47 results on '"Cicchiello, F"'
Search Results
2. Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study
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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. Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients: New insights beyond clinical trials. The EVA study
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Alù, M., Ancona, C., Andreis, D., Bajardi, E., Benedetto, C., Berardi, R., Bordin, E., Butti, C., Capri, G., Cicchiello, F., Cocciolone, V., Dester, M., D'Onofrio, L., Febbraro, A., Ferrarini, I., Fotia, V., Gervasi, E., Guaitoli, G., Licata, L., Liscia, N., Mentuccia, L., Miraglio, E., Nicolini, M., Paternò, E., Pedani, F., Pellegrini, D., Petrucelli, L., De Laurentiis, M., Pizzuti, L., Pogliani, C., Riva, F., Cazzaniga, M.E., Airoldi, M., Arcangeli, V., Artale, S., Atzori, F., Ballerio, A., Bianchi, G.V., Blasi, L., Campidoglio, S., Ciccarese, M., Cursano, M.C., Piezzo, M., Fabi, A., Ferrari, L., Ferzi, A., Ficorella, C., Frassoldati, A., Fumagalli, A., Garrone, O., Gebbia, V., Generali, D., La Verde, N., Maur, M., Michelotti, A., Moretti, G., Musolino, A., Palumbo, R., Pistelli, M., Porpiglia, M., Sartori, D., Scavelli, C., Schirone, A., Turletti, A., Valerio, M.R., Vici, P., Zambelli, A., Clivio, L., and Torri, V.
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- 2017
- Full Text
- View/download PDF
4. Baseline 18FDG-PET Metabolic Tumour Volume (MTV) as a Potential Predictive Factor of Response to Metronomic Chemotherapy (mCHT) in HR+/HER2- Metastatic Breast Cancer (MBC) Patients (pts). Preliminary Results of the Metro-pet Study
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Meazza Prina, M, Gotuzzo, I, Cazzaniga, M, De Bernardi, E, Cafaro, P, Capici, S, Cogliati, V, Fulvia Pepe, F, Cicchiello, F, Riva, F, Cordani, N, Cerrito, M, Turolla, E, Landoni, C, Elisei, F, Crivellaro, C, Virdone, L, Monaco, L, Guidi, A, Guerra, L, Meazza Prina, M, Gotuzzo, I, Cazzaniga, M, De Bernardi, E, Cafaro, P, Capici, S, Cogliati, V, Fulvia Pepe, F, Cicchiello, F, Riva, F, Cordani, N, Cerrito, M, Turolla, E, Landoni, C, Elisei, F, Crivellaro, C, Virdone, L, Monaco, L, Guidi, A, and Guerra, L
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mCHT, 18FDG-PET, MBC - Published
- 2023
5. Exceptional disease control with neratinib monotherapy in HER2-positive advanced breast cancer: A case report
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Di Mauro, P, Capici, S, Cogliati, V, Pepe, F, Maggioni, C, Riva, F, Cicchiello, F, Cazzaniga, M, Di Mauro P., Capici S., Cogliati V., Pepe F. F., Maggioni C., Riva F., Cicchiello F., Cazzaniga M. E., Di Mauro, P, Capici, S, Cogliati, V, Pepe, F, Maggioni, C, Riva, F, Cicchiello, F, Cazzaniga, M, Di Mauro P., Capici S., Cogliati V., Pepe F. F., Maggioni C., Riva F., Cicchiello F., and Cazzaniga M. E.
- Abstract
Human epidermal growth factor receptor 2 (HER2) represents a crucial drug target in breast cancer treatment. Currently, several agents that target HER2 are available, including monoclonal antibodies, antibody-drug conjugates, and tyrosine kinase inhibitors (TKIs). Despite major research efforts, no validated biomarker exists to identify patients who respond to anti-HER2 therapy alone and could be spared the toxicity of chemotherapy. Here we report the case of a 45-years-old patient with recurrent, hormone receptor-positive, and HER2-positive advanced breast cancer who had progressed various lines of treatment but showed an exceptional and prolonged response to neratinib monotherapy. A next-generation sequencing (NGS) analysis on her tumor showed a CDK12-PLXDC1 truncation and amplification of several genes, including CDK12. This case illustrates the activity of neratinib monotherapy and suggests its clinical potential without chemotherapy in a certain subtype of HER2-positive breast cancer, that may possess distinct molecular features, such as CDK12 expression.
- Published
- 2022
6. How to Treat HR+/HER2-Metastatic Breast Cancer Patients after CDK4/6 Inhibitors: An Unfinished Story
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Cogliati, V, Capici, S, Pepe, F, Di Mauro, P, Riva, F, Cicchiello, F, Maggioni, C, Cordani, N, Cerrito, M, Cazzaniga, M, Cogliati V., Capici S., Pepe F. F., Di Mauro P., Riva F., Cicchiello F., Maggioni C., Cordani N., Cerrito M. G., Cazzaniga M. E., Cogliati, V, Capici, S, Pepe, F, Di Mauro, P, Riva, F, Cicchiello, F, Maggioni, C, Cordani, N, Cerrito, M, Cazzaniga, M, Cogliati V., Capici S., Pepe F. F., Di Mauro P., Riva F., Cicchiello F., Maggioni C., Cordani N., Cerrito M. G., and Cazzaniga M. E.
- Abstract
CDK4/6 inhibitors in association with endocrine therapy represent the best therapeutic choice for either endocrine-sensitive or resistant hormone-receptor-positive advanced breast cancer patients. On the contrary, the optimal therapeutic strategy after the failure of CDK4/6 inhibitors-based treatment still remains an open question worldwide. In this review, we analyze the most studied mechanisms of resistance to CDK4/6 inhibitors treatment, as well as the most significant results of retrospective and prospective trials in the setting of progression after CDK4/6 inhibitors, to provide the reader a comprehensive overview from both a preclinical and especially a clinical perspective. In our opinion, an approach based on a deeper knowledge of resistance mechanisms to CDK4/6 inhibitors, but also on a careful analysis of what is done in clinical practice, can lead to a better definition of prospective randomized trials, to implement a personalized sequence approach, based on molecular analyses.
- Published
- 2022
7. Immunomodulatory effects of metronomic vinorelbine (mVRL), with or without metronomic capecitabine (mCAPE), in hormone receptor positive (HR+)/HER2-negative metastatic breast cancer (MBC) patients: final results of the exploratory phase 2 Victor-5 study
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Pepe, F, Cazzaniga, M, Baroni, S, Riva, F, Cicchiello, F, Capici, S, Cogliati, V, Maggioni, C, Cordani, N, Cerrito, M, Malandrin, S, Pepe F. F., Cazzaniga M. E., Baroni S., Riva F., Cicchiello F., Capici S., Cogliati V., Maggioni C., Cordani N., Cerrito M. G., Malandrin S., Pepe, F, Cazzaniga, M, Baroni, S, Riva, F, Cicchiello, F, Capici, S, Cogliati, V, Maggioni, C, Cordani, N, Cerrito, M, Malandrin, S, Pepe F. F., Cazzaniga M. E., Baroni S., Riva F., Cicchiello F., Capici S., Cogliati V., Maggioni C., Cordani N., Cerrito M. G., and Malandrin S.
- Abstract
Tregs are able of suppressing tumor-specific effector cells, such as lymphocytes CD8+, CD4+ and Natural Killer cells. Different drugs, especially different schedules of administration, like metronomic chemotherapy (mCHT), seem to be able to increase anticancer immunity, by acting on downregulation of Tregs. Most of the data available regarding the immunomodulating effect of mCHT have been obtained with Cyclophosphamide (CTX). Aim of the present study was to explore the effects of mVRL and mCAPE administration, alone or in combination, on T cells. Observation of 13 metastatic breast cancer patients lasted controlling for 56 days, where Treg frequencies and function, spontaneous anti-tumor T-cell responses were monitored, as well as the clinical outcome. No depletion in Treg absolute numbers, or percentage of T lymphocytes, was observed. Only in 5 patients, a modest and transient depletion of Tregs was observed during the first 14 days of treatment. To better describe the effect on Tregs, we subsequently looked at the variations in Memory, Naïve and Activated Treg subpopulations: we observed a trend in reduction for memory Treg (Treg MEM) and an increase for Treg Naïve (Treg NAIVE) and Treg Activated (Treg ACT) components. We finally analyzed the average trend of Treg in the Treg depleted patients and non-depleted ones, without fiding any significant differences. The trend of the Treg MEM appeared different, showing a reduction during the first 14 days, followed by an increase at the levels before treatment at Day 56 in the group of depleted patients and a progressive substantial reduction in the group of non-depleted patients along the entire course of treatment. Opposed to the data known, treatment with mVRL w/o mCAPE did not show any effect on Tregs.
- Published
- 2022
8. Metronomic chemotherapy with oral vinorelbine (mVNR) and capecitabine (mCAPE) in advanced HER2-negative breast cancer patients: is it a way to optimize disease control? Final results of the VICTOR-2 study
- Author
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Cazzaniga, M. E., Cortesi, L., Ferzi, A., Scaltriti, L., Cicchiello, F., Ciccarese, M., Della Torre, S., Villa, F., Giordano, M., Verusio, C., Nicolini, M., Gambaro, A. R., Zanlorenzi, L., Biraghi, E., Legramandi, L., Rulli, E., Riva, Francesca, Davide, Pelizzoni, Marchi, Isabella, Collovà, Elena, Prati, Giuseppe, Ardizzoia, Antonio, Toniolo, Davide, Pugliese, Palma, Pogliani, Claudia, Gambino, Abbondanza, Stocchi, Lucia, Colombo, Andrea, Fasola, Cinzia, Venezia, Raffaele, Galli, Fabio, Torri, Valter, and On behalf of VICTOR Study Group
- Published
- 2016
- Full Text
- View/download PDF
9. T.08.1 CHARACTERISTICS AND PREDICTORS OF LIVER TOXICITY IN ADVANCED BREAST CANCER PATIENTS TREATED WITH CYCLINDEPENDENT KINASE INHIBITORS: AN OBSERVATIONAL STUDY
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Ciaccio, A., primary, Scaravaglio, M., additional, Laffusa, A., additional, Lucà, M., additional, Longo, S., additional, Manna, M., additional, Maggioni, C., additional, Riva, F., additional, Cicchiello, F., additional, Cazzaniga, M.E., additional, Cortinovis, D.L., additional, and Invernizzi, P., additional
- Published
- 2022
- Full Text
- View/download PDF
10. Additional file 1 of Immunomodulatory effects of metronomic vinorelbine (mVRL), with or without metronomic capecitabine (mCAPE), in hormone receptor positive (HR+)/HER2-negative metastatic breast cancer (MBC) patients: final results of the exploratory phase 2 Victor-5 study
- Author
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Pepe, F. F., Cazzaniga, M. E., Baroni, S., Riva, F., Cicchiello, F., Capici, S., Cogliati, V., Maggioni, C., Cordani, N., Cerrito, M. G., and Malandrin, S.
- Abstract
Additional file 1.
- Published
- 2022
- Full Text
- View/download PDF
11. Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients: New insights beyond clinical trials. The EVA study
- Author
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Cicchiello, F., Riva, F., Cazzaniga, M. E., Pedani, F., Nicolini, Matteo, Butti, C., Liscia, N., Pogliani, C., Capri, Giorgia, Alu', Matteo, Febbraro, A., Petrucelli, L., D'Onofrio, L., De Laurentiis, M., Pellegrini, D., Mentuccia, L., Cocciolone, V., Miraglio, E., Bajardi, E., Dester, M., Paternò, Enrico, Guaitoli, G., Ferrarini, I., Gervasi, Elisea, Licata, L., Benedetto, C., Andreis, D., Bordin, E., Ancona, C., Pizzuti, L., Fotia, V., Berardi, R., Airoldi, M., Arcangeli, V., Artale, S., Atzori, F., Ballerio, A., Bianchi, G. V., Blasi, L., Campidoglio, S., Ciccarese, M., Cursano, M. C., Piezzo, M., Fabi, A., Ferrari, L., Ferzi, A., Ficorella, C., Frassoldati, A., Fumagalli, A., Garrone, O., Gebbia, V., Generali, D., La Verde, N., Maur, M., Michelotti, A., Moretti, G., Musolino, Anna, Palumbo, R., Pistelli, M., Porpiglia, M., Sartori, D., Scavelli, C., Schirone, A., Turletti, A., Valerio, M. R., Vici, P., Zambelli, Ruggero Astolfo, Clivio, L., Torri, V., Cicchiello, F, Riva, F, Cazzaniga, M, Pedani, F, Nicolini, M, Butti, C, Liscia, N, Pogliani, C, Capri, G, Alu, M, Febbraro, A, Petrucelli, L, D'Onofrio, L, De Laurentiis, M, Pellegrini, D, Mentuccia, L, Cocciolone, V, Miraglio, E, Bajardi, E, Dester, M, Paterno, E, Guaitoli, G, Ferrarini, I, Gervasi, E, Licata, L, Benedetto, C, Andreis, D, Bordin, E, Ancona, C, Pizzuti, L, Fotia, V, Berardi, R, Airoldi, M, Arcangeli, V, Artale, S, Atzori, F, Ballerio, A, Bianchi, G, Blasi, L, Campidoglio, S, Ciccarese, M, Cursano, M, Piezzo, M, Fabi, A, Ferrari, L, Ferzi, A, Ficorella, C, Frassoldati, A, Fumagalli, A, Garrone, O, Gebbia, V, Generali, D, La Verde, N, Maur, M, Michelotti, A, Moretti, G, Musolino, A, Palumbo, R, Pistelli, M, Porpiglia, M, Sartori, D, Scavelli, C, Schirone, A, Turletti, A, Valerio, M, Vici, P, Zambelli, A, Clivio, L, Torri, V, Cazzaniga, M. E, Bianchi, G. V, Cursano, M. C, Valerio, M. R, Torri, V., De Laurentiis, Michelino, Cicchiello, F., Riva, F., Cazzaniga, M. E., Pedani, F., Nicolini, M., Butti, C., Liscia, N., Pogliani, C., Capri, G., Alù, M., Febbraro, A., Petrucelli, L., D'Onofrio, L., De Laurentiis, M., Pellegrini, D., Mentuccia, L., Cocciolone, V., Miraglio, E., Bajardi, E., Dester, M., Paternò, E., Guaitoli, G., Ferrarini, I., Gervasi, E., Licata, L., Benedetto, C., Andreis, D., Bordin, E., Ancona, C., Pizzuti, L., Fotia, V., Berardi, R., Airoldi, M., Arcangeli, V., Artale, S., Atzori, F., Ballerio, A., Bianchi, G. V., Blasi, L., Campidoglio, S., Ciccarese, M., Cursano, M. C., Piezzo, M., Fabi, A., Ferrari, L., Ferzi, A., Ficorella, C., Frassoldati, A., Fumagalli, A., Garrone, O., Gebbia, V., Generali, D., La Verde, N., Maur, M., Michelotti, A., Moretti, G., Musolino, A., Palumbo, R., Pistelli, M., Porpiglia, M., Sartori, D., Scavelli, C., Schirone, A., Turletti, A., Valerio, M. R., Vici, P., Zambelli, A., Clivio, L., Cazzaniga, M., Ala, M., ARRIVAS BAJARDI, E., Paternã², E., Bianchi, G., Cursano, M., and Valerio, M.
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0301 basic medicine ,Oncology ,Receptor, ErbB-2 ,chemistry.chemical_compound ,ErbB-2 ,0302 clinical medicine ,Dose-intensity ,Exemestane ,80 and over ,Neoplasm Metastasis ,Fulvestrant ,Aged, 80 and over ,education.field_of_study ,Advanced breast cancer, Dose-intensity, Everolimus, Fulvestrant, Hormone-receptor positive ,Advanced breast cancer ,Everolimus ,Hormone-receptor positive ,Adult ,Aged ,Androstadienes ,Breast Neoplasms ,Female ,Follow-Up Studies ,Humans ,Middle Aged ,Neoplasm Staging ,Surgery ,General Medicine ,Everolimu ,030220 oncology & carcinogenesis ,Receptor ,medicine.drug ,medicine.medical_specialty ,Population ,Socio-culturale ,03 medical and health sciences ,Breast cancer ,Internal medicine ,medicine ,Adverse effect ,education ,Gynecology ,business.industry ,fungi ,Cancer ,medicine.disease ,Clinical trial ,030104 developmental biology ,chemistry ,business - Abstract
Background The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant. Patients and methods This study aimed to describe the outcome of ABC pts treated with EVE-EXE combination in terms of median duration of EVE treatment and ORR in a real-life setting. Results From July 2013 to December 2015, the EVA study enrolled 404 pts. Median age was 61 years (33–83). Main metastatic sites were: bone (69.1%), soft tissue (34.7%) and viscera (33.2%). Median number of previous treatments was 2 (1–7). 43.3% of the pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4–58.3) in the whole population. No difference was observed in terms of EVE exposure duration according to DI (p for trend = 0.27) or type of previous treatments (p = 0.33). ORR and Disease Control Rate (DCR) were observed in 31.6% and 60.7% of the patients, respectively, with the lowest ORRs confined in CHT pre-treated patients or in those who received the lowest DI of EVE. Grade 3-4 adverse events (AEs) were reported in 37.9% of the patients. Main AEs were: stomatitis (11.2%), non-infectious pneumonitis - NIP (3.8%), anaemia (3.8%) and fatigue (3.2%). Conclusions The EVA study provided new insights in the use of EVE-EVE combination in HR+ ABC pts many years after the publication of the pivotal trial. The combination is safe and the best response could be obtained in patients receiving the full dose of EVE and/or after hormone-therapy as Fulvestrant in ABC.
- Published
- 2017
12. Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study
- Author
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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
13. A possible biomarker for paclitaxel-induced peripheral neurotoxicity: Neurofilament light chain serum levels monitoring
- Author
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Alberti, P, Cicchiello, F, Riva, F, Cavaletti, G, Cazzaniga, ME, Alberti, P, Cicchiello, F, Riva, F, Cavaletti, G, and Cazzaniga, M
- Subjects
taxane induced peripheral neurotoxicity, neuropathy, neurofilament light chain, biomarkers - Published
- 2020
14. Comparison of tumor microenvironment in primary and paired metastatic ER+/HER2- breast cancers: results of a pilot study
- Author
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Zeppellini, A, Galimberti, S, Leone, B, Pacifico, C, Riva, F, Cicchiello, F, Capici, S, Maggioni, C, Sala, L, Cazzaniga, M, Zeppellini, Annalisa, Galimberti, Stefania, Leone, Biagio Eugenio, Pacifico, Claudia, Riva, Francesca, Cicchiello, Federica, Capici, Serena, Maggioni, Claudia, Sala, Luca, Cazzaniga, Marina Elena, Zeppellini, A, Galimberti, S, Leone, B, Pacifico, C, Riva, F, Cicchiello, F, Capici, S, Maggioni, C, Sala, L, Cazzaniga, M, Zeppellini, Annalisa, Galimberti, Stefania, Leone, Biagio Eugenio, Pacifico, Claudia, Riva, Francesca, Cicchiello, Federica, Capici, Serena, Maggioni, Claudia, Sala, Luca, and Cazzaniga, Marina Elena
- Abstract
BACKGROUND: Tumor microenvironment (TME) is a dynamic setting and changes in TILs and their subpopulations are potential candidates to influence the metastatic process. Aim of this pilot study is to describe the changes occurring between primary breast cancers and their paired metastases in terms of TILs composition. To assess if these changes influence the process of metastasis development, we used a control group of patients.METHODS: We retrospectively identified 18 Luminal patients, for whom primary and metastatic tissue were available (cases) and 18 paired-matched patients (controls), not relapsed after at least 9years of follow-up, and we quantified TILs and their composition (i.e. T CD8+ and CD4+/FOXP3+). The presence of TILs was defined as ≥10%.RESULTS: Our results showed that the microenvironment composition of relapsed patients was poor of TILs (median=5%, I-III quartiles=0.6-5%), CD8+ (2.5%, 0-5%) and CD4+/FOXP3+(0%, 0-0.6%) in the primary tumor. Comparable results were observed in their related metastases (TILs 3.8%, 0.6-5%; CD8+0%, 0-1.3%; CD4+/FOXP3+0%,0-1.9%). On the contrary, the microenvironment in the control group was richer of TILs (5%, 5-17.5%) in comparison to cases, both in primary tumor (p=0.035) and related metastases (p=0.018). Although CD8+ in controls were similar to cases at primary tumor (p=0.6498), but not at metastasis (p=0.0223), they expressed only one part on the TILs subpopulations (p=0.0060), while TILs in the cases at primary tumor were almost completely CD8+ (p=0.5034).CONCLUSIONS: These findings suggest that the lack of activation of immune system in the primary tumor might influence the multifactor process of cancer progression.
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- 2021
15. Validation of the Italian version of the full and abbreviated Trust in Oncologist Scale
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Bani, M, Rossi, E, Cortinovis, D, Russo, S, Gallina, F, Hillen, M, Canova, S, Cicchiello, F, Longarini, R, Cazzaniga, M, Bidoli, P, Valsecchi, M, Strepparava, M, Bani, Marco, Rossi, Emanuela, Cortinovis, Diego, Russo, Selena, Gallina, Francesca, Hillen, Marij A, Canova, Stefania, Cicchiello, Federica, Longarini, Raffaella, Cazzaniga, Marina Elena, Bidoli, Paolo, Valsecchi, Maria Grazia, Strepparava, Maria Grazia, Bani, M, Rossi, E, Cortinovis, D, Russo, S, Gallina, F, Hillen, M, Canova, S, Cicchiello, F, Longarini, R, Cazzaniga, M, Bidoli, P, Valsecchi, M, Strepparava, M, Bani, Marco, Rossi, Emanuela, Cortinovis, Diego, Russo, Selena, Gallina, Francesca, Hillen, Marij A, Canova, Stefania, Cicchiello, Federica, Longarini, Raffaella, Cazzaniga, Marina Elena, Bidoli, Paolo, Valsecchi, Maria Grazia, and Strepparava, Maria Grazia
- Abstract
Introduction: The Trust in Oncologist Scale (TiOS) is an 18-item questionnaire aimed to assess the cancer patients' trust in their oncologist and has been validated in Dutch and English language. This study aims to validate the Italian version of the TiOS (IT-TiOS) and the TiOS-Short Form (IT-TiOS-SF). Methods: The IT-TiOS was administered to 194 patients recruited in an Italian oncology department from April to December 2018. Data collected included socio-demographic data, health and clinical information, satisfaction with the most recent oncology visit and trust in the regional healthcare system. Internal consistency, test–retest reliability, convergent and the structural validity of both the full and short form were tested. Results: Factor analyses indicated that neither four-factor nor one-factor models of the full scale were acceptable. However, confirmatory factor analysis supported the one-dimensionality of the IT-TiOS-SF, and internal consistency assessed with Cronbach's alpha was 0.88. Mean scores on the IT-TiOS-SF correlated with satisfaction with the oncologist (rs = 0.64) and willingness to recommend the oncologist to others (rs = 0.67), confirming good construct validity. Conclusion: The IT-TiOS-SF demonstrates good psychometric properties and can be used to assess trust for both clinical and research purposes.
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- 2021
16. Neurofilament light chain serum levels as a possible paclitaxel-induced peripheral neurotoxicity biomarker: pilot and feasibility study.
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Alberti, P, Cicchiello, F, Riva, F, Cazzaniga, M, Cazzaniga, ME, Alberti, P, Cicchiello, F, Riva, F, Cazzaniga, M, and Cazzaniga, ME
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- 2020
17. Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study
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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
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- 2019
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18. Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients: New insights beyond clinical trials. The EVA study
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Cicchiello, F, Riva, F, Cazzaniga, M, Pedani, F, Nicolini, M, Butti, C, Liscia, N, Pogliani, C, Capri, G, Alu, M, Febbraro, A, Petrucelli, L, D'Onofrio, L, De Laurentiis, M, Pellegrini, D, Mentuccia, L, Cocciolone, V, Miraglio, E, Bajardi, E, Dester, M, Paterno, E, Guaitoli, G, Ferrarini, I, Gervasi, E, Licata, L, Benedetto, C, Andreis, D, Bordin, E, Ancona, C, Pizzuti, L, Fotia, V, Berardi, R, Airoldi, M, Arcangeli, V, Artale, S, Atzori, F, Ballerio, A, Bianchi, G, Blasi, L, Campidoglio, S, Ciccarese, M, Cursano, M, Piezzo, M, Fabi, A, Ferrari, L, Ferzi, A, Ficorella, C, Frassoldati, A, Fumagalli, A, Garrone, O, Gebbia, V, Generali, D, La Verde, N, Maur, M, Michelotti, A, Moretti, G, Musolino, A, Palumbo, R, Pistelli, M, Porpiglia, M, Sartori, D, Scavelli, C, Schirone, A, Turletti, A, Valerio, M, Vici, P, Zambelli, A, Clivio, L, Torri, V, Cicchiello F., Riva F., Cazzaniga M. E., Pedani F., Nicolini M., Butti C., Liscia N., Pogliani C., Capri G., Alu M., Febbraro A., Petrucelli L., D'Onofrio L., De Laurentiis M., Pellegrini D., Mentuccia L., Cocciolone V., Miraglio E., Bajardi E., Dester M., Paterno E., Guaitoli G., Ferrarini I., Gervasi E., Licata L., Benedetto C., Andreis D., Bordin E., Ancona C., Pizzuti L., Fotia V., Berardi R., Airoldi M., Arcangeli V., Artale S., Atzori F., Ballerio A., Bianchi G. V., Blasi L., Campidoglio S., Ciccarese M., Cursano M. C., Piezzo M., Fabi A., Ferrari L., Ferzi A., Ficorella C., Frassoldati A., Fumagalli A., Garrone O., Gebbia V., Generali D., La Verde N., Maur M., Michelotti A., Moretti G., Musolino A., Palumbo R., Pistelli M., Porpiglia M., Sartori D., Scavelli C., Schirone A., Turletti A., Valerio M. R., Vici P., Zambelli A., Clivio L., Torri V., Cicchiello, F, Riva, F, Cazzaniga, M, Pedani, F, Nicolini, M, Butti, C, Liscia, N, Pogliani, C, Capri, G, Alu, M, Febbraro, A, Petrucelli, L, D'Onofrio, L, De Laurentiis, M, Pellegrini, D, Mentuccia, L, Cocciolone, V, Miraglio, E, Bajardi, E, Dester, M, Paterno, E, Guaitoli, G, Ferrarini, I, Gervasi, E, Licata, L, Benedetto, C, Andreis, D, Bordin, E, Ancona, C, Pizzuti, L, Fotia, V, Berardi, R, Airoldi, M, Arcangeli, V, Artale, S, Atzori, F, Ballerio, A, Bianchi, G, Blasi, L, Campidoglio, S, Ciccarese, M, Cursano, M, Piezzo, M, Fabi, A, Ferrari, L, Ferzi, A, Ficorella, C, Frassoldati, A, Fumagalli, A, Garrone, O, Gebbia, V, Generali, D, La Verde, N, Maur, M, Michelotti, A, Moretti, G, Musolino, A, Palumbo, R, Pistelli, M, Porpiglia, M, Sartori, D, Scavelli, C, Schirone, A, Turletti, A, Valerio, M, Vici, P, Zambelli, A, Clivio, L, Torri, V, Cicchiello F., Riva F., Cazzaniga M. E., Pedani F., Nicolini M., Butti C., Liscia N., Pogliani C., Capri G., Alu M., Febbraro A., Petrucelli L., D'Onofrio L., De Laurentiis M., Pellegrini D., Mentuccia L., Cocciolone V., Miraglio E., Bajardi E., Dester M., Paterno E., Guaitoli G., Ferrarini I., Gervasi E., Licata L., Benedetto C., Andreis D., Bordin E., Ancona C., Pizzuti L., Fotia V., Berardi R., Airoldi M., Arcangeli V., Artale S., Atzori F., Ballerio A., Bianchi G. V., Blasi L., Campidoglio S., Ciccarese M., Cursano M. C., Piezzo M., Fabi A., Ferrari L., Ferzi A., Ficorella C., Frassoldati A., Fumagalli A., Garrone O., Gebbia V., Generali D., La Verde N., Maur M., Michelotti A., Moretti G., Musolino A., Palumbo R., Pistelli M., Porpiglia M., Sartori D., Scavelli C., Schirone A., Turletti A., Valerio M. R., Vici P., Zambelli A., Clivio L., and Torri V.
- Abstract
Background The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant. Patients and methods This study aimed to describe the outcome of ABC pts treated with EVE-EXE combination in terms of median duration of EVE treatment and ORR in a real-life setting. Results From July 2013 to December 2015, the EVA study enrolled 404 pts. Median age was 61 years (33–83). Main metastatic sites were: bone (69.1%), soft tissue (34.7%) and viscera (33.2%). Median number of previous treatments was 2 (1–7). 43.3% of the pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4–58.3) in the whole population. No difference was observed in terms of EVE exposure duration according to DI (p for trend = 0.27) or type of previous treatments (p = 0.33). ORR and Disease Control Rate (DCR) were observed in 31.6% and 60.7% of the patients, respectively, with the lowest ORRs confined in CHT pre-treated patients or in those who received the lowest DI of EVE. Grade 3-4 adverse events (AEs) were reported in 37.9% of the patients. Main AEs were: stomatitis (11.2%), non-infectious pneumonitis - NIP (3.8%), anaemia (3.8%) and fatigue (3.2%). Conclusions The EVA study provided new insights in the use of EVE-EVE combination in HR+ ABC pts many years after the publication of the pivotal trial. The combination is safe and the best response could be obtained in patients receiving the full dose of EVE and/or after hormone-therapy as Fulvestrant in ABC.
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- 2017
19. Metronomic Chemotherapy in Triple-Negative Metastatic Breast Cancer: The Future Is Now?
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Cazzaniga, M, Cortesi, L, Ferzi, A, Scaltriti, L, Cicchiello, F, Ciccarese, M, Torre, S, Villa, F, Giordano, M, Verusio, C, Nicolini, M, Gambaro, A, Zanlorenzi, L, Biraghi, E, Casini, E, Legramandi, L, Rulli, E, Cazzaniga M. E., Cortesi L., Ferzi A., Scaltriti L., Cicchiello F., Ciccarese M., Torre S. D., Villa F., Giordano M., Verusio C., Nicolini M., Gambaro A. R., Zanlorenzi L., Biraghi E., Casini E., Legramandi L., Rulli E., Cazzaniga, M, Cortesi, L, Ferzi, A, Scaltriti, L, Cicchiello, F, Ciccarese, M, Torre, S, Villa, F, Giordano, M, Verusio, C, Nicolini, M, Gambaro, A, Zanlorenzi, L, Biraghi, E, Casini, E, Legramandi, L, Rulli, E, Cazzaniga M. E., Cortesi L., Ferzi A., Scaltriti L., Cicchiello F., Ciccarese M., Torre S. D., Villa F., Giordano M., Verusio C., Nicolini M., Gambaro A. R., Zanlorenzi L., Biraghi E., Casini E., Legramandi L., and Rulli E.
- Abstract
Triple-negative breast cancer (TNBC) shows a very bad prognosis, even in early stages of disease. Metronomic chemotherapy 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. In the present article, we review preclinical and clinical data of metronomic administration of chemotherapy agents with or without biological agents in TNBC cell lines and patients, contextually reporting data from the VICTOR-2 study in the subgroup of patients with TNBC, in order to stimulate new ideas for the design of clinical trials in this subset of patients.
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- 2017
20. Gemcitabine-induced thrombocytosis as a potential predictive factor in non-small cell lung cancer: Analysis of 318 patients
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Canova, S, Cicchiello, F, Agustoni, F, Bianchini, G, Abbate, M, Bidoli, P, Cortinovis, D, Canova S, Cicchiello F, Agustoni F, Bianchini G, Abbate MI, Bidoli P, Cortinovis DL, Canova, S, Cicchiello, F, Agustoni, F, Bianchini, G, Abbate, M, Bidoli, P, Cortinovis, D, Canova S, Cicchiello F, Agustoni F, Bianchini G, Abbate MI, Bidoli P, and Cortinovis DL
- Abstract
Introduction: In spite of the progress in the treatment of non-small-cell lung cancer (NSCLC), the majority of patients with advanced disease still receive chemotherapy. Gemcitabine alone or combined with a platinum compound is a valid option. Thrombocytosis is a recognized prognostic factor in lung cancer and an adverse event that may occur during gemcitabine infusion. Methods: We retrospectively evaluated all patients with NSCLC treated with first-line gemcitabine-based chemotherapy in two Italian hospitals. We assessed the onset of thrombocytosis within the third cycle of therapy and the relation between thrombocytosis and survival. results: We included 318 patients. Thrombocytosis occurred in 156 patients (49.1%). Median progressionfree survival (PFS) was 5.6 months (95% CI, 4.7-6.9 months) in patients who developed thrombocytosis versus 6 months (95% CI, 5.1-7.2 months) in patients without thrombocytosis (p = 0.21). Median overall survival (OS) was 11.2 months (95% CI, 9.8-13.4 months) in patients with thrombocytosis versus 12 months (95% CI, 10.1- 14.4 months) in patients without thrombocytosis (p = 0.25). We observed no difference in terms of PFS or OS according to age, sex, stage, chemotherapy (single-agent versus combination chemotherapy) and thrombocytosis. Conclusions: Thrombocytosis is neither a prognostic nor a predictive factor for PFS or OS in patients with advanced NSCLC treated with first-line gemcitabine-based chemotherapy.
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- 2017
21. Efficacy and safety of vinorelbine-capecitabine oral metronomic combinaton in elderly metastatc breast cancer patents: VICTOR-1 study
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Cazzaniga, M, Torri, V, Riva, F, Porcu, L, Cicchiello, F, Capici, S, Cortinovis, D, Digiacomo, N, Bidoli, P, Cazzaniga ME, Torri V, Riva F, Porcu L, Cicchiello F, Capici S, Cortinovis D, Digiacomo N, Bidoli P, Cazzaniga, M, Torri, V, Riva, F, Porcu, L, Cicchiello, F, Capici, S, Cortinovis, D, Digiacomo, N, Bidoli, P, Cazzaniga ME, Torri V, Riva F, Porcu L, Cicchiello F, Capici S, Cortinovis D, Digiacomo N, and Bidoli P
- Abstract
Purpose: Elderly patents with metastatc breast cancer are expected to derive similar benefits from chemotherapy as younger patents, but are more likely to experience therapy-related toxicity. Data from the VICTOR-1 study showed that metronomic therapy with vinorelbine and capecitabine was effectve and well tolerated in patents with metastatc breast cancer. This analysis determined the efficacy and safety of the metronomic combinaton of oral vinorelbine and capecitabine in a subgroup of VICTOR-1 study patents aged ≥70 years. Methods: Eighteen of the 32 patents enrolled in VICTOR-1 were aged ≥70 years. Objectve response and clinical benefit rates were calculated and toxicity was determined using the NCI-CTCAE criteria. Results: All patents had at least 1 comorbidity (4 had 2 comorbidites), and 77.7% were taking concomitant medicaton. Eight patents (44%) had received ≥1 chemotherapy regimens for metastatc disease and most (78%) had ≥2 metastatc sites. Grade 1-2 adverse events occurred in 45.8% of cycles, whereas the incidence of grade 3 and grade 4 events was very low (1.5% and 0.7%, respectvely). Median tme to progression was 10.5 months (range 1-40). The objectve response rate was 33% and the clinical benefit rate was 67%. Conclusions: The all-oral metronomic combinaton of vinorelbine and capecitabine had an acceptable efficacy profile and appears to be beter tolerated than standard treatment schedules in elderly metastatc breast cancer patents (age ≥70 years).
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- 2017
22. Isolated cardiac metastasis from squamous cell esophageal cancer
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Abbate, M, Cicchiello, F, Canova, S, Cortinovis, D, Mariani, S, Maffini, F, Bidoli, P, Abbate MI, Cicchiello F, Canova S, Cortinovis D, Mariani S, Maffini F, Bidoli P, Abbate, M, Cicchiello, F, Canova, S, Cortinovis, D, Mariani, S, Maffini, F, Bidoli, P, Abbate MI, Cicchiello F, Canova S, Cortinovis D, Mariani S, Maffini F, and Bidoli P
- Abstract
Although heart metastases are uncommon and generally a sign of disseminated disease, they are up to 40 times more frequent than primary cancers of the heart, and typically arise from melanoma or primary mediastinal cancer, but also from lymphoma, breast cancer, esophageal cancer, and leukemia. They are usually asymptomatic and found only at autopsy. Symptomatic patients generally die within a few weeks of diagnosis and usual treatments are chemotherapy, radiotherapy, or both. Surgical resection is recommended only for a single lesion, which is rare. We describe a 49-year-old man treated for squamous cell cancer of the esophagus in whom a single asymptomatic left heart metastasis was discovered incidentally during follow-up. The lesion was debulked surgically and multimodal treatment followed. The patient survived 1 year after diagnosis with good performance status during which time no other lesion was discovered. Cardiac metastasis is challenging and necessitates skilled multidisciplinary management to maximize the clinical outcome.
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- 2015
23. Metronomic Chemotherapy in Triple-Negative Metastatic Breast Cancer: The Future Is Now?
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Cazzaniga, M. E., Cortesi, L., Ferzi, A., Scaltriti, L., Cicchiello, F., Ciccarese, M., Torre, S. Della, Villa, F., Giordano, M., Verusio, C., Nicolini, M., Gambaro, A. R., Zanlorenzi, L., Biraghi, E., Casini, E., Legramandi, L., and Rulli, E.
- Subjects
Article Subject - Abstract
Triple-negative breast cancer (TNBC) shows a very bad prognosis, even in early stages of disease. Metronomic chemotherapy 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. In the present article, we review preclinical and clinical data of metronomic administration of chemotherapy agents with or without biological agents in TNBC cell lines and patients, contextually reporting data from the VICTOR-2 study in the subgroup of patients with TNBC, in order to stimulate new ideas for the design of clinical trials in this subset of patients.
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- 2017
- Full Text
- View/download PDF
24. Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients: New insights beyond clinical trials. The EVA study
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Cazzaniga, M.E., primary, Airoldi, M., additional, Arcangeli, V., additional, Artale, S., additional, Atzori, F., additional, Ballerio, A., additional, Bianchi, G.V., additional, Blasi, L., additional, Campidoglio, S., additional, Ciccarese, M., additional, Cursano, M.C., additional, Piezzo, M., additional, Fabi, A., additional, Ferrari, L., additional, Ferzi, A., additional, Ficorella, C., additional, Frassoldati, A., additional, Fumagalli, A., additional, Garrone, O., additional, Gebbia, V., additional, Generali, D., additional, La Verde, N., additional, Maur, M., additional, Michelotti, A., additional, Moretti, G., additional, Musolino, A., additional, Palumbo, R., additional, Pistelli, M., additional, Porpiglia, M., additional, Sartori, D., additional, Scavelli, C., additional, Schirone, A., additional, Turletti, A., additional, Valerio, M.R., additional, Vici, P., additional, Zambelli, A., additional, Clivio, L., additional, Torri, V., additional, Alù, M., additional, Ancona, C., additional, Andreis, D., additional, Bajardi, E., additional, Benedetto, C., additional, Berardi, R., additional, Bordin, E., additional, Butti, C., additional, Capri, G., additional, Cicchiello, F., additional, Cocciolone, V., additional, Dester, M., additional, D'Onofrio, L., additional, Febbraro, A., additional, Ferrarini, I., additional, Fotia, V., additional, Gervasi, E., additional, Guaitoli, G., additional, Licata, L., additional, Liscia, N., additional, Mentuccia, L., additional, Miraglio, E., additional, Nicolini, M., additional, Paternò, E., additional, Pedani, F., additional, Pellegrini, D., additional, Petrucelli, L., additional, De Laurentiis, M., additional, Pizzuti, L., additional, Pogliani, C., additional, and Riva, F., additional
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- 2017
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25. Abstract P2-04-05: Immunomodulation effects of metronomic oral Vinorelbine (mVRL), with or without capecitabine (CAPE), on Treg levels in advanced breast cancer (ABC) patients (pts). Preliminary results of the VICTOR-5 study
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Cazzaniga, ME, primary, Baroni, S, additional, Riva, F, additional, Vigorè, L, additional, Malandrin, S, additional, Cicchiello, F, additional, Pelizzoni, D, additional, Lissoni, P, additional, Manfrida, I, additional, Brando, B, additional, and Bidoli, P, additional
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- 2017
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26. Isotretinoin plus clindamycin seem highly effective against severe erlotinib-induced skin rash in advanced non-small cell lung cancer
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Bidoli, P, Cortinovis, D, Colombo, I, Crippa, A, Cicchiello, F, Villa, F, Cazzaniga, M, Altomare, G, Bidoli P, Cortinovis DL, Colombo I, Crippa A, Cicchiello F, Villa F, Cazzaniga ME, Altomare G., Bidoli, P, Cortinovis, D, Colombo, I, Crippa, A, Cicchiello, F, Villa, F, Cazzaniga, M, Altomare, G, Bidoli P, Cortinovis DL, Colombo I, Crippa A, Cicchiello F, Villa F, Cazzaniga ME, and Altomare G.
- Abstract
Introduction: Erlotinib is useful in advanced non-small cell lung cancer although compliance and efficacy are diminished by skin rash in a high proportion of patients, often necessitating dose reduction or drug withdrawal. No effective treatment for the rash is available. Methods: We carried out a preliminary investigation on isotretinoin and clindamycin. Among 56 advanced lung cancer patients treated with erlotinib, 31 (53%) developed rash. Seven (35%) of the 20 G2/G3 cases agreed to treatment with clindamycin (450 mg/d, days 1-10; 300 mg/d, days 11-20) plus isotretinoin (20 mg/d, days 11-20) after being informed of the experimental nature of the combination. Results: In 6 of 7 (86%) patients, the rash resolved (G1/G0) without dose reduction; in the other patient (G3), the erlotinib dose also had to be reduced. Median time to resolution was 14 days (range 7-20 days). No rash-treatment adverse events occurred during 20 days of administration. Conclusions: Isotretinoin plus clindamycin promises to be the first effective treatment for erlotinib rash and is being tested further
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- 2010
27. Metronomic chemotherapy with oral vinorelbine (mVNR) and capecitabine (mCAPE) in advanced HER2-negative breast cancer patients: is it a way to optimize disease control? Final results of the VICTOR-2 study
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Cazzaniga, M, Cortesi, L, Ferzi, A, Scaltriti, L, Cicchiello, F, Ciccarese M, M, Della Torre, S, Villa, F, Giordano, M, Verusio, C, Nicolini, M, Gambaro, A, Zanlorenzi, L, Biraghi, E, Legramandi, L, Rulli, E, M. Cazzaniga, L. Cortesi, A. Ferzi, L. Scaltriti, F. Cicchiello, M. Ciccarese M, S. Della Torre, F. Villa, M. Giordano, C. Verusio, M. Nicolini, A. R. Gambaro, L. Zanlorenzi, E. Biraghi, L. Legramandi, E. Rulli, Cazzaniga, M, Cortesi, L, Ferzi, A, Scaltriti, L, Cicchiello, F, Ciccarese M, M, Della Torre, S, Villa, F, Giordano, M, Verusio, C, Nicolini, M, Gambaro, A, Zanlorenzi, L, Biraghi, E, Legramandi, L, Rulli, E, M. Cazzaniga, L. Cortesi, A. Ferzi, L. Scaltriti, F. Cicchiello, M. Ciccarese M, S. Della Torre, F. Villa, M. Giordano, C. Verusio, M. Nicolini, A. R. Gambaro, L. Zanlorenzi, E. Biraghi, L. Legramandi, and E. Rulli
- Abstract
Purpose: The VICTOR-1 study demonstrated that the all-oral metronomic combination of vinorelbine and capecitabine is highly active and well tolerated in hormone receptor-positive/HER2-negative patients. The VICTOR-2 study was designed to confirm these results. Methods: Patients received mVNR 40 mg three times a week and mCAPE 500 mg three times a day, continuously. The primary endpoint was the clinical benefit rate (CBR); secondary endpoints were toxicity, objective response rate (ORR), and progression-free survival (PFS). Results: Eighty patients were evaluable for the primary efficacy analysis. Median age was 65.3 years; most patients had HR-positive tumors (65 %). The CBR was 45.7 % (95 % CI 28.8–63.4) and 51.1 % (95 % CI 35.8–66.3) in first- and ≥ second-line therapy, respectively. The ORR was 35.5 % in first-line (95 % CI 19.2–54.6) and 25.6 % in ≥second-line (95 % CI 13.5–41.2). The median duration of response was 11.3 and 6.4 months and PFS rates at 1 year were 24.3 and 22.2 %, respectively. In triple-negative breast cancer patients (N = 28, 35 %) a lower, but clinically relevant CBR (35.7, 95 % CI 18.6–55.9) was observed. The main toxicities per cycle were non-febrile neutropenia (1.1 %), hand-foot syndrome (1.0 %), nausea and vomiting (1.0 %), leucopenia (0.8 %), fatigue (0.7 %), and diarrhea (0.4 %). Conclusion: The VICTOR-2 study confirms the clinical activity of mVNR and mCAPE in HER2-negative breast cancer patients, suggesting that the easy schedule of administration, which requires monthly blood tests and limits patients’ dependence on hospitals, and the low cost of the drugs are valuable elements, even for countries with limited access to innovative or expensive drugs.
- Published
- 2016
28. Subcutaneous Trastuzumab (scT) and metronomic oral Vinorelbine (mVRL) combination in HER2 + ve advanced breast cancer (ABC) patients (pts): a pilot evaluation of toxicity. Preliminary results of the VICTOR-4 study
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Cicchiello, F., primary, Riva, F., additional, Cazzaniga, M.E., additional, Digiacomo, N., additional, Pelizzoni, D., additional, Longarini, R., additional, Capici, S., additional, and Bidoli, P., additional
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- 2016
- Full Text
- View/download PDF
29. F44 - Subcutaneous Trastuzumab (scT) and metronomic oral Vinorelbine (mVRL) combination in HER2 + ve advanced breast cancer (ABC) patients (pts): a pilot evaluation of toxicity. Preliminary results of the VICTOR-4 study
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Cicchiello, F., Riva, F., Cazzaniga, M.E., Digiacomo, N., Pelizzoni, D., Longarini, R., Capici, S., and Bidoli, P.
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- 2016
- Full Text
- View/download PDF
30. Impressive efficacy of isotretinoin and clindamycin in treatment of G2/G3 skin rash induced by erlotinib in advanced NSCLC: A pilot study.
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Bidoli, P., primary, Cortinovis, D. L., additional, Colombo, I., additional, Crippa, A., additional, Cicchiello, F., additional, Villa, F., additional, Cazzaniga, M. E., additional, and Altomare, G., additional
- Published
- 2010
- Full Text
- View/download PDF
31. Metronomic chemotherapy for advanced breast cancer patients in the real world practice: Final results of the VICTOR-6 study
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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
32. How to Treat HR+/HER2- Metastatic Breast Cancer Patients after CDK4/6 Inhibitors: An Unfinished Story
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Viola Cogliati, Serena Capici, Francesca Fulvia Pepe, Pierluigi di Mauro, Francesca Riva, Federica Cicchiello, Claudia Maggioni, Nicoletta Cordani, Maria Grazia Cerrito, Marina Elena Cazzaniga, Cogliati, V, Capici, S, Pepe, F, Di Mauro, P, Riva, F, Cicchiello, F, Maggioni, C, Cordani, N, Cerrito, M, and Cazzaniga, M
- Subjects
Space and Planetary Science ,Treatment sequencing ,Therapy resistance ,Paleontology ,Metastatic breast cancer ,CDK4/6 inhibitor ,General Biochemistry, Genetics and Molecular Biology ,Ecology, Evolution, Behavior and Systematics - Abstract
CDK4/6 inhibitors in association with endocrine therapy represent the best therapeutic choice for either endocrine-sensitive or resistant hormone-receptor-positive advanced breast cancer patients. On the contrary, the optimal therapeutic strategy after the failure of CDK4/6 inhibitors-based treatment still remains an open question worldwide. In this review, we analyze the most studied mechanisms of resistance to CDK4/6 inhibitors treatment, as well as the most significant results of retrospective and prospective trials in the setting of progression after CDK4/6 inhibitors, to provide the reader a comprehensive overview from both a preclinical and especially a clinical perspective. In our opinion, an approach based on a deeper knowledge of resistance mechanisms to CDK4/6 inhibitors, but also on a careful analysis of what is done in clinical practice, can lead to a better definition of prospective randomized trials, to implement a personalized sequence approach, based on molecular analyses.
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- 2022
33. Comparison of tumor microenvironment in primary and paired metastatic ER+/HER2- breast cancers: results of a pilot study
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Federica Cicchiello, Marina Elena Cazzaniga, Luca Sala, Annalisa Zeppellini, Biagio Eugenio Leone, Stefania Galimberti, Serena Capici, Francesca Riva, Claudia Maggioni, Claudia Pacifico, Zeppellini, A, Galimberti, S, Leone, B, Pacifico, C, Riva, F, Cicchiello, F, Capici, S, Maggioni, C, Sala, L, and Cazzaniga, M
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0301 basic medicine ,Oncology ,Cancer Research ,Receptor, ErbB-2 ,T CD8 + ,Biopsy ,Pilot Projects ,Metastasis ,0302 clinical medicine ,Surgical oncology ,Tumor Microenvironment ,Breast ,Mastectomy ,Aged, 80 and over ,FOXP3 ,hemic and immune systems ,Middle Aged ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Prognosis ,Primary tumor ,Receptors, Estrogen ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Disease Progression ,Female ,Research Article ,medicine.medical_specialty ,Microenvironment ,chemical and pharmacologic phenomena ,Breast Neoplasms ,lcsh:RC254-282 ,Luminal ,03 medical and health sciences ,Breast cancer ,Lymphocytes, Tumor-Infiltrating ,Internal medicine ,Breast Cancer ,Genetics ,medicine ,Humans ,Aged ,Retrospective Studies ,Tumor microenvironment ,business.industry ,Cancer ,T CD4+ FOXP3+ ,medicine.disease ,030104 developmental biology ,Case-Control Studies ,Tumor infiltrating lymphocytes (TILs) ,Neoplasm Recurrence, Local ,business ,CD8 ,Follow-Up Studies - Abstract
Background Tumor microenvironment (TME) is a dynamic setting and changes in TILs and their subpopulations are potential candidates to influence the metastatic process. Aim of this pilot study is to describe the changes occurring between primary breast cancers and their paired metastases in terms of TILs composition. To assess if these changes influence the process of metastasis development, we used a control group of patients. Methods We retrospectively identified 18 Luminal patients, for whom primary and metastatic tissue were available (cases) and 18 paired-matched patients (controls), not relapsed after at least 9 years of follow-up, and we quantified TILs and their composition (i.e. T CD8+ and CD4+/FOXP3+). The presence of TILs was defined as ≥10%. Results Our results showed that the microenvironment composition of relapsed patients was poor of TILs (median = 5%, I-III quartiles = 0.6–5%), CD8+ (2.5%, 0–5%) and CD4+/FOXP3 + (0%, 0–0.6%) in the primary tumor. Comparable results were observed in their related metastases (TILs 3.8%, 0.6–5%; CD8+ 0%, 0–1.3%; CD4+/FOXP3+ 0%,0–1.9%). On the contrary, the microenvironment in the control group was richer of TILs (5%, 5–17.5%) in comparison to cases, both in primary tumor (p = 0.035) and related metastases (p = 0.018). Although CD8+ in controls were similar to cases at primary tumor (p = 0.6498), but not at metastasis (p = 0.0223), they expressed only one part on the TILs subpopulations (p = 0.0060), while TILs in the cases at primary tumor were almost completely CD8+ (p = 0.5034). Conclusions These findings suggest that the lack of activation of immune system in the primary tumor might influence the multifactor process of cancer progression.
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- 2020
34. Neurofilament light chain serum levels as a possible paclitaxel-induced peripheral neurotoxicity biomarker: pilot and feasibility study
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Paola Alberti, Cicchiello, Federica, Riva, Francesca, Cazzaniga, Marina, Alberti, P, Cicchiello, F, Riva, F, and Cazzaniga, M
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neurofilament light chian, biomarker, neuropathy, CIPN - Published
- 2020
35. Metronomic Chemotherapy in Triple-Negative Metastatic Breast Cancer: The Future Is Now?
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Federica Cicchiello, Monica Giordano, Mariangela Ciccarese, L. Zanlorenzi, M. Nicolini, L. Scaltriti, Laura Cortesi, Eliana Rulli, Marina Cazzaniga, Lorenzo Legramandi, E. Biraghi, Claudio Verusio, S. Della Torre, E. Casini, A. Ferzi, A. Gambaro, F. Villa, Cazzaniga, M, Cortesi, L, Ferzi, A, Scaltriti, L, Cicchiello, F, Ciccarese, M, Torre, S, Villa, F, Giordano, M, Verusio, C, Nicolini, M, Gambaro, A, Zanlorenzi, L, Biraghi, E, Casini, E, Legramandi, L, and Rulli, E
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0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,Disease ,Review Article ,lcsh:RC254-282 ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,Internal medicine ,medicine ,Pharmacology (medical) ,Triple negative ,Antitumor activity ,Chemotherapy ,business.industry ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,medicine.disease ,Metastatic breast cancer ,Metronomic Chemotherapy ,Clinical trial ,030104 developmental biology ,030220 oncology & carcinogenesis ,MED/06 - ONCOLOGIA MEDICA ,business ,breast cancer, TNBC - Abstract
Triple-negative breast cancer (TNBC) shows a very bad prognosis, even in early stages of disease. Metronomic chemotherapy 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. In the present article, we review preclinical and clinical data of metronomic administration of chemotherapy agents with or without biological agents in TNBC cell lines and patients, contextually reporting data from the VICTOR-2 study in the subgroup of patients with TNBC, in order to stimulate new ideas for the design of clinical trials in this subset of patients.
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- 2017
36. Gemcitabine-induced thrombocytosis as a potential predictive factor in non-small cell lung cancer: Analysis of 318 patients
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Federica Cicchiello, Francesco Agustoni, Stefania Canova, Maria Ida Abbate, Giampaolo Bianchini, Paolo Bidoli, Diego Cortinovis, Canova, S, Cicchiello, F, Agustoni, F, Bianchini, G, Abbate, M, Bidoli, P, and Cortinovis, D
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Adult ,Male ,0301 basic medicine ,Oncology ,Antimetabolites, Antineoplastic ,Cancer Research ,medicine.medical_specialty ,Lung Neoplasms ,medicine.medical_treatment ,Deoxycytidine ,Disease-Free Survival ,03 medical and health sciences ,0302 clinical medicine ,Carcinoma, Non-Small-Cell Lung ,Internal medicine ,medicine ,Carcinoma ,Humans ,Lung cancer ,Aged ,Retrospective Studies ,Aged, 80 and over ,Thrombocytosis ,Chemotherapy ,business.industry ,Retrospective cohort study ,General Medicine ,Middle Aged ,Prognosis ,medicine.disease ,Gemcitabine ,Predictive factor ,Treatment Outcome ,030104 developmental biology ,non-small-cell lung cancer ,030220 oncology & carcinogenesis ,Female ,Non small cell ,business ,medicine.drug - Abstract
Introduction In spite of the progress in the treatment of non-small-cell lung cancer (NSCLC), the majority of patients with advanced disease still receive chemotherapy. Gemcitabine alone or combined with a platinum compound is a valid option. Thrombocytosis is a recognized prognostic factor in lung cancer and an adverse event that may occur during gemcitabine infusion. Methods We retrospectively evaluated all patients with NSCLC treated with first-line gemcitabine-based chemotherapy in two Italian hospitals. We assessed the onset of thrombocytosis within the third cycle of therapy and the relation between thrombocytosis and survival. Results We included 318 patients. Thrombocytosis occurred in 156 patients (49.1%). Median progression-free survival (PFS) was 5.6 months (95% CI, 4.7-6.9 months) in patients who developed thrombocytosis versus 6 months (95% CI, 5.1-7.2 months) in patients without thrombocytosis (p = 0.21). Median overall survival (OS) was 11.2 months (95% CI, 9.8-13.4 months) in patients with thrombocytosis versus 12 months (95% CI, 10.1-14.4 months) in patients without thrombocytosis (p = 0.25). We observed no difference in terms of PFS or OS according to age, sex, stage, chemotherapy (single-agent versus combination chemotherapy) and thrombocytosis. Conclusions Thrombocytosis is neither a prognostic nor a predictive factor for PFS or OS in patients with advanced NSCLC treated with first-line gemcitabine-based chemotherapy.
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- 2017
37. Efficacy and safety of vinorelbine-capecitabine oral metronomic combination in elderly metastatic breast cancer patients: VICTOR-1 study
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Luca Porcu, Federica Cicchiello, Nunzio Digiacomo, Marina Elena Cazzaniga, Paolo Bidoli, Diego Cortinovis, Valter Torri, Serena Capici, Francesca Riva, Cazzaniga, M, Torri, V, Riva, F, Porcu, L, Cicchiello, F, Capici, S, Cortinovis, D, Digiacomo, N, and Bidoli, P
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0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,MEDLINE ,Breast Neoplasms ,Vinorelbine ,Vinblastine ,Capecitabine ,03 medical and health sciences ,Breast cancer ,Elderly ,0302 clinical medicine ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Medicine ,Humans ,Aged ,Aged, 80 and over ,Chemotherapy ,business.industry ,Metronomic chemotherapy ,General Medicine ,medicine.disease ,Metastatic breast cancer ,Metronomic Chemotherapy ,Clinical trial ,030104 developmental biology ,030220 oncology & carcinogenesis ,Female ,metastatic breast cancer ,business ,medicine.drug - Abstract
Purpose Elderly patients with metastatic breast cancer are expected to derive similar benefits from chemotherapy as younger patients, but are more likely to experience therapy-related toxicity. Data from the VICTOR-1 study showed that metronomic therapy with vinorelbine and capecitabine was effective and well tolerated in patients with metastatic breast cancer. This analysis determined the efficacy and safety of the metronomic combination of oral vinorelbine and capecitabine in a subgroup of VICTOR-1 study patients aged ≥70 years. Methods Eighteen of the 32 patients enrolled in VICTOR-1 were aged ≥70 years. Objective response and clinical benefit rates were calculated and toxicity was determined using the NCI-CTCAE criteria. Results All patients had at least 1 comorbidity (4 had 2 comorbidities), and 77.7% were taking concomitant medication. Eight patients (44%) had received ≥1 chemotherapy regimens for metastatic disease and most (78%) had ≥2 metastatic sites. Grade 1-2 adverse events occurred in 45.8% of cycles, whereas the incidence of grade 3 and grade 4 events was very low (1.5% and 0.7%, respectively). Median time to progression was 10.5 months (range 1-40). The objective response rate was 33% and the clinical benefit rate was 67%. Conclusions The all-oral metronomic combination of vinorelbine and capecitabine had an acceptable efficacy profile and appears to be better tolerated than standard treatment schedules in elderly metastatic breast cancer patients (age ≥70 years).
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- 2016
38. Isolated cardiac metastasis from squamous cell esophageal cancer
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Maria Ida Abbate, Stefania Canova, Silvia Mariani, Federica Cicchiello, Paolo Bidoli, Diego Cortinovis, Fausto Maffini, Abbate, M, Cicchiello, F, Canova, S, Cortinovis, D, Mariani, S, Maffini, F, and Bidoli, P
- Subjects
Male ,Oncology ,Cancer Research ,medicine.medical_specialty ,Esophageal Neoplasms ,medicine.medical_treatment ,Asymptomatic ,Heart Neoplasms ,heart metastases ,Fatal Outcome ,Breast cancer ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Carcinoma ,Humans ,Esophagus ,Patient Care Team ,Incidental Findings ,Jejunal Neoplasms ,Performance status ,business.industry ,Cancer ,Cytoreduction Surgical Procedures ,General Medicine ,Middle Aged ,Esophageal cancer ,medicine.disease ,Radiation therapy ,medicine.anatomical_structure ,Chemotherapy, Adjuvant ,Carcinoma, Squamous Cell ,Radiology ,medicine.symptom ,business - Abstract
Although heart metastases are uncommon and generally a sign of disseminated disease, they are up to 40 times more frequent than primary cancers of the heart, and typically arise from melanoma or primary mediastinal cancer, but also from lymphoma, breast cancer, esophageal cancer, and leukemia. They are usually asymptomatic and found only at autopsy. Symptomatic patients generally die within a few weeks of diagnosis and usual treatments are chemotherapy, radiotherapy, or both. Surgical resection is recommended only for a single lesion, which is rare. We describe a 49-year-old man treated for squamous cell cancer of the esophagus in whom a single asymptomatic left heart metastasis was discovered incidentally during follow-up. The lesion was debulked surgically and multimodal treatment followed. The patient survived 1 year after diagnosis with good performance status during which time no other lesion was discovered. Cardiac metastasis is challenging and necessitates skilled multidisciplinary management to maximize the clinical outcome.
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- 2015
39. Isotretinoin plus clindamycin seem highly effective against severe erlotinib-induced skin rash in advanced non-small cell lung cancer
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Marina Cazzaniga, Alessandra Crippa, F. Villa, Ilaria Colombo, Federica Cicchiello, Paolo Bidoli, Diego Cortinovis, Gianfranco Altomare, Bidoli, P, Cortinovis, D, Colombo, I, Crippa, A, Cicchiello, F, Villa, F, Cazzaniga, M, and Altomare, G
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Lung Neoplasms ,Erlotinib Hydrochloride ,Non-small cell lung cancer ,Carcinoma, Non-Small-Cell Lung ,medicine ,Humans ,Lung cancer ,Adverse effect ,Isotretinoin ,Survival rate ,Protein Kinase Inhibitors ,Skin rash ,business.industry ,Nonsmall cell lung cancer ,Clindamycin ,Exanthema ,medicine.disease ,Rash ,Dermatology ,Anti-Bacterial Agents ,ErbB Receptors ,Survival Rate ,Treatment Outcome ,Erlotinib ,Oncology ,Quinazolines ,Dermatologic Agents ,medicine.symptom ,business ,medicine.drug - Abstract
Introduction: Erlotinib is useful in advanced non-small cell lung cancer although compliance and efficacy are diminished by skin rash in a high proportion of patients, often necessitating dose reduction or drug withdrawal. No effective treatment for the rash is available. Methods: We carried out a preliminary investigation on isotretinoin and clindamycin. Among 56 advanced lung cancer patients treated with erlotinib, 31 (53%) developed rash. Seven (35%) of the 20 G2/G3 cases agreed to treatment with clindamycin (450 mg/d, days 1–10; 300 mg/d, days 11–20) plus isotretinoin (20 mg/d, days 11–20) after being informed of the experimental nature of the combination. Results: In 6 of 7 (86%) patients, the rash resolved (G1/G0) without dose reduction; in the other patient (G3), the erlotinib dose also had to be reduced. Median time to resolution was 14 days (range 7–20 days). No rash-treatment adverse events occurred during 20 days of administration. Conclusions: Isotretinoin plus clindamycin promises to be the first effective treatment for erlotinib rash and is being tested further.
- Published
- 2010
40. Metronomic chemotherapy with oral vinorelbine (mVNR) and capecitabine (mCAPE) in advanced HER2-negative breast cancer patients: is it a way to optimize disease control? Final results of the VICTOR-2 study
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M E, Cazzaniga, L, Cortesi, A, Ferzi, L, Scaltriti, F, Cicchiello, M, Ciccarese, S, Della Torre, F, Villa, M, Giordano, C, Verusio, M, Nicolini, A R, Gambaro, L, Zanlorenzi, E, Biraghi, L, Legramandi, E, Rulli, Valter, Torri, Cazzaniga, M, Cortesi, L, Ferzi, A, Scaltriti, L, Cicchiello, F, Ciccarese M, M, Della Torre, S, Villa, F, Giordano, M, Verusio, C, Nicolini, M, Gambaro, A, Zanlorenzi, L, Biraghi, E, Legramandi, L, and Rulli, E
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Adult ,0301 basic medicine ,Oncology ,medicine.medical_specialty ,Cancer Research ,Receptor, ErbB-2 ,Administration, Oral ,Breast Neoplasms ,Vinblastine ,Vinorelbine ,Capecitabine ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Humans ,Medicine ,Neoplasm Metastasis ,Aged ,Neoplasm Staging ,Aged, 80 and over ,business.industry ,Metronomic chemotherapy ,HER2 negative ,Middle Aged ,medicine.disease ,Metronomic Chemotherapy ,Disease control ,Clinical Trial ,stomatognathic diseases ,Treatment Outcome ,030104 developmental biology ,030220 oncology & carcinogenesis ,Administration, Metronomic ,Retreatment ,Female ,business ,medicine.drug - Abstract
Purpose: The VICTOR-1 study demonstrated that the all-oral metronomic combination of vinorelbine and capecitabine is highly active and well tolerated in hormone receptor-positive/HER2-negative patients. The VICTOR-2 study was designed to confirm these results. Methods: Patients received mVNR 40 mg three times a week and mCAPE 500 mg three times a day, continuously. The primary endpoint was the clinical benefit rate (CBR); secondary endpoints were toxicity, objective response rate (ORR), and progression-free survival (PFS). Results: Eighty patients were evaluable for the primary efficacy analysis. Median age was 65.3 years; most patients had HR-positive tumors (65 %). The CBR was 45.7 % (95 % CI 28.8–63.4) and 51.1 % (95 % CI 35.8–66.3) in first- and ≥ second-line therapy, respectively. The ORR was 35.5 % in first-line (95 % CI 19.2–54.6) and 25.6 % in ≥second-line (95 % CI 13.5–41.2). The median duration of response was 11.3 and 6.4 months and PFS rates at 1 year were 24.3 and 22.2 %, respectively. In triple-negative breast cancer patients (N = 28, 35 %) a lower, but clinically relevant CBR (35.7, 95 % CI 18.6–55.9) was observed. The main toxicities per cycle were non-febrile neutropenia (1.1 %), hand-foot syndrome (1.0 %), nausea and vomiting (1.0 %), leucopenia (0.8 %), fatigue (0.7 %), and diarrhea (0.4 %). Conclusion: The VICTOR-2 study confirms the clinical activity of mVNR and mCAPE in HER2-negative breast cancer patients, suggesting that the easy schedule of administration, which requires monthly blood tests and limits patients’ dependence on hospitals, and the low cost of the drugs are valuable elements, even for countries with limited access to innovative or expensive drugs.
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41. How to Treat HR+/HER2- Metastatic Breast Cancer Patients after CDK4/6 Inhibitors: An Unfinished Story.
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Cogliati V, Capici S, Pepe FF, di Mauro P, Riva F, Cicchiello F, Maggioni C, Cordani N, Cerrito MG, and Cazzaniga ME
- Abstract
CDK4/6 inhibitors in association with endocrine therapy represent the best therapeutic choice for either endocrine-sensitive or resistant hormone-receptor-positive advanced breast cancer patients. On the contrary, the optimal therapeutic strategy after the failure of CDK4/6 inhibitors-based treatment still remains an open question worldwide. In this review, we analyze the most studied mechanisms of resistance to CDK4/6 inhibitors treatment, as well as the most significant results of retrospective and prospective trials in the setting of progression after CDK4/6 inhibitors, to provide the reader a comprehensive overview from both a preclinical and especially a clinical perspective. In our opinion, an approach based on a deeper knowledge of resistance mechanisms to CDK4/6 inhibitors, but also on a careful analysis of what is done in clinical practice, can lead to a better definition of prospective randomized trials, to implement a personalized sequence approach, based on molecular analyses.
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- 2022
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42. Comparison of tumor microenvironment in primary and paired metastatic ER+/HER2- breast cancers: results of a pilot study.
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Zeppellini A, Galimberti S, Leone BE, Pacifico C, Riva F, Cicchiello F, Capici S, Maggioni C, Sala L, and Cazzaniga ME
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- Aged, Aged, 80 and over, Biopsy, Breast immunology, Breast surgery, Breast Neoplasms pathology, Breast Neoplasms therapy, Case-Control Studies, Chemotherapy, Adjuvant, Disease Progression, Female, Follow-Up Studies, Humans, Mastectomy, Middle Aged, Neoplasm Recurrence, Local pathology, Pilot Projects, Prognosis, Receptor, ErbB-2 analysis, Receptor, ErbB-2 metabolism, Receptors, Estrogen analysis, Receptors, Estrogen metabolism, Retrospective Studies, Breast pathology, Breast Neoplasms immunology, Lymphocytes, Tumor-Infiltrating immunology, Neoplasm Recurrence, Local immunology, Tumor Microenvironment immunology
- Abstract
Background: Tumor microenvironment (TME) is a dynamic setting and changes in TILs and their subpopulations are potential candidates to influence the metastatic process. Aim of this pilot study is to describe the changes occurring between primary breast cancers and their paired metastases in terms of TILs composition. To assess if these changes influence the process of metastasis development, we used a control group of patients., Methods: We retrospectively identified 18 Luminal patients, for whom primary and metastatic tissue were available (cases) and 18 paired-matched patients (controls), not relapsed after at least 9 years of follow-up, and we quantified TILs and their composition (i.e. T CD8+ and CD4+/FOXP3+). The presence of TILs was defined as ≥10%., Results: Our results showed that the microenvironment composition of relapsed patients was poor of TILs (median = 5%, I-III quartiles = 0.6-5%), CD8+ (2.5%, 0-5%) and CD4+/FOXP3 + (0%, 0-0.6%) in the primary tumor. Comparable results were observed in their related metastases (TILs 3.8%, 0.6-5%; CD8+ 0%, 0-1.3%; CD4+/FOXP3+ 0%,0-1.9%). On the contrary, the microenvironment in the control group was richer of TILs (5%, 5-17.5%) in comparison to cases, both in primary tumor (p = 0.035) and related metastases (p = 0.018). Although CD8+ in controls were similar to cases at primary tumor (p = 0.6498), but not at metastasis (p = 0.0223), they expressed only one part on the TILs subpopulations (p = 0.0060), while TILs in the cases at primary tumor were almost completely CD8+ (p = 0.5034)., Conclusions: These findings suggest that the lack of activation of immune system in the primary tumor might influence the multifactor process of cancer progression.
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- 2021
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43. Validation of the Italian version of the full and abbreviated Trust in Oncologist Scale.
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Bani M, Rossi E, Cortinovis D, Russo S, Gallina F, Hillen MA, Canova S, Cicchiello F, Longarini R, Cazzaniga ME, Bidoli P, Valsecchi MG, and Strepparava MG
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- Humans, Italy, Language, Psychometrics, Reproducibility of Results, Surveys and Questionnaires, Oncologists, Trust
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Introduction: The Trust in Oncologist Scale (TiOS) is an 18-item questionnaire aimed to assess the cancer patients' trust in their oncologist and has been validated in Dutch and English language. This study aims to validate the Italian version of the TiOS (IT-TiOS) and the TiOS-Short Form (IT-TiOS-SF)., Methods: The IT-TiOS was administered to 194 patients recruited in an Italian oncology department from April to December 2018. Data collected included socio-demographic data, health and clinical information, satisfaction with the most recent oncology visit and trust in the regional healthcare system. Internal consistency, test-retest reliability, convergent and the structural validity of both the full and short form were tested., Results: Factor analyses indicated that neither four-factor nor one-factor models of the full scale were acceptable. However, confirmatory factor analysis supported the one-dimensionality of the IT-TiOS-SF, and internal consistency assessed with Cronbach's alpha was 0.88. Mean scores on the IT-TiOS-SF correlated with satisfaction with the oncologist (rs = 0.64) and willingness to recommend the oncologist to others (rs = 0.67), confirming good construct validity., Conclusion: The IT-TiOS-SF demonstrates good psychometric properties and can be used to assess trust for both clinical and research purposes., (© 2020 John Wiley & Sons Ltd.)
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- 2021
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44. Gemcitabine-induced thrombocytosis as a potential predictive factor in non-small cell lung cancer: analysis of 318 patients.
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Canova S, Cicchiello F, Agustoni F, Bianchini G, Abbate MI, Bidoli P, and Cortinovis DL
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- Adult, Aged, Aged, 80 and over, Deoxycytidine adverse effects, Deoxycytidine therapeutic use, Disease-Free Survival, Female, Humans, Male, Middle Aged, Prognosis, Retrospective Studies, Treatment Outcome, Gemcitabine, Antimetabolites, Antineoplastic adverse effects, Antimetabolites, Antineoplastic therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Deoxycytidine analogs & derivatives, Lung Neoplasms drug therapy, Thrombocytosis chemically induced
- Abstract
Introduction: In spite of the progress in the treatment of non-small-cell lung cancer (NSCLC), the majority of patients with advanced disease still receive chemotherapy. Gemcitabine alone or combined with a platinum compound is a valid option. Thrombocytosis is a recognized prognostic factor in lung cancer and an adverse event that may occur during gemcitabine infusion., Methods: We retrospectively evaluated all patients with NSCLC treated with first-line gemcitabine-based chemotherapy in two Italian hospitals. We assessed the onset of thrombocytosis within the third cycle of therapy and the relation between thrombocytosis and survival., Results: We included 318 patients. Thrombocytosis occurred in 156 patients (49.1%). Median progression-free survival (PFS) was 5.6 months (95% CI, 4.7-6.9 months) in patients who developed thrombocytosis versus 6 months (95% CI, 5.1-7.2 months) in patients without thrombocytosis (p = 0.21). Median overall survival (OS) was 11.2 months (95% CI, 9.8-13.4 months) in patients with thrombocytosis versus 12 months (95% CI, 10.1-14.4 months) in patients without thrombocytosis (p = 0.25). We observed no difference in terms of PFS or OS according to age, sex, stage, chemotherapy (single-agent versus combination chemotherapy) and thrombocytosis., Conclusions: Thrombocytosis is neither a prognostic nor a predictive factor for PFS or OS in patients with advanced NSCLC treated with first-line gemcitabine-based chemotherapy.
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- 2017
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45. Efficacy and safety of vinorelbine-capecitabine oral metronomic combination in elderly metastatic breast cancer patients: VICTOR-1 study.
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Cazzaniga ME, Torri V, Riva F, Porcu L, Cicchiello F, Capici S, Cortinovis D, Digiacomo N, and Bidoli P
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- Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Breast Neoplasms pathology, Capecitabine administration & dosage, Female, Humans, Vinblastine administration & dosage, Vinblastine analogs & derivatives, Vinorelbine, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy
- Abstract
Purpose: Elderly patients with metastatic breast cancer are expected to derive similar benefits from chemotherapy as younger patients, but are more likely to experience therapy-related toxicity. Data from the VICTOR-1 study showed that metronomic therapy with vinorelbine and capecitabine was effective and well tolerated in patients with metastatic breast cancer. This analysis determined the efficacy and safety of the metronomic combination of oral vinorelbine and capecitabine in a subgroup of VICTOR-1 study patients aged ≥70 years., Methods: Eighteen of the 32 patients enrolled in VICTOR-1 were aged ≥70 years. Objective response and clinical benefit rates were calculated and toxicity was determined using the NCI-CTCAE criteria., Results: All patients had at least 1 comorbidity (4 had 2 comorbidities), and 77.7% were taking concomitant medication. Eight patients (44%) had received ≥1 chemotherapy regimens for metastatic disease and most (78%) had ≥2 metastatic sites. Grade 1-2 adverse events occurred in 45.8% of cycles, whereas the incidence of grade 3 and grade 4 events was very low (1.5% and 0.7%, respectively). Median time to progression was 10.5 months (range 1-40). The objective response rate was 33% and the clinical benefit rate was 67%., Conclusions: The all-oral metronomic combination of vinorelbine and capecitabine had an acceptable efficacy profile and appears to be better tolerated than standard treatment schedules in elderly metastatic breast cancer patients (age ≥70 years).
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- 2017
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46. Isolated cardiac metastasis from squamous cell esophageal cancer.
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Abbate MI, Cicchiello F, Canova S, Cortinovis D, Mariani S, Maffini F, and Bidoli P
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- Carcinoma, Squamous Cell diagnosis, Carcinoma, Squamous Cell therapy, Chemotherapy, Adjuvant, Esophageal Neoplasms diagnosis, Esophageal Neoplasms therapy, Fatal Outcome, Heart Neoplasms diagnosis, Heart Neoplasms therapy, Humans, Jejunal Neoplasms diagnosis, Jejunal Neoplasms therapy, Male, Middle Aged, Patient Care Team, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Squamous Cell secondary, Cytoreduction Surgical Procedures, Esophageal Neoplasms pathology, Heart Neoplasms secondary, Incidental Findings, Jejunal Neoplasms secondary
- Abstract
Although heart metastases are uncommon and generally a sign of disseminated disease, they are up to 40 times more frequent than primary cancers of the heart, and typically arise from melanoma or primary mediastinal cancer, but also from lymphoma, breast cancer, esophageal cancer, and leukemia. They are usually asymptomatic and found only at autopsy. Symptomatic patients generally die within a few weeks of diagnosis and usual treatments are chemotherapy, radiotherapy, or both. Surgical resection is recommended only for a single lesion, which is rare. We describe a 49-year-old man treated for squamous cell cancer of the esophagus in whom a single asymptomatic left heart metastasis was discovered incidentally during follow-up. The lesion was debulked surgically and multimodal treatment followed. The patient survived 1 year after diagnosis with good performance status during which time no other lesion was discovered. Cardiac metastasis is challenging and necessitates skilled multidisciplinary management to maximize the clinical outcome.
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- 2015
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47. Isotretinoin plus clindamycin seem highly effective against severe erlotinib-induced skin rash in advanced non-small cell lung cancer.
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Bidoli P, Cortinovis DL, Colombo I, Crippa A, Cicchiello F, Villa F, Cazzaniga ME, and Altomare G
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- Anti-Bacterial Agents therapeutic use, Carcinoma, Non-Small-Cell Lung pathology, Dermatologic Agents therapeutic use, ErbB Receptors antagonists & inhibitors, Erlotinib Hydrochloride, Exanthema chemically induced, Humans, Lung Neoplasms pathology, Protein Kinase Inhibitors adverse effects, Survival Rate, Treatment Outcome, Carcinoma, Non-Small-Cell Lung drug therapy, Clindamycin therapeutic use, Exanthema drug therapy, Isotretinoin therapeutic use, Lung Neoplasms drug therapy, Quinazolines adverse effects
- Abstract
Introduction: Erlotinib is useful in advanced non-small cell lung cancer although compliance and efficacy are diminished by skin rash in a high proportion of patients, often necessitating dose reduction or drug withdrawal. No effective treatment for the rash is available., Methods: We carried out a preliminary investigation on isotretinoin and clindamycin. Among 56 advanced lung cancer patients treated with erlotinib, 31 (53%) developed rash. Seven (35%) of the 20 G2/G3 cases agreed to treatment with clindamycin (450 mg/d, days 1-10; 300 mg/d, days 11-20) plus isotretinoin (20 mg/d, days 11-20) after being informed of the experimental nature of the combination., Results: In 6 of 7 (86%) patients, the rash resolved (G1/G0) without dose reduction; in the other patient (G3), the erlotinib dose also had to be reduced. Median time to resolution was 14 days (range 7-20 days). No rash-treatment adverse events occurred during 20 days of administration., Conclusions: Isotretinoin plus clindamycin promises to be the first effective treatment for erlotinib rash and is being tested further.
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- 2010
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