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51. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression >= 50%: a multicenter study with external validation

Author

Cortellini, A., Ricciuti, B., Tiseo, M., Bria, E., Banna, G.L., Aerts, J.G.J.V. (Joachim), Barbieri, F. (Federica), Giusti, R., Cortinovis, D.L., Migliorino, M.R., Catino, A., Passiglia, F., Torniai, M., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Occhipinti, M.A., Rastelli, F., Chiari, R., Rocco, D. (Daniela) de, Inno, A., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Grossi, F., Filetti, M., Pizzutilo, P., Russano, M., Citarella, F., Cantini, L., Targato, G., Nigro, O., Ferrara, M.G., Buti, S., Scodes, S., Landi, L., Guaitoli, G., Della Gravara, L., Tabbo, F., Ricciardi, S., De Toma, A., Friedlaender, A., Petrelli, F., Addeo, A., Porzio, G., Ficorella, C., Cortellini, A., Ricciuti, B., Tiseo, M., Bria, E., Banna, G.L., Aerts, J.G.J.V. (Joachim), Barbieri, F. (Federica), Giusti, R., Cortinovis, D.L., Migliorino, M.R., Catino, A., Passiglia, F., Torniai, M., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Occhipinti, M.A., Rastelli, F., Chiari, R., Rocco, D. (Daniela) de, Inno, A., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Grossi, F., Filetti, M., Pizzutilo, P., Russano, M., Citarella, F., Cantini, L., Targato, G., Nigro, O., Ferrara, M.G., Buti, S., Scodes, S., Landi, L., Guaitoli, G., Della Gravara, L., Tabbo, F., Ricciardi, S., De Toma, A., Friedlaender, A., Petrelli, F., Addeo, A., Porzio, G., and Ficorella, C.

Abstract

Background The association between obesity and outcomes in patients receiving programmed death-1/ programmed death ligand-1 (PD-L1) checkpoint inhibitors has already been confirmed in pre-treated non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 tumor expression. Methods We present the outcomes analysis according to baseline body mass index (BMI) and BMI variation in a large cohort of metastatic NSCLC patients with a PD-L1 expression ≥50%, receiving first line pembrolizumab. We also evaluated a control cohort of metastatic NSCLC patients treated with first line platinum-based chemotherapy. Normal weight was set as control group. Results 962 patients and 426 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Obese patients had a significantly higher objective response rate (ORR) (OR=1.61 (95% CI: 1.04– 2.50)) in the pembrolizumab cohort, while overweight patients had a significantly lower ORR (OR=0.59 (95% CI: 0.37–0.92)) within the chemotherapy cohort. Obese patients had a significantly longer progression-free survival (PFS) (HR=0.61 (95% CI: 0.45–0.82)) in the pembrolizumab cohort. Conversely, they had a significantly shorter PFS in the chemotherapy cohort (HR=1.27 (95% CI: 1.01–1.60)). Obese patients had a significantly longer overall survival (OS) within the pembrolizumab cohort (HR=0.70 (95% CI: 0.49–0.99)), while no significant differences according to baseline BMI were found in the chemotherapy cohort. BMI variation significantly affected ORR, PFS and OS in both the pembrolizumab and the chemotherapy cohorts. Conclusions Baseline obesity is associated to significantly improved ORR, PFS and OS in metastatic NSCLC patients with a PD-L1 expression of ≥50%, receiving first line pembrolizumab, but not among patients treated with chemotherapy. BMI variation is also significantly related to clinical outcomes.

Published
2020
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52. Impact of BMI on HER2+ metastatic breast cancer patients treated with pertuzumab and/or trastuzumab emtansine. Real-world evidence

Author

Krasniqi, E, Pizzuti, L, Barchiesi, G, Sergi, D, Carpano, S, Botti, C, Kayal, R, Sanguineti, G, Marchetti, P, Botticelli, A, Marinelli, D, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Tomao, S, Tonini, G, Santini, D, Michelotti, A, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Cazzaniga, M, Moscetti, L, Fabbri, A, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Garufi, C, Di Stefano, P, Mirabelli, R, Veltri, E, Paris, I, Giotta, F, Lorusso, V, Landucci, E, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Valerio, M, Berardi, R, Pistelli, M, Cannita, K, Zamagni, C, Garrone, O, Baldini, E, Livi, L, Meattini, I, Del Medico, P, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Villa, A, Sperduti, I, Mazzotta, M, Barba, M, Giordano, A, Vici, P, Krasniqi, Eriseld, Pizzuti, Laura, Barchiesi, Giacomo, Sergi, Domenico, Carpano, Silvia, Botti, Claudio, Kayal, Ramy, Sanguineti, Giuseppe, Marchetti, Paolo, Botticelli, Andrea, Marinelli, Daniele, Gamucci, Teresa, Natoli, Clara, Grassadonia, Antonino, Tinari, Nicola, Tomao, Silverio, Tonini, Giuseppe, Santini, Daniele, Michelotti, Aandrea, Mentuccia, Lucia, Vaccaro, Aangela, Magnolfi, Emanuela, Gelibter, Alain, Magri, Valentina, Cortesi, Enrico, D'Onofrio, Loretta, Cassano, Alessandra, Cazzaniga, Marina, Moscetti, Luca, Fabbri, Agnese, Scinto, Angelo Fedele, Corsi, Domenico, Carbognin, Luisa, Bria, Emilio, La Verde, Nicla, Garufi, Carlo, Di Stefano, Pia, Mirabelli, Rossana, Veltri, Enzo, Paris, Ida, Giotta, Francesco, Lorusso, Vito, Landucci, Elisa, Ficorella, Corrado, Roselli, Mario, Adamo, Vincenzo, Ricciardi, Giuseppina, Russo, Antonio, Valerio, Maria Rosaria, Berardi, Rossana, Pistelli, Mirco, Cannita, Katia, Zamagni, Claudio, Garrone, Ornella, Baldini, Editta, Livi, Lorenzo, Meattini, Icro, Del Medico, Pietro, Generali, Daniele, De Maria, Ruggero, Risi, Emanuela, Ciliberto, Gennaro, Villa, Alice, Sperduti, Isabella, Mazzotta, Marco, Barba, Maddalena, Giordano, Antonio, Vici, Patrizia, Krasniqi, E, Pizzuti, L, Barchiesi, G, Sergi, D, Carpano, S, Botti, C, Kayal, R, Sanguineti, G, Marchetti, P, Botticelli, A, Marinelli, D, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Tomao, S, Tonini, G, Santini, D, Michelotti, A, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Cazzaniga, M, Moscetti, L, Fabbri, A, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Garufi, C, Di Stefano, P, Mirabelli, R, Veltri, E, Paris, I, Giotta, F, Lorusso, V, Landucci, E, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Valerio, M, Berardi, R, Pistelli, M, Cannita, K, Zamagni, C, Garrone, O, Baldini, E, Livi, L, Meattini, I, Del Medico, P, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Villa, A, Sperduti, I, Mazzotta, M, Barba, M, Giordano, A, Vici, P, Krasniqi, Eriseld, Pizzuti, Laura, Barchiesi, Giacomo, Sergi, Domenico, Carpano, Silvia, Botti, Claudio, Kayal, Ramy, Sanguineti, Giuseppe, Marchetti, Paolo, Botticelli, Andrea, Marinelli, Daniele, Gamucci, Teresa, Natoli, Clara, Grassadonia, Antonino, Tinari, Nicola, Tomao, Silverio, Tonini, Giuseppe, Santini, Daniele, Michelotti, Aandrea, Mentuccia, Lucia, Vaccaro, Aangela, Magnolfi, Emanuela, Gelibter, Alain, Magri, Valentina, Cortesi, Enrico, D'Onofrio, Loretta, Cassano, Alessandra, Cazzaniga, Marina, Moscetti, Luca, Fabbri, Agnese, Scinto, Angelo Fedele, Corsi, Domenico, Carbognin, Luisa, Bria, Emilio, La Verde, Nicla, Garufi, Carlo, Di Stefano, Pia, Mirabelli, Rossana, Veltri, Enzo, Paris, Ida, Giotta, Francesco, Lorusso, Vito, Landucci, Elisa, Ficorella, Corrado, Roselli, Mario, Adamo, Vincenzo, Ricciardi, Giuseppina, Russo, Antonio, Valerio, Maria Rosaria, Berardi, Rossana, Pistelli, Mirco, Cannita, Katia, Zamagni, Claudio, Garrone, Ornella, Baldini, Editta, Livi, Lorenzo, Meattini, Icro, Del Medico, Pietro, Generali, Daniele, De Maria, Ruggero, Risi, Emanuela, Ciliberto, Gennaro, Villa, Alice, Sperduti, Isabella, Mazzotta, Marco, Barba, Maddalena, Giordano, Antonio, and Vici, Patrizia

Abstract

Body mass index (BMI) is a main indicator of obesity and its association with breast cancer is well established. However, little is known in the metastatic setting, especially in HER2-positive patients. We assessed the influence of BMI on clinical outcomes of patients treated with pertuzumab and/or trastuzumab emtansine (T-DM1) for HER2+ metastatic breast cancer (mBC). BMI was addressed as a categorical variable, being classified on the basis of the following ranges, that is, 18.5–24.9, 25–29.9, and 30.0–34.9, namely, normal weight, overweight, and Class I obesity. The outcomes chosen were progression-free survival to first-line chemotherapy (PFS1) and overall survival (OS). Overall (N = 709), no impact of BMI was observed on PFS1 (p =.15), while BMI ≥ 30 was associated with worse OS (p =.003). In subjects who progressed to first line (N = 575), analyzing data across PFS1 quartiles and strata of disease burden, BMI predicted lower PFS1 in patients within the I PFS1 quartile and with the lowest disease burden (p =.001). Univariate analysis showed a detrimental effect of BMI ≥ 30 on OS for women within the I PFS1 quartile (p =.03). Results were confirmed in multivariate analysis. According to PFS1 quartiles a higher percentage of patients with high BMI and low disease burden progressed within 6 months of therapy. The effect of BMI on prognosis was also confirmed in multivariate analysis of OS for overall population. In our cohort, a BMI ≥ 30 correlated with worse OS in patients with HER2+ mBC who received pertuzumab and/or T-DM1 but had no impact on PFS to first line. BMI predicted worse I PFS1 quartile.

Published
2020

53. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression >= 50%: a multicenter study with external validation

Author

Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, GL, Aerts, Joachim, Barbieri, F, Giusti, R, Cortinovis, DL, Migliorino, MR, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, MA, Rastelli, F, Chiari, R, De Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, Luca, Targato, G, Nigro, O, Ferrara, MG, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbo, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, GL, Aerts, Joachim, Barbieri, F, Giusti, R, Cortinovis, DL, Migliorino, MR, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, MA, Rastelli, F, Chiari, R, De Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, Luca, Targato, G, Nigro, O, Ferrara, MG, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbo, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, and Ficorella, C

Published
2020

54. Loss of HER2 and decreased T-DM1 efficacy in HER2 positive advanced breast cancer treated with dual HER2 blockade: the SePHER Study

Author

Bon, G., Pizzuti, L., Laquintana, V., Loria, R., Porru, M., Marchio, C., Krasniqi, E., Barba, M., Maugeri-Sacca, M., Gamucci, T., Berardi, R., Livi, L., Ficorella, C., Natoli, C., Cortesi, E., Generali, D., La Verde, N., Cassano, Alessandra, Bria, Emilio, Moscetti, L., Michelotti, A., Adamo, V., Zamagni, C., Tonini, G., Barchiesi, G., Mazzotta, M., Marinelli, D., Tomao, S., Marchetti, P., Valerio, M. R., Mirabelli, R., Russo, A., Fabbri, M. A., D'Ostilio, N., Veltri, E., Corsi, D., Garrone, O., Paris, I., Sarobba, G., Giotta, F., Garufi, C., Cazzaniga, M., Del Medico, P., Roselli, M., Sanguineti, G., Sperduti, I., Sapino, A., De Maria Marchiano, Ruggero, Leonetti, C., Di Leo, A., Ciliberto, G., Falcioni, R., Vici, P., Cassano A. (ORCID:0000-0002-3311-7163), Bria E. (ORCID:0000-0002-2333-704X), De Maria R. (ORCID:0000-0003-2255-0583), Bon, G., Pizzuti, L., Laquintana, V., Loria, R., Porru, M., Marchio, C., Krasniqi, E., Barba, M., Maugeri-Sacca, M., Gamucci, T., Berardi, R., Livi, L., Ficorella, C., Natoli, C., Cortesi, E., Generali, D., La Verde, N., Cassano, Alessandra, Bria, Emilio, Moscetti, L., Michelotti, A., Adamo, V., Zamagni, C., Tonini, G., Barchiesi, G., Mazzotta, M., Marinelli, D., Tomao, S., Marchetti, P., Valerio, M. R., Mirabelli, R., Russo, A., Fabbri, M. A., D'Ostilio, N., Veltri, E., Corsi, D., Garrone, O., Paris, I., Sarobba, G., Giotta, F., Garufi, C., Cazzaniga, M., Del Medico, P., Roselli, M., Sanguineti, G., Sperduti, I., Sapino, A., De Maria Marchiano, Ruggero, Leonetti, C., Di Leo, A., Ciliberto, G., Falcioni, R., Vici, P., Cassano A. (ORCID:0000-0002-3311-7163), Bria E. (ORCID:0000-0002-2333-704X), and De Maria R. (ORCID:0000-0003-2255-0583)

Abstract

Background: HER2-targeting agents have dramatically changed the therapeutic landscape of HER2+ advanced breast cancer (ABC). Within a short time frame, the rapid introduction of new therapeutics has led to the approval of pertuzumab combined with trastuzumab and a taxane in first-line, and trastuzumab emtansine (T-DM1) in second-line. Thereby, evidence of T-DM1 efficacy following trastuzumab/pertuzumab combination is limited, with data from some retrospective reports suggesting lower activity. The purpose of the present study is to investigate T-DM1 efficacy in pertuzumab-pretreated and pertuzumab naïve HER2 positive ABC patients. We also aimed to provide evidence on the exposure to different drugs sequences including pertuzumab and T-DM1 in HER2 positive cell lines. Methods: The biology of HER2 was investigated in vitro through sequential exposure of resistant HER2 + breast cancer cell lines to trastuzumab, pertuzumab, and their combination. In vitro experiments were paralleled by the analysis of data from 555 HER2 + ABC patients treated with T-DM1 and evaluation of T-DM1 efficacy in the 371 patients who received it in second line. Survival estimates were graphically displayed in Kaplan Meier curves, compared by log rank test and, when possibile, confirmed in multivariate models. Results: We herein show evidence of lower activity of T-DM1 in two HER2+ breast cancer cell lines resistant to trastuzumab+pertuzumab, as compared to trastuzumab-resistant cells. Lower T-DM1 efficacy was associated with a marked reduction of HER2 expression on the cell membrane and its nuclear translocation. HER2 downregulation at the membrane level was confirmed in biopsies of four trastuzumab/pertuzumab-pretreated patients. Among the 371 patients treated with second-line T-DM1, median overall survival (mOS) from diagnosis of advanced disease and median progression-free survival to second-line treatment (mPFS2) were 52 and 6 months in 177 patients who received trastuzumab/pertuzumab in f

Published
2020

55. Impact of BMI on HER2+ metastatic breast cancer patients treated with pertuzumab and/or trastuzumab emtansine. Real-world evidence

Author

Krasniqi, E., Pizzuti, L., Barchiesi, G., Sergi, D., Carpano, S., Botti, C., Kayal, R., Sanguineti, G., Marchetti, P., Botticelli, A., Marinelli, D., Gamucci, T., Natoli, C., Grassadonia, A., Tinari, N., Tomao, S., Tonini, Gerolamo, Santini, D., Michelotti, A., Mentuccia, L., Vaccaro, Ascanio Giuseppe, Magnolfi, E., Gelibter, A., Magri, V., Cortesi, E., D'Onofrio, L., Cassano, A., Cazzaniga, M., Moscetti, L., Fabbri, A., Scinto, A. F., Corsi, Domenico Cristiano, Carbognin, L., Bria, Emilio, La Verde, N., Garufi, C., Di Stefano, P., Mirabelli, R., Veltri, E., Paris, Ida, Giotta, F., Lorusso, V., Landucci, E., Ficorella, C., Roselli, M., Adamo, V., Ricciardi, Walter, Russo, A., Valerio, M. R., Berardi, R., Pistelli, M., Cannita, K., Zamagni, C., Garrone, O., Baldini, E., Livi, L., Meattini, I., Del Medico, P., Generali, Daniele, De Maria Marchiano, Ruggero, Risi, E., Ciliberto, G., Villa, Angela Ida, Sperduti, I., Mazzotta, M., Barba, M., Giordano, Alessandro, Vici, P., Tonini G., Vaccaro A., Corsi D., Bria E. (ORCID:0000-0002-2333-704X), Paris I., Ricciardi G. (ORCID:0000-0002-5655-688X), Generali D. (ORCID:0000-0003-2480-3855), De Maria R. (ORCID:0000-0003-2255-0583), Villa A. (ORCID:0000-0003-0679-334X), Giordano A. (ORCID:0000-0002-6978-0880), Krasniqi, E., Pizzuti, L., Barchiesi, G., Sergi, D., Carpano, S., Botti, C., Kayal, R., Sanguineti, G., Marchetti, P., Botticelli, A., Marinelli, D., Gamucci, T., Natoli, C., Grassadonia, A., Tinari, N., Tomao, S., Tonini, Gerolamo, Santini, D., Michelotti, A., Mentuccia, L., Vaccaro, Ascanio Giuseppe, Magnolfi, E., Gelibter, A., Magri, V., Cortesi, E., D'Onofrio, L., Cassano, A., Cazzaniga, M., Moscetti, L., Fabbri, A., Scinto, A. F., Corsi, Domenico Cristiano, Carbognin, L., Bria, Emilio, La Verde, N., Garufi, C., Di Stefano, P., Mirabelli, R., Veltri, E., Paris, Ida, Giotta, F., Lorusso, V., Landucci, E., Ficorella, C., Roselli, M., Adamo, V., Ricciardi, Walter, Russo, A., Valerio, M. R., Berardi, R., Pistelli, M., Cannita, K., Zamagni, C., Garrone, O., Baldini, E., Livi, L., Meattini, I., Del Medico, P., Generali, Daniele, De Maria Marchiano, Ruggero, Risi, E., Ciliberto, G., Villa, Angela Ida, Sperduti, I., Mazzotta, M., Barba, M., Giordano, Alessandro, Vici, P., Tonini G., Vaccaro A., Corsi D., Bria E. (ORCID:0000-0002-2333-704X), Paris I., Ricciardi G. (ORCID:0000-0002-5655-688X), Generali D. (ORCID:0000-0003-2480-3855), De Maria R. (ORCID:0000-0003-2255-0583), Villa A. (ORCID:0000-0003-0679-334X), and Giordano A. (ORCID:0000-0002-6978-0880)

Abstract

Body mass index (BMI) is a main indicator of obesity and its association with breast cancer is well established. However, little is known in the metastatic setting, especially in HER2-positive patients. We assessed the influence of BMI on clinical outcomes of patients treated with pertuzumab and/or trastuzumab emtansine (T-DM1) for HER2+ metastatic breast cancer (mBC). BMI was addressed as a categorical variable, being classified on the basis of the following ranges, that is, 18.5–24.9, 25–29.9, and 30.0–34.9, namely, normal weight, overweight, and Class I obesity. The outcomes chosen were progression-free survival to first-line chemotherapy (PFS1) and overall survival (OS). Overall (N = 709), no impact of BMI was observed on PFS1 (p =.15), while BMI ≥ 30 was associated with worse OS (p =.003). In subjects who progressed to first line (N = 575), analyzing data across PFS1 quartiles and strata of disease burden, BMI predicted lower PFS1 in patients within the I PFS1 quartile and with the lowest disease burden (p =.001). Univariate analysis showed a detrimental effect of BMI ≥ 30 on OS for women within the I PFS1 quartile (p =.03). Results were confirmed in multivariate analysis. According to PFS1 quartiles a higher percentage of patients with high BMI and low disease burden progressed within 6 months of therapy. The effect of BMI on prognosis was also confirmed in multivariate analysis of OS for overall population. In our cohort, a BMI ≥ 30 correlated with worse OS in patients with HER2+ mBC who received pertuzumab and/or T-DM1 but had no impact on PFS to first line. BMI predicted worse I PFS1 quartile.

Published
2020

56. Distinct HR expression patterns significantly affect the clinical behavior of metastatic HER2+ breast cancer and degree of benefit from novel anti-HER2 agents in the real world setting

Author

Pizzuti, L., Krasniqi, E., Barchiesi, G., Della Giulia, M., Izzo, F., Sanguineti, G., Marchetti, P., Mazzotta, M., Giusti, R., Botticelli, A., Gamucci, T., Natoli, C., Grassadonia, A., Tinari, N., Iezzi, L., Tomao, S., Tomao, F., Tonini, G., Santini, D., Astone, Antonio, Michelotti, A., De Angelis, C., Mentuccia, L., Vaccaro, A., Magnolfi, E., Gelibter, A., Magri, V., Cortesi, E., D'Onofrio, L., Cassano, A., Rossi, E., Cazzaniga, M., Moscetti, L., Omarini, C., Piacentini, F., Fabbri, M. A., Scinto, A. F., Corsi, D., Carbognin, L., Bria, Emilio, La Verde, N., Samaritani, R., Garufi, C., Barni, S., Mirabelli, R., Sarmiento, R., Veltri, E. M., D'Auria, G., Paris, I., Giotta, F., Lorusso, V., Cardillo, F., Landucci, E., Mauri, M., Ficorella, C., Roselli, M., Adamo, V., Ricciardi, G. R. R., Russo, A., Berardi, R., Pistelli, M., Fiorio, E., Cannita, K., Sini, V., D'Ostilio, N., Foglietta, J., Greco, F., Zamagni, C., Garrone, O., Di Cocco, B., Baldini, E., Livi, L., Desideri, I., Meattini, I., Sarobba, G., Del Medico, P., De Tursi, M., Generali, D., De Maria Marchiano, Ruggero, Risi, E., Ciliberto, G., Sperduti, I., Villa, A., Barba, M., Di Leo, A., Vici, P., Astone A. (ORCID:0000-0001-9572-309X), Bria E. (ORCID:0000-0002-2333-704X), De Maria R. (ORCID:0000-0003-2255-0583), Pizzuti, L., Krasniqi, E., Barchiesi, G., Della Giulia, M., Izzo, F., Sanguineti, G., Marchetti, P., Mazzotta, M., Giusti, R., Botticelli, A., Gamucci, T., Natoli, C., Grassadonia, A., Tinari, N., Iezzi, L., Tomao, S., Tomao, F., Tonini, G., Santini, D., Astone, Antonio, Michelotti, A., De Angelis, C., Mentuccia, L., Vaccaro, A., Magnolfi, E., Gelibter, A., Magri, V., Cortesi, E., D'Onofrio, L., Cassano, A., Rossi, E., Cazzaniga, M., Moscetti, L., Omarini, C., Piacentini, F., Fabbri, M. A., Scinto, A. F., Corsi, D., Carbognin, L., Bria, Emilio, La Verde, N., Samaritani, R., Garufi, C., Barni, S., Mirabelli, R., Sarmiento, R., Veltri, E. M., D'Auria, G., Paris, I., Giotta, F., Lorusso, V., Cardillo, F., Landucci, E., Mauri, M., Ficorella, C., Roselli, M., Adamo, V., Ricciardi, G. R. R., Russo, A., Berardi, R., Pistelli, M., Fiorio, E., Cannita, K., Sini, V., D'Ostilio, N., Foglietta, J., Greco, F., Zamagni, C., Garrone, O., Di Cocco, B., Baldini, E., Livi, L., Desideri, I., Meattini, I., Sarobba, G., Del Medico, P., De Tursi, M., Generali, D., De Maria Marchiano, Ruggero, Risi, E., Ciliberto, G., Sperduti, I., Villa, A., Barba, M., Di Leo, A., Vici, P., Astone A. (ORCID:0000-0001-9572-309X), Bria E. (ORCID:0000-0002-2333-704X), and De Maria R. (ORCID:0000-0003-2255-0583)

Abstract

We analyzed data from 738 HER2-positive metastatic breast cancer (mbc) patients treated with pertuzumab-based regimens and/or T-DM1 at 45 Italian centers. Outcomes were explored in relation to tumor subtype assessed by immunohistochemistry (IHC). The median progression-free survival at first-line (mPFS1) was 12 months. Pertuzumab as first-line conferred longer mPFS1 compared to other first-line treatments (16 vs. 9 months, p = 0.0001), regardless of IHC subtype. Median PFS in second-line (mPFS2) was 7 months, with no difference by IHC subtype, but it was more favorable with T-DM1 compared to other agents (7 vs. 6 months, p = 0.03). There was no PFS2 gain in patients with tumors expressing both hormonal receptors (HRs; p = 0.17), while a trend emerged for tumors with one HR (p = 0.05). Conversely, PFS2 gain was significant in HRs-negative tumors (p = 0.04). Median overall survival (mOS) was 74 months, with no significant differences by IHC subtypes. Survival rates at 2 and 3 years in patients treated with T-DM1 in second-line after pertuzumab were significantly lower compared to pertuzumab-naïve patients (p = 0.01). When analyzed by IHC subtype, the outcome was confirmed if both HRs or no HRs were expressed (p = 0.02 and p = 0.006, respectively). Our results confirm that HRs expression impacts the clinical behavior and novel treatment-related outcomes of HER2-positive tumors when treatment sequences are considered. Moreover, multivariate analysis showed that HRs expression had no effect on PFS and OS. Further studies are warranted to confirm our findings and clarify the interplay between HER2 and estrogen receptor pathways in HER2-positive (mbc) patients.

Published
2020

57. Single‐institution study of correlations between skeletal muscle mass, its density, and clinical outcomes in non‐small cell lung cancer patients treated with first‐line chemotherapy

Author

Cortellini, A., Palumbo, P., Porzio, G., Verna, L., Giordano, A. V., Masciocchi, C., Parisi, A., Cannita, K., Ficorella, C., and Bozzetti, F.

Subjects
Adult, Male, Lung Neoplasms, NSCLC, muscle density, sarcopenia, BMI, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Humans, Body Weights and Measures, Non-Small-Cell Lung, Muscle, Skeletal, Aged, Neoplasm Staging, Proportional Hazards Models, Retrospective Studies, Aged, 80 and over, Carcinoma, Skeletal, Original Articles, Organ Size, Middle Aged, Prognosis, lung cancer, Female, Neoplasm Grading, Treatment Outcome, Muscle, Original Article
Abstract

Background Sarcopenia and muscle tissue degradation are hallmarks of the majority of chronic diseases, including non‐small cell lung cancer (NSCLC). A computed tomography scan could be an easy modality to estimate the skeletal muscle mass through cross‐sectional image analysis at the level of the third lumbar vertebra. Methods Baseline skeletal muscle mass (SMM) was evaluated through the skeletal muscle index (SMI), together with skeletal muscle radiodensity (SMD), in NSCLC patients undergoing first‐line chemotherapy to evaluate correlations with safety and clinical outcomes. When SMIs at different time points were available, further comparison was made between patients with worse and improved SMIs. Results Among 81 stage IV NSCLC patients, 28 had low SMM and 23 had low SMD. There were no significant differences in univariate analysis of progression‐free survival (PFS) between patients with baseline low and non‐low SMM (P = 0.06388) or between patients with low and non‐low SMD (P = 0.9126). Baseline low SMM, however, proved a significant predictor of shorter PFS in multivariate analysis (hazard ratio 0.54, 95% confidence interval 0.31–0.93; P = 0.0278), but not low SMD. There were no differences in overall survival (OS) between patients with baseline low and non‐low SMM or low and non‐low SMD. No differences in PFS and OS between evaluable patients with worse or improved SMI were found. A significant difference in hematological toxicities between patients with baseline low and non‐low SMM (P = 0.0358) was observed. Conclusions Low SMM is predictive of shorter PFS, while consecutive changes in muscular mass do not seem to be a predictor of PFS or OS. The role of muscle radiodensity remains a matter of debate.

Published
2018

58. Functional categories of TP53 mutation in colorectal cancer: results of an International Collaborative Study

Author

Iacopetta, B., Russo, A., Bazan, V., Dardanoni, G., Gebbia, N., Soussi, T., Kerr, D., Elsaleh, H., Soong, R., Kandioler, D., Janschek, E., Kappel, S., Lung, M., Leung, C.-S.S., Ko, J.M., Yuen, S., Ho, J., Leung, S.Y., Crapez, E., Duffour, J., Ychou, M., Leahy, D.T., O'Donoghue, D.P., Agnese, V., Cascio, S., Di Fede, G., Chieco-Bianchi, L., Bertorelle, R., Belluco, C., Giaretti, W., Castagnola, P., Ricevuto, E., Ficorella, C., Bosari, S., Arizzi, C.D., Miyaki, M., Onda, M., Kampman, E., Diergaarde, B., Royds, J., Lothe, R.A., Diep, C.B., Meling, G.I., Ostrowski, J., Trzeciak, L., Guzińska-Ustymowicz, K., Zalewski, B., Capellá, G.M., Moreno, V., Peinado, M.A., Lönnroth, C., Lundholm, K., Sun, X.F., Jansson, A., Bouzourene, H., Hsieh, L.-L., Tang, R., Smith, D.R., Allen-Mersh, T.G., Khan, Z.A.J., Shorthouse, A.J., Silverman, M.L., Kato, S., and Ishioka, C.

Published
2006
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60. P-168 Second-line, anti-VEGF based after first-line, anti-EGFR based treatment in RAS wild-type metastatic colorectal cancer: The multicenter, retrospective, real-life SLAVE study

Author

Parisi, A., primary, Camarda, F., additional, Ribelli, M., additional, Rossini, D., additional, Germani, M., additional, Dell'Aquila, E., additional, Natoli, C., additional, Pietro, D., additional, Corsi, D., additional, Zurlo, I., additional, Lombardi, P., additional, Zanaletti, N., additional, Giampieri, R., additional, Merloni, F., additional, Occhipinti, M., additional, Marchetti, P., additional, Roberto, M., additional, Mazzuca, F., additional, Ghidini, M., additional, Garajová, I., additional, Zoratto, F., additional, and Ficorella, C., additional

Published
2020
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62. 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

73. Osimertinib beyond disease progression in T790M EGFR-positive NSCLC patients: a multicenter study of clinicians’ attitudes

Author

Cortellini, A., primary, Leonetti, A., additional, Catino, A., additional, Pizzutillo, P., additional, Ricciuti, B., additional, De Giglio, A., additional, Chiari, R., additional, Bordi, P., additional, Santini, D., additional, Giusti, R., additional, De Tursi, M., additional, Brocco, D., additional, Zoratto, F., additional, Rastelli, F., additional, Citarella, F., additional, Russano, M., additional, Filetti, M., additional, Marchetti, P., additional, Berardi, R., additional, Torniai, M., additional, Cortinovis, D., additional, Sala, E., additional, Maggioni, C., additional, Follador, A., additional, Macerelli, M., additional, Nigro, O., additional, Tuzi, A., additional, Iacono, D., additional, Migliorino, M. R., additional, Banna, G., additional, Porzio, G., additional, Cannita, K., additional, Ferrara, M. G., additional, Bria, E., additional, Galetta, D., additional, Ficorella, C., additional, and Tiseo, M., additional

Published
2019
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74. Clinical outcomes to pemetrexed-based versus non-pemetrexed-based platinum doublets in patients with KRAS-mutant advanced non-squamous non-small cell lung cancer

Author

Ricciuti, B., primary, Brambilla, M., additional, Cortellini, A., additional, De Giglio, A., additional, Ficorella, C., additional, Sidoni, A., additional, Bellezza, G., additional, Crinò, L., additional, Ludovini, V., additional, Baglivo, S., additional, Metro, G., additional, and Chiari, R., additional

Published
2019
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75. A real-life multicenter study on body weight loss and body mass index in advanced Gastric Cancer patients treated with Ramucirumab-based second-line therapy

Author

Parisi, A., primary, Cortellini, A., additional, Roberto, M., additional, Venditti, O., additional, Santini, D., additional, Dell’Aquila, E., additional, Stellato, M., additional, Marchetti, P., additional, Occhipinti, M., additional, Zoratto, F., additional, Mazzuca, F., additional, Tinari, N., additional, De Tursi, M., additional, Iezzi, L., additional, Natoli, C., additional, Ratti, M., additional, Pizzo, C., additional, Ghidini, M., additional, Ficorella, C., additional, and Cannita, K., additional

Published
2019
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78. INfluenza Vaccine Indication During therapy with Immune checkpoint inhibitors: a transversal challenge. The INVIDIa study.

Author

Bersanelli, M, Giannarelli, D, Castrignanò, P, Fornarini, G, Panni, S, Mazzoni, F, Tiseo, M, Rossetti, S, Gambale, E, Rossi, Ernesto, Papa, A, Cortellini, A, Lolli, C, Ratta, R, Michiara, M, Milella, M, De Luca, E, Sorarù, M, Mucciarini, C, Atzori, F, Banna, Gl, La Torre, L, Vitale, Mg, Massari, F, Rebuzzi, Se, Facchini, G, Schinzari, Giovanni, Tomao, S, Bui, S, Vaccaro, V, Procopio, G, De Giorgi, U, Santoni, M, Ficorella, C, Sabbatini, R, Maestri, A, Natoli, C, De Tursi, M, Di Maio, M, Rapacchi, E, Pireddu, A, Sava, T, Lipari, H, Comito, F, Verzoni, E, Leonardi, F, Buti, S1, Rossi Ernesto, Schinzari Giovanni (ORCID:0000-0001-6105-7252), Bersanelli, M, Giannarelli, D, Castrignanò, P, Fornarini, G, Panni, S, Mazzoni, F, Tiseo, M, Rossetti, S, Gambale, E, Rossi, Ernesto, Papa, A, Cortellini, A, Lolli, C, Ratta, R, Michiara, M, Milella, M, De Luca, E, Sorarù, M, Mucciarini, C, Atzori, F, Banna, Gl, La Torre, L, Vitale, Mg, Massari, F, Rebuzzi, Se, Facchini, G, Schinzari, Giovanni, Tomao, S, Bui, S, Vaccaro, V, Procopio, G, De Giorgi, U, Santoni, M, Ficorella, C, Sabbatini, R, Maestri, A, Natoli, C, De Tursi, M, Di Maio, M, Rapacchi, E, Pireddu, A, Sava, T, Lipari, H, Comito, F, Verzoni, E, Leonardi, F, Buti, S1, Rossi Ernesto, and Schinzari Giovanni (ORCID:0000-0001-6105-7252)

Abstract

AIM: Considering the unmet need for the counseling of cancer patients treated with immune checkpoint inhibitors (CKI) about influenza vaccination, an explorative study was planned to assess flu vaccine efficacy in this population. METHODS: INVIDIa was a retrospective, multicenter study, enrolling consecutive advanced cancer outpatients receiving CKI during the influenza season 2016-2017. RESULTS: Of 300 patients, 79 received flu vaccine. The incidence of influenza syndrome was 24.1% among vaccinated, versus 11.8% of controls; odds ratio: 2.4; 95% CI: 1.23-4.59; p = 0.009. The clinical ineffectiveness of vaccine was more pronounced among elderly: 37.8% among vaccinated patients, versus 6.1% of unvaccinated, odds ratio: 9.28; 95% CI: 2.77-31.14; p < 0.0001. CONCLUSION: Although influenza vaccine may be clinically ineffective in advanced cancer patients receiving CKI, it seems not to negatively impact the efficacy of anticancer therapy.

Published
2018

79. Clinical and psychometric validation of the BreSAS questionnaire for symptom assessment among breast cancer survivors

Author

Giusti, R., primary, Scarpi, E., additional, Cannita, K., additional, Silva, R.R., additional, Filetti, M., additional, Mazzotta, M., additional, Rossi, R., additional, Cocciolone, V., additional, Sidoni, T., additional, Tudini, M., additional, Ficorella, C., additional, Botticelli, A., additional, Marchetti, P., additional, Porzio, G., additional, and Verna, L., additional

Published
2018
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80. Correlation between immuno-related adverse events (IRAEs) occurrence and clinical outcome in metastatic renal cell carcinoma (mRCC) patients treated with nivolumab: IRAENE trial, an Italian multi-institutional retrospective study

Author

Vitale, M.G., primary, Pipitone, S., additional, Scagliarini, S., additional, Zucali, P.A., additional, Galli, L., additional, Rossetti, S., additional, Caserta, C., additional, Iacovelli, R., additional, Masini, C., additional, Ficorella, C., additional, Di Girolamo, S., additional, Buti, S., additional, Benedetti, B., additional, Santoni, M., additional, Porta, C., additional, Bracarda, S., additional, Baldessari, C., additional, Giaquinta, S., additional, Cascinu, S., additional, and Sabbatini, R., additional

Published
2018
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81. Timed-flat infusion (TFI) 5-fluorouracil with irinotecan and oxaliplatin in pancreatic adenocarcinomas: A single institution experience with FIr/FOx regimen

Author

Cortellini, A., primary, Parisi, A., additional, Cannita, K., additional, Venditti, O., additional, Pavese, F., additional, D'Orazio, C., additional, Lanfiuti Baldi, P., additional, Vicentini, V., additional, Vicentini, R., additional, Porzio, G., additional, Verna, L., additional, and Ficorella, C., additional

Published
2018
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82. Influenza vaccine indication during anticancer therapy with immune-checkpoint inhibitors: A transversal challenge for patient’s counselling – preliminary analysis of the INVIDIa study

Author

Bersanelli, M., primary, Castrignanò, P., additional, Gambale, E., additional, Cortellini, A., additional, Tiseo, M., additional, Natoli, C., additional, Ficorella, C., additional, Panni, S., additional, Rossetti, S., additional, Papa, A., additional, Mazzoni, F., additional, Facchini, G., additional, De Giorgi, U., additional, Procopio, G., additional, Atzori, F., additional, Sava, T., additional, De Luca, E., additional, Maestri, A., additional, Massari, F., additional, and Buti, S., additional

Published
2017
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83. A retrospective multicentric observational study of trastuzumab emtansine in HER2 positive metastatic breast cancer: a real- world experience

Author

Vici, P, Pizzuti, L, Michelotti, A, Sperduti, I, Natoli, C, Mentuccia, L, Di Lauro, L, Sergi, Daniele, Marchetti, Paolo, Santini, D, Magnolfi, E, Iezzi, L, Moscetti, L, Fabbri, Alessandro, Cassano, Alessandra, Grassadonia, A, Omarini, C, Piacentini, Francesca, Botticelli, A, Bertolini, I, Scinto, Af, Zampa, G, Mauri, Marco, D'Onofrio, L, Sini, V, Barba, Marta, Maugeri-Saccà, M, Rossi, Ernesto, Landucci, E, Tomao, S, Alberti, Andrea Maria, Giotta, F, Ficorella, C, Adamo, V, Russo, A, Lorusso, Vito, Cannita, K, Barni, S, Laudadio, L, Greco, F, Garrone, O, Della Giulia, M, Marolla, P, Sanguineti, G, Di Cocco, B, Ciliberto, G, De Maria Marchiano, Ruggero, Gamucci, Teresa, Sergi D, Marchetti P, Fabbri A, Cassano A (ORCID:0000-0002-3311-7163), Barba M (ORCID:0000-0001-6084-7666), Rossi E, Alberti AM, Lorusso V, De Maria Marchiano R (ORCID:0000-0003-2255-0583), Gamucci T., Vici, P, Pizzuti, L, Michelotti, A, Sperduti, I, Natoli, C, Mentuccia, L, Di Lauro, L, Sergi, Daniele, Marchetti, Paolo, Santini, D, Magnolfi, E, Iezzi, L, Moscetti, L, Fabbri, Alessandro, Cassano, Alessandra, Grassadonia, A, Omarini, C, Piacentini, Francesca, Botticelli, A, Bertolini, I, Scinto, Af, Zampa, G, Mauri, Marco, D'Onofrio, L, Sini, V, Barba, Marta, Maugeri-Saccà, M, Rossi, Ernesto, Landucci, E, Tomao, S, Alberti, Andrea Maria, Giotta, F, Ficorella, C, Adamo, V, Russo, A, Lorusso, Vito, Cannita, K, Barni, S, Laudadio, L, Greco, F, Garrone, O, Della Giulia, M, Marolla, P, Sanguineti, G, Di Cocco, B, Ciliberto, G, De Maria Marchiano, Ruggero, Gamucci, Teresa, Sergi D, Marchetti P, Fabbri A, Cassano A (ORCID:0000-0002-3311-7163), Barba M (ORCID:0000-0001-6084-7666), Rossi E, Alberti AM, Lorusso V, De Maria Marchiano R (ORCID:0000-0003-2255-0583), and Gamucci T.

Abstract

We addressed trastuzumab emtansine (T-DM1) e cacy in HER2+ metastatic breast cancer patients treated in real-world practice, and its activity in pertuzumab- pretreated patients. We conducted a retrospective, observational study involving 23 cancer centres, and 250 patients. Survival data were analyzed by Kaplan Meier curves and log rank test. Factors testing signi cant in univariate analysis were tested in multivariate models. Median follow-up was 15 months and median T-DM1 treatment-length 4 months. Response rate was 41.6%, clinical bene t 60.9%. Median progression-free and median overall survival were 6 and 20 months, respectively. Overall, no di erences emerged by pertuzumab pretreatment, with median progression-free and median overall survival of 4 and 17 months in pertuzumab- pretreated (p=0.13), and 6 and 22 months in pertuzumab-naïve patients (p=0.27). Patients who received second-line T-DM1 had median progression-free and median overall survival of 3 and 12 months (p=0.0001) if pertuzumab-pretreated, and 8 and 26 months if pertuzumab-naïve (p=0.06). In contrast, in third-line and beyond, median progression-free and median overall survival were 16 and 18 months in pertuzumab- pretreated (p=0.05) and 6 and 17 months in pertuzumab-naïve patients (p=0.30). In multivariate analysis, lower ECOG performance status was associated with progression-free survival bene t (p<0.0001), while overall survival was positively a ected by lower ECOG PS (p<0.0001), absence of brain metastases (p 0.05), and clinical bene t (p<0.0001). Our results are comparable with those from randomized trials. Further studies are warranted to con rm and interpret our data on apparently lower T-DM1 e cacy when given as second-line treatment after pertuzumab, and on the optimal sequence order.

Published
2017

84. 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

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

Published
2017
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85. Efficacy and safety of the combination of pertuzumab (P) plus trastuzumab (T) plus docetaxel (D) for HER-2 positive metastatic breast cancer (MBC) in pretreated patients (pts) with trastuzumab in the neo/adjuvant setting: a retrospective real-life study

Author

Ricciardi, G., primary, Ficorella, C., additional, Iezzi, L., additional, Marchetti, P., additional, Pizzuti, L., additional, Prestifilippo, A., additional, Schifano, S., additional, Maimone, S., additional, and Adamo, V., additional

Published
2017
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88. Feasibility of triplets (5-FU, oxaliplatin and irinotecan based) in front and subsequent lines of metastatic colorectal cancer patients

Author

LONGOBARDI, CIRO, BRANDI, GIOVANNI, CORBELLI, JODY, DE ROSA, FRANCESCO, AGOSTINI, VALENTINA, BIASCO, GUIDO, Bruera G, Di Girolamo S, Casolino R, GARAJOVA, INGRID, Ficorella C., Longobardi C, Brandi G, Bruera G, Corbelli J, de Rosa F, Di Girolamo S, Casolino R, Agostini V, Garajovà I, Biasco G, and Ficorella C.

Subjects
5-FU, irinotecan, oxaliplatinum
Published
2011

89. Breast cancer 'tailored follow-up' in Italian oncology units: a web-based survey

Author

Natoli, C., Brocco, D., Sperduti, I., Nuzzo, A., Tinari, N., De Tursi, M., Grassadonia, A., Mazzilli, L., Iacobelli, S., Gamucci, T., Vici, P., Study, Group, Adamo, V., Airoldi, M., Amoroso, D., Angelini, F., Angiolini, C., Angiolucci, G., Ardizzoia, A., Baldini, E., Ballardini, P., Barni, S., Barone, C., Battelli, N., Bernardi, D., Bianchetti, S., Bianco, N., Biglia, Nicoletta, Bilancia, D., Biti, G., Boni, C., Bordonaro, R., Botta, M., Bretti, S., Brunello, A., Brunetti, C., Bruno, D., Bucci, E., Buzzoni, R., Cagossi, K., Cappelletti, C., Cappuzzo, F., Cardillo, F., Carroccio, R., Cascinu, S., Cavanna, L., Cianchetti, E., Clerico, M., Contu, A., Corsi, D., Cortesi, L., Cretella, E., Crispino, S., Di Lieto, M., Di Lullo, L., Durini, E., Fabi, A., Failla, G., Fattorusso, S., Ferraù, F., Ferro, A., Ficorella, C., Fogazzi, G., Foglietta, J., Francini, G., Fusco, O., Gennari, A., Ghiani, M., Gianni, L., Giordano, M., Giotta, F., Giuliani, R., Gori, S., Graiff, C., Guarneri, V., Guarneri, D., Guglielmi, F., Landriscina, M., Laudadio, L., Lombardo, M., Longo, F., Macellari, G., Madeddu, C., Magnanini, S., Maiorino, L., Mangiameli, A., Marini, G., Massidda, B., Mattioli, R., Michelotti, A., Molino, A., Montesarchio, V., Morale, A., Murgo, R., Naso, G., Natale, D., Orditura, M., Orrù, S., Pace, R., Palazzo, A., Palma, F., Pancotti, A., Pandoli, G., Papaldo, P., Parisi, A. M., Passalacqua, R., Pellegrino, A., Perrucci, B., Proietti, E., Recchia, F., Riccardi, F., Rispoli, A. I., Rocca, A., Romaniello, I., Rossetti, R., Rossi, D., Rosti, G., Ruggeri, E. M., Russo, A., Savarino, A., Savastano, C., Scognamiglio, G., Scognamiglio, M., Seminara, P., Serrachini, S., Sidoti, V., Silva, R. R., Surace, G., Tomao, S., Tonini, G., Trenta, P., Turazza, M., Valenza, R., Veltri, E., Zampa, G., Zaniboni, A., Zanirato, S., C, Natoli, D, Brocco, I, Sperduti, A, Nuzzo, N, Tinari, M, De Tursi, A, Grassadonia, L, Mazzilli, S, Iacobelli, T, Gamucci, P, Vici, Study Group, 'FOLLOW-UP', and Orditura, Michele

Subjects
Oncology, breast cancer, Follow-up, survey, Medical Oncology, law.invention, Randomized controlled trial, law, Aged, Breast Neoplasms, Female, Follow-Up Studies, Health Care Surveys, Humans, Italy, Middle Aged, Secondary Prevention, Guideline Adherence, Breast Tumors, Medicine and Health Sciences, Web based survey, Multidisciplinary, Pharmaceutics, Surgical Oncology, Cancer Therapy, Medicine, medicine.symptom, Disease staging, Research Article, medicine.medical_specialty, Adjuvant Cancer Chemotherapy, Science, MEDLINE, Asymptomatic, Breast cancer, Drug Therapy, Internal medicine, medicine, Cancer Detection and Diagnosis, Chemotherapy, Modalities, business.industry, Cancers and Neoplasms, medicine.disease, Blood chemistry, Women's Health, Clinical Medicine, business
Abstract

PurposeBreast cancer follow-up procedures after primary treatment are still a controversial issue. Aim of this study was to investigate, through a web-based survey, surveillance methodologies selected by Italian oncologists in everyday clinical practice.MethodsReferents of Italian medical oncology units were invited to participate to the study via e-mail through the SurveyMonkey website. Participants were asked how, in their institution, exams of disease staging and follow-up are planned in asymptomatic women and if surveillance continues beyond the 5th year.ResultsBetween February and May 2013, 125 out of 233 (53.6%) invited referents of Italian medical oncology units agreed to participate in the survey. Ninety-seven (77.6%) referents state that modalities of breast cancer follow-up are planned according to the risk of disease progression at diagnosis and only 12 (9.6%) oncology units apply the minimal follow-up procedures according to international guidelines. Minimal follow-up is never applied in high risk asymptomatic women. Ninety-eight (78.4%) oncology units continue follow-up in all patients beyond 5 years.ConclusionsOur survey shows that 90.4% of participating Italian oncology units declare they do not apply the minimal breast cancer follow-up procedures after primary treatment in asymptomatic women, as suggested by national and international guidelines. Interestingly, about 80.0% of interviewed referents performs the so called "tailored follow-up", high intensity for high risk, low intensity for low risk patients. There is an urgent need of randomized clinical trials able to determine the effectiveness of risk-based follow-up modalities, their ideal frequency and persistence in time.

Published
2014

91. Breast cancer 'tailored follow-up' in Italian oncology units: a web-based survey

Author

Natoli, C, Adamo, V, Airoldi, M, Amoroso, D, Angelini, F, Angiolini, C, Angiolucci, G, Ardizzoia, A, Baldini, E, Ballardini, P, Barni, S, Barone, C, Battelli, N, Bernardi, D, Bianchetti, S, Bianco, N, Biglia, N, Bilancia, D, Biti, G, Boni, C, Bordonaro, R, Botta, M, Bretti, S, Brunello, A, Brunetti, C, Bruno, D, Bucci, E, Buzzoni, R, Cagossi, K, Cappelletti, C, Cappuzzo, F, Cardillo, F, Carroccio, R, Cascinu, S, Cavanna, L, Cianchetti, E, Clerico, M, Contu, A, Corsi, D, Cortesi, L, Cretella, E, Crispino, S, Di Lieto, M, Di Lullo, L, Durini, E, Fabi, A, Failla, G, Fattorusso, S, Ferraù, F, Ferro, A, Ficorella, C, Fogazzi, G, Foglietta, J, Francini, G, Fusco, O, Gennari, A, Ghiani, M, Gianni, L, Giordano, M, Giotta, F, Giuliani, R, Gori, S, Graiff, C, Guarneri, V, Guarneri, D, Guglielmi, F, Landriscina, M, Laudadio, L, Lombardo, M, Longo, F, Macellari, G, Madeddu, C, Magnanini, S, Maiorino, L, Mangiameli, A, Marini, G, Massidda, B, Mattioli, R, Michelotti, A, Molino, A, Montesarchio, V, Morale, A, Murgo, R, Naso, Giuseppe, Natale, D, Orditura, M, Orrù, S, Pace, R, Palazzo, Antonella, Palma, F, Pancotti, A, Pandoli, G, Papaldo, P, Parisi, Am, Passalacqua, R, Pellegrino, A, Perrucci, B, Proietti, E, Recchia, F, Riccardi, F, Rispoli, Ai, Rocca, A, Romaniello, I, Rossetti, R, Rossi, D, Rosti, G, Ruggeri, Em, Russo, A, Savarino, A, Savastano, C, Scognamiglio, G, Scognamiglio, M, Seminara, Patrizia, Serrachini, S, Sidoti, V, Silva, Rr, Surace, G, Tomao, Silverio, Tonini, G, Trenta, P, Turazza, M, Valenza, R, Veltri, E, Zampa, G, Zaniboni, A, and Zanirato, S.

Published
2014

93. Bioclinical Parameters Driving Decision-Making of Subsequent Lines of Treatment in Metastatic Castration-Resistant Prostate Cancer

Author

Irelli, A., Bruera, G., Cannita, K., Palluzzi, E., Gravina, G. L., Festuccia, C., Ficorella, C., and Ricevuto, E.

Subjects
Article Subject
Abstract

Different options are available as second-line treatment of metastatic castrate-resistant prostate cancer: cabazitaxel, abiraterone, and enzalutamide. Phase III studies evaluating cabazitaxel and the two hormonal agents have been shown to significantly prolong overall survival compared to mitoxantrone and placebo, respectively. Several studies have also demonstrated feasibility and activity of docetaxel rechallenge in case of a sufficient progression-free interval (3–6 months), good performance status, and previous acceptable safety profile, thus providing an additional treatment option in clinical practice. Clinical and biological parameters should be considered to tailor II line treatment. In clinical practice, we can primarily evaluate patients’ fitness according to age, performance status, symptomatic disease, comorbidities, and expected safety profile of each drug. Different prognostic/predictive factors may be considered, such as presence of bone-limited or visceral metastases, length of androgen deprivation therapy (ADT) before chemotherapy, time to progression after docetaxel, Gleason score, PSA doubling time, and serum testosterone, even if their clinical relevance is still debated. This review will discuss current options of innovative drugs sequencing and selection according to bioclinical parameters.

Published
2014
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94. Novel P53 mutations detected by FAMA in colorectal cancers

Author

DE GALITIIS, F, Cannita, K, Tessitore, A, Martella, F, DI ROCCO ZC, Russo, A, Adamo, V, Iacobelli, S, Martinotti, S, Marchetti, Paolo, Ficorella, C, Ricevuto, E, CONSORZIO INTERUNIVERSITARIO NAZIONALE BIO ONCOLOGIA, DE GALITIIS F, CANNITA K, TESSITORE A, MARTELLA F, DI ROCCO ZC, RUSSO A, ADAMO V, IACOBELLI S, MARTINOTTI S, MARCHETTI P, FICORELLA C, and RICEVUTO E

Subjects
Oncology, medicine.medical_specialty, Mutant, DNA Mutational Analysis, Mutation, Missense, Gene mutation, medicine.disease_cause, Exon, Internal medicine, medicine, Missense mutation, Humans, Key words: colon cancer, p53, mutations, FAMA, Allele, Gene, Mutation, business.industry, Hematology, DNA, Neoplasm, Exons, Genes, p53, Molecular biology, business, Colorectal Neoplasms, Heteroduplex
Abstract

Background The aim of the study was to identify p53 gene mutations by FAMA (fluorescence-assisted mismatch analysis) in colorectal cancers. Patients and methods Analytical scanning of the p53 gene (exons 5–9) was performed in colon cancer samples from 44 consecutive patients by FAMA. FAMA is a semiautomatic scanning approach based on the chemical cleavage of the mismatch in fluorescently labeled heteroduplex DNA, obtained from the combination of a normal and a mutated allele. FAMA has already shown optimal levels of diagnostic accuracy and sensitivity in detecting gene mutations (nucleotide substitutions, insertions/deletions) both at the germline and somatic level. The peculiar feature of FAMA is its ability to detect and localize mutations, by a redundant pattern of signals due to fluorescent DNA fragments generated by chemical cleavage. Moreover, previous data have demonstrated that normal contaminating DNA from stromal cells in the sample does not affect the sensitivity of the procedure, leading to the identification of the mutation even when the ratio mutant/normal allele is 10%. Results Eighteen mutations (12 missense, one nonsense, two deletions, three nucleotide substitutions at the level of the splice-junctions) and two polymorphisms were detected by FAMA in 17 patients (39%) and then confirmed by automated sequence analysis. Six of 18 mutations (33%) were not previously reported for colon cancer samples and two of 18 lesions (11%) were identified as novel p53 mutations. Conclusions Analytical scanning of the p53 gene by FAMA in DNA from colon cancer samples provides a sensitive, accurate and specific diagnostic procedure for routine clinical application.

Published
2006

95. Trastuzumab emtansine (T-DM1) in patients (pts) with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC): Results from a multicenter retrospective analysis

Author

Pizzuti, L., primary, Sperduti, I., additional, Michelotti, A., additional, Omarini, C., additional, Gamucci, T., additional, Natoli, C., additional, D'Onofrio, L., additional, Giotta, F., additional, Ficorella, C., additional, Laudadio, L., additional, Cassano, A., additional, Marchetti, P., additional, Adamo, V., additional, Mauri, M., additional, Scinto, A.F., additional, Zampa, G., additional, Fabbri, A., additional, Mentuccia, L., additional, Barni, S., additional, and Vici, P., additional

Published
2016
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96. Efficacy and safety of everolimus (eve) and exemestane (exe) in postmenopausal hormone-receptor positive (hr+) advanced breast cancer (abc) patients (pts) beyond clinical trials: preliminary results of the observational multicenter eva study

Author

Torri, V., primary, Cazzaniga, M.E., additional, Galli, F., additional, Valerio, M.R., additional, Ficorella, C., additional, Garrone, O., additional, Palumbo, R., additional, Fumagalli, A., additional, Moretti, G., additional, De Laurentiis, M., additional, Frassoldati, A., additional, Artale, S., additional, Zambelli, A., additional, Vici, P., additional, Maur, M., additional, Sartori, D., additional, and Fabi, A., additional

Published
2016
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99. COMBINED TARGETING OF EGFR AND MDM2 BY GEFITINIB AND ANTISENSE MDM2 COOPERATIVELY INHIBIT HORMONE-INDEPENDENT PROSTATE CANCER

Author

BIANCO, ROBERTO, DE PLACIDO, SABINO, CAPUTO R, DAMIANO V, FICORELLA C, AGRAWAL S, BIANCO AR, CIARDIELLO F, G. TORTORA, Bianco, Roberto, Caputo, R, Damiano, V, DE PLACIDO, Sabino, Ficorella, C, Agrawal, S, Bianco, Ar, Ciardiello, F, and G., Tortora

Subjects
mdm2, EGFR, prostate cancer
Abstract

EGFR) may play a relevant role in the progression, hormone therapy resistance, and prognosis of prostate cancer patients. Also MDM2, a negative p53 regulator that interacts with retinoblastoma (Rb), E2F, p19arf and the rasmitogen- activated protein kinase(MAPK) cascade plays an important role in prostate cancer progression and prognosis. On the basis of the EGFR and MDM2 role in integrating signaling pathways critical for prostate cancer progression, we investigated whether their selective combined blockade may have a cooperative antitumor effect in prostate cancer. For this purpose, we have used the EGFR tyrosine kinase inhibitor gefitinib (ZD1839, Iressa) and a second generation hybrid oligonucleotide antisense MDM2 (AS-MDM2), respectively. Experimental Design: Gefitinib and AS-MDM2 were administered to hormone-refractory and hormone-dependent human prostate cancer cells in vitro and to mice bearing tumor xenografts, evaluating the effects on growth, apoptosis, and protein expression, in vitro and in vivo. Results: We demonstrated that the combination of gefitinib and AS-MDM2 synergistically inhibits the growth of hormone-independent prostate cancer cells in vitro. This effect is accompanied by the inhibition of MDM2, phosphorylated Akt (pAkt), phosphorylated MAPK (pMAPK), and vascular endothelial growth factor (VEGF) expression and by Rb hypophosphorylation. The combination of the two agents in nude mice bearing the same hormone-independent tumors caused a potent cooperative antitumor effect. Tumor samples analysis confirmed the inhibition of MDM2, pAkt, pMAPK, VEGF, and basic fibroblast growth factor expression. Conclusions: This study shows that EGFR and MDM2 play a critical role in the growth of prostate cancer, especially hormone-dependent, and that their combined blockade by gefitinib and AS-MDM2 causes a cooperative antitumor effect, supporting the clinical development of this therapeutic strategy.

Published
2004

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