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

Author

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

Published
2023
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2. Factors influencing 5-year persistence to adjuvant endocrine therapy in young women with breast cancer

Author

Pagan, E, Ruggeri, M, Bianco, N, Bucci, E, Graffeo, R, Borner, M, Giordano, M, Gianni, L, Rabaglio, M, Freschi, A, Cretella, E, Seles, E, Farolfi, A, Simoncini, E, Ciccarese, M, Rauch, D, Favaretto, A, Honecker, F, Berardi, R, Franzetti-Pellanda, A, Gelber, S, Partridge, A, Goldhirsch, A, Bagnardi, V, Pagani, O, Ribi, K, Pagan, Eleonora, Ruggeri, Monica, Bianco, Nadia, Bucci, Eraldo Oreste, Graffeo, Rossella, Borner, Markus, Giordano, Monica, Gianni, Lorenzo, Rabaglio, Manuela, Freschi, Andrea, Cretella, Elisabetta, Seles, Elena, Farolfi, Alberto, Simoncini, Edda, Ciccarese, Mariangela, Rauch, Daniel, Favaretto, Adolfo, Honecker, Friedemann, Berardi, Rossana, Franzetti-Pellanda, Alessandra, Gelber, Shari, Partridge, Ann H., Goldhirsch, Aron, Bagnardi, Vincenzo, Pagani, Olivia, Ribi, Karin, Pagan, E, Ruggeri, M, Bianco, N, Bucci, E, Graffeo, R, Borner, M, Giordano, M, Gianni, L, Rabaglio, M, Freschi, A, Cretella, E, Seles, E, Farolfi, A, Simoncini, E, Ciccarese, M, Rauch, D, Favaretto, A, Honecker, F, Berardi, R, Franzetti-Pellanda, A, Gelber, S, Partridge, A, Goldhirsch, A, Bagnardi, V, Pagani, O, Ribi, K, Pagan, Eleonora, Ruggeri, Monica, Bianco, Nadia, Bucci, Eraldo Oreste, Graffeo, Rossella, Borner, Markus, Giordano, Monica, Gianni, Lorenzo, Rabaglio, Manuela, Freschi, Andrea, Cretella, Elisabetta, Seles, Elena, Farolfi, Alberto, Simoncini, Edda, Ciccarese, Mariangela, Rauch, Daniel, Favaretto, Adolfo, Honecker, Friedemann, Berardi, Rossana, Franzetti-Pellanda, Alessandra, Gelber, Shari, Partridge, Ann H., Goldhirsch, Aron, Bagnardi, Vincenzo, Pagani, Olivia, and Ribi, Karin

Abstract

Purpose: Although younger age has been negatively associated with persistence to adjuvant endocrine therapy (ET), factors contributing to non-persistence remain poorly understood. We assessed factors associated with non-persistence to ET and described the 5-year trajectories of quality of life (QoL) and symptoms in young women (≤40 years) with hormone receptor-positive breast cancer (BC). Methods: We retrieved data on clinical characteristics and non-persistence from the medical annual records in the European cohort of the “Helping Ourselves, Helping Others: The Young Women's BC Study” (IBCSG 43-09 HOHO). Women completed surveys at baseline, biannually for three years, and annually for another seven years. Data collection included sociodemographic information, QoL aspects assessed by the Cancer Rehabilitation Evaluation System-Short Form and symptoms assessed by the Breast Cancer Prevention Trial symptom scales. Cox regression models were applied to identify factors associated with non-persistence. Results: The cumulative risk of interrupting ET within 5 years was 27.7 % (95 % CI, 21.5–35.2). The QoL subscale scores remained stable over 5 years, with slight improvements in the physical subscale. Hot flashes decreased (p < 0.001), while vaginal problems intensified (p < 0.001) over time. Being married without children and having difficulties interacting and communicating with the medical team were significantly associated with non-persistence. Conclusions: Discussing the desire to conceive with partnered childless women and establishing a good relationship with the medical team may be important in addressing the non-persistence in young BC survivors. As recent data suggests the safety of pausing ET to conceive, this approach may be a reasonable future option to limit non-persistence.

Published
2024

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

Author

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

Abstract

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

Published
2023

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

Author

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

Published
2019
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5. Fertility concerns, preservation strategies and quality of life in young women with breast cancer: Baseline results from an ongoing prospective cohort study in selected European Centers

Author

Ruggeri, M., Pagan, E., Bagnardi, V., Bianco, N., Gallerani, E., Buser, K., Giordano, M., Gianni, L., Rabaglio, M., Freschi, A., Cretella, E., Clerico, M., Farolfi, A., Simoncini, E., Ciccarese, M., Rauch, D., Ramello, M., Glaus, A., Berardi, R., Pellanda, A. Franzetti, Ribi, K., Gelber, S., Partridge, A.H., Goldhirsch, A., and Pagani, O.

Published
2019
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6. 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

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.

Published
2017
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7. Employment trajectories of young women with breast cancer: an ongoing prospective cohort study in Italy and Switzerland

Author

Ribi, K, Pagan, E, Sala, I, Ruggeri, M, Bianco, N, Bucci, E, Graffeo, R, Borner, M, Giordano, M, Gianni, L, Rabaglio, M, Freschi, A, Cretella, E, Seles, E, Farolfi, A, Simoncini, E, Ciccarese, M, Rauch, D, Favaretto, A, Glaus, A, Berardi, R, Franzetti-Pellanda, A, Bagnardi, V, Gelber, S, Partridge, A, Goldhirsch, A, Pagani, O, Ribi K., Pagan E., Sala I., Ruggeri M., Bianco N., Bucci E. O., Graffeo R., Borner M., Giordano M., Gianni L., Rabaglio M., Freschi A., Cretella E., Seles E., Farolfi A., Simoncini E., Ciccarese M., Rauch D., Favaretto A., Glaus A., Berardi R., Franzetti-Pellanda A., Bagnardi V., Gelber S., Partridge A. H., Goldhirsch A., Pagani O., Ribi, K, Pagan, E, Sala, I, Ruggeri, M, Bianco, N, Bucci, E, Graffeo, R, Borner, M, Giordano, M, Gianni, L, Rabaglio, M, Freschi, A, Cretella, E, Seles, E, Farolfi, A, Simoncini, E, Ciccarese, M, Rauch, D, Favaretto, A, Glaus, A, Berardi, R, Franzetti-Pellanda, A, Bagnardi, V, Gelber, S, Partridge, A, Goldhirsch, A, Pagani, O, Ribi K., Pagan E., Sala I., Ruggeri M., Bianco N., Bucci E. O., Graffeo R., Borner M., Giordano M., Gianni L., Rabaglio M., Freschi A., Cretella E., Seles E., Farolfi A., Simoncini E., Ciccarese M., Rauch D., Favaretto A., Glaus A., Berardi R., Franzetti-Pellanda A., Bagnardi V., Gelber S., Partridge A. H., Goldhirsch A., and Pagani O.

Abstract

Purpose: Despite extensive research on cancer and work-related outcomes, evidence from longitudinal cohort studies is limited, especially in young women with breast cancer (BC). We aimed to investigate employment trajectories in young BC survivors and to identify potential factors associated with changes in work activity. Methods: The HOHO European prospective multicenter cohort study enrolled 300 young women (≤ 40 years) with newly diagnosed BC. Women completed surveys at baseline and every 6 months for 3 years, then yearly for up to 10 years to assess, among other variables, employment status, sociodemographic, medical, and treatment data. Symptoms were assessed by the Breast Cancer Prevention Trial symptom scales and single items from the Cancer Rehabilitation Evaluation System. Univariable and multivariable multinomial logistic regression analyses identified factors associated with changes in employment status. Results: Among the 245 women included in this analysis, 85% were employed at the last individual post-baseline assessment (1 to 10 years). At 5 years, women had a 29.4% probability (95% CI: 23.6–35.5) of experiencing any reduction and a 14.9% probability (95% CI: 10.6–19.9) of experiencing any increase in work activities. Being enrolled in Switzerland (vs. Italy) and reporting more trouble in performing daily activities were significantly associated with work reduction. Conclusion: Our results suggest that most young BC survivors remain employed in the long-term. Implications for Cancer Survivors: Regular evaluation of symptoms which may interfere with daily life and identification of financial discomfort is critical in providing timely and individually tailored interventions and in limiting unwanted reductions in work activities.

Published
2022

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

Author

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

Abstract

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

Published
2021

9. 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

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
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10. Is There Still a Role for Endocrine Therapy Alone in HR+/HER2- Advanced Breast Cancer Patients? Results from the Analysis of Two Data Sets of Patients Treated with High-Dose Fulvestrant as First-Line Therapy in the Real-World Setting: The EVA and GIM-13 AMBRA Studies

Author

Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Gianni, L, Michelotti, A, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, De Laurentiis, M, Atzori, F, Turletti, A, Porpiglia, M, Santini, D, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Giordano, M, Donadio, M, Biganzoli, L, Del Mastro, L, Bisagni, G, Livi, L, Natoli, C, Montemurro, F, Riccardi, F, Romagnoli, E, Marchetti, P, Torri, V, Pronzato, P, Mustacchi, G, Cazzaniga M. E., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Gianni L., Michelotti A., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G. V., Artale S., Blasi L., De Laurentiis M., Atzori F., Turletti A., Porpiglia M., Santini D., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Giordano M., Donadio M., Biganzoli L., Del Mastro L., Bisagni G., Livi L., Natoli C., Montemurro F., Riccardi F., Romagnoli E., Marchetti P., Torri V., Pronzato P., Mustacchi G., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Gianni, L, Michelotti, A, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, De Laurentiis, M, Atzori, F, Turletti, A, Porpiglia, M, Santini, D, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Giordano, M, Donadio, M, Biganzoli, L, Del Mastro, L, Bisagni, G, Livi, L, Natoli, C, Montemurro, F, Riccardi, F, Romagnoli, E, Marchetti, P, Torri, V, Pronzato, P, Mustacchi, G, Cazzaniga M. E., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Gianni L., Michelotti A., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G. V., Artale S., Blasi L., De Laurentiis M., Atzori F., Turletti A., Porpiglia M., Santini D., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Giordano M., Donadio M., Biganzoli L., Del Mastro L., Bisagni G., Livi L., Natoli C., Montemurro F., Riccardi F., Romagnoli E., Marchetti P., Torri V., Pronzato P., and Mustacchi G.

Abstract

Background: Different studies suggest that fulvestrant 500 mg every 28 days (HD-FUL) could be an active treatment in HR+ advanced breast cancer (ABC) patients even treated with aromatase inhibitors in the adjuvant setting. The aim of this analysis is to describe the outcome of ABC patients treated with HD-FUL as first-line treatment in terms of median duration of treatment and the overall response rate in a real-world setting. Methods: For the purpose of the present analysis, we considered two data sets of HR+ ABC patients collected in Italy between 2012 and 2015 (EVA and GIM-13 AMBRA studies). Results: Eighty-one and 91 patients have been identified from the two data sets. The median age was 63 years (range 35-82) for the EVA and 57.8 years (range 35.0-82.3) for the AMBRA patients. ORRs were 23.5 and 24.3% in the whole population, 26.9% in the patients with bone only, and 21.8 and 21.4% in those with visceral metastases. The median duration of HD-FUL was 11.6 months (range 1-48) and 12.4 months (range 2.9-70.0) in the two data sets, respectively. Conclusion: These data suggest that HD-FUL should still continue to play a significant role as first-line therapy in HR+ ABC patients.

Published
2020

12. 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

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.

Subjects
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
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13. Eribulin Mesylate as Third or Subsequent Line Chemotherapy for Elderly Patients with Locally Recurrent or Metastatic Breast Cancer: A Multicentric Observational Study of GIOGer (Italian Group of Geriatric Oncology)-ERIBE

Author

Leo, S, Arnoldi, E, Repetto, L, Coccorullo, Z, Cinieri, S, Fedele, P, Cazzaniga, M, Lorusso, V, Latorre, A, Campanella, G, Ciccarese, M, Accettura, C, Pisconti, S, Rinaldi, A, Brunetti, C, Raffaele, M, Coltelli, L, Spazzapan, S, Fratino, L, Petrucelli, L, Biganzoli, L, Leo S., Arnoldi E., Repetto L., Coccorullo Z., Cinieri S., Fedele P., Cazzaniga M., Lorusso V., Latorre A., Campanella G., Ciccarese M., Accettura C., Pisconti S., Rinaldi A., Brunetti C., Raffaele M., Coltelli L., Spazzapan S., Fratino L., Petrucelli L., Biganzoli L., Leo, S, Arnoldi, E, Repetto, L, Coccorullo, Z, Cinieri, S, Fedele, P, Cazzaniga, M, Lorusso, V, Latorre, A, Campanella, G, Ciccarese, M, Accettura, C, Pisconti, S, Rinaldi, A, Brunetti, C, Raffaele, M, Coltelli, L, Spazzapan, S, Fratino, L, Petrucelli, L, Biganzoli, L, Leo S., Arnoldi E., Repetto L., Coccorullo Z., Cinieri S., Fedele P., Cazzaniga M., Lorusso V., Latorre A., Campanella G., Ciccarese M., Accettura C., Pisconti S., Rinaldi A., Brunetti C., Raffaele M., Coltelli L., Spazzapan S., Fratino L., Petrucelli L., and Biganzoli L.

Abstract

Background: Metastatic breast cancer (MBC) is highly prevalent in middle-aged or elderly patients. Eribulin is a nontaxane microtubule inhibitor, approved for the treatment of pretreated MBC. This multicentric study (sponsored by GIOGer, Italian Group for Geriatric Oncology) was designed to assess the efficacy and tolerability of eribulin, according to parameters usually used in geriatric oncology. Subjects, Materials, and Methods: An observational study was conducted on 50 consecutive elderly patients with MBC. The primary endpoint was to evaluate the change in items score of comprehensive geriatric assessment (CGA) and health-related quality of life (HRQL). Italian versions of the CGA and HRQL questionnaires were administered at baseline, before the third and fifth cycles, and then every three cycles until treatment discontinuation. Secondary endpoints were efficacy and safety. Results: Overall, both EQ-5D scores and EQ-5D-3 L visual analogic scale did not significantly change from baseline; the percentage of subjects without problems doing usual activities tended to decrease during treatment (p for linear trend.018), and the percentage of patients with minor problems performing usual activities tended to increase (p for linear trend.012). Among CGA items, Instrumental Activities of Daily Living tended to decrease during treatment and Geriatric Depression Scale tended to increase. After 12 months follow-up, 24 patients (out of 47) showed clinical benefits; median progression-free survival was 4.49 months (2.10–10.33) and median OS was 7.31 months (3.70–14.03). The treatment was associated with mild toxicity. Conclusion: Eribulin treatment preserved quality of life and geriatric parameters included in the CGA, except for instrumental functioning and geriatric depression, in elderly patients with MBC. Implications for Practice: A collaboration between oncologist and geriatric specialists is essential in the management of patients with metastatic breast cancer, who a

Published
2019

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

Author

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

Abstract

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

Published
2019

15. Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study

Author

Cazzaniga, M., Verusio, C., Ciccarese, M., Fumagalli, A., Sartori, D., Ancona, C., Airoldi, M., Moretti, G., Ficorella, C., Arcangeli, V., Diodati, L., Zambelli, A., Febbraro, A., Generali, D., Pistelli, M., Garrone, O., Musolino, A., Vici, P., Maur, M., Mentuccia, L., La Verde, N., Bianchi, G., Artale, S., Blasi, L., Piezzo, M., Atzori, F., Turletti, A., Benedetto, C., Cursano, M. C., Fabi, A., Gebbia, V., Schirone, A., Palumbo, R., Ferzi, A., Frassoldati, A., Scavelli, C., Clivio, L., Torri, V., On behalf of The EVA Study Group, Cazzaniga, Marina, Verusio, Claudio, Ciccarese, Mariangela, Fumagalli, Alberto, Sartori, Donata, D'Ancona, Cristina, Airoldi, Mario, Moretti, Gabriella, Ficorella, Corrado, Arcangeli, Valentina, Diodati, Lucrezia, Zambelli, Alberto, Febbraro, Antonio, Generali, Daniele, Pistelli, Mirco, Garrone, Ornella, Musolino, Antonino, Vici, Patrizia, Maur, Michela, Mentuccia, Lucia, La Verde, Nicla, Bianchi, Giulia, Artale, Salvatore, Blasi, Livio, Piezzo, Matilde, Atzori, Francesco, Turletti, Anna, Benedetto, Chiara, Cursano, Maria Concetta, Fabi, Alessandra, Gebbia, Vittorio, Schirone, Antonio, Palumbo, Raffaella, Ferzi, Antonella, Frassoldati, Antonio, Scavelli, Claudio, Clivio, Luca, Torri, Valter, Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Ancona, C, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, On behalf of The EVA Study, G, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio MR., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M.C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., and On behalf of The EVA Study Group

Subjects
medicine.medical_specialty, Socio-culturale, Hormone-receptor positive, Exemestane, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Breast cancer, Elderly, Weight loss, Internal medicine, Advanced breast cancer, Everolimus, Oncology, medicine, 030212 general & internal medicine, Stomatitis, Pneumonitis, business.industry, Cancer, medicine.disease, Rash, Everolimu, chemistry, 030220 oncology & carcinogenesis, MED/06 - ONCOLOGIA MEDICA, medicine.symptom, business, Research Paper, medicine.drug
Abstract

BACKGROUND: The present analysis focuses on real-world data of Everolimus- Exemestane in advanced HR+ve, HER2-ve elderly breast cancer patients (aged 65 years) included in the EVA study, with unique findings in those aged 70 years. METHODS: Data are collected from clinical records and analysed according to age cut-off (< 65 years; 65 - 69 years and [greater than or equal to] 70 years). Relationship of analyzed variables with response were tested by mean of a Mantel- Haenszel chi square test. Time to event analysis was described by Kaplan Meier approach and association with baseline characteristics was analysed by stratified log-rank test and proportional hazard model. RESULTS: From July 2013 to December 2015, the EVA study enrolled overall 404 pts. 154 patients out of 404 (38,1%) were aged [greater than or equal to] 65 years, of whom 87 were [greater than or equal to] 70 years. Median duration of EVE treatment was 28.5 weeks (95% CI 19.0 - 33.8) in patients aged 65-69 years and 24,4 weeks (95% CI 19,2 - 33,2) in those aged [greater than or equal to] 70 years. Fewer patients aged 65 years received the highest EVE Dose-Intensity (> 7.5 mg/day) in comparison to younger patients (49,6% vs. 66,8%). Grade 3-4 toxicities occurred to 55 patients (35,7%), mainly stomatitis (10,9%), rash (5,8%) and non-infectious pneumonitis (NIP) (3,6%). Some toxicities, such as weight loss and anaemia were peculiarly observed in patients aged [greater than or equal to] 70 years. Five treatment-related deaths were collected (3,2%). CONCLUSIONS: EVE-EXE combination remains one of the potential treatments in HR+ patients also for elderly ones.

Published
2018

16. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Author

De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., Zoboli A., De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., and Zoboli A.

Abstract

Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely removed by surgery, any pathological tumour size, and axillary nodal status. Key exclusion criteria were hormone replacement therapy, recurrent or metastatic disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised minimisation procedure stratified for oestrogen receptor, progesterone receptor, and HER2 status; previous chemotherapy; and pathological nodal status. Neither the patients nor the physicians were masked to treatment allocation. The primary endpoint was disease-free survival. The minimum cutoff to declare superiority of the upfront strategy over the switch strategy was assumed to be a 2% difference in disease-free survival at 5 years. Primary efficacy analyses were done by intention to treat; safety analyses included all patients for whom at least one safety case report form had been completed. Follow-up is ongoing. This trial is regist

Published
2018

17. Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study

Author

Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Ancona, C, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, On behalf of The EVA Study, G, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Ancona C., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., On behalf of The EVA Study Group, Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Ancona, C, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, On behalf of The EVA Study, G, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Ancona C., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., and On behalf of The EVA Study Group

Abstract

BACKGROUND: The present analysis focuses on real-world data of Everolimus- Exemestane in advanced HR+ve, HER2-ve elderly breast cancer patients (aged 65 years) included in the EVA study, with unique findings in those aged 70 years. METHODS: Data are collected from clinical records and analysed according to age cut-off (< 65 years; 65 - 69 years and [greater than or equal to] 70 years). Relationship of analyzed variables with response were tested by mean of a Mantel- Haenszel chi square test. Time to event analysis was described by Kaplan Meier approach and association with baseline characteristics was analysed by stratified log-rank test and proportional hazard model. RESULTS: From July 2013 to December 2015, the EVA study enrolled overall 404 pts. 154 patients out of 404 (38,1%) were aged [greater than or equal to] 65 years, of whom 87 were [greater than or equal to] 70 years. Median duration of EVE treatment was 28.5 weeks (95% CI 19.0 - 33.8) in patients aged 65-69 years and 24,4 weeks (95% CI 19,2 - 33,2) in those aged [greater than or equal to] 70 years. Fewer patients aged 65 years received the highest EVE Dose-Intensity (> 7.5 mg/day) in comparison to younger patients (49,6% vs. 66,8%). Grade 3-4 toxicities occurred to 55 patients (35,7%), mainly stomatitis (10,9%), rash (5,8%) and non-infectious pneumonitis (NIP) (3,6%). Some toxicities, such as weight loss and anaemia were peculiarly observed in patients aged [greater than or equal to] 70 years. Five treatment-related deaths were collected (3,2%). CONCLUSIONS: EVE-EXE combination remains one of the potential treatments in HR+ patients also for elderly ones.

Published
2018

18. Correction: Everolimus (Eve) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study (Oncotarget (2018) 9:77 (34639-34640) DOI: 10.18632/oncotarget.25874)

Author

Cazzaniga M., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., Cazzaniga M., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., and Torri V.

Abstract

This article has been corrected: The correct author names are given below: Chiara Ancona and Michela Piezzo.

Published
2018

19. Erratum: Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study (Oncotarget (2018) 9 (31877-31887) DOI: 10.18632/oncotarget.25874)

Author

Cazzaniga M., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., Cazzaniga M., Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Valerio, M, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio M. R., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M. C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., and Torri V.

Abstract

This article has been corrected: The correct author name is given below:.

Published
2018

21. Prevalence of germline BRCA pathogenic variants in a monoinstitutional cohort of patients with triple negative breast cancer

Author

De Matteis, E., primary, Ciccarese, M., additional, Ronzino, G., additional, Forcignanò, R., additional, Chiuri, V.E., additional, Cairo, G., additional, Bovenga, I., additional, Spro, E., additional, De Giorgio, M.R., additional, Tarantino, P., additional, Palma, L., additional, Mauro, S., additional, and Leo, S., additional

Published
2020
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22. 339P Impact of blood glucose levels on the efficacy of everolimus-exemestane in patients with advanced HR-positive/HER2 negative breast cancer: The EVERMET study

Author

Vernieri, C., primary, Nichetti, F., additional, Guarneri, V., additional, Cortesi, E., additional, Moscetti, L., additional, Del Mastro, L., additional, Fabbri, A., additional, Curigliano, G., additional, Montemurro, F., additional, Losurdo, A., additional, Generali, D.G., additional, Fabi, A., additional, Pedersini, R., additional, Ciccarese, M., additional, Rocca, A., additional, Arpino, G., additional, La Verde, N.M., additional, Puglisi, F., additional, Mariani, L., additional, and de Braud, F., additional

Published
2020
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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

Author

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.

Published
2017

25. Dose intensity and efficacy of the combination of everolimus and exemestane (EVE/EXE) in a real-world population of hormone receptor-positive (ER+/PgR+), HER2-negative advanced breast cancer (ABC) patients: a multicenter Italian experience

Author

Ciccarese, M, Fabi, A, Moscetti, L, Cazzaniga, M, Petrucelli, L, Forcignanò, R, Lupo, L, De Matteis, E, Chiuri, V, Cairo, G, Febbraro, A, Giordano, G, Giampaglia, M, Bilancia, D, La Verde, N, Maiello, E, Morritti, M, Giotta, F, Lorusso, V, Latorre, A, Scavelli, C, Romito, S, Cusmai, A, Palmiotti, G, Surico, Ciccarese M, Fabi A, Moscetti L, Cazzaniga M, Petrucelli L, Forcignanò R, Lupo LI, De Matteis E, Chiuri VE, Cairo G, Febbraro A, Giordano G, Giampaglia M, Bilancia D, La Verde N, Maiello E, Morritti M, Giotta F, Lorusso V, Latorre A, Scavelli C, Romito S, Cusmai A, Palmiotti G, Ciccarese, M, Fabi, A, Moscetti, L, Cazzaniga, M, Petrucelli, L, Forcignanò, R, Lupo, L, De Matteis, E, Chiuri, V, Cairo, G, Febbraro, A, Giordano, G, Giampaglia, M, Bilancia, D, La Verde, N, Maiello, E, Morritti, M, Giotta, F, Lorusso, V, Latorre, A, Scavelli, C, Romito, S, Cusmai, A, Palmiotti, G, Surico, Ciccarese M, Fabi A, Moscetti L, Cazzaniga M, Petrucelli L, Forcignanò R, Lupo LI, De Matteis E, Chiuri VE, Cairo G, Febbraro A, Giordano G, Giampaglia M, Bilancia D, La Verde N, Maiello E, Morritti M, Giotta F, Lorusso V, Latorre A, Scavelli C, Romito S, Cusmai A, and Palmiotti G

Abstract

Aim: This retrospective analysis focused on the effect of treatment with EVE/EXE in a real-world population outside of clinical trials. We examined the efficacy of this combination in terms of PFS and RR related to dose intensity (5 mg daily versus 10 mg daily) and tolerability. Methods: 163 HER2-negative ER+/PgR+ ABC patients, treated with EVE/EXE from May 2011 to March 2016, were included in the analysis. The primary endpoints were the correlation between the daily dose and RR and PFS, as well as an evaluation of the tolerability of the combination. Secondary endpoints were RR, PFS, and OS according to the line of treatment. Patients were classified into three different groups, each with a different dose intensity of everolimus (A, B, C). Results: RR was 29.8% (A), 27.8% (B) (p = 0.953), and not evaluable (C). PFS was 9 months (95% CI 7–11) (A), 10 months (95% CI 9–11) (B), and 5 months (95% CI 2–8) (C), p = 0.956. OS was 38 months (95% CI 24–38) (A), median not reached (B), and 13 months (95% CI 10–25) (C), p = 0.002. Adverse events were stomatitis 57.7% (11.0% grade 3–4), asthenia 46.0% (6.1% grade 3–4), hypercholesterolemia 46.0% (0.6% grade 3–4), and hyperglycemia 35.6% (5.5% grade 3–4). The main reason for discontinuation/interruption was grade 2–3 stomatitis. Conclusions: No correlation was found between dose intensity (5 vs. 10 mg labeled dose) and efficacy in terms of RR and PFS. The tolerability of the higher dose was poor in our experience, although this had no impact on efficacy.

Published
2017

26. Metronomic Chemotherapy in Triple-Negative Metastatic Breast Cancer: The Future Is Now?

Author

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.

Published
2017

34. Fertility concerns, preservation strategies and quality of life in young women with breast cancer: Baseline results from an ongoing prospective cohort study in selected European Centers

Author

Ruggeri, M, Pagan, E, Bagnardi, V, Bianco, N, Gallerani, E, Buser, K, Giordano, M, Gianni, L, Rabaglio, M, Freschi, A, Cretella, E, Clerico, M, Farolfi, A, Simoncini, E, Ciccarese, M, Rauch, D, Ramello, M, Glaus, A, Berardi, R, Pellanda, A, Ribi, K, Gelber, S, Partridge, A, Goldhirsch, A, Pagani, O, Pellanda, A Franzetti, Partridge, A H, Ruggeri, M, Pagan, E, Bagnardi, V, Bianco, N, Gallerani, E, Buser, K, Giordano, M, Gianni, L, Rabaglio, M, Freschi, A, Cretella, E, Clerico, M, Farolfi, A, Simoncini, E, Ciccarese, M, Rauch, D, Ramello, M, Glaus, A, Berardi, R, Pellanda, A, Ribi, K, Gelber, S, Partridge, A, Goldhirsch, A, Pagani, O, Pellanda, A Franzetti, and Partridge, A H

Abstract

Objectives: Most research addressing needs and concerns of young patients with breast cancer (≤40 years) is retrospective. The HOHO European protocol is a prospective multicenter cohort study of young women with newly diagnosed breast cancer, about fertility, psychosocial and quality of life concerns. Here we report the baseline data and focus on predictors of fertility concerns. Materials and methods: Patient surveys and medical record review were used. The baseline survey included sociodemographic, medical and treatment data as well as questions on fertility concerns and preservation strategies. Subscales from the CAncer Rehabilitation Evaluation System-Short Form (CARES-SF) were administered to measure specific quality of life aspects. Uni- and multivariable modeling were used to investigate predictors of greater fertility concern. Results: Among 297 eligible respondents, 67% discussed fertility issues before starting therapy, 64% were concerned about becoming infertile after treatment, and 15% decided not to follow prescribed therapies. Fifty-four percent of women wished future children before diagnosis; of these, 71% still desired biologic children afterwards. In multivariable analysis, not having children was the only patient characteristic significantly associated with fertility concerns at diagnosis. Twenty-seven percent used fertility preservation strategies. Women who received chemotherapy reported greater physical (p = 0.021) and sexual difficulties (p = 0.039) than women who did not. Women who were married or had a partner reported less psychosocial problems than single women (p = 0.039). Conclusions: Young women with newly diagnosed breast cancer have several concerns, including, but not limited to, fertility. The HOHO European study provides valuable information to develop targeted interventions.

Published
2019

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

Author

Cazzaniga, M. E., Vallini, I., Montagna, E., Amoroso, D., Berardi, R., Butera, A., Cagossi, K., Cavanna, L., Ciccarese, M., Cinieri, S., Cretella, E., De Conciliis, E., Febbraro, A., Ferraù, F., Ferzi, A., Baldelli, A., Fontana, A., Gambaro, A. R., Garrone, O., and Gebbia, V.

Abstract

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

Published
2021
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37. Cyclical variation of plasma lipids, apolipoproteins, and lipoprotein(a) during menstrual cycle of normal women

Author

Tonolo, G., Ciccarese, M., Brizzi, P., Milia, S., Dessole, S., Pussu, L., Secchi, G., and Maioli, M.

Subjects
Menstrual cycle -- Physiological aspects, Lipid metabolism -- Physiological aspects, Hormones, Sex -- Physiological aspects, Coronary heart disease -- Risk factors, Biological sciences
Abstract

Sixteen nulliparous healthy women with ages ranging from 25 to 36 yrs. participated in a study to determine the effects of hormonal changes associated with the menstrual cycle on lipid and lipoprotein levels in the blood. The results show that endogenous female sex hormones modulate the plasma levels of lipids and apolipoproteins, including lipoprotein(a). Thus, the phase of the menstrual cycle should be taken into consideration when evaluating the lipid risk profile of women who have not reached menopause.

Published
1995

39. 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

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

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

Author

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

Published
2019
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45. Metronomic Chemotherapy in Triple-Negative Metastatic Breast Cancer: The Future Is Now?

Author

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.

Published
2017
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47. Abstract P1-17-02: Ado-trastuzumab emtansine (TDM-1) treatment and brain metastases in HER2 positive metastatic breast cancer patients: Final analysis of an italian multicenter study

Author

Fabi, A, primary, Alesini, D, additional, Valle, E, additional, Carbognin, L, additional, Arpino, G, additional, Montemurro, F, additional, Ciccarese, M, additional, Cannita, K, additional, Paris, I, additional, Cursano, MC, additional, Moscetti, L, additional, Ferretti, G, additional, De Laurentiis, M, additional, Zambelli, A, additional, La Verde, N, additional, Nisticò, C, additional, Gasparro, S, additional, Giannarelli, D, additional, and Cognetti, F, additional

Published
2018
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50. Brain metastases and ado-trastuzumab emtansine (TDM-1) treatment in HER2 positive metastatic patients: an Italian multicenter analysis

Author

Fabi, A., primary, Alesini, D., additional, Valle, E., additional, Carbognin, L., additional, Arpino, G., additional, Santini, D., additional, Montemurro, F., additional, Ciccarese, M., additional, Cannita, K., additional, Paris, I., additional, Moscetti, L., additional, De Laurentiis, M., additional, Zambelli, A., additional, La Verde, N., additional, Nisticò, C., additional, Ferretti, G., additional, Gasparro, S., additional, Giannarelli, D., additional, and Cognetti, F., additional

Published
2017
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