult, Healthcare resource, Internal medicine, medicine, Humans, Adverse effect, Aged, Neoplasm Staging, Patient-reported outcomes, business.industry, Confidence interval, 030104 developmental biology, business
Abstract

Aim: The aim of the study was to assess patient preference for the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in patients with HER2-positive early breast cancer in PHranceSCa (NCT03674112). Materials and methods: Patients who completed neoadjuvant P + H + chemotherapy + surgery were randomised 1:1 to three intravenous (IV) P + H cycles followed by three cycles of PH FDC SC or vice versa (crossover) and then chose subcutaneous (SC) injection or IV infusion to continue up to 18 cycles (continuation). Assessments were via patient and healthcare professional (HCP) questionnaires. Results: One hundred and sixty patients were randomised (cut-off: 24 February 2020); 136 (85.0%, 95% confidence interval: 78.5–90.2%) preferred SC; 22 (13.8%) preferred IV; 2 (1.3%) had no preference. The main reasons for SC preference were reduced clinic time (n = 119) and comfort during administration (n = 73). One hundred and forty-one patients (88.1%) were very satisfied/satisfied with SC injection versus 108 (67.5%) with IV infusion; 86.9% chose PH FDC SC continuation. HCP perceptions of median patient treatment room time ranged from 33.0–50.0 min with SC and 130.0–300.0 min with IV. Most adverse events (AEs) were grade 1/2 (no 4/5s); serious AE rates were low. AE rates before and after switching were similar (cycles 1–3 IV → cycles 4–6 SC: 77.5% → 72.5%; cycles 1–3 SC → cycles 4–6 IV: 77.5% → 63.8%). Conclusion: Most patients strongly preferred PH FDC SC over P + H IV. PH FDC SC was generally well tolerated, with no new safety signals (even when switching), and offers a quicker alternative to IV infusion.

Published
2021

5. Electrochemotherapy in the treatment of cutaneous malignancy:Outcomes and subgroup analysis from the cumulative results from the pan-European International Network for Sharing Practice in Electrochemotherapy database for 2482 lesions in 987 patients (2008–2019)

Author

Clover, A. J.P., de Terlizzi, F., Bertino, G., Curatolo, P., Odili, J., Campana, L. G., Kunte, C., Muir, T., Brizio, M., Sersa, G., Pritchard Jones, R., Moir, G., Orlando, A., Banerjee, S. M., Kis, E., McCaul, J. A., Grischke, E. M., Matteucci, P., Mowatt, D., Bechara, F. G., Mascherini, M., Lico, V., Giorgione, R., Seccia, V., Schepler, H., Pecorari, G., MacKenzie Ross, A. D., Bisase, B., Gehl, J., Clover, A. J.P., de Terlizzi, F., Bertino, G., Curatolo, P., Odili, J., Campana, L. G., Kunte, C., Muir, T., Brizio, M., Sersa, G., Pritchard Jones, R., Moir, G., Orlando, A., Banerjee, S. M., Kis, E., McCaul, J. A., Grischke, E. M., Matteucci, P., Mowatt, D., Bechara, F. G., Mascherini, M., Lico, V., Giorgione, R., Seccia, V., Schepler, H., Pecorari, G., MacKenzie Ross, A. D., Bisase, B., and Gehl, J.

Abstract

Background: Electrochemotherapy (ECT) is a treatment for both primary and secondary cutaneous tumours. The international Network for sharing practices on ECT group investigates treatment outcomes after ECT using a common database with defined parameters. Methods: Twenty-eight centres across Europe prospectively uploaded data over an 11-year period. Response rates were investigated in relation to primary diagnosis, tumour size, choice of electrode type, route of bleomycin administration, electrical parameters recorded and previous irradiation in the treated field. Results: Nine hundred eighty-seven patients, with 2482 tumour lesions were included in analysis. The overall response (OR) rate was 85% (complete response [CR]: 70%, partial response rate: 15%, stable disease: 11%, and progressive disease: 2%). For different histologies, OR and CR rates for metastases of malignant melanoma were 82% and 64%, basal cell carcinoma were 96% and 85%, breast cancer metastases were 77% and 62%, squamous cell carcinoma were 80% and 63% as well as Kaposi's sarcoma were 98% and 91%, respectively. Variance was demonstrated across histotypes (p < 0.0001) and in accordance with size of lesion treated (dichotomised at diameter of 3 cm (p < 0.0001). Hexagonal electrodes were generally used for larger tumours, but for tumours up to 3 cm, linear array electrodes provided better tumour control than hexagonal electrodes (80%:74%, p < 0.003). For tumours more than 2 cm, intravenous administration was superior to intratumoural (IT) administration (p < 0.05). Current recorded varied across tumour histologies and size but did not influence response rate. In previously irradiated areas, responses were selectively lower for IT administration. Conclusions: These cumulative data endorse efficiency of ECT across a broad range of histotypes. Analysis of 2482 lesions details subgroup analysis on treatment response informing future treatment choices.

Published
2020

6. Electrochemotherapy of unresectable cutaneous tumours with reduced dosages of intravenous bleomycin:analysis of 57 patients from the International Network for Sharing Practices of Electrochemotherapy registry

Author

Rotunno, R, Campana, L G, Quaglino, P, de Terlizzi, F, Kunte, C, Odili, J, Gehl, J., Ribero, S, Liew, S H, Marconato, R, Brizio, M, Curatolo, P, Rotunno, R, Campana, L G, Quaglino, P, de Terlizzi, F, Kunte, C, Odili, J, Gehl, J., Ribero, S, Liew, S H, Marconato, R, Brizio, M, and Curatolo, P

Abstract

BACKGROUND: Electrochemotherapy (ECT) is currently used to treat unresectable superficial tumours of different histotypes through the combination of cytotoxic chemotherapy and local application of electric pulses. In 2006, a collaborative project defined the ESOPE (European Standard Operating Procedures of Electrochemotherapy) guidelines to standardize the procedure. The International Network for Sharing Practices of Electrochemotherapy (InspECT) aims to refine the ESOPE and improve clinical practice. Limiting patient exposure to systemic chemotherapy would be advisable to ameliorate ECT safety profile.OBJECTIVE: The aim of this study was to evaluate the efficacy and toxicity of ECT with reduced chemotherapy dosages.METHODS: In a retrospective analysis of a prospectively maintained database (InspECT registry), we evaluated the outcome of patients who received ECT with reduced dosages of bleomycin (7500, 10 000 or 13 500 IU/m2 , instead of the standard dose of 15 000 IU/m2 ). Tumour response in melanoma patients was compared with melanoma patients of the InspECT registry who received the standard dose of bleomycin.RESULTS: We identified 57 patients with 147 tumours (melanoma, 38.6%; squamous cell carcinoma, 22.8%; basal cell carcinoma, 17.5%; breast cancer 7%; Kaposi sarcoma 7%; other histotypes, 7.1%). Per-tumour complete response (CR) rate at 60 days was 70.1% (partial, 16.3%); per-patient CR was 57.9% (partial, 21.1%). Local pain was the most frequently reported side-effect (n = 22 patients [39%]), mostly mild; two patients experienced flu-like symptoms, one patient nausea. We observed the same CR rate (55%) in patients with melanoma treated by reduced or conventional bleomycin dosages (P = 1.00).CONCLUSIONS: Electrochemotherapy performed with reduced bleomycin dosages could be as effective as with currently recommended dose. Patients with impaired renal function or candidate to multiple ECT cycles could benefit from a reduced dose p

Published
2018

7. Electrochemotherapy in the treatment of metastatic malignant melanoma:a prospective cohort study by InspECT

Author

Kunte, C, Letulé, V, Gehl, J, Dahlstroem, K, Curatolo, P, Rotunno, R, Muir, T, Occhini, A, Bertino, G, Powell, B, Saxinger, W, Lechner, G, Liew, S-H, Pritchard-Jones, R, Rutkowski, P, Zdzienicki, M, Mowatt, D, Sykes, A J, Orlando, A, Mitsala, G, Rossi, C R, Campana, L, Brizio, M, de Terlizzi, F, Quaglino, P, Odili, J, Kunte, C, Letulé, V, Gehl, J, Dahlstroem, K, Curatolo, P, Rotunno, R, Muir, T, Occhini, A, Bertino, G, Powell, B, Saxinger, W, Lechner, G, Liew, S-H, Pritchard-Jones, R, Rutkowski, P, Zdzienicki, M, Mowatt, D, Sykes, A J, Orlando, A, Mitsala, G, Rossi, C R, Campana, L, Brizio, M, de Terlizzi, F, Quaglino, P, and Odili, J

Abstract

BACKGROUND: (ECT) is an effective local treatment for cutaneous metastasis. Treatment involves the administration of chemotherapeutic drugs followed by delivery of electrical pulses to the tumour.OBJECTIVES: To investigate the effectiveness of ECT in cutaneous metastases of melanoma and to identify factors that affect (beneficially or adversely) the outcome.METHODS: Thirteen cancer centres in the International Network for Sharing Practices on Electrochemotherapy consecutively and prospectively uploaded data to a common database. ECT consisted of intratumoral or intravenous injection of bleomycin, followed by application of electric pulses under local or general anaesthesia.RESULTS: In total, 151 patients with metastatic melanoma were identified from the database, 114 of whom had follow-up data of 60 days or more. Eighty-four of these patients (74%) experienced an overall response (OR = complete response + partial response). Overall, 394 lesions were treated, of which 306 (78%) showed OR, with 229 showing complete response (58%). In multivariate analysis, factors positively associated with overall response were coverage of deep margins, absence of visceral metastases, presence of lymphoedema and treatment of nonirradiated areas. Factors significantly associated with complete response to ECT treatment were coverage of deep margins, previous irradiation of the treated area and tumour size (< 3 cm). One-year overall survival in this cohort of patients was 67% (95% confidence interval 57-77%), while melanoma-specific survival was 74% (95% confidence interval 64-84%). No serious adverse events were reported, and the treatment was in general very well tolerated.CONCLUSIONS: ECT is a highly effective local treatment for melanoma metastases in the skin, with no severe adverse effects noted in this study. In the presence of certain clinical factors, ECT may be considered for local tumour control as an alternative to established local treatmen

Published
2017

14. Relationship between the Clinical Frailty Scale and short-term mortality in patients ≥ 80 years old acutely admitted to the ICU: a prospective cohort study

Author

Fronczek, Jakub, Polok, Kamil, de Lange, Dylan W., Jung, Christian, Beil, Michael, Rhodes, Andrew, Fjølner, Jesper, Górka, Jacek, Andersen, Finn H., Artigas, Antonio, Cecconi, Maurizio, Christensen, Steffen, Joannidis, Michael, Leaver, Susannah, Marsh, Brian, Morandi, Alessandro, Moreno, Rui, Oeyen, Sandra, Agvald-Öhman, Christina, Bollen Pinto, Bernardo, Schefold, Joerg C., Valentin, Andreas, Walther, Sten, Watson, Ximena, Zafeiridis, Tilemachos, Sviri, Sigal, van Heerden, Peter Vernon, Flaatten, Hans, Guidet, Bertrand, Szczeklik, Wojciech, Schmutz, R., Wimmer, F., Eller, P., Joannidis, M., De Buysscher, P., De Neve, N., Oeyen, S., Swinnen, W., Bollen Pinto, B., Abraham, P., Hergafi, L., Schefold, J. C., Biskup, E., Piza, P., Taliadoros, I., Fjølner, J., Dey, N., Sølling, C., Rasmussen, B. S., Christensen, S., Forceville, X., Besch, G., Mentec, H., Michel, P., Mateu, P., Vettoretti, L., Bourenne, J., Marin, N., Guillot, M., Aissaoui, N., Goulenok, C., Thieulot-Rolin, N., Messika, J., Lamhaut, L., Guidet, B., Charron, C., Lauten, A., Sacher, A. L., Brenner, T., Franz, M., Bloos, F., Ebelt, H., Schaller, S. J., Fuest, K., Rabe, C., Dieck, T., Steiner, S., Graf, T., Nia, A. M., Jung, C., Janosi, R. A., Meybohm, P., Simon, P., Utzolino, S., Rahmel, T., Barth, E., Schuster, M., Aidoni, Z., Aloizos, S., Tasioudis, P., Lampiri, K., Zisopoulou, V., Ravani, I., Pagaki, E., Antoniou, A., Katsoulas, T. A., Kounougeri, A., Marinakis, G., Tsimpoukas, F., Spyropoulou, A., Zygoulis, P., Kyparissi, A., Gupta, M., Gurjar, M., Maji, I. M., Hayes, I., Marsh, B., Kelly, Y., Westbrook, A., Fitzpatrick, G., Maheshwari, D., Motherway, C., Negri, G., Spadaro, S., Nattino, G., Pedeferri, M., Boscolo, A., Rossi, S., Calicchio, G., Cubattoli, L., Di Lascio, G., Barbagallo, M., Berruto, F., Codazzi, D., Bottazzi, A., Fumagalli, P., Negro, G., Lupi, G., Savelli, F., Vulcano, G. A., Fumagalli, R., Marudi, A., Lefons, U., Lembo, R., Babini, M., Paggioro, A., Parrini, V., Zaccaria, M., Clementi, S., Gigliuto, C., Facondini, F., Pastorini, S., Munaron, S., Calamai, I., Bocchi, A., Adorni, A., Bocci, M. G., Cortegiani, A., Casalicchio, T., Mellea, S., Graziani, E., Barattini, M., Brizio, E., Rossi, M., Hahn, M., Flaatten, H., Kemmerer, N., Strietzel, H. F., Dybwik, K., Legernaes, T., Klepstad, P., Olaussen, E. B., Olsen, K. I., Brresen, O. M., Bjorsvik, G., Andersen, F. H., Maini, S., Fehrle, L., Czuczwar, M., Krawczyk, P., Ziętkiewicz, M., Nowak, Ł. R., Kotfis, K., Cwyl, K., Gajdosz, R., Biernawska, J., Bohatyrewicz, R., Gawda, R., Grudzień, P., Nasiłowski, P., Popek, N., Cyrankiewicz, W., Wawrzyniak, K., Wnuk, M., Maciejewski, D., Studzińska, D., Żukowski, M., Bernas, S., Piechota, M., Szczeklik, W., Nowak-Kózka, I., Fronczek, J., Serwa, M., Machała, W., Stefaniak, J., Wujtewicz, M., Maciejewski, P., Szymkowiak, M., Adamik, B., Polok, K., Górka, J., Catorze, N., Branco, M. C., Barros, N., Barros, I., Krystopchuk, A., Honrado, T., Sousa, C., Munoz, F., Rebelo, M., Gomes, R., Nunes, J., Dias, C., Fernandes, A. M., Petrisor, C., Constantin, B., Belskiy, V., Boskholov, B., Rodriguez, E., Aguilar, G., Masdeu, G., Jaimes, M. I., Mira, A. P., Bodi, M. A., Mendoza, J. A. B., López-Cuenca, S., Guzman, M. H., Rico-Feijoo, J., Ibarz, M., Alvarez, J. Trenado, Kawati, R., Sivik, J., Nauska, J., Smole, D., Parenmark, F., Lyrén, J., Rockstroh, K., Rydén, S., Spångfors, M., Strinnholm, M., Walther, S., De Geer, L., Nordlund, P., Pålsson, S., Zetterquist, H., Nilsson, A., Thiringer, K., Jungner, M., Bark, B., Nordling, B., Sköld, H., Brorsson, C., Persson, S., Bergström, A., Berkius, J., Holmström, J., van Dijk, I., van Lelyveld-Haas, L. E. M., Jansen, T., Nooteboom, F., van der Voort, P. H. J., de Lange, D., Dieperink, W., de Waard, M. C., de Smet, A. G. E., Bormans, L., Dormans, T., Dempsey, G., Mathew, S. J., Raj, A. S., Grecu, I., Cupitt, J., Lawton, T., Clark, R., Popescu, M., Spittle, N., Faulkner, M., Cowton, A., Williams, P., Elloway, E., Reay, M., Chukkambotla, S., Kumar, R., Al-Subaie, N., Kent, L., Tamm, T., Kajtor, I., Burns, K., Pugh, R., Ostermann, M., Kam, E., Bowyer, H., Smith, N., Templeton, M., Henning, J., Goffin, K., Kapoor, R., Laha, S., Chilton, P., Khaliq, W., Crayford, A., Coetzee, S., Tait, M., Stoker, W., Gimenez, M., Pope, A., Camsooksai, J., Pogson, D., Quigley, K., Ritzema, J., Hormis, A., Boulanger, C., Balasubramaniam, M., Vamplew, L., Burt, K., Martin, D., Craig, J., Prowle, J., Doyle, N., Shelton, J., Scott, C., Donnison, P., Shelton, S., Frey, C., Ryan, C., Spray, D., Barnes, V., Barnes, K., Ridgway, S., Saha, R., Clark, T., Wood, J., Bolger, C., Bassford, C., Lewandowski, J., Zhao, X., Humphreys, S., Dowling, S., Richardson, N., Burtenshaw, A., Stevenson, C., Wilcock, D., Nalapko, Y., Helbok, R., Nollet, J., de Neve, N., Mikačić, M., Bastiansen, A., Husted, A., Dahle, B. E. S., Cramer, C., Ørsnes, D., Thomsen, J. Edelberg, Pedersen, J. J., Enevoldsen, M. Hummelmose, Elkmann, T., Kubisz-Pudelko, A., Collins, A., Hart, C., Randell, G., Filipe, H., Welters, I. D., Evans, J., Lord, J., Jones, J., Ball, J., North, J., Salaunkey, K., De Gordoa, L. Ortiz-Ruiz, Bell, L., Vizcaychipi, M., Mupudzi, M., Lea-Hagerty, M., Spivey, M., Love, N., White, N., Morgan, P., Wakefield, P., Savine, R., Jacob, R., Innes, R., Rose, S., Leaver, S., Mane, T., Ogbeide, V., Baird, Y., Romen, A., Galbois, A., Vinsonneau, C., Thevenin, D., Guerot, E., Savary, G., Chagnon, J. L., Rigaud, J. P., Quenot, J. P., Castaneray, J., Rosman, J., Maizel, J., Tiercelet, K., Hovaere, M. M., Messika, M., Djibré, M., Rolin, N., Burtin, P., Garcon, P., Nseir, S., Valette, X., Horacek, M., Bruno, R. Romano, Allgäuer, S., Dubler, S., Schering, S., Koutsikou, A., Vakalos, A., Raitsiou, B., Flioni, E. N., Neou, E., Papathanakos, G., Koutsodimitropoulos, I., Aikaterini, K., Rovina, N., Kourelea, S., Polychronis, T., Zidianakis, V., Konstantinia, V., Read, C., Martin-Loeches, I., Cracchiolo, A. Neville, Morigi, A., Brusa, S., Elhadi, A., Tarek, A., Khaled, A., Ahmed, H., Belkhair, W. Ali, Cornet, A. D., Gommers, D., van Boven, E., Haringman, J., Haas, L., van den Berg, L., Hoiting, O., de Jager, P., Gerritsen, R. T., Breidablik, A., Slapgard, A., Rime, A. K., Jannestad, B., Sjøbøe, B., Rice, E., Jensen, J. P., Langørgen, J., Tøien, K., Strand, K., Biernacka, A., Kluzik, A., Kudlinski, B., Hymczak, H., Solek-Pastuszka, J., Zorska, J., Krzych, Ł. J., Zukowski, M., Lipińska-Gediga, M., Pietruszko, M., Kozera, N., Sendur, P., Zatorski, P., Galkin, P., Kościuczuk, U., Gola, W., Pinto, A. F., Santos, A. R., Ferreira, I. A., Blanco, J. B., Carvalho, J. T., Maia, J., Candeias, N., Lores, A., Cilloniz, C., Perez-Torres, D., Maseda, E., Prol-Silva, E., Eixarch, G., Gomà, G., Velasco, G. Navarro, Jaimes, M. Irazábal, Villamayor, M. Ibarz, Fernández, N. Llamas, Cubero, P. Jimeno, Tomasa, T., Sjöqvist, A., Schiöler, F., Westberg, H., Thiringer, K. Kleiven, Boroli, F., Eckert, P., Yıldız, I., Yovenko, I., for the VIP1, [missing], VIP2 study group, [missing], Fronczek, Jakub, Polok, Kamil, de Lange, Dylan W, Jung, Christian, Beil, Michael, Rhodes, Andrew, Fjølner, Jesper, Górka, Jacek, Andersen, Finn H, Artigas, Antonio, Cecconi, Maurizio, Christensen, Steffen, Joannidis, Michael, Leaver, Susannah, Marsh, Brian, Morandi, Alessandro, Moreno, Rui, Oeyen, Sandra, Agvald-Öhman, Christina, Bollen Pinto, Bernardo, Schefold, Joerg C, Valentin, Andrea, Walther, Sten, Watson, Ximena, Zafeiridis, Tilemacho, Sviri, Sigal, van Heerden, Peter Vernon, Flaatten, Han, Guidet, Bertrand, Szczeklik, Wojciech, R Schmutz, F Wimmer, P Eller, M Joannidis, P De Buysscher, N De Neve, S Oeyen, W Swinnen, B Bollen Pinto, P Abraham, L Hergafi, J C Schefold, E Biskup, P Piza, I Taliadoros, J Fjølner, N Dey, C Sølling, B S Rasmussen, S Christensen, X Forceville, G Besch, H Mentec, P Michel, P Mateu, P Michel, L Vettoretti, J Bourenne, N Marin, M Guillot, N Aissaoui, C Goulenok, N Thieulot-Rolin, J Messika, L Lamhaut, B Guidet, C Charron, A Lauten, A L Sacher, T Brenner, M Franz, F Bloos, H Ebelt, S J Schaller, K Fuest, C Rabe, T Dieck, S Steiner, T Graf, A M Nia, C Jung, R A Janosi, P Meybohm, P Simon, S Utzolino, T Rahmel, E Barth, C Jung, M Schuster, Z Aidoni, S Aloizos, P Tasioudis, K Lampiri, V Zisopoulou, I Ravani, E Pagaki, A Antoniou, T A Katsoulas, A Kounougeri, G Marinakis, F Tsimpoukas, A Spyropoulou, P Zygoulis, A Kyparissi, M Gupta, M Gurjar, I M Maji, I Hayes, B Marsh, Y Kelly, A Westbrook, G Fitzpatrick, D Maheshwari, C Motherway, G Negri, S Spadaro, G Nattino, M Pedeferri, A Boscolo, S Rossi, G Calicchio, L Cubattoli, G Di Lascio, M Barbagallo, F Berruto, D Codazzi, A Bottazzi, P Fumagalli, G Negro, G Lupi, F Savelli, G A Vulcano, R Fumagalli, A Marudi, U Lefons, R Lembo, M Babini, A Paggioro, V Parrini, M Zaccaria, S Clementi, C Gigliuto, F Facondini, S Pastorini, S Munaron, I Calamai, A Bocchi, A Adorni, M G Bocci, A Cortegiani, T Casalicchio, S Mellea, E Graziani, M Barattini, E Brizio, M Rossi, M Hahn, H Flaatten, N Kemmerer, H F Strietzel, K Dybwik, T Legernaes, P Klepstad, E B Olaussen, K I Olsen, O M Brresen, G Bjorsvik, F H Andersen, S Maini, L Fehrle, M Czuczwar, P Krawczyk, M Ziętkiewicz, Ł R Nowak, K Kotfis, K Cwyl, R Gajdosz, J Biernawska, R Bohatyrewicz, R Gawda, P Grudzień, P Nasiłowski, N Popek, W Cyrankiewicz, K Wawrzyniak, M Wnuk, D Maciejewski, D Studzińska, M Żukowski, S Bernas, M Piechota, W Szczeklik, I Nowak-Kózka, J Fronczek, M Serwa, W Machała, J Stefaniak, M Wujtewicz, P Maciejewski, M Szymkowiak, B Adamik, K Polok, J Górka, N Catorze, M C Branco, N Barros, I Barros, A Krystopchuk, T Honrado, C Sousa, F Munoz, M Rebelo, R Gomes, J Nunes, C Dias, A M Fernandes, C Petrisor, B Constantin, V Belskiy, B Boskholov, E Rodriguez, G Aguilar, G Masdeu, M I Jaimes, A P Mira, M A Bodi, J A B Mendoza, S López-Cuenca, M H Guzman, J Rico-Feijoo, M Ibarz, J Trenado Alvarez, R Kawati, J Sivik, J Nauska, D Smole, F Parenmark, J Lyrén, K Rockstroh, S Rydén, M Spångfors, M Strinnholm, S Walther, L De Geer, P Nordlund, S Pålsson, H Zetterquist, A Nilsson, K Thiringer, M Jungner, B Bark, B Nordling, H Sköld, C Brorsson, S Persson, A Bergström, J Berkius, J Holmström, I van Dijk, L E M van Lelyveld-Haas, T Jansen, F Nooteboom, P H J van der Voort, D de Lange, W Dieperink, M C de Waard, A G E de Smet, L Bormans, T Dormans, G Dempsey, S J Mathew, A S Raj, I Grecu, J Cupitt, T Lawton, R Clark, M Popescu, N Spittle, M Faulkner, A Cowton, P Williams, E Elloway, M Reay, S Chukkambotla, R Kumar, N Al-Subaie, L Kent, T Tamm, I Kajtor, K Burns, R Pugh, M Ostermann, E Kam, H Bowyer, N Smith, M Templeton, J Henning, K Goffin, R Kapoor, S Laha, P Chilton, W Khaliq, A Crayford, S Coetzee, M Tait, W Stoker, M Gimenez, A Pope, J Camsooksai, D Pogson, K Quigley, J Ritzema, A Hormis, C Boulanger, M Balasubramaniam, L Vamplew, K Burt, D Martin, I Grecu, J Craig, J Prowle, N Doyle, J Shelton, C Scott, P Donnison, S Shelton, C Frey, C Ryan, D Spray, C Ryan, V Barnes, K Barnes, S Ridgway, R Saha, L Kent, T Clark, J Wood, C Bolger, C Bassford, A Cowton, J Lewandowski, X Zhao, S Humphreys, S Dowling, N Richardson, A Burtenshaw, C Stevenson, D Wilcock, Y Nalapko, M Joannidis, P Eller, R Helbok, R Schmutz, J Nollet, N de Neve, P De Buysscher, S Oeyen, W Swinnen, M Mikačić, A Bastiansen, A Husted, B E S Dahle, C Cramer, C Sølling, D Ørsnes, J Edelberg Thomsen, J J Pedersen, M Hummelmose Enevoldsen, T Elkmann, A Kubisz-Pudelko, A Pope, A Collins, A S Raj, C Boulanger, C Frey, C Hart, C Bolger, D Spray, G Randell, H Filipe, I D Welters, I Grecu, J Evans, J Cupitt, J Lord, J Henning, J Jones, J Ball, J North, K Salaunkey, L Ortiz-Ruiz De Gordoa, L Bell, M Balasubramaniam, M Vizcaychipi, M Faulkner, M Mupudzi, M Lea-Hagerty, M Reay, M Spivey, N Love, N Spittle, N White, P Williams, P Morgan, P Wakefield, R Savine, R Jacob, R Innes, R Kapoor, S Humphreys, S Rose, S Dowling, S Leaver, T Mane, T Lawton, V Ogbeide, W Khaliq, Y Baird, A Romen, A Galbois, B Guidet, C Vinsonneau, C Charron, D Thevenin, E Guerot, G Besch, G Savary, H Mentec, J L Chagnon, J P Rigaud, J P Quenot, J Castaneray, J Rosman, J Maizel, K Tiercelet, L Vettoretti, M M Hovaere, M Messika, M Djibré, N Rolin, P Burtin, P Garcon, S Nseir, X Valette, C Rabe, E Barth, H Ebelt, K Fuest, M Franz, M Horacek, M Schuster, P Meybohm, R Romano Bruno, S Allgäuer, S Dubler, S J Schaller, S Schering, S Steiner, T Dieck, T Rahmel, T Graf, A Koutsikou, A Vakalos, B Raitsiou, E N Flioni, E Neou, F Tsimpoukas, G Papathanakos, G Marinakis, I Koutsodimitropoulos, K Aikaterini, N Rovina, S Kourelea, T Polychronis, V Zidianakis, V Konstantinia, Z Aidoni, B Marsh, C Motherway, C Read, I Martin-Loeches, A Neville Cracchiolo, A Morigi, I Calamai, S Brusa, A Elhadi, A Tarek, A Khaled, H Ahmed, W Ali Belkhair, A D Cornet, D Gommers, D de Lange, E van Boven, J Haringman, L Haas, L van den Berg, O Hoiting, P de Jager, R T Gerritsen, T Dormans, W Dieperink, A Breidablik, A Slapgard, A K Rime, B Jannestad, B Sjøbøe, E Rice, F H Andersen, H F Strietzel, J P Jensen, J Langørgen, K Tøien, K Strand, M Hahn, P Klepstad, A Biernacka, A Kluzik, B Kudlinski, D Maciejewski, D Studzińska, H Hymczak, J Stefaniak, J Solek-Pastuszka, J Zorska, K Cwyl, Ł J Krzych, M Zukowski, M Lipińska-Gediga, M Pietruszko, M Piechota, M Serwa, M Czuczwar, M Ziętkiewicz, N Kozera, P Nasiłowski, P Sendur, P Zatorski, P Galkin, R Gawda, U Kościuczuk, W Cyrankiewicz, W Gola, A F Pinto, A M Fernandes, A R Santos, C Sousa, I Barros, I A Ferreira, J B Blanco, J T Carvalho, J Maia, N Candeias, N Catorze, V Belskiy, A Lores, A P Mira, C Cilloniz, D Perez-Torres, E Maseda, E Rodriguez, E Prol-Silva, G Eixarch, G Gomà, G Aguilar, G Navarro Velasco, M Irazábal Jaimes, M Ibarz Villamayor, N Llamas Fernández, P Jimeno Cubero, S López-Cuenca, T Tomasa, A Sjöqvist, C Brorsson, F Schiöler, H Westberg, J Nauska, J Sivik, J Berkius, K Kleiven Thiringer, L De Geer, S Walther, F Boroli, J C Schefold, L Hergafi, P Eckert, I Yıldız, I Yovenko, Y Nalapko, R Pugh, and Critical Care

Subjects
Male, Short term mortality, Critical Care and Intensive Care Medicine, Cohort Studies, 0302 clinical medicine, kwetsbaarheid, Medicine and Health Sciences, 80 and over, Medicine, 610 Medicine & health, Prospective cohort study, Correlation of Data, 11 Medical and Health Sciences, Aged, 80 and over, OUTCOMES, Intensive care units, Frailty, VIP1, Aged,&nbsp, Medical emergencies. Critical care. Intensive care. First aid, Scale (social sciences), Female, prospectief onderzoek, Life Sciences & Biomedicine, CRITICALLY-ILL PATIENTS, Study groups, medicine.medical_specialty, Anestesi och intensivvård, 80 jaar en ouder, INTENSIVE-CARE, BED AVAILABILITY, NO, 03 medical and health sciences, Critical Care Medicine, Intensive care, sterfte, General & Internal Medicine, Humans, Aged, Prospective studies, Mortality, In patient, ddc:610, Intensive Care Units, Logistic Models, Prospective Studies, Science & Technology, Anesthesiology and Intensive Care, business.industry, RC86-88.9, Research, 030208 emergency & critical care medicine, ADULTS, Aged, 80 and over, Emergency & Critical Care Medicine, 030228 respiratory system, intensivecareafdelingen, Critical illness, Emergency medicine, VIP2 study group, &nbsp, CRITICAL ILLNESS, business
Abstract

Background The Clinical Frailty Scale (CFS) is frequently used to measure frailty in critically ill adults. There is wide variation in the approach to analysing the relationship between the CFS score and mortality after admission to the ICU. This study aimed to evaluate the influence of modelling approach on the association between the CFS score and short-term mortality and quantify the prognostic value of frailty in this context. Methods We analysed data from two multicentre prospective cohort studies which enrolled intensive care unit patients ≥ 80 years old in 26 countries. The primary outcome was mortality within 30-days from admission to the ICU. Logistic regression models for both ICU and 30-day mortality included the CFS score as either a categorical, continuous or dichotomous variable and were adjusted for patient’s age, sex, reason for admission to the ICU, and admission Sequential Organ Failure Assessment score. Results The median age in the sample of 7487 consecutive patients was 84 years (IQR 81–87). The highest fraction of new prognostic information from frailty in the context of 30-day mortality was observed when the CFS score was treated as either a categorical variable using all original levels of frailty or a nonlinear continuous variable and was equal to 9% using these modelling approaches (p p Conclusion Knowledge about a patient’s frailty status adds a substantial amount of new prognostic information at the moment of admission to the ICU. Arbitrary simplification of the CFS score into fewer groups than originally intended leads to a loss of information and should be avoided. Trial registration NCT03134807 (VIP1), NCT03370692 (VIP2)

Published
2021

15. Cytokine priming enhances the antifibrotic effects of human adipose derived mesenchymal stromal cells conditioned medium.

Author

Brizio M, Mancini M, Lora M, Joy S, Zhu S, Brilland B, Reinhardt DP, Farge D, Langlais D, and Colmegna I

Subjects
Humans, Culture Media, Conditioned pharmacology, Myofibroblasts metabolism, Myofibroblasts drug effects, Fibrosis, Cytokines metabolism, Extracellular Matrix metabolism, Tumor Necrosis Factor-alpha metabolism, Interferon-gamma pharmacology, Interferon-gamma metabolism, Cells, Cultured, Mesenchymal Stem Cells metabolism, Mesenchymal Stem Cells cytology, Adipose Tissue cytology, Adipose Tissue metabolism
Abstract

Background: Fibrosis is a pathological scarring process characterized by persistent myofibroblast activation with excessive accumulation of extracellular matrix (ECM). Fibrotic disorders represent an increasing burden of disease-associated morbidity and mortality worldwide for which there are limited therapeutic options. Reversing fibrosis requires the elimination of myofibroblasts, remodeling of the ECM, and regeneration of functional tissue. Multipotent mesenchymal stromal cells (MSC) have antifibrotic properties mediated by secreted factors present in their conditioned medium (MSC-CM). However, there are no standardized in vitro assays to predict the antifibrotic effects of human MSC. As a result, we lack evidence on the effect of cytokine priming on MSC's antifibrotic effects. We hypothesize that the MSC-CM promotes fibrosis resolution in vitro and that this effect is enhanced following MSC cytokine priming., Methods: We compared the antifibrotic effects of resting versus interferon gamma (IFN-γ) and tumor necrosis factor alpha (TNF-α) primed MSC-CM in four in vitro assays: prevention of fibroblast activation, myofibroblasts deactivation, ECM degradation and fibrosis resolution in lung explant cultures. Furthermore, we performed transcriptomic analysis of myofibroblasts treated or not with resting or primed MSC-CM and proteomic characterization of resting and primed MSC-CM., Results: We isolated MSC from adipose tissue of 8 donors, generated MSC-CM and tested each MSC-CM independently. We report that MSC-CM treatment prevented TGF-β induced fibroblast activation to a similar extent as nintedanib but, in contrast to nintedanib, MSC-CM reduced fibrogenic myofibroblasts (i.e. transcriptomic upregulation of apoptosis, senescence, and inflammatory pathways). These effects were larger when primed rather than resting MSC-CM were used. Priming increased the ability of MSC-CM to remodel the ECM, reducing its content of collagen I and fibronectin, and reduced the fibrotic load in TGF-β treated lung explant cultures. Priming increased the following antifibrotic proteins in MSC-CM: DKK1, MMP-1, MMP-3, follistatin and cathepsin S. Inhibition of DKK1 reduced the antifibrotic effects of MSC-CM., Conclusions: In vitro, MSC-CM promote fibrosis resolution, an effect enhanced following MSC cytokine priming. Specifically, MSC-CM reduces fibrogenic myofibroblasts through apoptosis, senescence, and by enhancing ECM degradation. Future studies will establish the in vivo relevance of MSC priming to fibrosis resolution., (© 2024. The Author(s).)

Published
2024
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16. Saliva screening of health care workers for SARS-CoV-2 detection.

Author

Echavarria M, Reyes NS, Rodriguez PE, Ricarte C, Ypas M, Seoane A, Querci M, Brizio M, Stryjewski ME, and Carballal G

Subjects
Humans, Saliva, Health Personnel, Nasopharynx, SARS-CoV-2, COVID-19 diagnosis
Abstract

Health care workers (HCWs) are at high risk for SARS-CoV-2. In addition, pre-symptomatic or asymptomatic transmission accounts for around half of the cases. Saliva testing is an option to detect SARS-CoV-2 infection. To determine the performance of saliva samples for screening, HCWs were tested for SARS-CoV-2 by RT-PCR. Those with a positive result in saliva were tested by nasopharyngeal swabbing for viral RNA detection and blood collection to search for the presence of specific antibodies. In September-October 2020, 100 HCWs were enrolled and followed up. Six subjects (6%) tested positive in saliva. Of them, 5/6 were positive in a subsequent nasopharyngeal swab and 4/6 developed signs and symptoms compatible with COVID-19. Among the latter, 3 seroconverted while asymptomatic HCWs remained seronegative. Saliva screening was helpful for identifying SARS-CoV-2 infection in HCWs. This screening permitted rapid personnel isolation avoiding further transmission of the virus in the hospital setting., (Copyright © 2022 Asociación Argentina de Microbiología. Publicado por Elsevier España, S.L.U. All rights reserved.)

Published
2022
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17. Safety and Efficacy of Influenza Vaccination in Patients Receiving Immune Checkpoint Inhibitors. Systematic Review with Meta-Analysis.

Author

Lopez-Olivo MA, Valerio V, Karpes Matusevich AR, Brizio M, Kwok M, Geng Y, Suarez-Almazor ME, and Colmegna I

Abstract

The potential increased risk of immune-related adverse events (irAEs) post-influenza vaccine is a concern in patients receiving immune checkpoint inhibitors (ICI). We conducted a systematic review with meta-analysis of studies reporting the effects of influenza vaccination in patients with cancer during ICI treatment. We searched five electronic databases until 01/2022. Two authors independently selected studies, appraised their quality, and collected data. The primary outcome was the determination of pooled irAE rates. Secondary outcomes included determination of immunogenicity and influenza infection rates and cancer-related outcomes. Nineteen studies (26 publications, n = 4705) were included; 89.5% were observational. Vaccinated patients reported slighter lower rates of irAEs compared to unvaccinated patients (32% versus 41%, respectively). Seroprotection for influenza type A was 78%-79%, and for type B was 75%. Influenza and irAE-related death rates were similar between groups. The pooled proportion of participants reporting a laboratory-confirmed infection was 2% (95% CI 0% to 6%), and influenza-like illness was 14% (95% CI 2% to 32%). No differences were reported on the rates of laboratory-confirmed infection between vaccinated and unvaccinated patients. Longer progression-free and overall survival was also observed in vaccinated compared with unvaccinated patients. Current evidence suggests that influenza vaccination is safe in patients receiving ICIs, does not increase the risk of irAEs, and may improve survival.

Published
2022
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18. Anti-BRAF/anti-MEK targeted therapies for metastatic melanoma patients during the COVID-19 outbreak: experience from an Italian skin cancer unit.

Author

Quaglino P, Fava P, Brizio M, Marra E, Rubatto M, Merli M, Tonella L, Ribero S, and Fierro MT

Subjects
Humans, MAP Kinase Signaling System physiology, Melanoma secondary, Molecular Targeted Therapy, Skin Neoplasms pathology, COVID-19 epidemiology, Melanoma drug therapy, Mitogen-Activated Protein Kinase Kinases antagonists & inhibitors, Proto-Oncogene Proteins B-raf antagonists & inhibitors, SARS-CoV-2, Skin Neoplasms drug therapy
Published
2021
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19. Electrochemotherapy for advanced cutaneous angiosarcoma: A European register-based cohort study from the International Network for Sharing Practices of electrochemotherapy (InspECT).

Author

Campana LG, Kis E, Bottyán K, Orlando A, de Terlizzi F, Mitsala G, Careri R, Curatolo P, Snoj M, Sersa G, Valpione S, Quaglino P, Mowatt D, Brizio M, and Schepler H

Subjects
Aged, Aged, 80 and over, Antibiotics, Antineoplastic adverse effects, Antibiotics, Antineoplastic therapeutic use, Bleomycin adverse effects, Bleomycin therapeutic use, Cohort Studies, Electrochemotherapy adverse effects, Feasibility Studies, Female, Hemangiosarcoma pathology, Hemangiosarcoma secondary, Humans, Kaplan-Meier Estimate, Middle Aged, Pain etiology, Patient Reported Outcome Measures, Prospective Studies, Registries, Skin Neoplasms pathology, Skin Neoplasms secondary, Skin Ulcer chemically induced, Treatment Outcome, Electrochemotherapy methods, Hemangiosarcoma drug therapy, Skin Neoplasms drug therapy
Abstract

Background: Cutaneous angiosarcoma (cAS) is a highly aggressive malignancy that challenges the radicality of surgical treatment. Electrochemotherapy (ECT), a skin-directed treatment based on cytotoxic chemotherapy combined with local electric pulses, may be an intraoperative adjunct and a new opportunity in the therapeutic strategy. This cohort study reports the experience with ECT as an option., Methods: Data on patients with locally-advanced/metastatic cAS who underwent ECT between October 2013 and October 2018 at eight European centres were prospectively submitted to the InspECT (International network for sharing practices of ECT) register. Patients received therapy according to the European Standard Operating Procedures of ECT (ESOPE). Treatment feasibility was assessed based on tumour coverage with electrodes and recorded tissue current; treatment toxicity and tumour response were graded according to CTCAE v5.0 and RECIST v1.1 criteria, respectively; patient-reported outcomes (PRO) were evaluated using a visual analogue score (VAS) for pain, acceptance of retreatment and the EQ-5D questionnaire., Results: We enrolled 20 patients with advanced cAS in the scalp/face (n = 7), breast/trunk (n = 10) or limbs (n = 3). Target tumours (n = 51) had a median size of 2.3 cm (range, 1-20). We administered 24 ECT courses using 1-4 cm treatment safety margin around tumours. In five patients, ECT was combined/sequenced with surgery. Median tissue current was 3 A (range, 1.5-10), tumour margins coverage rate was 75% (15/20 patients). The objective response rate (ORR) was 80% (complete, 40%). Grade-3 toxicity included skin ulceration (15%) and pain (10%), with no significant change of PRO scores. Bleeding control was achieved in 13/14 patients with ulcerated tumours. With a median overall survival of 12.5 months, the local progression-free survival (LPFS) was 10.9 months., Conclusion: ECT produces sustained response rate with minimal side effects and should be considered an option for advanced cAS. Palliative benefits include patient tolerability, local haemostasis and durable local control. Definition of optimal timing, treatment safety margins and combination with surgery need further investigation., (Copyright © 2019 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.)

Published
2019
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20. Metastatic sebaceous cell carcinoma, review of the literature and use of electrochemotherapy as possible new treatment modality.

Author

Ribero S, Baduel ES, Brizio M, Picciotto F, Dika E, Fierro MT, Macripò G, and Quaglino P

Abstract

Background: Metastatic extraorbital sebaceous carcinoma is a rare event that could involve the head and neck. The treatment of choice for the initial stage of the disease is surgery and/or radiotherapy. The treatment of recurrent or advanced disease is still controversial., Material and Methods: Extensive literature search was done, and the treatment options are discussed., Results: Results. The literature search found several treatment modalities in use for the treatment of metastatic extraorbital sebaceous carcinoma. Electrochemotherapy was not included in the reported treatments. We used this technique for a man of 85 years old with a recurrent and locally metastatic extraorbital sebaceous carcinoma of the scalp. During the period of 8 months, two sessions of electrochemotherapy were employed, which resulted in an objective response of the tumour and good quality of life., Conclusions: Electrochemotherapy has shown to be a interesting tools for treatment of metastatic extraorbital sebaceous carcinoma when other radical options are not available or convenient.

Published
2016
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