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1. Immuno markers in newly diagnosed glioblastoma patients underwent Stupp protocol after neurosurgery: a retrospective series

Author

Gurrieri, Lorena, Mercatali, Laura, Ibrahim, Toni, Fausti, Valentina, Dall’Agata, Monia, Riva, Nada, Ranallo, Nicoletta, Pasini, Giuseppe, Tazzari, Marcella, Foca, Flavia, Bartolini, Daniela, Riccioni, Luca, Cavatorta, Chiara, Morigi, Federico Paolo, Bulgarelli, Jenny, Cocchi, Claudia, Ghini, Virginia, Tosatto, Luigino, Martinelli, Giovanni, Pession, Andrea, and Ridolfi, Laura

Published
2023
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4. Development of a predictive model for patients with bone metastases referred to palliative radiotherapy: Secondary analysis of a multicenter study (the PRAIS trial).

Author

Rossi, Romina, Medici, Federica, Habberstad, Ragnhild, Klepstad, Pal, Cilla, Savino, Dall'Agata, Monia, Kaasa, Stein, Caraceni, Augusto Tommaso, Morganti, Alessio Giuseppe, and Maltoni, Marco

Subjects
LEUKOCYTE count, LYMPHOCYTE count, BODY mass index, BONE metastasis, RECEIVER operating characteristic curves, CANCER pain
Abstract

Background: The decision to administer palliative radiotherapy (RT) to patients with bone metastases (BMs), as well as the selection of treatment protocols (dose, fractionation), requires an accurate assessment of survival expectancy. In this study, we aimed to develop three predictive models (PMs) to estimate short‐, intermediate‐, and long‐term overall survival (OS) for patients in this clinical setting. Materials and Methods: This study constitutes a sub‐analysis of the PRAIS trial, a longitudinal observational study collecting data from patients referred to participating centers to receive palliative RT for cancer‐induced bone pain. Our analysis encompassed 567 patients from the PRAIS trial database. The primary objectives were to ascertain the correlation between clinical and laboratory parameters with the OS rates at three distinct time points (short: 3 weeks; intermediate: 24 weeks; prolonged: 52 weeks) and to construct PMs for prognosis. We employed machine learning techniques, comprising the following steps: (i) identification of reliable prognostic variables and training; (ii) validation and testing of the model using the selected variables. The selection of variables was accomplished using the LASSO method (Least Absolute Shrinkage and Selection Operator). The model performance was assessed using receiver operator characteristic curves (ROC) and the area under the curve (AUC). Results: Our analysis demonstrated a significant impact of clinical parameters (primary tumor site, presence of non‐bone metastases, steroids and opioid intake, food intake, and body mass index) and laboratory parameters (interleukin 8 [IL‐8], chloride levels, C‐reactive protein, white blood cell count, and lymphocyte count) on OS. Notably, different factors were associated with the different times for OS with only IL‐8 included both in the PMs for short‐ and long‐term OS. The AUC values for ROC curves for 3‐week, 24‐week, and 52‐week OS were 0.901, 0.767, and 0.806, respectively. Conclusions: We successfully developed three PMs for OS based on easily accessible clinical and laboratory parameters for patients referred to palliative RT for painful BMs. While our findings are promising, it is important to recognize that this was an exploratory trial. The implementation of these tools into clinical practice warrants further investigation and confirmation through subsequent studies with separate databases. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Systematic vs. on-demand early palliative care in gastric cancer patients: a randomized clinical trial assessing patient and healthcare service outcomes

Author

Scarpi, Emanuela, Dall’Agata, Monia, Zagonel, Vittorina, Gamucci, Teresa, Bertè, Raffaella, Sansoni, Elisabetta, Amaducci, Elena, Broglia, Chiara Maria, Alquati, Sara, Garetto, Ferdinando, Schiavon, Stefania, Quadrini, Silvia, Orlandi, Elena, Casadei Gardini, Andrea, Ruscelli, Silvia, Ferrari, Daris, Pino, Maria Simona, Bortolussi, Roberto, Negri, Federica, Stragliotto, Silvia, Narducci, Filomena, Valgiusti, Martina, Farolfi, Alberto, Nanni, Oriana, Rossi, Romina, Maltoni, Marco, and on behalf of the Early Palliative Care Italian Study Group (EPCISG)

Published
2019
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7. Identification of palliative care needs and prognostic factors of survival in tailoring appropriate interventions in advanced oncological, renal and pulmonary diseases: a prospective observational protocol

Author

Valenti, Vanessa, primary, Rossi, Romina, additional, Scarpi, Emanuela, additional, Dall'Agata, Monia, additional, Bassi, Ilaria, additional, Cravero, Paola, additional, La Manna, Gaetano, additional, Magnoni, Giacomo, additional, Marchello, Martina, additional, Mosconi, Giovanni, additional, Nanni, Oriana, additional, Nava, Stefano, additional, Pallotti, Maria Caterina, additional, Rapposelli, Ilario Giovanni, additional, Ricci, Marianna, additional, Scrivo, Anna, additional, Spazzoli, Alessandra, additional, Valenti, Danila, additional, Zambianchi, Loretta, additional, Caraceni, Augusto, additional, and Maltoni, Marco, additional

Published
2023
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8. Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life

Author

Farolfi, Alberto, Ruscelli, Silvia, Valgiusti, Martina, Pini, Sara, Faedi, Marina, Ragazzini, Angela, Pittureri, Cristina, Amaducci, Elena, Guglieri, Irene, Bergamo, Francesca, Lonardi, Sara, Di Nunzio, Camilla, Bosco, Monica, Bocci, Barbara, Bramanti, Alfina, Gandini, Chiara, Buonadonna, Angela, Comandone, Alessandro, Zoccali, Sonia, Pino, Maria Simona, Dalu, Davide, Sozzi, Pietro, Gozza, Alberto, Giordano, Monica, Longhi, Carla, Autelitano, Cristina, Gamucci, Teresa, Mastromauro, Cataldo, Scognamiglio, Rodolfo, Degiovanni, Daniela, Negri, Federica, Caraceni, Augusto, Montanari, Luigi, Maltoni, Marco, Scarpi, Emanuela, Dall’Agata, Monia, Schiavon, Stefania, Biasini, Claudia, Codecà, Carla, Broglia, Chiara Maria, Sansoni, Elisabetta, Bortolussi, Roberto, Garetto, Ferdinando, Fioretto, Luisa, Cattaneo, Maria Teresa, Giacobino, Alice, Luzzani, Massimo, Luchena, Giovanna, Alquati, Sara, Quadrini, Silvia, Zagonel, Vittorina, Cavanna, Luigi, Ferrari, Daris, Pedrazzoli, Paolo, Frassineti, Giovanni Luca, Galiano, Antonella, Casadei Gardini, Andrea, Monti, Manlio, and Nanni, Oriana

Published
2016
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9. Systematic versus on-demand early palliative care: results from a multicentre, randomised clinical trial

Author

Frassineti, Giovanni Luca, Sansoni, Elisabetta, Ragazzini, Angela, Ruscelli, Silvia, Crivellari, Gino, Galiano, Antonella, Rodriquenz, Maria Grazia, Biasini, Claudia, Porzio, Rosa, Pittureri, Cristina, Amaducci, Elena, Faedi, Marina, Codecà, Carla, Crepaldi, Francesca, Pedrazzoli, Paolo, Bramanti, Alfina, Buonadonna, Angela, Garetto, Ferdinando, Comandone, Alessandro, Giordano, Monica, Luchena, Giovanna, Luzzani, Massimo, Cifatte, Chiara, Pino, Maria Simona, Zoccali, Sonia, Cattaneo, Maria Teresa, Dalu, Davide, Sozzi, Pietro, Gauna, Roberta, Alquati, Sara, Costantini, Massimo, Quadrini, Silvia, Narducci, Filomena, Mastromauro, Cataldo, Scognamiglio, Rodolfo, Degiovanni, Daniela, Negri, Federica, Caraceni, Augusto, Montanari, Luigi, Maltoni, Marco, Scarpi, Emanuela, Dall'Agata, Monia, Zagonel, Vittorina, Bertè, Raffaella, Ferrari, Daris, Broglia, Chiara Maria, Bortolussi, Roberto, Trentin, Leonardo, Valgiusti, Martina, Pini, Sara, Farolfi, Alberto, Casadei Gardini, Andrea, Nanni, Oriana, and Amadori, Dino

Published
2016
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11. Carboplatin and paclitaxel plus avelumab compared with carboplatin and paclitaxel in advanced or recurrent endometrial cancer (MITO END-3): a multicentre, open-label, randomised, controlled, phase 2 trial

Author

Pignata, Sandro, primary, Scambia, Giovanni, additional, Schettino, Clorinda, additional, Arenare, Laura, additional, Pisano, Carmela, additional, Lombardi, Davide, additional, De Giorgi, Ugo, additional, Andreetta, Claudia, additional, Cinieri, Saverio, additional, De Angelis, Carmine, additional, Priolo, Domenico, additional, Casanova, Claudia, additional, Rosati, Marta, additional, Greco, Filippo, additional, Zafarana, Elena, additional, Schiavetto, Ilaria, additional, Mammoliti, Serafina, additional, Cecere, Sabrina Chiara, additional, Salutari, Vanda, additional, Scalone, Simona, additional, Farolfi, Alberto, additional, Di Napoli, Marilena, additional, Lorusso, Domenica, additional, Gargiulo, Piera, additional, Califano, Daniela, additional, Russo, Daniela, additional, Spina, Anna, additional, De Cecio, Rossella, additional, Chiodini, Paolo, additional, Perrone, Francesco, additional, Accinno, Valentina, additional, Altavilla, Chiara, additional, Antonelli, Giovanna, additional, Artioli, Grazia, additional, Avola, Francesco, additional, Barbara, Bonifacio, additional, Barbato, Valentina, additional, Bartoletti, Michele, additional, Bevilacqua, Simona, additional, Bordonaro, Roberto, additional, Borghese, Oriana, additional, Buonfanti, Gaetano, additional, Camarda, Floriana, additional, Canzanella, Giuliana, additional, Carbone, Vittoria, additional, Carbone, Maria Rita, additional, Carlo Stella, Giulia, additional, Cassani, Chiara, additional, Castagna, Fabrizio, additional, Cattaneo, Monica, additional, Cinefra, Margherita, additional, Colombo, Nicoletta, additional, Corsetti, Serena, additional, Dall'Agata, Monia, additional, D'Amico, Maria, additional, Daniele, Gennaro, additional, De Marino, Elvira, additional, De Matteis, Giovanni, additional, De Placido, Sabino, additional, Del Bene, Gabriella, additional, Del Giudice, Antonia, additional, Del Monte, Francesca, additional, Del Sesto, Michele, additional, Donini, Maddalena, additional, Drudi, Giuliana, additional, Falcone, Gianluca, additional, Favaretto, Adolfo, additional, Ferrera, Giulia, additional, Florio, Manuela, additional, Forestieri, Valeria, additional, Gallo, Maria Stella, additional, Gallo, Ciro, additional, Garibaldi, Francesca, additional, Gerevini, Fabiana, additional, Ghizzoni, Viola, additional, Giganti, Maria Olga, additional, Gimigliano, Anna, additional, Giudice, Elena, additional, Gnocchi, Nicoletta, additional, Gravina, Adriano, additional, Greggi, Stefano, additional, Iaia, Maria Laura, additional, Ilardi, Annalisa, additional, Iovine, Gelsomina, additional, Ippoliti, Gabriella, additional, Irollo, Giulia, additional, Isidori, Ilenia, additional, Lapresa, Mariateresa, additional, Lavenia, Giuseppe, additional, Longhitano, Laura, additional, Lucia, Bortot, additional, Luzi, Gabriella, additional, Mariano, Sara, additional, Marino, Valentina, additional, Marrapese, Giovanna, additional, Martino, Marilena, additional, Matocci, Roberta, additional, Mazzoni, Enrica, additional, Mercuri, Daniela, additional, Mirto, Maria, additional, Mollo, Giovanna, additional, Montinaro, Abbondanza, additional, Moscatelli, Marta, additional, Mosconi, Anna Maria, additional, Musacchio, Lucia, additional, Nanni, Nicoletta, additional, Natalucci, Pamela, additional, Nicoloso, Milena Sabrina, additional, Orditura, Michele, additional, Parma, Gabriella Maria, additional, Passalacqua, Rodolfo, additional, Pelone, Michela, additional, Perri, Maria Teresa, additional, Perrucci, Bruno, additional, Piancastelli, Alessandra, additional, Piccirillo, Maria Carmela, additional, Piccolo, Antonio, additional, Pignata, Sandro, additional, Rapisardi, Stefania, additional, Ravaglia, Giorgia, additional, Ribecco, Teresa, additional, Ricci, Caterina, additional, Roccio, Marianna, additional, Romano, Fiorella, additional, Sambataro, Daniela, additional, Savio, Alfonso, additional, Sbriglia, Ada, additional, Scaffa, Cono, additional, Sergi, Concetta, additional, Sgandurra, Francesca, additional, Sorio, Roberto, additional, Stabile, Stefano, additional, Tabaro, Gianna, additional, Tambaro, Margherita, additional, Tamberi, Stefano, additional, Tecchiato, Angelica, additional, Trujillo, Angela Maria, additional, and Zaccarelli, Eleonora, additional

Published
2023
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14. Nurse‐led telephone follow‐up for early palliative care patients with advanced cancer.

Author

Valenti, Vanessa, Rossi, Romina, Scarpi, Emanuela, Ricci, Marianna, Pallotti, Maria Caterina, Dall'Agata, Monia, Montalti, Sandra, and Maltoni, Marco

Subjects
PATIENT aftercare, CAREGIVER attitudes, ONCOLOGY nursing, SCIENTIFIC observation, RETROSPECTIVE studies, PATIENTS' attitudes, CANCER patients, MEDICATION therapy management, MEDICAL referrals, DESCRIPTIVE statistics, INTERPROFESSIONAL relations, DATA analysis software, TELENURSING, PALLIATIVE treatment, PAIN management
Abstract

Aim and objectives: To present our experience of a nursing telephone consultation service, describing patient and caregiver requests, and outlining ensuing nursing or medical interventions. Background: Recently, there has been an increase in the use of telephone consultation for cancer patients. However, there is still limited data on the characteristics of this type of service and on the nature of the interventions carried out. Design and methods: In this observational retrospective study, we evaluated the phone calls made over a 6‐month period by patients or caregivers to the early palliative care team of a cancer institute. Information regarding telephone calls (frequency, reason and management) was systematically collected by a nursing case manager. The study complies with the STROBE checklist File S1. Results: 171 patients used the service, for a total of 323 phone calls. The majority (80.8%) were from patients followed at the outpatient clinic and the most common requests were for pain management (38.4%) and for updates on the clinical situation (23.8%). Other frequent requests were for medication management (18.9%) and scheduling (18.3%). 210 of the 323 phone calls were handled by the nurse, while 22 were managed in collaboration with a physician. An 87.6% effectiveness in telephone management was observed. Conclusion: The overall use of the phone service was higher for early palliative care patients. The majority of phone calls were effectively handled by the nursing case manager. Relevance to clinical practice: An effective and feasible nurse‐led telephone follow‐up of early palliative care patients with advanced cancer could improve their care experience. Specifically, it could impact on patients and families improving quality of life and symptom control securing access to timely care without travel or additional cost.It can also improve continuity of care, adherence to oncological treatments and minimise acute care visits. [ABSTRACT FROM AUTHOR]

Published
2023
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15. Predictors of survival and effect of short (40 Gy) or standard-course (60 Gy) irradiation plus concomitant temozolomide in elderly patients with glioblastoma: a multicenter retrospective study of AINO (Italian Association of Neuro-Oncology)

Author

Lombardi, Giuseppe, Pace, Andrea, Pasqualetti, Francesco, Rizzato, Simona, Faedi, Marina, Anghileri, Elena, Nicolotto, Elisa, Bazzoli, Elena, Bellu, Luisa, Villani, Veronica, Fabi, Alessandra, Ferrazza, Patrizia, Gurrieri, Lorena, Dall’Agata, Monia, Eoli, Marica, Della Puppa, Alessandro, Pambuku, Ardi, D’Avella, Domenico, Berti, Franco, Rudà, Roberta, and Zagonel, Vittorina

Published
2015
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17. Patients with multiple myeloma referred for palliative care consultation: from retrospective analysis to future directions to improve clinical outcomes

Author

Pallotti, Maria Caterina, primary, Rossi, Romina, additional, Scarpi, Emanuela, additional, Dall’Agata, Monia, additional, Ricci, Marianna, additional, Ceccolini, Michela, additional, Ronconi, Sonia, additional, Valenti, Vanessa, additional, Maltoni, Marco, additional, Martinelli, Giovanni, additional, and Cerchione, Claudio, additional

Published
2021
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19. sj-pdf-1-tam-10.1177_1758835920985632 – Supplemental material for Phase II study of liposomal doxorubicin, docetaxel and trastuzumab in combination with metformin as neoadjuvant therapy for HER2-positive breast cancer

Author

Rocca, Andrea, Cortesi, Pietro, Cortesi, Laura, Gianni, Lorenzo, Matteucci, Federica, Fantini, Lorenzo, Maestri, Antonio, Giunchi, Donata Casadei, Cavanna, Luigi, Ciani, Rosa, Falcini, Fabio, Bagni, Antonella, Meldoli, Elena, Dall’Agata, Monia, Volpi, Roberta, Andreis, Daniele, Nanni, Oriana, Curcio, Annalisa, Lucchi, Leonardo, Amadori, Dino, and Fedeli, Anna

Subjects
110203 Respiratory Diseases, FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, sj-pdf-1-tam-10.1177_1758835920985632 for Phase II study of liposomal doxorubicin, docetaxel and trastuzumab in combination with metformin as neoadjuvant therapy for HER2-positive breast cancer by Andrea Rocca, Pietro Cortesi, Laura Cortesi, Lorenzo Gianni, Federica Matteucci, Lorenzo Fantini, Antonio Maestri, Donata Casadei Giunchi, Luigi Cavanna, Rosa Ciani, Fabio Falcini, Antonella Bagni, Elena Meldoli, Monia Dall’Agata, Roberta Volpi, Daniele Andreis, Oriana Nanni, Annalisa Curcio, Leonardo Lucchi, Dino Amadori and Anna Fedeli in Therapeutic Advances in Medical Oncology

Published
2021
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20. How Many Cancer Clinical Trials Can a Clinical Research Coordinator Manage? The Clinical Research Coordinator Workload Assessment Tool

Author

Fabbri, Francesca, primary, Gentili, Giorgia, additional, Serra, Patrizia, additional, Vertogen, Bernadette, additional, Andreis, Daniele, additional, Dall'Agata, Monia, additional, Fabbri, Greta, additional, Gallà, Valentina, additional, Massa, Ilaria, additional, Montanari, Emanuela, additional, Monti, Manuela, additional, Pagan, Flavia, additional, Piancastelli, Alessandra, additional, Ragazzini, Angela, additional, Rudnas, Britt, additional, Testoni, Sara, additional, Valmorri, Linda, additional, Zingaretti, Chiara, additional, Zumaglini, Federica, additional, and Nanni, Oriana, additional

Published
2021
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21. Phase II study of liposomal doxorubicin, docetaxel and trastuzumab in combination with metformin as neoadjuvant therapy for HER2-positive breast cancer

Author

Rocca, Andrea, primary, Cortesi, Pietro, additional, Cortesi, Laura, additional, Gianni, Lorenzo, additional, Matteucci, Federica, additional, Fantini, Lorenzo, additional, Maestri, Antonio, additional, Giunchi, Donata Casadei, additional, Cavanna, Luigi, additional, Ciani, Rosa, additional, Falcini, Fabio, additional, Bagni, Antonella, additional, Meldoli, Elena, additional, Dall’Agata, Monia, additional, Volpi, Roberta, additional, Andreis, Daniele, additional, Nanni, Oriana, additional, Curcio, Annalisa, additional, Lucchi, Leonardo, additional, Amadori, Dino, additional, and Fedeli, Anna, additional

Published
2021
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23. Evaluation of prognostic role of inflammatory index in glioblastoma multiforme patients undergoing to concomitant radio-chemotherapy.

Author

Fausti, Valentina, primary, Foca, Flavia, additional, Riva, Nada, additional, Bongiovanni, Alberto, additional, Gurrieri, Lorena, additional, Di Menna, Giandomenico, additional, Calpona, Sebastiano, additional, De Bonis, Silvia Angela, additional, Mercatali, Laura, additional, Spadazzi, Chiara, additional, De Vita, Alessandro, additional, Liverani, Chiara, additional, Miserocchi, Giacomo, additional, Cocchi, Claudia, additional, Dall'Agata, Monia, additional, Tosatto, Luigino, additional, Romeo, Antonino, additional, Amadori, Dino, additional, Martinelli, Giovanni, additional, and Ibrahim, Toni, additional

Published
2019
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24. Randomized phase II study with two gemcitabine- and docetaxel-based combinations as first-line chemotherapy for metastatic non-small cell lung cancer

Author

Zoli Wainer, Zumaglini Federica, Oliverio Giovanni, Pasquini Enzo, Dazzi Claudio, Dall'Agata Monia, Cecconetto Lorenzo, Passardi Alessandro, Nanni Oriana, Milandri Carlo, Frassineti Giovanni, and Amadori Dino

Subjects
Medicine
Abstract

Abstract Background Docetaxel and gemcitabine combinations have proven active for the treatment of non-small cell lung cancer (NSCLC). The aim of the present study was to evaluate and compare two treatment schedules, one based on our own preclinical data and the other selected from the literature. Methods Patients with stage IV NSCLC and at least one bidimensionally-measurable lesion were eligible. Adequate bone marrow reserve, normal hepatic and renal function, and an ECOG performance status of 0 to 2 were required. No prior chemotherapy was permitted. Patients were randomized to arm A (docetaxel 70 mg/m2on day 1 and gemcitabine 900 mg/m2 on days 3–8, every 3 weeks) or B (gemcitabine 900 mg/m2 on days 1 and 8, and docetaxel 70 mg/m2 on day 8, every 3 weeks). Results The objective response rate was 20% (95% CI:10.0–35.9) and 18% (95% CI:8.6–33.9) in arms A and B, respectively. Disease control rates were very similar (54% in arm A and 53% in arm B). No differences were noted in median survival (32 vs. 33 weeks) or 1-year survival (33% vs. 35%). Toxicity was mild in both treatment arms. Conclusion Our results highlighted acceptable activity and survival outcomes for both experimental and empirical schedules as first-line treatment of NSCLC, suggesting the potential usefulness of drug sequencing based on preclinical models. Trial registration number IOR 162 02

Published
2008
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25. Erratum to 'Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life' [Eur J Cancer (2016) 69 (110–118)] (S095980491632487X)(10.1016/j.ejca.2016.10.004)

Author

Maltoni, Marco, Scarpi, Emanuela, Dall'Agata, Monia, Schiavon, Stefania, Biasini, Claudia, Codecà, Carla, Broglia, Chiara Maria, Sansoni, Elisabetta, Bortolussi, Roberto, Garetto, Ferdinando, Fioretto, Luisa, Cattaneo, Maria Teresa, Giacobino, Alice, Luzzani, Massimo, Luchena, Giovanna, Alquati, Sara, Quadrini, Silvia, Zagonel, Vittorina, Cavanna, Luigi, Ferrari, Daris, Pedrazzoli, Paolo, Frassineti, Giovanni Luca, Galiano, Antonella, Casadei Gardini, Andrea, Monti, Manlio, Nanni, Oriana, Farolfi, Alberto, Ruscelli, Silvia, Valgiusti, Martina, Pini, Sara, Faedi, Marina, Ragazzini, Angela, Pittureri, Cristina, Amaducci, Elena, Guglieri, Irene, Bergamo, Francesca, Lonardi, Sara, Di Nunzio, Camilla, Bosco, Monica, Bocci, Barbara, Bramanti, Alfina, Gandini, Chiara, Buonadonna, Angela, Comandone, Alessandro, Zoccali, Sonia, Pino, Maria Simona, Dalu, Davide, Sozzi, Pietro, Gozza, Alberto, Giordano, Monica, Longhi, Carla, Autelitano, Cristina, Gamucci, Teresa, Mastromauro, Cataldo, Scognamiglio, Rodolfo, Degiovanni, Daniela, Negri, Federica, Caraceni, Augusto, Montanari, Luigi, Maltoni, Marco, Scarpi, Emanuela, Dall'Agata, Monia, Schiavon, Stefania, Biasini, Claudia, Codecà, Carla, Broglia, Chiara Maria, Sansoni, Elisabetta, Bortolussi, Roberto, Garetto, Ferdinando, Fioretto, Luisa, Cattaneo, Maria Teresa, Giacobino, Alice, Luzzani, Massimo, Luchena, Giovanna, Alquati, Sara, Quadrini, Silvia, Zagonel, Vittorina, Cavanna, Luigi, Ferrari, Dari, Pedrazzoli, Paolo, Frassineti, Giovanni Luca, Galiano, Antonella, Casadei Gardini, Andrea, Monti, Manlio, Nanni, Oriana, Farolfi, Alberto, Ruscelli, Silvia, Valgiusti, Martina, Pini, Sara, Faedi, Marina, Ragazzini, Angela, Pittureri, Cristina, Amaducci, Elena, Guglieri, Irene, Bergamo, Francesca, Lonardi, Sara, Di Nunzio, Camilla, Bosco, Monica, Bocci, Barbara, Bramanti, Alfina, Gandini, Chiara, Buonadonna, Angela, Comandone, Alessandro, Zoccali, Sonia, Pino, Maria Simona, Dalu, Davide, Sozzi, Pietro, Gozza, Alberto, Giordano, Monica, Longhi, Carla, Autelitano, Cristina, Gamucci, Teresa, Mastromauro, Cataldo, Scognamiglio, Rodolfo, Degiovanni, Daniela, Negri, Federica, Caraceni, Augusto, and Montanari, Luigi

Subjects
Cancer Research, Oncology
Abstract

The publisher regrets that the collaborators for this paper were not listed as such within the author details of the published paper. The collaborators were published in the Acknowledgements and are as follows: Alberto Farolfi, Silvia Ruscelli, Martina Valgiusti, Sara Pini, Marina Faedi, Department of Medical Oncology, IRST IRCCS, Meldola; Angela Ragazzini, Unit of Biostatistics and Clinical Trials, IRST IRCCS, Meldola; Cristina Pittureri and Elena Amaducci, Palliative Care and Hospice Unit, AUSL Romagna, Cesena; Irene Guglieri, Psychooncology Service, Veneto Institute of Oncology IOV – IRCCS, Padua; Francesca Bergamo, Sara Lonardi, Department of Clinical and Experimental Oncology, Medical Oncology 1, Veneto Institute of Oncology IOV – IRCCS, Padua; Camilla Di Nunzio, Medical Oncology Unit, Oncology–Hematology Department, Guglielmo da Saliceto Hospital, Piacenza; Monica Bosco, Palliative Care Unit, Oncology–Hematology Department, Guglielmo da Saliceto Hospital, Piacenza; Barbara Bocci, Medical Oncology Unit, San Paolo Hospital, Milan; Alfina Bramanti and Chiara Gandini, Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia; Angela Buonadonna, Medical Oncology Unit, Aviano National Cancer Institute, Aviano; Alessandro Comandone, Medical Oncology Unit, Presidio Humanitas Gradenigo, Turin; Sonia Zoccali, Coordinamento Cure Palliative (supported by F.I.L.E., Leniterapia Italian Foundatio), Florence; Maria Simona Pino, Medical Oncology Unit, Oncology Department, S. Maria Annunziata Hospital, Florence; Davide Dalu, Palliative Care Unit, Oncology Department, L. Sacco Hospital, Milan; Pietro Sozzi, Oncology Unit, Ospedale degli Infermi, Ponderano; Alberto Gozza, Medical Oncology, Department of Medicine, E.O. Galliera Hospitals, Genoa; Monica Giordano and Carla Longhi, Oncology Unit, Sant'Anna Hospital, Como; Cristina Autelitano, Palliative Care Unit, Arcispedale S. Maria Nuova – IRCCS, Reggio Emilia; Teresa Gamucci, Oncology Unit, SS Trinità Hospital Sora, ASL Frosinone, Frosinone; Cataldo Mastromauro, Oncology Unit, ULSS 12 Veneziana, Venice; Rodolfo Scognamiglio, Hospice Nazareth, Mestre; Daniela Degiovanni, Palliative Care Unit, Casale Monferrato, ASL Alessandria; Federica Negri, Medical Oncology Unit, Istituti Ospitalieri, Cremona; Augusto Caraceni, Palliative Care, Pain Therapy and Rehabilitation Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan; and Luigi Montanari, Palliative Care Unit Ravenna, AUSL Romagna, Italy. The publisher would like to apologise for any inconvenience caused.

Published
2017

29. Prognostic role of inflammatory index in head and neck squamous-cell carcinoma patients in first line chemotherapy.

Author

Fausti, Valentina, primary, Recine, Federica, additional, Foca, Flavia, additional, Calpona, Sebastiano, additional, Bruschi, Davide, additional, Bongiovanni, Alberto, additional, Riva, Nada, additional, Mercatali, Laura, additional, Miserocchi, Giacomo, additional, Liverani, Chiara, additional, De Vita, Alessandro, additional, Spadazzi, Chiara, additional, Di Iorio, Valentina, additional, Fabbri, Greta, additional, Dall'Agata, Monia, additional, Zavoiu, Venetia, additional, Martinelli, Giovanni, additional, Amadori, Dino, additional, and Ibrahim, Toni, additional

Published
2018
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30. Erratum to “Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life” [Eur J Cancer 69 (2016) 110–118]

Author

Maltoni, Marco, primary, Scarpi, Emanuela, additional, Dall’Agata, Monia, additional, Schiavon, Stefania, additional, Biasini, Claudia, additional, Codecà, Carla, additional, Broglia, Chiara Maria, additional, Sansoni, Elisabetta, additional, Bortolussi, Roberto, additional, Garetto, Ferdinando, additional, Fioretto, Luisa, additional, Cattaneo, Maria Teresa, additional, Giacobino, Alice, additional, Luzzani, Massimo, additional, Luchena, Giovanna, additional, Alquati, Sara, additional, Quadrini, Silvia, additional, Zagonel, Vittorina, additional, Cavanna, Luigi, additional, Ferrari, Daris, additional, Pedrazzoli, Paolo, additional, Frassineti, Giovanni Luca, additional, Galiano, Antonella, additional, Casadei Gardini, Andrea, additional, Monti, Manlio, additional, Nanni, Oriana, additional, Farolfi, Alberto, additional, Ruscelli, Silvia, additional, Valgiusti, Martina, additional, Pini, Sara, additional, Faedi, Marina, additional, Ragazzini, Angela, additional, Pittureri, Cristina, additional, Amaducci, Elena, additional, Guglieri, Irene, additional, Bergamo, Francesca, additional, Lonardi, Sara, additional, Di Nunzio, Camilla, additional, Bosco, Monica, additional, Bocci, Barbara, additional, Bramanti, Alfina, additional, Gandini, Chiara, additional, Buonadonna, Angela, additional, Comandone, Alessandro, additional, Zoccali, Sonia, additional, Pino, Maria Simona, additional, Dalu, Davide, additional, Sozzi, Pietro, additional, Gozza, Alberto, additional, Giordano, Monica, additional, Longhi, Carla, additional, Autelitano, Cristina, additional, Gamucci, Teresa, additional, Mastromauro, Cataldo, additional, Scognamiglio, Rodolfo, additional, Degiovanni, Daniela, additional, Negri, Federica, additional, Caraceni, Augusto, additional, and Montanari, Luigi, additional

Published
2017
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31. Systematic vs. on-demand early palliative care in gastric cancer patients: a randomized clinical trial assessing patient and healthcare service outcomes.

Author

Early Palliative Care Italian Study Group (EPCISG), Scarpi, Emanuela, Dall'Agata, Monia, Nanni, Oriana, Orlandi, Elena, Casadei Gardini, Andrea, Ruscelli, Silvia, Valgiusti, Martina, Farolfi, Alberto, Ferrari, Daris, Pino, Maria Simona, Bortolussi, Roberto, Negri, Federica, Zagonel, Vittorina, Schiavon, Stefania, Stragliotto, Silvia, Gamucci, Teresa, Quadrini, Silvia, Narducci, Filomena, and Bertè, Raffaella

Subjects
FUNCTIONAL independence measure, CLINICAL trials, CANCER patient care, PALLIATIVE treatment, CLINICAL trial registries, ONCOLOGISTS, PATIENT selection
Abstract

Purpose: Early palliative care (EPC) has shown a positive impact on quality of life (QoL), quality of care, and healthcare costs. We evaluated such effects in patients with advanced gastric cancer.Methods: In this prospective, multicenter study, 186 advanced gastric cancer patients were randomized 1:1 to receive standard cancer care (SCC) plus on-demand EPC (standard arm) or SCC plus systematic EPC (interventional arm). Primary outcome was a change in QoL between randomization (T0) and T1 (12 weeks after T0) in the Trial Outcome Index (TOI) scores evaluated through the Functional Assessment of Cancer Therapy-Gastric questionnaire. Secondary outcomes were patient mood, overall survival, and family satisfaction with healthcare and care aggressiveness.Results: The mean change in TOI scores from T0 to T1 was - 1.30 (standard deviation (SD) 20.01) for standard arm patients and 1.65 (SD 22.38) for the interventional group, with a difference of 2.95 (95% CI - 4.43 to 10.32) (p = 0.430). The change in mean Gastric Cancer Subscale values for the standard arm was 0.91 (SD 14.14) and 3.19 (SD 15.25) for the interventional group, with a difference of 2.29 (95% CI - 2.80 to 7.38) (p = 0.375). Forty-three percent of patients in the standard arm received EPC.Conclusions: Our results indicated a slight, albeit not significant, benefit from EPC. Findings on EPC studies may be underestimated in the event of suboptimally managed issues: type of intervention, shared decision-making process between oncologists and PC physicians, risk of standard arm contamination, study duration, timeliness of assessment of primary outcomes, timeliness of cohort inception, and recruitment of patients with a significant symptom burden.Clinical Trial Registration: ClinicalTrials.gov (NCT01996540). [ABSTRACT FROM AUTHOR]

Published
2019
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32. Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life

Author

Maltoni, Marco, primary, Scarpi, Emanuela, additional, Dall’Agata, Monia, additional, Schiavon, Stefania, additional, Biasini, Claudia, additional, Codecà, Carla, additional, Broglia, Chiara Maria, additional, Sansoni, Elisabetta, additional, Bortolussi, Roberto, additional, Garetto, Ferdinando, additional, Fioretto, Luisa, additional, Cattaneo, Maria Teresa, additional, Giacobino, Alice, additional, Luzzani, Massimo, additional, Luchena, Giovanna, additional, Alquati, Sara, additional, Quadrini, Silvia, additional, Zagonel, Vittorina, additional, Cavanna, Luigi, additional, Ferrari, Daris, additional, Pedrazzoli, Paolo, additional, Frassineti, Giovanni Luca, additional, Galiano, Antonella, additional, Casadei Gardini, Andrea, additional, Monti, Manlio, additional, Nanni, Oriana, additional, Farolfi, Alberto, additional, Ruscelli, Silvia, additional, Valgiusti, Martina, additional, Pini, Sara, additional, Faedi, Marina, additional, Ragazzini, Angela, additional, Pittureri, Cristina, additional, Amaducci, Elena, additional, Guglieri, Irene, additional, Bergamo, Francesca, additional, Lonardi, Sara, additional, Di Nunzio, Camilla, additional, Bosco, Monica, additional, Bocci, Barbara, additional, Bramanti, Alfina, additional, Gandini, Chiara, additional, Buonadonna, Angela, additional, Comandone, Alessandro, additional, Zoccali, Sonia, additional, Pino, Maria Simona, additional, Dalu, Davide, additional, Sozzi, Pietro, additional, Gozza, Alberto, additional, Giordano, Monica, additional, Longhi, Carla, additional, Autelitano, Cristina, additional, Gamucci, Teresa, additional, Mastromauro, Cataldo, additional, Scognamiglio, Rodolfo, additional, Degiovanni, Daniela, additional, Negri, Federica, additional, Caraceni, Augusto, additional, and Montanari, Luigi, additional

Published
2016
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33. Systematic versus on-demand early palliative care: results from a multicentre, randomised clinical trial

Author

Maltoni, Marco, primary, Scarpi, Emanuela, additional, Dall'Agata, Monia, additional, Zagonel, Vittorina, additional, Bertè, Raffaella, additional, Ferrari, Daris, additional, Broglia, Chiara Maria, additional, Bortolussi, Roberto, additional, Trentin, Leonardo, additional, Valgiusti, Martina, additional, Pini, Sara, additional, Farolfi, Alberto, additional, Casadei Gardini, Andrea, additional, Nanni, Oriana, additional, Amadori, Dino, additional, Frassineti, Giovanni Luca, additional, Sansoni, Elisabetta, additional, Ragazzini, Angela, additional, Ruscelli, Silvia, additional, Crivellari, Gino, additional, Galiano, Antonella, additional, Rodriquenz, Maria Grazia, additional, Biasini, Claudia, additional, Porzio, Rosa, additional, Pittureri, Cristina, additional, Amaducci, Elena, additional, Faedi, Marina, additional, Codecà, Carla, additional, Crepaldi, Francesca, additional, Pedrazzoli, Paolo, additional, Bramanti, Alfina, additional, Buonadonna, Angela, additional, Garetto, Ferdinando, additional, Comandone, Alessandro, additional, Giordano, Monica, additional, Luchena, Giovanna, additional, Luzzani, Massimo, additional, Cifatte, Chiara, additional, Pino, Maria Simona, additional, Zoccali, Sonia, additional, Cattaneo, Maria Teresa, additional, Dalu, Davide, additional, Sozzi, Pietro, additional, Gauna, Roberta, additional, Alquati, Sara, additional, Costantini, Massimo, additional, Quadrini, Silvia, additional, Narducci, Filomena, additional, Mastromauro, Cataldo, additional, Scognamiglio, Rodolfo, additional, Degiovanni, Daniela, additional, Negri, Federica, additional, Caraceni, Augusto, additional, and Montanari, Luigi, additional

Published
2016
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34. Inflammatory indexes as predictors of prognosis and bevacizumab efficacy in patients with metastatic colorectal cancer

Author

Passardi, Alessandro, primary, Scarpi, Emanuela, additional, Cavanna, Luigi, additional, Dall’Agata, Monia, additional, Tassinari, Davide, additional, Leo, Silvana, additional, Bernardini, Ilaria, additional, Gelsomino, Fabio, additional, Tamberi, Stefano, additional, Brandes, Alba A., additional, Tenti, Elena, additional, Vespignani, Roberto, additional, Frassineti, Giovanni L., additional, Amadori, Dino, additional, and De Giorgi, Ugo, additional

Published
2016
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35. Patients’ understanding of clinical research: An Italian cancer patient survey

Author

Rudnas, Britt, Montanari, Emanuela, Dall’Agata, Monia, Petracci, Elisabetta, and Nanni, Oriana

Abstract

Introduction: Patients’ awareness of clinical research and their involvement in clinical trials is of great importance, but it is difficult to estimate the extent of knowledge on the research being undertaken.Methods: We evaluated the level of knowledge about clinical research using a self-reporting survey distributed to 967 adult patients with cancer attending the Departments of Medical Oncology and Onco-Haematology Units of IRST IRCCS and 4 hospitals in the region of Emilia-Romagna, Italy. The questionnaire was composed of 10 specific items on research knowledge. Patients responding correctly to at least 8 of the 10 items were considered to have a good understanding of clinical research.Results: The questionnaire was completed by 769 patients (response rate 79.5%). Only 19% of patients were found to have a good understanding of clinical research. Patients with higher education and those who had previous clinical trial experience showed a significantly better understanding. Fifty-three percent of patients said that they would be willing to participate in a trial studying a new drug and 75% expressed an interest in taking part in informative meetings/events about clinical studies.Conclusions: Our results show that patients’ understanding of clinical research is limited and highlight an interest in learning more.

Published
2019
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36. Temozolomide (TMZ) and radiation therapy (RT) combination in elderly patients with glioblastoma: A multicenter retrospective study of AINO (Italian Association of Neuro-Oncology).

Author

Lombardi, Giuseppe, primary, Pace, Andrea, additional, Pasqualetti, Francesco, additional, Rizzato, Simona, additional, Faedi, Marina, additional, Anghileri, Elena, additional, Nicolotto, Elisa, additional, Bazzoli, Elena, additional, Bellu, Luisa, additional, Villani, Veronica, additional, Fabi, Alessandra, additional, Ferrazza, Patrizia, additional, Gurrieri, Lorena, additional, Dall'Agata, Monia, additional, Eoli, Marica, additional, Della Puppa, Alessandro, additional, Pambuku, Ardi, additional, D'Avella, Domenico, additional, Ruda, Roberta, additional, and Zagonel, Vittorina, additional

Published
2015
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38. Erratum to “Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life” [Eur J Cancer 69 (2016) 110–118]

Author

Farolfi, Alberto, Ruscelli, Silvia, Valgiusti, Martina, Pini, Sara, Faedi, Marina, Ragazzini, Angela, Pittureri, Cristina, Amaducci, Elena, Guglieri, Irene, Bergamo, Francesca, Lonardi, Sara, Di Nunzio, Camilla, Bosco, Monica, Bocci, Barbara, Bramanti, Alfina, Gandini, Chiara, Buonadonna, Angela, Comandone, Alessandro, Zoccali, Sonia, Pino, Maria Simona, Dalu, Davide, Sozzi, Pietro, Gozza, Alberto, Giordano, Monica, Longhi, Carla, Autelitano, Cristina, Gamucci, Teresa, Mastromauro, Cataldo, Scognamiglio, Rodolfo, Degiovanni, Daniela, Negri, Federica, Caraceni, Augusto, Montanari, Luigi, Maltoni, Marco, Scarpi, Emanuela, Dall’Agata, Monia, Schiavon, Stefania, Biasini, Claudia, Codecà, Carla, Broglia, Chiara Maria, Sansoni, Elisabetta, Bortolussi, Roberto, Garetto, Ferdinando, Fioretto, Luisa, Cattaneo, Maria Teresa, Giacobino, Alice, Luzzani, Massimo, Luchena, Giovanna, Alquati, Sara, Quadrini, Silvia, Zagonel, Vittorina, Cavanna, Luigi, Ferrari, Daris, Pedrazzoli, Paolo, Frassineti, Giovanni Luca, Galiano, Antonella, Casadei Gardini, Andrea, Monti, Manlio, and Nanni, Oriana

Published
2017
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39. Results from the first step of a phase II study of vaccination with autologous dendritic cells loaded with autologous tumour homogenate in glioblastoma.

Author

Ridolfi, Laura, Gurrieri, Lorena, Riva, Nada, Bulgarelli, Jenny, De Rosa, Francesco, Guidoboni, Massimo, Fausti, Valentina, Ranallo, Nicoletta, Tazzari, Marcella, Petrini, Massimiliano, Granato, Anna Maria, Pancisi, Elena, Foca, Flavia, Dall'Agata, Monia, Amadori, Elena, Cortesi, Pietro, Gamboni, Alessandro, Pasini, Giuseppe, Ibrahim, Toni, and Tosatto, Luigino

Published
2023
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41. Analysis of long-term survival in patients with glioblastoma.

Author

Melegari, Elisabetta, primary, Dall'Agata, Monia, additional, Guiducci, Graziano, additional, Cremonini, Anna Maria, additional, Cerasoli, Serenella, additional, Ibrahim, Toni, additional, Sintini, Michele, additional, Cenni, Patrizia, additional, Bomprezzi, Chiara, additional, and Faedi, Marina, additional

Published
2013
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42. Randomized phase II study with two gemcitabine- and docetaxel-based combinations as first-line chemotherapy for metastatic non-small cell lung cancer

Author

Passardi, Alessandro, primary, Cecconetto, Lorenzo, additional, Dall'Agata, Monia, additional, Dazzi, Claudio, additional, Pasquini, Enzo, additional, Oliverio, Giovanni, additional, Zumaglini, Federica, additional, Zoli, Wainer, additional, Nanni, Oriana, additional, Milandri, Carlo, additional, Frassineti, Giovanni Luca, additional, and Amadori, Dino, additional

Published
2008
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43. Prognostication in palliative radiotherapy-ProPaRT: Accuracy of prognostic scores

Author

Marco Maltoni, Emanuela Scarpi, Monia Dall’Agata, Simona Micheletti, Maria Caterina Pallotti, Martina Pieri, Marianna Ricci, Antonino Romeo, Maria Valentina Tenti, Luca Tontini, Romina Rossi, Maltoni, Marco, Scarpi, Emanuela, Dall'Agata, Monia, Micheletti, Simona, Pallotti, Maria Caterina, Pieri, Martina, Ricci, Marianna, Romeo, Antonino, Tenti, Maria Valentina, Tontini, Luca, and Rossi, Romina

Subjects
Cancer Research, aggressiveness of care, Oncology, personalized palliative care, palliative radiotherapy, prognostication, outpatient palliative care
Abstract

BackgroundPrognostication can be used within a tailored decision-making process to achieve a more personalized approach to the care of patients with cancer. This prospective observational study evaluated the accuracy of the Palliative Prognostic score (PaP score) to predict survival in patients identified by oncologists as candidates for palliative radiotherapy (PRT). We also studied interrater variability for the clinical prediction of survival and PaP scores and assessed the accuracy of the Survival Prediction Score (SPS) and TEACHH score.Materials and methodsConsecutive patients were enrolled at first access to our Radiotherapy and Palliative Care Outpatient Clinic. The discriminating ability of the prognostic models was assessed using Harrell’s C index, and the corresponding 95% confidence intervals (95% CI) were obtained by bootstrapping.ResultsIn total, 255 patients with metastatic cancer were evaluated, and 123 (48.2%) were selected for PRT, all of whom completed treatment without interruption. Then, 10.6% of the irradiated patients who died underwent treatment within the last 30 days of life. The PaP score showed an accuracy of 74.8 (95% CI, 69.5–80.1) for radiation oncologist (RO) and 80.7 (95% CI, 75.9–85.5) for palliative care physician (PCP) in predicting 30-day survival. The accuracy of TEACHH was 76.1 (95% CI, 70.9–81.3) and 64.7 (95% CI, 58.8–70.6) for RO and PCP, respectively, and the accuracy of SPS was 70 (95% CI, 64.4–75.6) and 72.8 (95% CI, 67.3–78.3).ConclusionAccurate prognostication can identify candidates for low-fraction PRT during the last days of life who are more likely to complete the planned treatment without interruption.All the scores showed good discriminating capacity; the PaP had the higher accuracy, especially when used in a multidisciplinary way.

Published
2022

44. Phase II study of liposomal doxorubicin, docetaxel and trastuzumab in combination with metformin as neoadjuvant therapy for HER2-positive breast cancer

Author

Oriana Nanni, Rosa Ciani, Lorenzo Gianni, Donata Casadei Giunchi, Antonella Bagni, Luigi Cavanna, Laura Cortesi, Federica Matteucci, Annalisa Curcio, Andrea Rocca, Elena Meldoli, Antonio Maestri, Dino Amadori, Daniele Andreis, Pietro Cortesi, Anna Fedeli, Leonardo Lucchi, Roberta Volpi, Fabio Falcini, Lorenzo Fantini, Monia Dall'Agata, Rocca, Andrea, Cortesi, Pietro, Cortesi, Laura, Gianni, Lorenzo, Matteucci, Federica, Fantini, Lorenzo, Maestri, Antonio, Giunchi, Donata Casadei, Cavanna, Luigi, Ciani, Rosa, Falcini, Fabio, Bagni, Antonella, Meldoli, Elena, Dall'Agata, Monia, Volpi, Roberta, Andreis, Daniele, Nanni, Oriana, Curcio, Annalisa, Lucchi, Leonardo, Amadori, Dino, and Fedeli, Anna

Subjects
Oncology, medicine.medical_specialty, medicine.medical_treatment, Liposomal Doxorubicin, Phases of clinical research, lcsh:RC254-282, Breast cancer, Trastuzumab, Internal medicine, HER2 Positive Breast Cancer, Medicine, neoadjuvant therapy, primary systemic therapy, Neoadjuvant therapy, Original Research, business.industry, HER2+ breast cancer, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, Metformin, trastuzumab, Docetaxel, metformin, non-pegylated liposomal doxorubicin, business, medicine.drug
Abstract

Background: The aim of this study was to improve activity over single human epidermal growth factor receptor 2 (HER2)-blockade sequential neaodjuvant regimens for HER2-positive breast cancer, by exploiting the concomitant administration of trastuzumab, taxane and anthracycline, while restraining cardiac toxicity with use of liposomal doxorubicin, and by adding metformin, based on preliminary evidence of antitumor activity. Patients and methods: This multi-center, single-arm, two-stage phase II trial, assessed the safety and the activity of a new treatment regimen for HER2-positive, early or locally advanced breast cancer. Patients received six 21-day cycles of non-pegylated liposomal doxorubicin, 50 mg/m2 intravenously (i.v.) on day 1, docetaxel, 30 mg/m2 i.v. on days 2 and 9, trastuzumab, 2 mg/kg/week i.v. on days 2, 9, and 16 (with 4 mg/kg loading dose), in association with metformin 1000 mg orally twice daily. The primary endpoint was the rate of pathological complete response (pCR) in the breast and axilla (ypT0/is ypN0). A subgroup of patients performed a 3-deoxy-3-18F-fluorothymidine positron emission tomography (FLT-PET) at baseline and after one cycle. Results: Among 47 evaluable patients, there were 18 pCR [38.3%, 95% confidence interval (CI) 24.5–53.6%]. A negative estrogen-receptor status, high Ki67, and histological grade 3 were related with pCR, although only grade reached statistical significance. FLT-PET maximum standardized uptake value after one cycle was inversely related to pCR in the breast (odds ratio 0.29, 95% CI 0.06–1.30, p = 0.11). Toxicity included grade 3–4 neutropenia in 70% and febrile neutropenia in 4% of patients, grade 1–2 nausea/vomiting in 60%/38%, and grade 3 in 4%/2%, respectively, grade 1–2 diarrhea in 72%, and grade 3 in 6%. There were two cases of reversible grade 2 left-ventricular ejection-fraction decrease, and one case of sharp troponin-T increase. Conclusions: The concomitant administration of trastuzumab, liposomal doxorubicin, docetaxel, and metformin is safe and shows good activity, but does not appear to improve activity over conventional sequential regimens.

Published
2021
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45. Systematic versus on-demand early palliative care: A randomised clinical trial assessing quality of care and treatment aggressiveness near the end of life

Author

Andrea Casadei Gardini, Francesca Bergamo, Sonia Zoccali, Teresa Gamucci, Manlio Monti, C. Gandini, Carla Longhi, Angela Buonadonna, Carla Codecà, Paolo Pedrazzoli, Monica Bosco, Oriana Nanni, Cristina Autelitano, Daniela Degiovanni, Augusto Caraceni, Ferdinando Garetto, Alfina Bramanti, Stefania Schiavon, Monica Giordano, Chiara Broglia, Elena Amaducci, Elisabetta Sansoni, Marina Faedi, Daris Ferrari, F. Negri, Emanuela Scarpi, Camilla Di Nunzio, Roberto Bortolussi, Rodolfo Scognamiglio, Angela Ragazzini, Giovanni Luca Frassineti, Davide Dalu, Martina Valgiusti, Antonella Galiano, Sara Pini, Alessandro Comandone, Irene Guglieri, Maria Simona Pino, Sara Alquati, Giovanna Luchena, Alice Giacobino, Claudia Biasini, Barbara Bocci, Maria Teresa Cattaneo, Alberto Farolfi, Pietro Sozzi, Luigi Cavanna, Silvia Quadrini, Sara Lonardi, Alberto Gozza, Luigi Montanari, Cristina Pittureri, Marco Maltoni, Luisa Fioretto, Silvia Ruscelli, Massimo Luzzani, Monia Dall'Agata, Vittorina Zagonel, Cataldo Mastromauro, Maltoni M., Scarpi E., Dall'Agata M., Schiavon S., Biasini C., Codeca C., Broglia C.M., Sansoni E., Bortolussi R., Garetto F., Fioretto L., Cattaneo M.T., Giacobino A., Luzzani M., Luchena G., Alquati S., Quadrini S., Zagonel V., Cavanna L., Ferrari D., Pedrazzoli P., Frassineti G.L., Galiano A., Casadei Gardini A., Monti M., Nanni O., Maltoni, Marco, Scarpi, Emanuela, Dall'Agata, Monia, Schiavon, Stefania, Biasini, Claudia, Codecà, Carla, Broglia, Chiara Maria, Sansoni, Elisabetta, Bortolussi, Roberto, Garetto, Ferdinando, Fioretto, Luisa, Cattaneo, Maria Teresa, Giacobino, Alice, Luzzani, Massimo, Luchena, Giovanna, Alquati, Sara, Quadrini, Silvia, Zagonel, Vittorina, Cavanna, Luigi, Ferrari, Dari, Pedrazzoli, Paolo, Frassineti, Giovanni Luca, Galiano, Antonella, Casadei Gardini, Andrea, Monti, Manlio, and Nanni, Oriana

Subjects
Adult, Male, medicine.medical_specialty, Care aggressiveness near the end of life, Early palliative care, Use of health care services, Oncology, Cancer Research, Palliative care, Time Factors, Antineoplastic Agents, 03 medical and health sciences, 0302 clinical medicine, On demand, Secondary analysis, Metastatic pancreatic cancer, Medicine, Humans, 030212 general & internal medicine, Quality of care, Neoplasm Metastasis, Intensive care medicine, Hospice care, Aged, Quality of Health Care, Aged, 80 and over, Terminal Care, business.industry, Palliative Care, Cancer, Middle Aged, medicine.disease, Clinical trial, Pancreatic Neoplasms, Hospice Care, 030220 oncology & carcinogenesis, Emergency medicine, Quality of Life, Female, business, Delivery of Health Care
Abstract

Aim Early palliative care (EPC) in oncology has shown sparse evidence of a positive impact on patient outcomes, quality of care outcomesand costs. Patients and methods Data for this secondary analysis were taken from a trial of 207 outpatients with metastatic pancreatic cancer randomly assigned to receive standard cancer care plus on-demand EPC (standard arm) or standard cancer care plus systematic EPC (interventional arm). After 20 months’ follow-up, 149 (80%) had died. Outcome measures were frequency, type and timing of chemotherapy administration, use of resources, place of death and overall survival. Results Some indices of end-of-life (EoL) aggressiveness had a favourable impact from systematic EPC. Interventional arm patients showed higher use of hospice services: a significantly longer median and mean period of hospice care (P=0.025 for both indexes) and a significantly higher median and mean number of hospice admissions (both P&nbsp

Published
2016

46. Systematic versus on-demand early palliative care: results from a multicentre, randomised clinical trial

Author

F. Negri, Emanuela Scarpi, Giovanna Luchena, Sara Alquati, Alessandro Comandone, Silvia Quadrini, Maria Simona Pino, Angela Buonadonna, Maria Grazia Rodriquenz, Ferdinando Garetto, Monica Giordano, Rodolfo Scognamiglio, Giovanni Luca Frassineti, Marina Faedi, Paolo Pedrazzoli, Roberta Gauna, Silvia Ruscelli, Massimo Costantini, Chiara Broglia, Filomena Narducci, Antonella Galiano, Sonia Zoccali, Chiara Cifatte, Daniela Degiovanni, Massimo Luzzani, Monia Dall'Agata, Alberto Farolfi, Raffaella Bertè, Vittorina Zagonel, Dino Amadori, Elena Amaducci, Elisabetta Sansoni, Pietro Sozzi, Maria Teresa Cattaneo, Daris Ferrari, Andrea Casadei Gardini, Francesca Crepaldi, Martina Valgiusti, Roberto Bortolussi, Cristina Pittureri, Rosa Porzio, Cataldo Mastromauro, Alfina Bramanti, Angela Ragazzini, Marco Maltoni, Luigi Montanari, Leonardo Trentin, Carla Codecà, Augusto Caraceni, Gino Crivellari, Oriana Nanni, Davide Dalu, Sara Pini, Claudia Biasini, Maltoni, Marco, Scarpi, Emanuela, Dall'Agata, Monia, Zagonel, Vittorina, Bertè, Raffaella, Ferrari, Dari, Broglia, Chiara Maria, Bortolussi, Roberto, Trentin, Leonardo, Valgiusti, Martina, Pini, Sara, Farolfi, Alberto, Casadei Gardini, Andrea, Nanni, Oriana, Amadori, Dino, Frassineti, Giovanni Luca, Sansoni, Elisabetta, Ragazzini, Angela, Ruscelli, Silvia, Crivellari, Gino, Galiano, Antonella, Rodriquenz, Maria Grazia, Biasini, Claudia, Porzio, Rosa, Pittureri, Cristina, Amaducci, Elena, Faedi, Marina, Codecà, Carla, Crepaldi, Francesca, Pedrazzoli, Paolo, Bramanti, Alfina, Buonadonna, Angela, Garetto, Ferdinando, Comandone, Alessandro, Giordano, Monica, Luchena, Giovanna, Luzzani, Massimo, Cifatte, Chiara, Pino, Maria Simona, Zoccali, Sonia, Cattaneo, Maria Teresa, Dalu, Davide, Sozzi, Pietro, Gauna, Roberta, Alquati, Sara, Costantini, Massimo, Quadrini, Silvia, Narducci, Filomena, Mastromauro, Cataldo, Scognamiglio, Rodolfo, Degiovanni, Daniela, Negri, Federica, Caraceni, Augusto, Montanari, Luigi, Maltoni M., Scarpi E., Dall'Agata M., Zagonel V., Berte R., Ferrari D., Broglia C.M., Bortolussi R., Trentin L., Valgiusti M., Pini S., Farolfi A., Casadei Gardini A., Nanni O., Amadori D., Frassineti G.L., Sansoni E., Ragazzini A., Ruscelli S., Crivellari G., Galiano A., Rodriquenz M.G., Biasini C., Porzio R., Pittureri C., Amaducci E., Faedi M., Codeca C., Crepaldi F., Pedrazzoli P., Bramanti A., Buonadonna A., Garetto F., Comandone A., Giordano M., Luchena G., Luzzani M., Cifatte C., Pino M.S., Zoccali S., Cattaneo M.T., Dalu D., Sozzi P., Gauna R., Alquati S., Costantini M., Quadrini S., Narducci F., Mastromauro C., Scognamiglio R., Degiovanni D., Negri F., Caraceni A., and Montanari L.

Subjects
Adult, Male, Quality of life, medicine.medical_specialty, Cancer Research, Palliative care, Anxiety, 03 medical and health sciences, 0302 clinical medicine, Early palliative care, On demand, Internal medicine, Pancreatic cancer, Humans, Medicine, Prospective Studies, 030212 general & internal medicine, Patient Comfort, Aged, Quality of Health Care, Aged, 80 and over, Depression, business.industry, Palliative Care, Quality of care, Cancer, Oncology, Middle Aged, medicine.disease, Confidence interval, Pancreatic Neoplasms, Clinical trial, 030220 oncology & carcinogenesis, Physical therapy, Female, business, Cancer pain
Abstract

Background Early palliative care (EPC) in oncology has been shown to have a positive impact on clinical outcome, quality-of-care outcomes, and costs. However, the optimal way for activating EPC has yet to be defined. Methods This prospective, multicentre, randomised study was conducted on 207 outpatients with metastatic or locally advanced inoperable pancreatic cancer. Patients were randomised to receive ‘standard cancer care plus on-demand EPC’ (n=100) or ‘standard cancer care plus systematic EPC’ (n=107). Primary outcome was change in quality of life (QoL) evaluated through the Functional Assessment of Cancer Therapy – Hepatobiliary questionnaire between baseline (T0) and after 12 weeks (T1), in particular the integration of physical, functional, and Hepatic Cancer Subscale (HCS) combined in the Trial Outcome Index (TOI). Patient mood, survival, relatives' satisfaction with care, and indicators of aggressiveness of care were also evaluated. Findings The mean changes in TOI score and HCS score between T0 and T1 were −4.47 and −0.63, with a difference between groups of 3.83 (95% confidence interval [CI] 0.10–7.57) (p=0.041), and −2.23 and 0.28 (difference between groups of 2.51, 95% CI 0.40–4.61, p=0.013), in favour of interventional group. QoL scores at T1 of TOI scale and HCS were 84.4 versus 78.1 (p=0.022) and 52.0 versus 48.2 (p=0.008), respectively, for interventional and standard arm. Until February 2016, 143 (76.9%) of the 186 evaluable patients had died. There was no difference in overall survival between treatment arms. Interpretations Systematic EPC in advanced pancreatic cancer patients significantly improved QoL with respect to on-demand EPC.

Published
2016

47. First step results from a phase II study of a dendritic cell vaccine in glioblastoma patients (CombiG-vax).

Author

Ridolfi L, Gurrieri L, Riva N, Bulgarelli J, De Rosa F, Guidoboni M, Fausti V, Ranallo N, Calpona S, Tazzari M, Petrini M, Granato AM, Pancisi E, Foca F, Dall'Agata M, Bondi I, Amadori E, Cortesi P, Zani C, Ancarani V, Gamboni A, Polselli A, Pasini G, Bartolini D, Maimone G, Arpa D, and Tosatto L

Subjects
Humans, Middle Aged, Female, Male, Adult, Aged, Temozolomide therapeutic use, Temozolomide administration & dosage, Progression-Free Survival, Glioblastoma therapy, Glioblastoma immunology, Glioblastoma mortality, Cancer Vaccines immunology, Cancer Vaccines therapeutic use, Cancer Vaccines administration & dosage, Cancer Vaccines adverse effects, Dendritic Cells immunology, Dendritic Cells transplantation, Brain Neoplasms therapy, Brain Neoplasms immunology, Brain Neoplasms mortality
Abstract

Background: Glioblastoma (GBM) is a poor prognosis grade 4 glioma. After surgical resection, the standard therapy consists of concurrent radiotherapy (RT) and temozolomide (TMZ) followed by TMZ alone. Our previous data on melanoma patients showed that Dendritic Cell vaccination (DCvax) could increase the amount of intratumoral-activated cytotoxic T lymphocytes., Methods: This is a single-arm, monocentric, phase II trial in two steps according to Simon's design. The trial aims to evaluate progression-free survival (PFS) at three months and the safety of a DCvax integrated with standard therapy in resected GBM patients. DCvax administration begins after completion of RT-CTwith weekly administrations for 4 weeks, then is alternated monthly with TMZ cycles. The primary endpoints are PFS at three months and safety. One of the secondary objectives is to evaluate the immune response both in vitro and in vivo (DTH skin test)., Results: By December 2022, the first pre-planned step of the study was concluded with the enrollment, treatment and follow up of 9 evaluable patients. Two patients had progressed within three months after leukapheresis, but none had experienced DCvax-related G3-4 toxicities Five patients experienced a positive DTH test towards KLH and one of these also towards autologous tumor homogenate. The median PFS from leukapheresis was 11.3 months and 12.2 months from surgery., Conclusions: This combination therapy is well-tolerated, and the two endpoints required for the first step have been achieved. Therefore, the study will proceed to enroll the remaining 19 patients. (Eudract number: 2020-003755-15 https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-003755-15/IT)., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 Ridolfi, Gurrieri, Riva, Bulgarelli, De Rosa, Guidoboni, Fausti, Ranallo, Calpona, Tazzari, Petrini, Granato, Pancisi, Foca, Dall'Agata, Bondi, Amadori, Cortesi, Zani, Ancarani, Gamboni, Polselli, Pasini, Bartolini, Maimone, Arpa and Tosatto.)

Published
2024
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48. Chemotherapy with or without low-dose interleukin-2 in advanced non-small cell lung cancer: results from a phase III randomized multicentric trial.

Author

Ridolfi L, Bertetto O, Santo A, Naglieri E, Lopez M, Recchia F, Lissoni P, Galliano M, Testore F, Porta C, Maglie M, Dall'agata M, Fumagalli L, and Ridolfi R

Subjects
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carcinoma, Non-Small-Cell Lung pathology, Cisplatin administration & dosage, Cisplatin adverse effects, Deoxycytidine administration & dosage, Deoxycytidine adverse effects, Deoxycytidine analogs & derivatives, Disease-Free Survival, Female, Follow-Up Studies, Humans, Interleukin-2 administration & dosage, Interleukin-2 adverse effects, Maintenance Chemotherapy, Male, Medication Adherence, Middle Aged, Neoplasm Staging methods, Gemcitabine, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms drug therapy, Lung Neoplasms pathology
Abstract

Non-small cell lung cancer (NSCLC) is associated with IL-2-dependent cell-mediated immunodeficiency. As IL-2 is the main lymphocyte growth factor, a phase III randomized multicenter trial was conducted to evaluate the impact of subcutaneous low-dose IL-2 added to standard chemotherapy (CT) on overall survival (OS) in advanced NSCLC patients. Patients (n=241) with histologically confirmed stage IIIb or IV non-operable NSCLC underwent stratified randomization on the basis of center, ECOG PS, stage of disease and percentage of weight loss. Patients received gemcitabine (1000 mg/m2) on days 1 and 8 + cisplatin (100 mg/m2) on day 2 every 21 days for a maximum of 6 cycles [chemotherapy (CT) arm]. In the CT+IL-2 arm, patients also received low-dose subcutaneous IL-2 3,000,000 IU/die on days 3-5, 9-11, 15-17. The study had 90% power to detect a 20% absolute increase in 1-year OS with 118 patients/arm. An overall response (OR) rate of 12.8% (14% in the CT+IL-2 arm and 11.4% in CT arm) was observed. Stable disease was 70 and 66.7%, and progressive disease 16 and 21.8% in the CT+IL-2 and CT arms, respectively. No differences in response were found in any subgroup analysis. At a median follow-up of 32 months, 1-year OS was 45% for the CT+IL-2 arm vs. 51% for the CT arm (p=0.456 log-rank). Median progression-free survival was 6.6 months in the CT+IL-2 arm vs. 6.9 months in the CT arm (p=0.573, log-rank). A higher number of grade 4 toxicities were reported with CT+IL-2. The most common grade ≥3 adverse events were gastrointestinal toxicity (mainly nausea and diarrhea) and myelosuppression. No relevant differences in clinical outcome were observed from the addition of IL-2 to CT. Future studies investigating the role of T-regulators in chemoimmunotherapeutic regimens could be performed.

Published
2011
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