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3. POS1131 EVOLUTIONARY TRAJECTORY OF UNDIFFERENTIATED CONNECTIVE TISSUE DISEASE: IMPACT OF THE 2019 EULAR/ACR CLASSIFICATION CRITERIA FOR SYSTEMIC LUPUS ERYTHEMATOSUS

Author

Ciancarella, C., primary, Ceccarelli, F., additional, Picciariello, L., additional, Natalucci, F., additional, Celia, A. I., additional, Garufi, C., additional, Mancuso, S., additional, Truglia, S., additional, Gattamelata, A., additional, Spinelli, F. R., additional, Alessandri, C., additional, and Conti, F., additional

Published
2024
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6. AB0672 DETECTION OF MACROPHAGE MIGRATION INHIBITORY FACTOR IN SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS COMPLAINING PAINFUL DISTURBANCES: A SINGLE CENTER STUDY

Author

Pirone, C., primary, Ceccarelli, F., additional, Colasanti, T., additional, Galosi, E., additional, Orefice, V., additional, Garufi, C., additional, Natalucci, F., additional, Olivieri, G., additional, Picciariello, L., additional, Falco, P., additional, Di Pietro, G., additional, Spinelli, F. R., additional, Truglia, S., additional, Alessandri, C., additional, Truini, A., additional, and Conti, F., additional

Published
2023
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9. AB0590 CROSS-SECTIONAL ASSESSMENT OF THE QUALITY OF LIFE IN SLE PATIENTS: ROLE OF DISEASE ACTIVITY, CHRONIC DAMAGE, FIBROMYALGIA SYNDROME AND MOOD DISORDERS

Author

Natalucci, F., primary, Ceccarelli, F., additional, Massari, C., additional, Pirone, C., additional, Olivieri, G., additional, Orefice, V., additional, Picciariello, L., additional, Ciancarella, C., additional, Garufi, C., additional, Mancuso, S., additional, Truglia, S., additional, Spinelli, F. R., additional, Alessandri, C., additional, and Conti, F., additional

Published
2023
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10. POS0862 PRESCRIPTION PATTERN OF JAK INHIBITORS OVER 5 YEARS IN ITALY: DATA FROM THE ITALIAN NATIONAL GISEA REGISTRY

Author

Spinelli, F. R., primary, Iannone, F., additional, Favalli, E. G., additional, Gremese, E., additional, Bugatti, S., additional, Garufi, C., additional, Atzeni, F., additional, Cauli, A., additional, Sebastiani, M., additional, Carletto, A., additional, Govoni, M., additional, Semeraro, A., additional, Foti, R., additional, Cantatore, F. P., additional, Bazzani, C., additional, Parisi, S., additional, Chimenti, M. S., additional, Frediani, B., additional, Caporali, R., additional, and Conti, F., additional

Published
2023
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11. Regret affects the choice between neoadjuvant therapy and upfront surgery for potentially resectable pancreatic cancer

Author

Cucchetti, A., Djulbegovic, B., Crippa, S., Hozo, I., Sbrancia, M., Tsalatsanis, A., Binda, C., Fabbri, C., Salvia, R., Falconi, M., Ercolani, G., Alfieri, Sergio, Amato, A., Amisano, M., Anderloni, A., Maestri, A., Coluccio, C., Brandi, G., Casadei-Gardini, A., Cennamo, V., Crino, S. F., Valle, R. D., De Angelis, C., Di Battista, M., Di Maio, M., Di Marco, M., Di Matteo, F., Di Mitri, R., Ettorre, G. M., Facciorusso, A., Farina, G., Ferrari, G., Fornaro, L., Frigerio, I., Frisone, D., Fuccio, L., Gardini, A., Garufi, C., Giampieri, R., Grazi, G. L., Jovine, E., Kauffmann, E., Langella, S., Larghi, Alberto Leonardo, Manno, M., Marciano, E., Marzioni, M., Merighi, A., Mutignani, M., Nardo, B., Niger, M., Palmisano, V., Partelli, S., Pinto, C., Piras, E., Rapposelli, I. G., Reni, M., Ricci, C., Rimassa, L., Siena, S., Spada, Cristiano, Sperti, E., Spezzaferro, M., Sposito, C., Tamberi, S., Troisi, R., Veneroni, L., Vivarelli, M., Zerbi, A., Alfieri S. (ORCID:0000-0002-0404-724X), Larghi A., Spada C. (ORCID:0000-0002-5692-0960), Cucchetti, A., Djulbegovic, B., Crippa, S., Hozo, I., Sbrancia, M., Tsalatsanis, A., Binda, C., Fabbri, C., Salvia, R., Falconi, M., Ercolani, G., Alfieri, Sergio, Amato, A., Amisano, M., Anderloni, A., Maestri, A., Coluccio, C., Brandi, G., Casadei-Gardini, A., Cennamo, V., Crino, S. F., Valle, R. D., De Angelis, C., Di Battista, M., Di Maio, M., Di Marco, M., Di Matteo, F., Di Mitri, R., Ettorre, G. M., Facciorusso, A., Farina, G., Ferrari, G., Fornaro, L., Frigerio, I., Frisone, D., Fuccio, L., Gardini, A., Garufi, C., Giampieri, R., Grazi, G. L., Jovine, E., Kauffmann, E., Langella, S., Larghi, Alberto Leonardo, Manno, M., Marciano, E., Marzioni, M., Merighi, A., Mutignani, M., Nardo, B., Niger, M., Palmisano, V., Partelli, S., Pinto, C., Piras, E., Rapposelli, I. G., Reni, M., Ricci, C., Rimassa, L., Siena, S., Spada, Cristiano, Sperti, E., Spezzaferro, M., Sposito, C., Tamberi, S., Troisi, R., Veneroni, L., Vivarelli, M., Zerbi, A., Alfieri S. (ORCID:0000-0002-0404-724X), Larghi A., and Spada C. (ORCID:0000-0002-5692-0960)

Abstract

Background: When treating potentially resectable pancreatic adenocarcinoma, therapeutic decisions are left to the sensibility of treating clinicians who, faced with a decision that post hoc can be proven wrong, may feel a sense of regret that they want to avoid. A regret-based decision model was applied to evaluate attitudes to-ward neoadjuvant therapy versus upfront surgery for potentially resectable pancreatic adenocarcinoma.Methods: Three clinical scenarios describing high-, intermediate-, and low-risk disease-specific mortality after upfront surgery were presented to 60 respondents (20 oncologists, 20 gastroenterologists, and 20 surgeons). Respondents were asked to report their regret of omission and commission regarding neo-adjuvant chemotherapy on a scale between 0 (no regret) and 100 (maximum regret). The threshold model and a multilevel mixed regression were applied to analyze respondents' attitudes toward neo-adjuvant therapy.Results: The lowest regret of omission was elicited in the low-risk scenario, and the highest regret in the high-risk scenario (P < .001). The regret of the commission was diametrically opposite to the regret of omission (P < .001). The disease-specific threshold mortality at which upfront surgery is favored over the neoadjuvant therapy progressively decreased from the low-risk to the high-risk scenarios (P <=.001). The nonsurgeons working in or with lower surgical volume centers (P = .010) and surgeons (P = .018) accepted higher disease-specific mortality after upfront surgery, which resulted in the lower likelihood of adopting neoadjuvant therapy.Conclusion: Regret drives decision making in the management of pancreatic adenocarcinoma. Being a surgeon or a specialist working in surgical centers with lower patient volumes reduces the likelihood of recommending neoadjuvant therapy.(c) 2023 Elsevier Inc. All rights reserved.

Published
2023

12. The prognostic relevance of HER2-positivity gain in metastatic breast cancer in the ChangeHER trial

Author

Pizzuti, L, Barba, M, Mazzotta, M, Krasniqi, E, Maugeri-Sacca, M, Gamucci, T, Berardi, R, Livi, L, Ficorella, C, Natoli, C, Cortesi, E, Generali, D, La Verde, N, Cassano, A, Bria, E, Moscetti, L, Michelotti, A, Adamo, V, Zamagni, C, Tonini, G, Sergi, D, Marinelli, D, Paoletti, G, Tomao, S, Botticelli, A, Marchetti, P, Tinari, N, Grassadonia, A, Valerio, M, Mirabelli, R, Fabbri, M, D'Ostilio, N, Veltri, E, Corsi, D, Garrone, O, Paris, I, Sarobba, G, Meattini, I, Pistelli, M, Giotta, F, Lorusso, V, Garufi, C, Russo, A, Cazzaniga, M, Del Medico, P, Roselli, M, Vaccaro, A, Perracchio, L, di Benedetto, A, Daralioti, T, Sperduti, I, De Maria, R, Di Leo, A, Sanguineti, G, Ciliberto, G, Vici, P, Pizzuti L., Barba M., Mazzotta M., Krasniqi E., Maugeri-Sacca M., Gamucci T., Berardi R., Livi L., Ficorella C., Natoli C., Cortesi E., Generali D., La Verde N., Cassano A., Bria E., Moscetti L., Michelotti A., Adamo V., Zamagni C., Tonini G., Sergi D., Marinelli D., Paoletti G., Tomao S., Botticelli A., Marchetti P., Tinari N., Grassadonia A., Valerio M. R., Mirabelli R., Fabbri M. A., D'Ostilio N., Veltri E., Corsi D., Garrone O., Paris I., Sarobba G., Meattini I., Pistelli M., Giotta F., Lorusso V., Garufi C., Russo A., Cazzaniga M., Del Medico P., Roselli M., Vaccaro A., Perracchio L., di Benedetto A., Daralioti T., Sperduti I., De Maria R., Di Leo A., Sanguineti G., Ciliberto G., Vici P., Pizzuti, L, Barba, M, Mazzotta, M, Krasniqi, E, Maugeri-Sacca, M, Gamucci, T, Berardi, R, Livi, L, Ficorella, C, Natoli, C, Cortesi, E, Generali, D, La Verde, N, Cassano, A, Bria, E, Moscetti, L, Michelotti, A, Adamo, V, Zamagni, C, Tonini, G, Sergi, D, Marinelli, D, Paoletti, G, Tomao, S, Botticelli, A, Marchetti, P, Tinari, N, Grassadonia, A, Valerio, M, Mirabelli, R, Fabbri, M, D'Ostilio, N, Veltri, E, Corsi, D, Garrone, O, Paris, I, Sarobba, G, Meattini, I, Pistelli, M, Giotta, F, Lorusso, V, Garufi, C, Russo, A, Cazzaniga, M, Del Medico, P, Roselli, M, Vaccaro, A, Perracchio, L, di Benedetto, A, Daralioti, T, Sperduti, I, De Maria, R, Di Leo, A, Sanguineti, G, Ciliberto, G, Vici, P, Pizzuti L., Barba M., Mazzotta M., Krasniqi E., Maugeri-Sacca M., Gamucci T., Berardi R., Livi L., Ficorella C., Natoli C., Cortesi E., Generali D., La Verde N., Cassano A., Bria E., Moscetti L., Michelotti A., Adamo V., Zamagni C., Tonini G., Sergi D., Marinelli D., Paoletti G., Tomao S., Botticelli A., Marchetti P., Tinari N., Grassadonia A., Valerio M. R., Mirabelli R., Fabbri M. A., D'Ostilio N., Veltri E., Corsi D., Garrone O., Paris I., Sarobba G., Meattini I., Pistelli M., Giotta F., Lorusso V., Garufi C., Russo A., Cazzaniga M., Del Medico P., Roselli M., Vaccaro A., Perracchio L., di Benedetto A., Daralioti T., Sperduti I., De Maria R., Di Leo A., Sanguineti G., Ciliberto G., and Vici P.

Abstract

In metastatic breast cancer (mBC), the change of human epidermal growth factor receptor 2 (HER2) status between primary and metastatic lesions is widely recognized, however clinical implications are unknown. Our study address the question if relevant differences exist between subjects who preserve the HER2 status and those who gain the HER2 positivity when relapsed. Data of patients affected by HER2-positive mBC, treated with pertuzumab and/or trastuzumab-emtansine (T-DM1) in a real-world setting at 45 Italian cancer centers were retrospectively collected and analyzed. From 2003 to 2017, 491 HER2‐positive mBC patients were included. Of these, 102 (20.7%) had been initially diagnosed as HER2-negative early BC. Estrogen and/or progesterone receptor were more expressed in patients with HER2-discordance compared to patients with HER2-concordant status (p < 0.0001 and p = 0.006, respectively). HER2-discordant tumors were characterized also by a lower rate of brain metastases (p = 0.01) and a longer disease free interval (p < 0.0001). Median overall survival was longer, although not statistically significant, in the subgroup of patients with HER2-discordant cancer with respect to patients with HER2-concordant status (140 vs 78 months, p = 0.07). Our findings suggest that patients with HER2-positive mBC with discordant HER2 status in early BC may have different clinical, biological and prognostic behavior compared to HER2-concordant patients.

Published
2021

13. 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, A, Bria, E, Moscetti, L, Michelotti, A, Adamo, V, Zamagni, C, Tonini, G, Barchiesi, G, Mazzotta, M, Marinelli, D, Tomao, S, Marchetti, P, Valerio, M, Mirabelli, R, Russo, A, Fabbri, M, 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, R, Leonetti, C, Di Leo, A, Ciliberto, G, Falcioni, R, Vici, P, 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 A., Bria E., 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 R., Leonetti C., Di Leo A., Ciliberto G., Falcioni R., Vici P., 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, A, Bria, E, Moscetti, L, Michelotti, A, Adamo, V, Zamagni, C, Tonini, G, Barchiesi, G, Mazzotta, M, Marinelli, D, Tomao, S, Marchetti, P, Valerio, M, Mirabelli, R, Russo, A, Fabbri, M, 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, R, Leonetti, C, Di Leo, A, Ciliberto, G, Falcioni, R, Vici, P, 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 A., Bria E., 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 R., Leonetti C., Di Leo A., Ciliberto G., Falcioni R., and Vici P.

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

14. 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, A, 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, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Samaritani, R, Garufi, C, Barni, S, Mirabelli, R, Sarmiento, R, Veltri, E, D'Auria, G, Paris, I, Giotta, F, Lorusso, V, Cardillo, F, Landucci, E, Mauri, M, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, 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, R, Risi, E, Ciliberto, G, Sperduti, I, Villa, A, Barba, M, Di Leo, A, Vici, P, 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 A., 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 E., 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 R., Risi E., Ciliberto G., Sperduti I., Villa A., Barba M., Di Leo A., Vici P., 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, A, 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, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Samaritani, R, Garufi, C, Barni, S, Mirabelli, R, Sarmiento, R, Veltri, E, D'Auria, G, Paris, I, Giotta, F, Lorusso, V, Cardillo, F, Landucci, E, Mauri, M, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, 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, R, Risi, E, Ciliberto, G, Sperduti, I, Villa, A, Barba, M, Di Leo, A, Vici, P, 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 A., 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 E., 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 R., Risi E., Ciliberto G., Sperduti I., Villa A., Barba M., Di Leo A., and Vici P.

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

15. The Detrimental Effect of Thyroiditis on Pregnancy Outcome of Patients Affected by Autoimmune Diseases: An Open Question

Author

Botta, Angela, Rizzo, Francesca, Antonielli, T., Ciliberti, Alessandra, Garufi, Ester, Lanzone, Antonio, Garufi, C., De Carolis, Sara, Botta A., Rizzo F., Ciliberti A., Garufi E., Lanzone A. (ORCID:0000-0003-4119-414X), De Carolis S. (ORCID:0000-0002-5160-7609), Botta, Angela, Rizzo, Francesca, Antonielli, T., Ciliberti, Alessandra, Garufi, Ester, Lanzone, Antonio, Garufi, C., De Carolis, Sara, Botta A., Rizzo F., Ciliberti A., Garufi E., Lanzone A. (ORCID:0000-0003-4119-414X), and De Carolis S. (ORCID:0000-0002-5160-7609)

Abstract

Few data are available evaluating obstetrical outcome when thyroiditis coexist with autoimmune diseases. Objectives of our study were: 1) To assess the prevalence of thyroiditis in pregnant women with autoimmune diseases; 2) To evaluate the effects on pregnancy outcome when different autoimmune diseases are associated with thyroiditis. Two groups of pregnant women were analysed: a study group of pregnant women with autoimmune diseases (n = 268) versus a control group of pregnant women (n = 1,150). In both groups the research for thyroid antibodies, anti-thyroid peroxidase antibodies and anti-thyroglobulin antibodies, was performed. The positivity had a prevalence of 17.54% in women with autoimmune diseases (n = 47) versus 5.57% in the control group (n = 64) (p-value < 0.00001). Only major rheumatic diseases (MRD) were analysed for pregnancy outcome (week of delivery, birth weight and birth weight percentile): systemic lupus erythematosus (SLE) n = 36, antiphospholipid syndrome (APS) n = 44 and connective tissue diseases (CTD) n = 23. MRD were divided according to positive or negative results for thyroid antibodies. Thyroiditis in CDT patients showed a detrimental effect on pregnancy outcome, in terms of earlier week of delivery: 37.86 ± 0.90 (mean ± SD) in CTD with thyroiditis versus 38.56 ± 0.73 (mean ± SD) in CTD without thyroiditis (p-value = 0.03) and lower birth weight: 2,790.71 g ± 257.17 SD in CTD with thyroiditis versus 3,019.33 g ± 305.48 g in CTD without thyroiditis (p-value < 0.05). In SLE and APS thyroiditis did not appear to influence pregnancy outcome. However, we suggest investigating anti-thyroid antibodies in all autoimmune diseases with special attention to pregnant women with thyroiditis and CTD.

Published
2022

19. POS0118 SMALL FIBER NEUROPATHY EVALUATION IN SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS: A SINGLE CENTER STUDY.

Author

Pirone, C., primary, Ceccarelli, F., additional, Galosi, E., additional, Falco, P., additional, Garufi, C., additional, Miranda, F., additional, Orefice, V., additional, Pacucci, V. A., additional, Spinelli, F. R., additional, Alessandri, C., additional, Leopizzi, M., additional, Di Maio, V., additional, Truini, A., additional, and Conti, F., additional

Published
2022
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21. POS1266 MULTICENTER RETROSPECTIVE STUDY EVALUATING THE SAFETY OF ANTI-SARS-CoV-2 VACCINE IN A COHORT OF PATIENTS WITH SYSTEMIC VASCULITIS

Author

Simoncelli, E., primary, Colafrancesco, S., additional, Spinelli, F. R., additional, Gattamelata, A., additional, Giardina, F., additional, Truglia, S., additional, Garufi, C., additional, Izzo, R., additional, Cantarini, L., additional, Frediani, B., additional, Conticini, E., additional, Grazzini, S., additional, Priori, R., additional, and Conti, F., additional

Published
2022
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27. Hydroxychloroquine cardiotoxicity: a case-control study comparing patients with COVID-19 and patients with systemic lupus erythematosus

Author

Mancuso, S, Spinelli, Fr, Agati, L, Ciardi, Mr, Garufi, C, Natalucci, F, Molteni, E, Truglia, S, Riccieri, V, Priori, R, Mastroianni, Cm, and Conti, F

Subjects
Adult, SARS-CoV-2, Immunology, COVID-19, QT prolongation, COVID-19 Drug Treatment, Electrocardiography, Long QT Syndrome, systemic lupus erythematosus, Rheumatology, hydroxychloroquine, rheumatologic diseases, Case-Control Studies, Humans, Lupus Erythematosus, Systemic, Immunology and Allergy, Aged, Hydroxychloroquine
Abstract

Antimalarials have been associated with QT prolongation in COVID-19 patients but are generally safe in systemic lupus erythematosus (SLE).We compared the prevalence of QTc prolongation between COVID-19 and SLE patients treated with hydroxychloroquine (HCQ).We included patients with SARS-CoV-2 infection confirmed by nasopharyngeal swab and patients taking HCQ for SLE. A prolonged QTc was defined as an increase in QTc intervals60 ms (compared with baseline) or as a QTc of ≥500 ms. We performed the univariate and multivariate logistic regression to investigate the risk factors for QTc prolongation in COVID-19 patients.We enrolled 58 COVID-19 patients (median age 70.5 years, IQR 25), grouped into group A (patients with HCQ) group B (patients with HCQ + azithromycin) and group C (not received either drug). Fifty (26%) COVID-19 patients presented a QTc prolongation (12 QTc≥500 ms, 3 patients ΔQTc60 ms). We did not find any differences in QTc prolongation among the three treatment groups. Baseline QTc (OR 111.5) and D-dimer (OR 78.3) were independently associated to QTc prolongation. Compared to the 50 SLE patients (median age 38.5 years, IQR 22), chronically treated with HCQ, COVID-19 patients showed significantly longer QTc (p0.001).This is the first study demonstrating that, unlike COVID-19 patients, patients with SLE are not susceptible to HCQ-induced long QT syndrome and arrhythmia. The combined arrhythmogenic effect of SARS-CoV-2 infection and HCQ could account for the excess of QTc prolongation and fatal arrhythmias described in patients with COVID-19.

Published
2021

28. Effectiveness and safety of baricitinib in rheumatoid arthritis. a monocentric, longitudinal, real-life experience

Author

Spinelli, F. R., Ceccarelli, F., Garufi, C., Duca, I., Mancuso, S., Cipriano, E., Dell’unto, E., Alessandri, C., Di Franco, M., Perricone, C., Priori, R., Valeria RICCIERI, Scrivo, R., Sili Scavalli, A., Truglia, S., Valesini, G., and Conti, F.

Subjects
rheumatoid arthritis, safety, Sulfonamides, therapy, Immunology, effectiveness, Middle Aged, Arthritis, Rheumatoid, remission, Rheumatology, Purines, Antirheumatic Agents, Immunology and Allergy, Azetidines, Humans, Pyrazoles, baricitinib, safety, remission, pain
Abstract

Baricitinib is a Janus-kinase (JAK) 1/2 inhibitor, approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) patients with inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). We report the first real-life experience with baricitinib in a monocentric cohort of unselected RA patients.We enrolled consecutive RA patients starting baricitinib. At baseline and after 4, 12, 24 and 48 weeks we assessed the disease activity by composite indices (SDAI, CDAI and DAS28CRP) and ultrasonography, and we recorded any adverse events. The primary endpoint was the percentage of patients achieving SDAI remission at week 4.We enrolled 59 patients [(F:M = 50:9, median age 58.1 years (IQR 12.8), median disease duration 144 (IQR 150) months] treated with baricitinib in combination with a csDMARD (52.5%) or monotherapy (47.5%) for a median follow-up of 24 weeks (IQR 36). The 12-month drug retention rate was 74%. At weeks 4, 12, 24 and 48 we observed a significant reduction of DAS28, CDAI and SDAI, global health and pain (p0.001 for all). After 4 weeks of treatment, 12% of patients achieved SDAI remission. Concomitant csDMARDs, previous biological DMARDs, gender, seropositivity and BMI did not affect the efficacy of baricitinib. Baricitinib allowed a significant reduction in prednisone dose after 12 and 24 weeks and a rapid and sustained ultrasound improvement. No serious adverse events, serious infections or cardiovascular events were recorded.Our study confirms the efficacy and safety profile and rapid onset of the effect of baricitinib in RA patients in a real-life setting.

Published
2021

29. The prognostic relevance of HER2-positivity gain in metastatic breast cancer in the ChangeHER trial

Author

Pizzuti, L., Barba, M., Mazzotta, M., Krasniqi, E., Maugeri-Sacca, M., Gamucci, T., Berardi, R., Livi, L., Ficorella, C., Natoli, C., Cortesi, E., Generali, D., La Verde, N., Cassano, A., Bria, Emilio, Moscetti, L., Michelotti, A., Adamo, V., Zamagni, C., Tonini, G., Sergi, D., Marinelli, D., Paoletti, G., Tomao, S., Botticelli, A., Marchetti, P., Tinari, N., Grassadonia, A., Valerio, M. R., Mirabelli, R., Fabbri, M. A., D'Ostilio, N., Veltri, E., Corsi, Domenico Cristiano, Garrone, O., Paris, Ida, Sarobba, G., Meattini, I., Pistelli, M., Giotta, F., Lorusso, V., Garufi, C., Russo, A., Cazzaniga, M., Del Medico, P., Roselli, M., Vaccaro, A., Perracchio, L., di Benedetto, A., Daralioti, T., Sperduti, I., De Maria Marchiano, Ruggero, Di Leo, A., Sanguineti, G., Ciliberto, G., Vici, P., Bria E. (ORCID:0000-0002-2333-704X), Corsi D., Paris I., De Maria R. (ORCID:0000-0003-2255-0583), Pizzuti, L., Barba, M., Mazzotta, M., Krasniqi, E., Maugeri-Sacca, M., Gamucci, T., Berardi, R., Livi, L., Ficorella, C., Natoli, C., Cortesi, E., Generali, D., La Verde, N., Cassano, A., Bria, Emilio, Moscetti, L., Michelotti, A., Adamo, V., Zamagni, C., Tonini, G., Sergi, D., Marinelli, D., Paoletti, G., Tomao, S., Botticelli, A., Marchetti, P., Tinari, N., Grassadonia, A., Valerio, M. R., Mirabelli, R., Fabbri, M. A., D'Ostilio, N., Veltri, E., Corsi, Domenico Cristiano, Garrone, O., Paris, Ida, Sarobba, G., Meattini, I., Pistelli, M., Giotta, F., Lorusso, V., Garufi, C., Russo, A., Cazzaniga, M., Del Medico, P., Roselli, M., Vaccaro, A., Perracchio, L., di Benedetto, A., Daralioti, T., Sperduti, I., De Maria Marchiano, Ruggero, Di Leo, A., Sanguineti, G., Ciliberto, G., Vici, P., Bria E. (ORCID:0000-0002-2333-704X), Corsi D., Paris I., and De Maria R. (ORCID:0000-0003-2255-0583)

Abstract

In metastatic breast cancer (mBC), the change of human epidermal growth factor receptor 2 (HER2) status between primary and metastatic lesions is widely recognized, however clinical implications are unknown. Our study address the question if relevant differences exist between subjects who preserve the HER2 status and those who gain the HER2 positivity when relapsed. Data of patients affected by HER2-positive mBC, treated with pertuzumab and/or trastuzumab-emtansine (T-DM1) in a real-world setting at 45 Italian cancer centers were retrospectively collected and analyzed. From 2003 to 2017, 491 HER2‐positive mBC patients were included. Of these, 102 (20.7%) had been initially diagnosed as HER2-negative early BC. Estrogen and/or progesterone receptor were more expressed in patients with HER2-discordance compared to patients with HER2-concordant status (p < 0.0001 and p = 0.006, respectively). HER2-discordant tumors were characterized also by a lower rate of brain metastases (p = 0.01) and a longer disease free interval (p < 0.0001). Median overall survival was longer, although not statistically significant, in the subgroup of patients with HER2-discordant cancer with respect to patients with HER2-concordant status (140 vs 78 months, p = 0.07). Our findings suggest that patients with HER2-positive mBC with discordant HER2 status in early BC may have different clinical, biological and prognostic behavior compared to HER2-concordant patients.

Published
2021

30. Impact of chorioamnionitis on maternal and fetal levels of proinflammatory S100A12

Author

Bersani, I., De Carolis, Sara, Foell, D., Weinhage, T., Garufi, C., De Carolis, Maria Pia, Rossi, E. D., Casella, G., Rubortone, Serena Antonia, Speer, C. P., De Carolis S. (ORCID:0000-0002-5160-7609), De Carolis M. P. (ORCID:0000-0003-2054-8228), Rubortone S. A., Bersani, I., De Carolis, Sara, Foell, D., Weinhage, T., Garufi, C., De Carolis, Maria Pia, Rossi, E. D., Casella, G., Rubortone, Serena Antonia, Speer, C. P., De Carolis S. (ORCID:0000-0002-5160-7609), De Carolis M. P. (ORCID:0000-0003-2054-8228), and Rubortone S. A.

Abstract

Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS). The aim of this pilot study was to evaluate S100A12, a marker of innate immune activation, in mothers with or without HCA and in their infants. Concentrations of S100A12, interleukin 6 (IL-6), and C-reactive protein (CRP) were evaluated in maternal, cord, and neonatal blood of very preterm infants. Histologic examinations of the placenta and umbilical cords were performed. The 48 mother-neonate pairs enrolled were subdivided into two groups: HCA group (N = 15) and control group without HCA (N = 33). Maternal S100A12 levels were similar between HCA and control group. Similarly, S100A12 concentrations in cord and neonatal blood did not differ between the groups. However, high S100A12 concentrations were detected in cord and neonatal blood of two out of three neonates exposed to HCA associated with advanced funisitis. Concentrations of IL-6 and CRP were higher in maternal blood of the HCA group compared with controls (p < 0.05, p < 0.001; respectively), but no differences in cord or neonatal blood was found. Conclusion:S100A12 did neither identify mothers with HCA nor very preterm infants exposed to HCA. It is currently unknown if S100A12 may identify neonates with FIRS.What is known:• Histologic chorioamnionitis (HCA) may lead to the fetal inflammatory response syndrome (FIRS).• S100A12 represents an early, sensitive, and specific diagnostic marker of inflammatory processes.What is new:• S100A12 did neither identify mothers with HCA nor very preterm infants exposed to HCA.• It is currently still unclear if S100A12 has a potential in identifying preterm infants with FIRS.

Published
2021

33. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib

Author

Hammel P., Kindler H. L., Reni M., Van Cutsem E., MacArulla T., Hall M. J., Park J. O., Hochhauser D., Arnold D., Oh D. -Y., Reinacher-Schick A., Tortora G., Algul H., O'Reilly E. M., McGuinness D., Cui K. Y., Joo S., Yoo H. K., Patel N., Golan T., Chantrill L., Goldstein D., Joubert W., Pavlakis N., Tognela A., Van Fraeyenhove F., Van Laethem J. -L., Peeters M., Dhani N., Kavan P., Lemay F., Adenis A., Artru P., Baba-Hamed N., Belletier C., Ben Abdelghani M., Blanc J. -F., Borg C., Coriat R., Deplanque G., Faroux R., Follana P., Guimbaud R., El Hajbi F., Hautefeuille V., Malka D., Metges J. -P., Tougeron D., Walter T., Ettrich T., Hacker U. T., Hennes E., Jacobasch L., Kanzler S., Pession U., Scholz C., Sinn M., Stein A., Strassburg C., Vogel A., Ben-Shahar M., Brenner R., Epelbaum R., Geva R., Gluzman A., Idelevich E., Kolin M., Semenisty V., Shai A., Stemmer S., Yarom N., Celio L., Conte P., Garufi C., Gianni L., Leonardi F., Maiello E., Di Marco M., Milella M., Pinto C., Santini D., Scartozzi M., Vaccaro V., Vasile E., Kim J. -W., Oh Park J., Wilmink H., Gallego R. A., Ogalla G. D., Velasco A. G., Cabanas E. G., Gomez Martin C., Ponce C. G., Saez B. L., Lopez R., Martin A. M., Pazo R., Pijaume C. P., Rodriguez J., Yaya-Tur R., Arora A., Anthoney D. A., Jeffrey Evans T. R., Harrison M., Palmer D., Sarker D., Starling N., Valle J., Wall L., Agajanian R., Bearden J., Bekaii-Saab T., Carter C., Cohen D., Distefano A., Dragovich T., Ejadi S., Ford J., Grabelsky S., Hall M., Hochster H., Hosein P., Javle M., Kindler H., Lacy J., Laheru D., Leong S., Lowery M., Marsh R., Noonan A., Oberstein P., Ocean A., O'Reilly E., Ryan D., Seery T., Subramaniam S., Van Echo D., Wang-Gillam A., Weekes C., Welch S., Hammel P., Kindler H.L., Reni M., Van Cutsem E., MacArulla T., Hall M.J., Park J.O., Hochhauser D., Arnold D., Oh D.-Y., Reinacher-Schick A., Tortora G., Algul H., O'Reilly E.M., McGuinness D., Cui K.Y., Joo S., Yoo H.K., Patel N., Golan T., Chantrill L., Goldstein D., Joubert W., Pavlakis N., Tognela A., Van Fraeyenhove F., Van Laethem J.-L., Peeters M., Dhani N., Kavan P., Lemay F., Adenis A., Artru P., Baba-Hamed N., Belletier C., Ben Abdelghani M., Blanc J.-F., Borg C., Coriat R., Deplanque G., Faroux R., Follana P., Guimbaud R., El Hajbi F., Hautefeuille V., Malka D., Metges J.-P., Tougeron D., Walter T., Ettrich T., Hacker U.T., Hennes E., Jacobasch L., Kanzler S., Pession U., Scholz C., Sinn M., Stein A., Strassburg C., Vogel A., Ben-Shahar M., Brenner R., Epelbaum R., Geva R., Gluzman A., Idelevich E., Kolin M., Semenisty V., Shai A., Stemmer S., Yarom N., Celio L., Conte P., Garufi C., Gianni L., Leonardi F., Maiello E., Di Marco M., Milella M., Pinto C., Santini D., Scartozzi M., Vaccaro V., Vasile E., Kim J.-W., Oh Park J., Wilmink H., Gallego R.A., Ogalla G.D., Velasco A.G., Cabanas E.G., Gomez Martin C., Ponce C.G., Saez B.L., Lopez R., Martin A.M., Pazo R., Pijaume C.P., Rodriguez J., Yaya-Tur R., Arora A., Anthoney D.A., Jeffrey Evans T.R., Harrison M., Palmer D., Sarker D., Starling N., Valle J., Wall L., Agajanian R., Bearden J., Bekaii-Saab T., Carter C., Cohen D., Distefano A., Dragovich T., Ejadi S., Ford J., Grabelsky S., Hall M., Hochster H., Hosein P., Javle M., Kindler H., Lacy J., Laheru D., Leong S., Lowery M., Marsh R., Noonan A., Oberstein P., Ocean A., O'Reilly E., Ryan D., Seery T., Subramaniam S., Van Echo D., Wang-Gillam A., Weekes C., Welch S., Institut Català de la Salut, [Hammel P] Department of Digestive Oncology, Hôpital Beaujon (AP-HP), Clichy, and University Paris VII, Paris, France. [Kindler HL] Department of Medicine, Section of Hematology/Oncology, University of Chicago, Chicago, USA. [Reni M] Department of Oncology, IRCCS Ospedale San Raffaele Scientific Institute, Milan, Italy. [Van Cutsem E] Division of Digestive Oncology, University Hospitals Gasthuisberg and KU Leuven, Leuven, Belgium. [Macarulla T] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology, Barcelona, Spain. [Hall MJ] Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, USA, Vall d'Hebron Barcelona Hospital Campus, CCA - Cancer Treatment and Quality of Life, and Oncology

Subjects
Male, 0301 basic medicine, Oncology, medicine.medical_treatment, BRCA, pancreatic cancer, Disease, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Piperazines, Germline, Medicaments antineoplàstics, chemistry.chemical_compound, 0302 clinical medicine, Quality of life, Neoplasm Metastasis, neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias pancreáticas [ENFERMEDADES], ambiente y salud pública::salud pública::medidas epidemiológicas::demografía::estado de salud::calidad de vida [ATENCIÓN DE SALUD], BRCA1 Protein, Neoplasms::Neoplastic Processes::Neoplasm Metastasis [DISEASES], Hematology, Middle Aged, Progression-Free Survival, humanities, 3. Good health, metastatic, health-related quality of life, 030220 oncology & carcinogenesis, Female, Adult, medicine.medical_specialty, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Poly(ADP-ribose) Polymerase Inhibitors, Placebo, olaparib, Olaparib, 03 medical and health sciences, Double-Blind Method, Metàstasi, Pancreatic cancer, Internal medicine, Gastrointestinal Tumors, medicine, Humans, Germ-Line Mutation, Aged, BRCA2 Protein, Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Pancreatic Neoplasms [DISEASES], Chemotherapy, Pàncrees - Càncer, business.industry, BRCA mutation, Original Articles, medicine.disease, Pancreatic Neoplasms, Environment and Public Health::Public Health::Epidemiologic Measurements::Demography::Health Status::Quality of Life [HEALTH CARE], 030104 developmental biology, chemistry, neoplasias::procesos neoplásicos::metástasis neoplásica [ENFERMEDADES], Quality of Life, Phthalazines, Neoplasm Recurrence, Local, business
Abstract

Qualitat de vida relacionada amb la salut; Olaparib; Càncer de pàncrees Calidad de vida relacionada con la salud; Olaparib, Cáncer de páncreas Health-related quality of life; Olaparib; Pancreatic cancer Background Patients with metastatic pancreatic cancer often have a detriment in health-related quality of life (HRQoL). In the randomized, double-blind, phase III POLO trial progression-free survival was significantly longer with maintenance olaparib, a poly(ADP-ribose) polymerase inhibitor, than placebo in patients with a germline BRCA1 and/or BRCA2 mutation (gBRCAm) and metastatic pancreatic cancer whose disease had not progressed during first-line platinum-based chemotherapy. The prespecified HRQoL evaluation is reported here. Patients and methods Patients were randomized to receive maintenance olaparib (300 mg b.i.d.; tablets) or placebo. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item module at baseline, every 4 weeks until disease progression, at discontinuation, and 30 days after last dose. Scores ranged from 0 to 100; a ≥10-point change or difference between arms was considered clinically meaningful. Adjusted mean change from baseline was analysed using a mixed model for repeated measures. Time to sustained clinically meaningful deterioration (TSCMD) was analysed using a log-rank test. Results Of 154 randomized patients, 89 of 92 olaparib-arm and 58 of 62 placebo-arm patients were included in HRQoL analyses. The adjusted mean change in Global Health Status (GHS) score from baseline was

Published
2019

38. P-57 Atezolizumab in combination with bevacizumab in patients with unresectable HCC previously untreated with systemic therapy: Interim analysis results from phase IIIb Italian AMETHISTA trial

Author

Martinelli, E., Masi, G., Piscaglia, F., Cabibbo, G., Di Maio, M., Gasbarrini, A., Iavarone, M., Pellegrini, E., Mazzaferro, V., Ballestrero, A., Garufi, C., Bergamo, F., Celsa, C., Marino, D., Tovoli, F., Ponziani, F., Pressiani, T., Astolfi, C., Ciardiello, F., Daniele, B., and Rimassa, L.

Published
2023
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39. 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

40. Autoimmune Congenital Heart Block: A Review of Biomarkers and Management of Pregnancy

Author

De Carolis, Sara, Garufi, C., Garufi, E., De Carolis, Maria Pia, Botta, Angela, Tabacco, S., Salvi, Silvia, De Carolis S. (ORCID:0000-0002-5160-7609), De Carolis M. P. (ORCID:0000-0003-2054-8228), Botta A., Salvi S. (ORCID:0000-0001-7793-9612), De Carolis, Sara, Garufi, C., Garufi, E., De Carolis, Maria Pia, Botta, Angela, Tabacco, S., Salvi, Silvia, De Carolis S. (ORCID:0000-0002-5160-7609), De Carolis M. P. (ORCID:0000-0003-2054-8228), Botta A., and Salvi S. (ORCID:0000-0001-7793-9612)

Abstract

Autoimmune Congenital Heart Block (CHB) is an immune-mediated disease due to transplacental passage of circulating anti-Ro/SSA and anti-La/SSB autoantibodies. It occurs in 2% of anti-Ro/SSA-exposed pregnancies, and recurrence rate is nine times higher in subsequent pregnancies. Aim of this review is to identify biomarkers of CHB and treatment strategies. The Ro-system is constituted by two polypeptides targeted by the anti-Ro52 and anti-Ro60 autoantibodies. The central portion of Ro52 (p200), more than the full amino-acid sequence of Ro-52, is recognized to be the fine specificity of anti-Ro associated to the highest risk of cardiac damage. If anti-p200 antibody should be tested, as biomarker of CHB, over standard commercial ELISAs is still debated. Recent studies indicate that type I-Interferon (IFN) can activate fibroblasts in fetal heart. In the mother the anti-Ro/La antibodies activate the type I IFN-signature, and maternal IFN-regulated genes correlate with a similar neonatal IFN-gene expression. Evaluation of maternal IFN-signature could be used as novel biomarker of CHB. The measurement of “mechanical” PR interval with weekly fetal echocardiogram (ECHO) from 16 to at least 24 weeks of gestation is strongly recommended for CHB prenatal diagnosis. However, ECHO screening presents some limitations due to difficult identification of first-degree block and possible occurrence of a complete block from a normal rhythm in few days. Maternal administration of Hydroxychloroquine from the tenth week of gestation, modulating toll-like receptor and autoantibody-dependent type I IFN activation on the fetus, has an important role in preventing CHB in pregnant women with high risk for recurrent CHB.

Published
2020

41. 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

42. 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

43. 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

44. SAT0153 GENDER DOES NOT INFLUENCE CLINICAL RESPONSE TO JAK INHIBITORS IN RHEUMATOID ARTHRITIS: AN ITALIAN MULTICENTRE ANALYSIS

Author

Spinelli, F. R., primary, Chimenti, M. S., additional, Vadacca, M., additional, Iannuccelli, C., additional, Conigliaro, P., additional, Bosello, S. L., additional, Ceccarelli, F., additional, Garufi, C., additional, Raffone, G., additional, Di Noi, P., additional, Bruno, D., additional, Afeltra, A., additional, Perricone, R., additional, Conti, F., additional, and Gremese, E., additional

Published
2020
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46. THU0281 EXPLORING THE GENETIC DIVERSITY OF STAPHYLOCOCCUS AUREUS IN PATIENTS AFFECTED BY SYSTEMIC LUPUS ERYTHEMATOSUS: ASSOCIATION WITH DISEASE-RELATED FEATURES AND ACTIVITY

Author

Olivieri, G., primary, Ceccarelli, F., additional, Lo Presti, A., additional, Angeletti, S., additional, Perricone, C., additional, Iaiani, G., additional, De Florio, L., additional, Antonelli, F., additional, Amori, L., additional, Garufi, C., additional, Spinelli, F. R., additional, Alessandri, C., additional, Valesini, G., additional, Cicozzi, M., additional, and Conti, F., additional

Published
2020
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48. OP0204 LUPUS COMPREHENSIVE DISEASE CONTROL IN SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS: APPLICATION OF A NEW INDEX

Author

Ceccarelli, F., primary, Olivieri, G., additional, Dominici, L., additional, Celia, A. I., additional, Cipriano, E., additional, Garufi, C., additional, Mancuso, S., additional, Natalucci, F., additional, Orefice, V., additional, Perricone, C., additional, Pirone, C., additional, Pacucci, V. A., additional, Morello, F., additional, Truglia, S., additional, Miranda, F., additional, Spinelli, F. R., additional, Alessandri, C., additional, and Conti, F., additional

Published
2020
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