Search

Your search keyword '"Taverniti, C."' showing total 34 results
Start Over Author "Taverniti, C."
34 results on '"Taverniti, C."'

1. Final results of the real-life observational VICTOR-6 study on metronomic chemotherapy in elderly metastatic breast cancer (MBC) patients

Author

Trevisan, B., Pepe, F. F., Vallini, I., Montagna, E., Amoroso, D., Berardi, R., Butera, A., Cagossi, K., Cavanna, L., Ciccarese, M., Cinieri, S., Cretella, E., De Conciliis, E., Febbraro, A., Ferraù, F., Ferzi, A., Baldelli, A., Fontana, A., Gambaro, A. R., Garrone, O., Gebbia, V., Generali, D., Gianni, L., Giovanardi, F., Grassadonia, A., Leonardi, V., Sarti, S., Musolino, A., Nicolini, M., Putzu, C., Riccardi, F., Santini, D., Sarobba, M. G., Schintu, M. G., Scognamiglio, G., Spadaro, P., Taverniti, C., Toniolo, D., Tralongo, P., Turletti, A., Valenza, R., Valerio, M. R., Vici, P., Clivio, L., Torri, V., and Cazzaniga, M. E.

Published
2023
Full Text
View/download PDF

2. Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study

Author

Cicchiello, F., Riva, F., Vallini, I., Mazza, M., Bonfadini, C., Bordin, E., Canicattì, M., Cappuccio, F., Collovà, E., De Angelis, C., Desorte, R., Donati, S., Drudi, G., Galanti, D., Mocerino, C., Orlando, L., Pellegrino, B., Pizzuti, L., Ridolfi, C., Rocca, A., Sarti, D., Spagnoletti, I., Tinari, N., Vandone, A., Vizzini, L., Cazzaniga, M.E., Pinotti, G., Montagna, E., Amoroso, D., Berardi, R., Butera, A., Cagossi, K., Cavanna, L., Ciccarese, M., Cinieri, S., Cretella, E., De Conciliis, E., Febbraro, A., Ferraù, F., Ferzi, A., Fiorentini, G., Fontana, A., Gambaro, A.R., Garrone, O., Gebbia, V., Generali, D., Gianni, L., Giovanardi, F., Grassadonia, A., Leonardi, V., Marchetti, P., Melegari, E., Musolino, A., Nicolini, M., Putzu, C., Riccardi, F., Santini, D., Saracchini, S., Sarobba, M.G., Schintu, M.G., Scognamiglio, G., Spadaro, P., Taverniti, C., Toniolo, D., Tralongo, P., Turletti, A., Valenza, R., Valerio, M.R., Vici, P., Clivio, L., and Torri, V.

Published
2019
Full Text
View/download PDF

3. Final results of the real-life observational VICTOR-6 study on metronomic chemotherapy in elderly metastatic breast cancer (MBC) patients

Author

Trevisan, B, Pepe, F, Vallini, I, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Baldelli, A, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Sarti, S, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Clivio, L, Torri, V, Cazzaniga, M, Trevisan B., Pepe F. F., Vallini I., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Baldelli A., Fontana A., Gambaro A. R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Sarti S., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Sarobba M. G., Schintu M. G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M. R., Vici P., Clivio L., Torri V., Cazzaniga M. E., Trevisan, B, Pepe, F, Vallini, I, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Baldelli, A, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Sarti, S, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Clivio, L, Torri, V, Cazzaniga, M, Trevisan B., Pepe F. F., Vallini I., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Baldelli A., Fontana A., Gambaro A. R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Sarti S., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Sarobba M. G., Schintu M. G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M. R., Vici P., Clivio L., Torri V., and Cazzaniga M. E.

Abstract

Nowadays, treatment of metastatic breast cancer (MBC) has been enriched with novel therapeutical strategies. Metronomic chemotherapy (mCHT) is a continuous and frequent administration of chemotherapy at a lower dose and so whit less toxicity. Thus, this strategy could be attractive for elderly MBC patients. Aim of this analysis is to provide insights into mCHT’s activity in a real-life setting of elderly MBC patients. Data of patients ≥ 75 years old included in VICTOR-6 study were analyzed. VICTOR-6 is a multicentre, Italian, retrospective study, which collected data on mCHT in MBC patients treated between 2011 and 2016. A total of 112 patients were included. At the beginning of mCHT, median age was 81 years (75–98) and in 33% of the patients mCHT was the first line choice. Overall Response Rate (ORR) and Disease Control Rate (DCR) were 27.9% and 79.3%, respectively. Median PFS ranged between 7.6 and 9.1 months, OS between 14.1 and 18.5 months. The most relevant toxicity was the hematological one (24.1%); severe toxicity (grade 3–4) ranged from 0.9% for skin toxicity up to 8% for hematologic one. This is a large study about mCHT in elderly MBC patients, providing insights to be further investigated in this subgroup of frail patients.

Published
2023

4. Metronomic chemotherapy (mCHT) in metastatic triple-negative breast cancer (TNBC) patients: results of the VICTOR-6 study

Author

Cazzaniga, M, Vallini, I, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Baldelli, A, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Marchetti, P, Sarti, S, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Saracchini, S, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Di Mauro, P, Cogliati, V, Capici, S, Clivio, L, Torri, V, Cazzaniga M. E., Vallini I., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Baldelli A., Fontana A., Gambaro A. R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Marchetti P., Sarti S., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Saracchini S., Sarobba M. G., Schintu M. G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M. R., Vici P., Di Mauro P., Cogliati V., Capici S., Clivio L., Torri V., Cazzaniga, M, Vallini, I, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Baldelli, A, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Marchetti, P, Sarti, S, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Saracchini, S, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Di Mauro, P, Cogliati, V, Capici, S, Clivio, L, Torri, V, Cazzaniga M. E., Vallini I., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Baldelli A., Fontana A., Gambaro A. R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Marchetti P., Sarti S., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Saracchini S., Sarobba M. G., Schintu M. G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M. R., Vici P., Di Mauro P., Cogliati V., Capici S., Clivio L., and Torri V.

Abstract

Purpose: Triple-negative breast cancer (TNBC) represents a subtype of breast cancer which lacks the expression of oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (HER2): TNBC accounts for approximately 20% of newly diagnosed breast cancers and is associated with younger age at diagnosis, greater recurrence risk and shorter survival time. Therapeutic options are very scarce. Aim of the present analysis is to provide further insights into the clinical activity of metronomic chemotherapy (mCHT), in a real-life setting. Methods: We used data included in the VICTOR-6 study for the present analysis. VICTOR-6 is an Italian multicentre retrospective cohort study, which collected data of metastatic breast cancer (MBC) patients who have received mCHT between 2011 and 2016. Amongst the 584 patients included in the study, 97 were triple negative. In 40.2% of the TNBC patients, mCHT was the first chemotherapy treatment, whereas 32.9% had received 2 or more lines of treatment for the metastatic disease. 45.4% out of 97 TNBC patients received a vinorelbine (VRL)-based regimen, which resulted in the most used type of mCHT, followed by cyclophosphamide (CTX)-based regimens (30.9%) and capecitabine (CAPE)-based combinations (22.7%). Results: Overall response rate (ORR) and disease control rate (DCR) were 17.5% and 64.9%, respectively. Median progression free survival (PFS) and overall survival (OS) were 6.0 months (95% CI: 4.9–7.2) and 12.1 months (95% CI: 9.6–16.7). Median PFS was 6.9 months for CAPE-based regimens (95% CI: 5.0–18.4), 6.1 months (95% CI: 4.0–8.9) for CTX-based and 5.3 months (95% CI: 4.1–9.5) for VRL-based ones. Median OS was 18.2 months (95% CI: 9.1-NE) for CAPE-based regimens and 11.8 months for VRL- (95% CI: 9.3–16.7 and CTX-based ones (95%CI: 8.7–52.8). Tumour response, PFS and OS decreased proportionally in later lines. Conclusion: This analysis represents the largest series of TNBC patients treated with mCHT in

Published
2021

5. Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study

Author

Cazzaniga, M, Pinotti, G, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Fiorentini, G, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Marchetti, P, Melegari, E, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Saracchini, S, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Clivio, L, Torri, V, Cicchiello, F, Riva, F, Vallini, I, Mazza, M, Bonfadini, C, Bordin, E, Canicatti, M, Cappuccio, F, Collova, E, De Angelis, C, Desorte, R, Donati, S, Drudi, G, Galanti, D, Mocerino, C, Orlando, L, Pellegrino, B, Pizzuti, L, Ridolfi, C, Rocca, A, Sarti, D, Spagnoletti, I, Tinari, N, Vandone, A, Vizzini, L, Cazzaniga M. E., Pinotti G., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Fiorentini G., Fontana A., Gambaro A. R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Marchetti P., Melegari E., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Saracchini S., Sarobba M. G., Schintu M. G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M. R., Vici P., Clivio L., Torri V., Cicchiello F., Riva F., Vallini I., Mazza M., Bonfadini C., Bordin E., Canicatti M., Cappuccio F., Collova E., De Angelis C., Desorte R., Donati S., Drudi G., Galanti D., Mocerino C., Orlando L., Pellegrino B., Pizzuti L., Ridolfi C., Rocca A., Sarti D., Spagnoletti I., Tinari N., Vandone A., Vizzini L., Cazzaniga, M, Pinotti, G, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Fiorentini, G, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Marchetti, P, Melegari, E, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Saracchini, S, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Clivio, L, Torri, V, Cicchiello, F, Riva, F, Vallini, I, Mazza, M, Bonfadini, C, Bordin, E, Canicatti, M, Cappuccio, F, Collova, E, De Angelis, C, Desorte, R, Donati, S, Drudi, G, Galanti, D, Mocerino, C, Orlando, L, Pellegrino, B, Pizzuti, L, Ridolfi, C, Rocca, A, Sarti, D, Spagnoletti, I, Tinari, N, Vandone, A, Vizzini, L, Cazzaniga M. E., Pinotti G., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Fiorentini G., Fontana A., Gambaro A. R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Marchetti P., Melegari E., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Saracchini S., Sarobba M. G., Schintu M. G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M. R., Vici P., Clivio L., Torri V., Cicchiello F., Riva F., Vallini I., Mazza M., Bonfadini C., Bordin E., Canicatti M., Cappuccio F., Collova E., De Angelis C., Desorte R., Donati S., Drudi G., Galanti D., Mocerino C., Orlando L., Pellegrino B., Pizzuti L., Ridolfi C., Rocca A., Sarti D., Spagnoletti I., Tinari N., Vandone A., and Vizzini L.

Abstract

Metronomic chemotherapy (mCHT) refers to the minimum biologically effective dose of a chemotherapy agent given as a continuous dosing regimen, with no prolonged drug-free breaks, that leads to antitumor activity. Aim of the present study is to describe the use of mCHT in a retrospective cohort of metastatic breast cancer (MBC) patients in order to collect data regarding the different types and regimens of drugs employed, their efficacy and safety. Between January 2011 and December 2016, data of 584 metastatic breast cancer patients treated with mCHT were collected. The use of VRL-based regimens increased during the time of observation (2011: 16.8% - 2016: 29.8%), as well as CTX-based ones (2011: 17.1% - 2016: 25.6%), whereas CAPE-based and MTX-based regimens remained stable. In the 1st-line setting, the highest ORR and DCR were observed for VRL-based regimens (single agent: 44% and 88%; combination: 36.7% and 82.4%, respectively). Assuming VRL-single agent as the referee treatment (median PFS: 7.2 months, 95% CI: 5.3–10.3), the longest median PFS were observed in VRL-combination regimens (9.5, 95%CI 88.8–11.3, HR = 0.72) and in CAPE-single agent (10.7, 95%CI 8.3–15.8, HR = 0.70). The VICTOR-6 study provides new data coming from the real-life setting, by adding new information regarding the use of mCHT as an option of treatment for MBC patients.

Published
2019

6. Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized Short-HER study

Author

Conte, P., Frassoldati, A., Bisagni, G., Brandes, A. A., Donadio, M., Garrone, O., Piacentini, F., Cavanna, L., Giotta, F., Aieta, M., Gebbia, V., Molino, A., Musolino, A., Ferro, A., Maltoni, R., Danese, S., Zamagni, C., Rimanti, A., Cagossi, K., Russo, A., Pronzato, P., Giovanardi, F., Moretti, G., Lombardo, L., Schirone, A., Beano, A., Amaducci, L., Bajardi, E. A., Vicini, R., Balduzzi, S., D'Amico, R., Guarneri, Falci C, V., Giarratano, T, Mcmahon, L, De Salvo GL, Dieci, Mv, Maiorana, A, Ficarra, G, Caggia, F, Grisolia, D, Bartolini, S, Lorusso, V, Ardito, R, Tartarone, A, Vanella, P, Taverniti, C, Porpiglia, M, Spanu, Pg, Biglia, N, Andreis, D, Piancastelli, A, Fedeli, A, Parra, Hs, Gambaro, Ar, Romito, S, Malossi, A, Gori, S, Miglietta, L, Del Mastro, L, Amoroso, D, Mansutti, M, Generali, D, Prati, G, Bertolini, A, Berardi, R, Zanni, A, Cottafavi, L, Bologna, A, Naso, G, Pancotti, A, Farci, D, Zoboli, A, Silva, R, Laudadio, L, Bordonaro, R, Marenco, D, Dongiovanni, V, Baldini, E, Saggia, C, Gorzegno, G, Cariello, A, Biganzoli, L, Rampello, E., Conte P., Frassoldati A., Bisagni G., Brandes A.A., Donadio M., Garrone O., Piacentini F., Cavanna L., Giotta F., Aieta M., Gebbia V., Molino A., Musolino A., Ferro A., Maltoni R., Danese S., Zamagni C., Rimanti A., Cagossi K., Russo A., Pronzato P., Giovanardi F., Moretti G., Lombardo L., Schirone A., Beano A., Amaducci L., Bajardi E.A., Vicini R., Balduzzi S., D'Amico R., and Guarneri V.

Subjects
Oncology, Time Factors, Adjuvant, Breast cancer, Cardiac safety, De-escalated treatment, Trastuzumab, Settore MED/06 - Oncologia Medica, Receptor, ErbB-2, medicine.medical_treatment, Anthracycline, 030204 cardiovascular system & hematology, Breast cancer, Antineoplastic Agents, Immunological, ErbB-2, 0302 clinical medicine, Trastuzumab, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, Anthracyclines, skin and connective tissue diseases, Adjuvant, Mastectomy, Cardiac safety, De-escalated treatment, Hazard ratio, Hematology, Middle Aged, Chemotherapy regimen, Bridged-Ring Compound, Immunological, Local, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Taxoids, Trastuzumab, adjuvant, breast cancer, cardiac safety, de-escalated treatment, Breast Neoplasm, Human, Receptor, medicine.drug, Adult, Bridged-Ring Compounds, medicine.medical_specialty, Time Factor, Socio-culturale, Breast Neoplasms, Antineoplastic Agents, Disease-Free Survival, Drug Administration Schedule, 03 medical and health sciences, Taxoid, Internal medicine, medicine, Humans, Chemotherapy, Risk factor, Aged, Neoplasm Staging, Antineoplastic Combined Chemotherapy Protocol, business.industry, medicine.disease, Cardiotoxicity, Neoplasm Recurrence, Neoplasm Recurrence, Local, business
Abstract

Background: Chemotherapy plus 1-year trastuzumab is the standard adjuvant treatment of HER2-positive breast cancer. The efficacy of less extended trastuzumab exposure is under investigation. The short-HER study was aimed to assess the non-inferiority of 9 weeks versus 1 year of adjuvant trastuzumab combined with chemotherapy. Patients and methods: HER2-positive breast cancer patients with node-positive or, if node negative, with at least one risk factor (pT>2 cm, G3, lympho-vascular invasion, Ki-67 > 20%, age 35 years, or hormone receptor negativity) were randomly assigned to receive sequential anthracycline-taxane combinations plus 1-year trastuzumab (arm A, long) or plus 9 weeks trastuzumab (arm B, short). This study was designed as a non-inferiority trial with disease-free survival (DFS) as primary end point. A DFS hazard ratio (HR)

Published
2018

8. 1779P Revolutionizing clinical trial units in the pandemic era

Author

Cagnazzo, C., primary, Franchina, V., additional, Maggiora, P., additional, Stabile, S., additional, Taverniti, C., additional, Guarrera, A., additional, Federici, I., additional, Testoni, S., additional, Monti, M., additional, Cresta, S., additional, and Fragioli, F., additional

Published
2020
Full Text
View/download PDF

11. Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study

Author

Cazzaniga, M.E., primary, Pinotti, G., additional, Montagna, E., additional, Amoroso, D., additional, Berardi, R., additional, Butera, A., additional, Cagossi, K., additional, Cavanna, L., additional, Ciccarese, M., additional, Cinieri, S., additional, Cretella, E., additional, De Conciliis, E., additional, Febbraro, A., additional, Ferraù, F., additional, Ferzi, A., additional, Fiorentini, G., additional, Fontana, A., additional, Gambaro, A.R., additional, Garrone, O., additional, Gebbia, V., additional, Generali, D., additional, Gianni, L., additional, Giovanardi, F., additional, Grassadonia, A., additional, Leonardi, V., additional, Marchetti, P., additional, Melegari, E., additional, Musolino, A., additional, Nicolini, M., additional, Putzu, C., additional, Riccardi, F., additional, Santini, D., additional, Saracchini, S., additional, Sarobba, M.G., additional, Schintu, M.G., additional, Scognamiglio, G., additional, Spadaro, P., additional, Taverniti, C., additional, Toniolo, D., additional, Tralongo, P., additional, Turletti, A., additional, Valenza, R., additional, Valerio, M.R., additional, Vici, P., additional, Clivio, L., additional, Torri, V., additional, Cicchiello, F., additional, Riva, F., additional, Vallini, I., additional, Mazza, M., additional, Bonfadini, C., additional, Bordin, E., additional, Canicattì, M., additional, Cappuccio, F., additional, Collovà, E., additional, De Angelis, C., additional, Desorte, R., additional, Donati, S., additional, Drudi, G., additional, Galanti, D., additional, Mocerino, C., additional, Orlando, L., additional, Pellegrino, B., additional, Pizzuti, L., additional, Ridolfi, C., additional, Rocca, A., additional, Sarti, D., additional, Spagnoletti, I., additional, Tinari, N., additional, Vandone, A., additional, and Vizzini, L., additional

Published
2019
Full Text
View/download PDF

12. 9 weeks versus 1 year adjuvant trastuzumab for HER2+ early breast cancer: Subgroup analysis of the ShortHER trial allows to identify patients for whom a shorter trastuzumab administration may have a favourable risk/benefit ratio

Author

Conte, P.F., primary, Guarneri, V., additional, Bisagni, G., additional, Piacentini, F., additional, Brandes, A.A., additional, Cavanna, L., additional, Giotta, F., additional, Aieta, M., additional, Gebbia, V., additional, Frassoldati, A., additional, Musolino, A., additional, Garrone, O., additional, Taverniti, C., additional, Rimanti, A., additional, Sarti, S., additional, Rubino, D., additional, Bologna, A., additional, Vicini, R., additional, Balduzzi, S., additional, and D'Amico, R., additional

Published
2018
Full Text
View/download PDF

14. Clinical trials and risk-based approach: reality or Utopia?

Author

Cagnazzo, C., primary, Arizio, F., additional, Piccinni Leopardi, M., additional, Di Costanzo, A., additional, Crotto, L., additional, Matocci, R., additional, Lucarelli, A., additional, Grassi, E., additional, Saracino, V., additional, Fugazza, C., additional, Cinefra, M., additional, Marchetti, F., additional, Taverniti, C., additional, Stabile, S., additional, Monti, M., additional, and Marchesi, E., additional

Published
2017
Full Text
View/download PDF

19. Saving in clinical trial: a possible challenge for health care

Author

Taverniti, C., primary, Pradotto, M., additional, Rossi, L., additional, Ignazzi, G., additional, Cibrario Rocchietti, E., additional, Battista, D., additional, Polizzano, D., additional, Linardi, A., additional, Gianetta, M., additional, Alemanni, A., additional, Demartini, P., additional, Arizio, F., additional, Nuzzo, A., additional, Cagnazzo, C., additional, and Bonfadini, C., additional

Published
2016
Full Text
View/download PDF

20. 191PD_PR - 9 weeks versus 1 year adjuvant trastuzumab for HER2+ early breast cancer: Subgroup analysis of the ShortHER trial allows to identify patients for whom a shorter trastuzumab administration may have a favourable risk/benefit ratio

Author

Conte, P.F., Guarneri, V., Bisagni, G., Piacentini, F., Brandes, A.A., Cavanna, L., Giotta, F., Aieta, M., Gebbia, V., Frassoldati, A., Musolino, A., Garrone, O., Taverniti, C., Rimanti, A., Sarti, S., Rubino, D., Bologna, A., Vicini, R., Balduzzi, S., and D'Amico, R.

Published
2018
Full Text
View/download PDF

28. Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study

Author

M.E. Cazzaniga, G. Pinotti, E. Montagna, D. Amoroso, R. Berardi, A. Butera, K. Cagossi, L. Cavanna, M. Ciccarese, S. Cinieri, E. Cretella, E. De Conciliis, A. Febbraro, F. Ferraù, A. Ferzi, G. Fiorentini, A. Fontana, A.R. Gambaro, O. Garrone, V. Gebbia, D. Generali, L. Gianni, F. Giovanardi, A. Grassadonia, V. Leonardi, P. Marchetti, E. Melegari, A. Musolino, M. Nicolini, C. Putzu, F. Riccardi, D. Santini, S. Saracchini, M.G. Sarobba, M.G. Schintu, G. Scognamiglio, P. Spadaro, C. Taverniti, D. Toniolo, P. Tralongo, A. Turletti, R. Valenza, M.R. Valerio, P. Vici, L. Clivio, V. Torri, F. Cicchiello, F. Riva, I. Vallini, M. Mazza, C. Bonfadini, E. Bordin, M. Canicattì, F. Cappuccio, E. Collovà, C. De Angelis, R. Desorte, S. Donati, G. Drudi, D. Galanti, C. Mocerino, L. Orlando, B. Pellegrino, L. Pizzuti, C. Ridolfi, A. Rocca, D. Sarti, I. Spagnoletti, N. Tinari, A. Vandone, L. Vizzini, Cazzaniga M.E., Pinotti G., Montagna E., Amoroso D., Berardi R., Butera A., Cagossi K., Cavanna L., Ciccarese M., Cinieri S., Cretella E., De Conciliis E., Febbraro A., Ferrau F., Ferzi A., Fiorentini G., Fontana A., Gambaro A.R., Garrone O., Gebbia V., Generali D., Gianni L., Giovanardi F., Grassadonia A., Leonardi V., Marchetti P., Melegari E., Musolino A., Nicolini M., Putzu C., Riccardi F., Santini D., Saracchini S., Sarobba M.G., Schintu M.G., Scognamiglio G., Spadaro P., Taverniti C., Toniolo D., Tralongo P., Turletti A., Valenza R., Valerio M.R., Vici P., Clivio L., Torri V., Cicchiello F., Riva F., Vallini I., Mazza M., Bonfadini C., Bordin E., Canicatti M., Cappuccio F., Collova E., De Angelis C., Desorte R., Donati S., Drudi G., Galanti D., Mocerino C., Orlando L., Pellegrino B., Pizzuti L., Ridolfi C., Rocca A., Sarti D., Spagnoletti I., Tinari N., Vandone A., Vizzini L., Cazzaniga, M, Pinotti, G, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Fiorentini, G, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Marchetti, P, Melegari, E, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Saracchini, S, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Clivio, L, Torri, V, Cicchiello, F, Riva, F, Vallini, I, Mazza, M, Bonfadini, C, Bordin, E, Canicatti, M, Cappuccio, F, Collova, E, De Angelis, C, Desorte, R, Donati, S, Drudi, G, Galanti, D, Mocerino, C, Orlando, L, Pellegrino, B, Pizzuti, L, Ridolfi, C, Rocca, A, Sarti, D, Spagnoletti, I, Tinari, N, Vandone, A, and Vizzini, L

Subjects
Adult, Oncology, medicine.medical_specialty, Cyclophosphamide, Settore MED/06 - Oncologia Medica, Antineoplastic Agents, Breast Neoplasms, Vinorelbine, Drug Administration Schedule, Antineoplastic Agent, Efficacy, Capecitabine, 03 medical and health sciences, Breast cancer, 0302 clinical medicine, Retrospective Studie, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, 030212 general & internal medicine, Progression-free survival, Retrospective Studies, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocol, business.industry, Metronomic chemotherapy, General Medicine, Middle Aged, medicine.disease, Metastatic breast cancer, Metronomic Chemotherapy, Survival Rate, Methotrexate, Treatment Outcome, 030220 oncology & carcinogenesis, MED/06 - ONCOLOGIA MEDICA, Female, Surgery, business, Breast Neoplasm, Human, medicine.drug
Abstract

Metronomic chemotherapy (mCHT) refers to the minimum biologically effective dose of a chemotherapy agent given as a continuous dosing regimen, with no prolonged drug-free breaks, that leads to antitumor activity. Aim of the present study is to describe the use of mCHT in a retrospective cohort of metastatic breast cancer (MBC) patients in order to collect data regarding the different types and regimens of drugs employed, their efficacy and safety. Between January 2011 and December 2016, data of 584 metastatic breast cancer patients treated with mCHT were collected. The use of VRL-based regimens increased during the time of observation (2011: 16.8% - 2016: 29.8%), as well as CTX-based ones (2011: 17.1% - 2016: 25.6%), whereas CAPE-based and MTX-based regimens remained stable. In the 1st-line setting, the highest ORR and DCR were observed for VRL-based regimens (single agent: 44% and 88%; combination: 36.7% and 82.4%, respectively). Assuming VRL-single agent as the referee treatment (median PFS: 7.2 months, 95% CI: 5.3–10.3), the longest median PFS were observed in VRL-combination regimens (9.5, 95%CI 88.8–11.3, HR = 0.72) and in CAPE-single agent (10.7, 95%CI 8.3–15.8, HR = 0.70). The VICTOR-6 study provides new data coming from the real-life setting, by adding new information regarding the use of mCHT as an option of treatment for MBC patients.

Published
2019

29. Metronomic chemotherapy (mCHT) in metastatic triple-negative breast cancer (TNBC) patients: results of the VICTOR-6 study

Author

Katia Cagossi, A. Ferzi, Domenico Amoroso, A. Baldelli, Luca Clivio, Mariangela Ciccarese, Viola Cogliati, Ornella Garrone, P. Spadaro, Daniele Santini, Vita Leonardi, Elisabetta Cretella, Luca Gianni, A. Gambaro, Alfredo Butera, A. Turletti, M.G. Sarobba, Giovanni Scognamiglio, Vittorio Gebbia, Cristiana Taverniti, F. Ferraù, D. Toniolo, Saverio Cinieri, C. Putzu, S. Capici, Antonino Musolino, Daniele Generali, Paolo Tralongo, Marina Elena Cazzaniga, Valter Torri, Antonino Grassadonia, Andrea Fontana, Emilia Montagna, E. de Conciliis, P. Di Mauro, Maria Rosaria Valerio, Rossana Berardi, Silvana Saracchini, Ferdinando Riccardi, Antonio Febbraro, I. Vallini, Patrizia Vici, Luigi Cavanna, M. G. Schintu, Roberto Valenza, F. Giovanardi, M. Nicolini, Samanta Sarti, Paolo Marchetti, Cazzaniga, M, Vallini, I, Montagna, E, Amoroso, D, Berardi, R, Butera, A, Cagossi, K, Cavanna, L, Ciccarese, M, Cinieri, S, Cretella, E, De Conciliis, E, Febbraro, A, Ferrau, F, Ferzi, A, Baldelli, A, Fontana, A, Gambaro, A, Garrone, O, Gebbia, V, Generali, D, Gianni, L, Giovanardi, F, Grassadonia, A, Leonardi, V, Marchetti, P, Sarti, S, Musolino, A, Nicolini, M, Putzu, C, Riccardi, F, Santini, D, Saracchini, S, Sarobba, M, Schintu, M, Scognamiglio, G, Spadaro, P, Taverniti, C, Toniolo, D, Tralongo, P, Turletti, A, Valenza, R, Valerio, M, Vici, P, Di Mauro, P, Cogliati, V, Capici, S, Clivio, L, Torri, V, Cazzaniga, M. E., Vallini, I., Montagna, E., Amoroso, D., Berardi, R., Butera, A., Cagossi, K., Cavanna, L., Ciccarese, M., Cinieri, S., Cretella, E., De Conciliis, E., Febbraro, A., Ferrau, F., Ferzi, A., Baldelli, A., Fontana, A., Gambaro, A. R., Garrone, O., Gebbia, V., Generali, D., Gianni, L., Giovanardi, F., Grassadonia, A., Leonardi, V., Marchetti, P., Sarti, S., Musolino, A., Nicolini, M., Putzu, C., Riccardi, F., Santini, D., Saracchini, S., Sarobba, M. G., Schintu, M. G., Scognamiglio, G., Spadaro, P., Taverniti, C., Toniolo, D., Tralongo, P., Turletti, A., Valenza, R., Valerio, M. R., Vici, P., Clivio, L., Torri, V., Cazzaniga, M E, Ferraù, F, Gambaro, A R, Sarobba, M G, Schintu, M G, and Valerio, M R

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Receptor, ErbB-2, Breast Neoplasms, Triple Negative Breast Neoplasms, Vinorelbine, Capecitabine, Cyclophosphamide, Methotrexate, Metronomic chemotherapy, Triple-negative breast cancer, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Retrospective Studies, ErbB-2, Breast cancer, Retrospective Studie, Internal medicine, medicine, Progression-free survival, Antineoplastic Combined Chemotherapy Protocol, business.industry, medicine.disease, Clinical Trial, Metronomic Chemotherapy, Metastatic breast cancer, Regimen, business, Breast Neoplasm, Human, Receptor, medicine.drug
Abstract

Purpose Triple-negative breast cancer (TNBC) represents a subtype of breast cancer which lacks the expression of oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (HER2): TNBC accounts for approximately 20% of newly diagnosed breast cancers and is associated with younger age at diagnosis, greater recurrence risk and shorter survival time. Therapeutic options are very scarce. Aim of the present analysis is to provide further insights into the clinical activity of metronomic chemotherapy (mCHT), in a real-life setting. Methods We used data included in the VICTOR-6 study for the present analysis. VICTOR-6 is an Italian multicentre retrospective cohort study, which collected data of metastatic breast cancer (MBC) patients who have received mCHT between 2011 and 2016. Amongst the 584 patients included in the study, 97 were triple negative. In 40.2% of the TNBC patients, mCHT was the first chemotherapy treatment, whereas 32.9% had received 2 or more lines of treatment for the metastatic disease. 45.4% out of 97 TNBC patients received a vinorelbine (VRL)-based regimen, which resulted in the most used type of mCHT, followed by cyclophosphamide (CTX)-based regimens (30.9%) and capecitabine (CAPE)-based combinations (22.7%). Results Overall response rate (ORR) and disease control rate (DCR) were 17.5% and 64.9%, respectively. Median progression free survival (PFS) and overall survival (OS) were 6.0 months (95% CI: 4.9–7.2) and 12.1 months (95% CI: 9.6–16.7). Median PFS was 6.9 months for CAPE-based regimens (95% CI: 5.0–18.4), 6.1 months (95% CI: 4.0–8.9) for CTX-based and 5.3 months (95% CI: 4.1–9.5) for VRL-based ones. Median OS was 18.2 months (95% CI: 9.1-NE) for CAPE-based regimens and 11.8 months for VRL- (95% CI: 9.3–16.7 and CTX-based ones (95%CI: 8.7–52.8). Tumour response, PFS and OS decreased proportionally in later lines. Conclusion This analysis represents the largest series of TNBC patients treated with mCHT in a real-life setting and provides further insights into the advantages of using this strategy even in this poor prognosis subpopulation.

Published
2021

30. Metronomic chemotherapy (mCHT) in metastatic triple-negative breast cancer (TNBC) patients: results of the VICTOR-6 study.

Author

Cazzaniga ME, Vallini I, Montagna E, Amoroso D, Berardi R, Butera A, Cagossi K, Cavanna L, Ciccarese M, Cinieri S, Cretella E, De Conciliis E, Febbraro A, Ferraù F, Ferzi A, Baldelli A, Fontana A, Gambaro AR, Garrone O, Gebbia V, Generali D, Gianni L, Giovanardi F, Grassadonia A, Leonardi V, Marchetti P, Sarti S, Musolino A, Nicolini M, Putzu C, Riccardi F, Santini D, Saracchini S, Sarobba MG, Schintu MG, Scognamiglio G, Spadaro P, Taverniti C, Toniolo D, Tralongo P, Turletti A, Valenza R, Valerio MR, Vici P, Di Mauro P, Cogliati V, Capici S, Clivio L, and Torri V

Subjects
Antineoplastic Combined Chemotherapy Protocols therapeutic use, Capecitabine therapeutic use, Cyclophosphamide therapeutic use, Female, Humans, Receptor, ErbB-2 genetics, Retrospective Studies, Breast Neoplasms drug therapy, Triple Negative Breast Neoplasms drug therapy
Abstract

Purpose: Triple-negative breast cancer (TNBC) represents a subtype of breast cancer which lacks the expression of oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (HER2): TNBC accounts for approximately 20% of newly diagnosed breast cancers and is associated with younger age at diagnosis, greater recurrence risk and shorter survival time. Therapeutic options are very scarce. Aim of the present analysis is to provide further insights into the clinical activity of metronomic chemotherapy (mCHT), in a real-life setting., Methods: We used data included in the VICTOR-6 study for the present analysis. VICTOR-6 is an Italian multicentre retrospective cohort study, which collected data of metastatic breast cancer (MBC) patients who have received mCHT between 2011 and 2016. Amongst the 584 patients included in the study, 97 were triple negative. In 40.2% of the TNBC patients, mCHT was the first chemotherapy treatment, whereas 32.9% had received 2 or more lines of treatment for the metastatic disease. 45.4% out of 97 TNBC patients received a vinorelbine (VRL)-based regimen, which resulted in the most used type of mCHT, followed by cyclophosphamide (CTX)-based regimens (30.9%) and capecitabine (CAPE)-based combinations (22.7%)., Results: Overall response rate (ORR) and disease control rate (DCR) were 17.5% and 64.9%, respectively. Median progression free survival (PFS) and overall survival (OS) were 6.0 months (95% CI: 4.9-7.2) and 12.1 months (95% CI: 9.6-16.7). Median PFS was 6.9 months for CAPE-based regimens (95% CI: 5.0-18.4), 6.1 months (95% CI: 4.0-8.9) for CTX-based and 5.3 months (95% CI: 4.1-9.5) for VRL-based ones. Median OS was 18.2 months (95% CI: 9.1-NE) for CAPE-based regimens and 11.8 months for VRL- (95% CI: 9.3-16.7 and CTX-based ones (95%CI: 8.7-52.8). Tumour response, PFS and OS decreased proportionally in later lines., Conclusion: This analysis represents the largest series of TNBC patients treated with mCHT in a real-life setting and provides further insights into the advantages of using this strategy even in this poor prognosis subpopulation., (© 2021. The Author(s).)

Published
2021
Full Text
View/download PDF

31. Clinical research and burnout syndrome in Italy - only a physicians' affair?

Author

Cagnazzo C, Filippi R, Zucchetti G, Cenna R, Taverniti C, Guarrera ASE, Stabile S, Federici I, Monti M, Pirondi S, Testoni S, and Fagioli F

Subjects
Humans, Italy, Surveys and Questionnaires, Workload, Burnout, Professional diagnosis, Burnout, Professional epidemiology, Physicians
Abstract

Background: The burnout phenomenon has been extensively investigated among health care professionals, particularly focusing on physicians and nurses. However, literature concerning burnout in clinical research is poor and often neglects the other professional categories involved., Methods: In March 2019, all members of Italian Group of Clinical Research Coordinator were invited to participate to a web survey, consisting of three sections: general information and workload; Maslach Burnout Inventory (MBI) test; subjective perception of oneself's work stress and possible causes., Results: The majority of respondents felt a form of distress. The main source was contract type (31.2%), followed by workload (20.5%) and lack of skills recognition (17.8%). Results from MBI test confirmed the interviewees' subjective perception: an intermediate level of emotional exhaustion (19.1 points) and a very high sense of reduced professional achievement (26.8 points) were observed. Both depersonalization and sense of reduced professional achievement showed weak to moderate correlations with emotional exhaustion. Emotional exhaustion was associated with contract type with high significance., Conclusion: It is necessary to act on those qualitative factors that are greatly increasing the level of perceived stress, jeopardizing the quality of clinical research coordinators work and significantly amplifying the phenomenon of migration towards the private sector.

Published
2021
Full Text
View/download PDF

32. Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Local and Contralateral Recurrence in Breast Intraepithelial Neoplasia.

Author

DeCensi A, Puntoni M, Guerrieri-Gonzaga A, Caviglia S, Avino F, Cortesi L, Taverniti C, Pacquola MG, Falcini F, Gulisano M, Digennaro M, Cariello A, Cagossi K, Pinotti G, Lazzeroni M, Serrano D, Branchi D, Campora S, Petrera M, Buttiron Webber T, Boni L, and Bonanni B

Subjects
Aged, Antineoplastic Agents, Hormonal administration & dosage, Antineoplastic Agents, Hormonal adverse effects, Biomarkers, Tumor metabolism, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Incidence, Middle Aged, Placebos adverse effects, Research Design, Tamoxifen adverse effects, Treatment Outcome, Breast Neoplasms drug therapy, Carcinoma, Intraductal, Noninfiltrating drug therapy, Neoplasm Recurrence, Local, Tamoxifen administration & dosage
Abstract

Purpose: Tamoxifen administered for 5 years at 20 mg/d is effective in breast cancer treatment and prevention, but toxicity has limited its broad use. Biomarker trials showed that 5 mg/d is not inferior to 20 mg/d in decreasing breast cancer proliferation. We hypothesized that a lower dose given for a shorter period could be as effective in preventing recurrence from breast intraepithelial neoplasia but have a lower toxicity than the standard dose., Patients and Methods: We conducted a multicenter randomized trial of tamoxifen, 5 mg/d or placebo administered for 3 years after surgery in women with hormone-sensitive or unknown breast intraepithelial neoplasia, including atypical ductal hyperplasia and lobular or ductal carcinoma in situ. The primary end point was the incidence of invasive breast cancer or ductal carcinoma in situ., Results: Five hundred women 75 years of age or younger were included. After a median follow-up of 5.1 years (interquartile range, 3.9-6.3 years), there were 14 neoplastic events with tamoxifen and 28 with placebo (11.6 v 23.9 per 1,000 person-years; hazard ratio, 0.48; 95% CI, 0.26 to 0.92; P = .02), which resulted in a 5-year number needed to treat of 22 (95% CI, 20 to 27). Tamoxifen decreased contralateral breast events by 75% (three v 12 events; hazard ratio, 0.25; 95% CI, 0.07 to 0.88; P = .02). Patient-reported outcomes were not different between arms except for a slight increase in frequency of daily hot flashes with tamoxifen ( P = .02). There were 12 serious adverse events with tamoxifen and 16 with placebo, including one deep vein thrombosis and one stage I endometrial cancer with tamoxifen and one pulmonary embolism with placebo., Conclusion: Tamoxifen at 5 mg/d for 3 years can halve the recurrence of breast intraepithelial neoplasia with a limited toxicity, which provides a new treatment option in these disorders.

Published
2019
Full Text
View/download PDF

33. [Clinical research: enough players to get out there?]

Author

Cagnazzo C, Guarrera A, Cenna R, Taverniti C, Stabile S, Federici I, Pirondi S, Testoni S, and Monti M

Subjects
Contracts, Humans, Italy, Professional Role, Biomedical Research organization & administration, Clinical Trials as Topic organization & administration, Employment, Research Personnel organization & administration
Abstract

Despite the presence of experienced and multidisciplinary staff is now essential due to the increasing complexity of clinical research, many national collective health contracts do not yet contemplate the new professional figures. This instability risks causing an alarming professional gap, especially for non-profit clinical research. For this reason, we would try to evaluate the extent to which the problem is widespread among Italian clinical research coordinators, verifying how much the Italian institutes have permanently integrated this professional figure into organic plant, through stable and specific employment contracts. In November 2016, when the Italian Government has declared for the first time its intention to prevent further renewal of contracts with atypical employment, we conducted a survey with the intent of mapping the extent of the contractual issues related to the figure of the clinical research coordinator. Two years later, we repeated the survey to see if something was changed and if it was any improvement in the employment situation. In November 2016, only a small fraction of the respondents (13.8%) was hired with a permanent contract, while the majority (73.2%) were employed with an atypical one. Regarding the impossibility to renew the atypical contracts due to the new Government provisions starting from January 2017: the 67.5% of the respondents stated that the issue would directly affect him. Two years later, the situation looks even worse: only the 11.5% of the respondents are hired on a permanent contract, while there is a very high percentage (74.8%) of atypical contracts, with even some coordinators who say they have been working for several months as unpaid volunteers. It is interesting to note that over 30% of staff with atypical contracts work in research institutes and research-related scientific societies, with a strong interest in non-profit clinical research. Adopt Clinical Trials Units officially and contractually recognized would be essential to bring back our nation on the top of the world health systems ranking, but yet the Italian research-dedicated infrastructures continue to be a ghost reality, deeply characterized by a continuous professional turnover and by the lack of long-term prospects. In the absence of a permanent solution, Italy is unlikely to reach the required standards, denying patients of possible therapeutic available options. Our non-profit research will pay the most for it.

Published
2019
Full Text
View/download PDF

34. [Clinical research coordinators: a crucial resource.]

Author

Cagnazzo C, Testoni S, Guarrera AS, Stabile S, Taverniti C, Federici I, Pirondi S, and Monti M

Subjects
Humans, Italy, Professional Role, Biomedical Research organization & administration, Clinical Trials as Topic organization & administration, Research Personnel organization & administration
Abstract

The increasing complexity that characterizes the world of clinical trials, both in terms of procedures and bureaucracy, has made it necessary to create dedicated infrastructures composed of experienced and qualified personnel, who constantly work to ensure high ethical and qualitative standards. A key role in these infrastructures is played by the clinical research coordinator, a key figure able to manage the workflow required, placing himself as a reference for the coordination of the various activities and professional figures involved. The literature has widely demonstrated how the presence of this professional figure is a valid contribution both from a documentary and administrative point of view as well as a crucial resource for what concerns the indicators of ethics and quality of research. Despite that, there is no yet an institutional recognition of the professional figure, neither a specific economical agreement within the National Health System. The lack of institutional recognition is causing a worrying phenomenon of migration of qualified personnel towards contract research organizations and pharmaceutical companies. That could be detrimental to the competitiveness of Italian clinical research and hinder the possibility of offering innovative experiments therapies to patients, with serious ethical consequences.

Published
2019
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results