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42 results on '"Pisano, Carmela"'

1. Harmonization of homologous recombination deficiency testing in ovarian cancer: Results from the MITO16A/MaNGO-OV2 trial

Author

Roma, Cristin, Esposito Abate, Riziero, Sacco, Alessandra, Califano, Daniela, Arenare, Laura, Bergantino, Francesca, Pisano, Carmela, Cecere, Sabrina Chiara, Scambia, Giovanni, Lorusso, Domenica, Artioli, Grazia, Tasca, Giulia, Spina, Anna, Russo, Daniela, Gadducci, Angiolo, De Angelis, Carmine, Bologna, Alessandra, Marchini, Sergio, Capoluongo, Ettore Domenico, Perrone, Francesco, Pignata, Sandro, and Normanno, Nicola

Published
2024
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2. Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study

Author

Makker, Vicky, Perez-Fidalgo, Jose Alejandro, Valabrega, Giorgio, Hamilton, Erika, Van Gorp, Toon, Sehouli, Jalid, Regináčová, Klaudia, Richardson, Debra L., Perri, Tamar, Oza, Amit M., Miller, David S., Alía, Eva Maria Guerra, De Giorgi, Ugo, Henry, Stephanie, Spitz, Daniel L., Wimberger, Pauline, Bednaříková, Markéta, Chon, Hye Sook, Martínez-Garcia, Jerónimo, Pisano, Carmela, Berek, Jonathan S., Romero, Ignacio, Scambia, Giovanni, Fariñas-Madrid, Lorena, Buscema, Joseph, Schochter, Fabienne, Li, Kai, Kalyanapu, Pratheek, Walker, Christopher J., and Vergote, Ignace

Published
2024
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3. Real-life efficacy and safety of cemiplimab in advanced cervical cancer from a nominal use program in Italy: The MITO 44 study

Author

Tuninetti, Valentina, Virano, Elisa, Salutari, Vanda, Ricotti, Andrea, Pisano, Carmela, Ducceschi, Monika, Turitto, Giacinto, Scandurra, Giuseppa, Petrella, Maria Cristina, Forestieri, Valeria, Rizzetto, Monica, Mammoliti, Serafina, Artioli, Grazia, Cioffi, Raffaella, Borsotti, Lucia, Bellero, Marco, Rognone, Chiara, Carbone, Vittoria, Ferrandina, Gabriella, Mantiero, Mara, Azzolina, Carmen, Geninatti, Eleonora, Pignata, Sandro, and Valabrega, Giorgio

Published
2024
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4. Health-related quality of life in patients with newly diagnosed advanced ovarian cancer treated with niraparib vs placebo: Results from the phase 3 randomized PRIMA/ENGOT-OV26/GOG-3012 trial

Author

Pothuri, Bhavana, Han, Sileny, Chase, Dana M., Heitz, Florian, Burger, Robert A., Gaba, Lydia, Van Le, Linda, Guerra, Eva, Bender, David, Korach, Jacob, Cloven, Noelle, Churruca, Cristina, Follana, Philippe, DiSilvestro, Paul, Baurain, Jean-François, Jardon, Kris, Pisano, Carmela, Peen, Ulla, Mäenpää, Johanna, Gupta, Divya, Bacqué, Emeline, Li, Yong, Compton, Natalie, Antonova, Jenya, Monk, Bradley J., and González-Martín, Antonio

Published
2024
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5. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial

Author

Abadie-Lacourtoisie, Sophie, Andreetta, Claudia, Anzizar, Nerea, Aoki, Daiseuke, Barretina-Ginesta, Maria-Pilar, Battista, Marco, Bellier, Charlotte, Bentzen, Anne Gry, Berton, Dominique, Billemont, Bertrand, Bjørge, Line, Bjurberg, Maria, Black, Destin, Bologna, Alessandra, Braicu, Elena Ioana, Casanova, Claudia, Chekerov, Radoslav, Chevalier, Annick, Cueva, Juan Fernando, Czogalla, Bastian, Delanoy, Nicolas, Denschlag, Dominik, Derke, Oscar, Eichbaum, Michael, Enomoto, Takayuki, Esteban, Carmen, Fabbro, Michel, Fehm, Tanja, Ferrero, Annamaria, Fleisch, Markus, Floquet, Anne, Frassoldati, Antonio, Gaba, Lydia, Gadducci, Angiolo, García, Yolanda, Geuna, Elena, Guerra, Eva, Hanker, Lars, Hardy-Bessard, Anne-Claire, Harter, Philipp, Hasegawa, Kosei, Hellman, Kristina, Herrero, Ana, Hilpert, Felix, Katsaros, Dionyssios, Koegel, Matthias, Koliadi, Anthoula, Kurtz, Jean-Emmanuel, Lampe, Bjoern, Lissoni, Andrea Alberto, Lortholary, Alain, Mangili, Giorgia, Mansi, Laura, Marmé, Frederik, Mathews, Cara, Mina, William, Minobe, Shinichiro, Moxley, Katherine, Nagao, Shoji, Nicoletto, Ornella, Nishino, Koji, Nishio, Hiroshi, Nishio, Shin, Oaknin, Ana, Onstad, Michaela, Pardo, Beatriz, Pérez-Fidalgo, J Alejandro, Pisano, Carmela, Poveda, Andrés, Radosa, Julia, Randall, Leslie M., Ray-Coquard, Isabelle, Redondo, Andrés, Richardson, Debra, Romero, Ignacio, Ronzino, Graziana, Rubio, Maria Jesús, Selle, Frederic, Takekuma, Munetaka, Takeshima, Nobuhiro, Tasca, Giulia, Tewari, Krishnansu, Todo, Yukiharu, Valabrega, Giorgio, Wimberger, Pauline, Woelber, Linn, Yamaguchi, Satoshi, You, Benoît, Yunokawa, Mayu, Gladieff, Laurence, Martínez-García, Jerónimo, Villacampa, Guillermo, De Giorgi, Ugo, Lindemann, Kristina, Colombo, Nicoletta, Duska, Linda, Leary, Alexandra, Godoy-Ortiz, Ana, Angelergues, Antoine, Fariñas-Madrid, Lorena, Lorusso, Domenica, Manso, Luis, Joly, Florence, Alarcón, Jesús, Follana, Philippe, Lebreton, Coriolan, Dahlstrand, Hanna, D'Hondt, Véronique, and Randall, Leslie M

Published
2024
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6. Clinical characteristics and molecular aspects of low-grade serous ovarian and peritoneal cancer: a multicenter, observational, retrospective analysis of MITO Group (MITO 22)

Author

Musacchio, Lucia, Califano, Daniela, Bartoletti, Michele, Arenare, Laura, Lorusso, Domenica, Losito, Nunzia Simona, Cormio, Gennaro, Greggi, Stefano, Raspagliesi, Francesco, Valabrega, Giorgio, Salutari, Vanda, Pisano, Carmela, Spina, Anna, Russo, Daniela, Del Sesto, Michele, Canzonieri, Vincenzo, Ferraù, Francesco, Zannoni, Gian Franco, Loizzi, Vera, Ghizzoni, Viola, Casanova, Claudia, Tuninetti, Valentina, Ducceschi, Monika, Del Vecchio, Vittoria, Scalone, Simona, Priolo, Domenico, Perrone, Francesco, Scambia, Giovanni, and Pignata, Sandro

Published
2022
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8. Olaparib Addition to Maintenance Bevacizumab Therapy in Ovarian Carcinoma With BRCA-Like Genomic Aberrations

Author

Schouten, Philip C., primary, Schmidt, Sandra, additional, Becker, Kerstin, additional, Thiele, Holger, additional, Nürnberg, Peter, additional, Richters, Lisa, additional, Ernst, Corinna, additional, Treilleux, Isabelle, additional, Medioni, Jacques, additional, Heitz, Florian, additional, Pisano, Carmela, additional, Garcia, Yolanda, additional, Petru, Edgar, additional, Hietanen, Sakari, additional, Colombo, Nicoletta, additional, Vergote, Ignace, additional, Nagao, Shoji, additional, Linn, Sabine C., additional, Pujade-Lauraine, Eric, additional, Ray-Coquard, Isabelle, additional, Harter, Philipp, additional, Hahnen, Eric, additional, and Schmutzler, Rita K., additional

Published
2024
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9. Single-Agent Trabectedin Versus Physician's Choice Chemotherapy in Patients With Recurrent Ovarian Cancer With BRCA -Mutated and/or BRCAness Phenotype: A Randomized Phase III Trial.

Author

Lorusso, Domenica, Raspagliesi, Francesco, Ronzulli, Dominique, Valabrega, Giorgio, Colombo, Nicoletta, Pisano, Carmela, Cassani, Chiara, Tognon, Germana, Tamberi, Stefano, Mangili, Giorgia, Mammoliti, Serafina, De Giorgi, Ugo, Greco, Filippo, Mosconi, Anna Maria, Breda, Enrico, Artioli, Grazia, Andreetta, Claudia, Casanova, Claudia, Ceccherini, Rita, and Frassoldati, Antonio

Published
2024
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10. Corrigendum: Management of metastatic endometrial cancer: physicians’ choices beyond the first line after approval of checkpoint inhibitors

Author

Arezzo, Francesca, primary, Giannone, Gaia, additional, Castaldo, Daniele, additional, Scotto, Giulia, additional, Tuninetti, Valentina, additional, Turinetto, Margherita, additional, Bartoletti, Michele, additional, Mammoliti, Serafina, additional, Artioli, Grazia, additional, Mangili, Giorgia, additional, Salutari, Vanda, additional, Lorusso, Domenica, additional, Cormio, Gennaro, additional, Loizzi, Vera, additional, Zamagni, Claudio, additional, Savarese, Antonella, additional, Di Maio, Massimo, additional, Ronzino, Graziana, additional, Pisano, Carmela, additional, Pignata, Sandro, additional, and Valabrega, Giorgio, additional

Published
2024
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11. A plain language summary of publication of the efficacy and safety of individualized niraparib dosing based on baseline body weight and platelet count in the PRIMA/ENGOT-OV26/GOG-3012 trial

Author

Mirza, Mansoor R, primary, González-Martín, Antonio, additional, Graybill, Whitney S, additional, O'Malley, David M, additional, Gaba, Lydia, additional, Stephanie Yap, Oi Wah, additional, Guerra, Eva M, additional, Rose, Peter G, additional, Baurain, Jean-François, additional, Ghamande, Sharad A, additional, Denys, Hannelore, additional, Prendergast, Emily, additional, Pisano, Carmela, additional, Follana, Philippe, additional, Baumann, Klaus, additional, Calvert, Paula M, additional, Korach, Jacob, additional, Li, Yong, additional, Malinowska, Izabela A, additional, Gupta, Divya, additional, and Monk, Bradley J, additional

Published
2024
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12. Updated progression-free survival and final overall survival with maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed advanced ovarian cancer in the phase III PAOLA-1/ENGOT-ov25 trial

Author

Lorusso, Domenica, primary, Mouret-Reynier, Marie-Ange, additional, Harter, Philipp, additional, Cropet, Claire, additional, Caballero, Cristina, additional, Wolfrum-Ristau, Pia, additional, Satoh, Toyomi, additional, Vergote, Ignace, additional, Parma, Gabriella, additional, Nøttrup, Trine J, additional, Lebreton, Coriolan, additional, Fasching, Peter A, additional, Pisano, Carmela, additional, Manso, Luis, additional, Bourgeois, Hugues, additional, Runnebaum, Ingo, additional, Zamagni, Claudio, additional, Hardy-Bessard, Anne-Claire, additional, Schnelzer, Andreas, additional, Fabbro, Michel, additional, Schmalfeldt, Barbara, additional, Berton, Dominique, additional, Belau, Antje, additional, Lotz, Jean-Pierre, additional, Gropp-Meier, Martina, additional, Gladieff, Laurence, additional, Lück, Hans-Joachim, additional, Abadie-Lacourtoisie, Sophie, additional, Pujade-Lauraine, Eric, additional, and Ray-Coquard, Isabelle, additional

Published
2023
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13. MITO39: Efficacy and Tolerability of Pegylated Liposomal Doxorubicin (PLD)–Trabectedin in the Treatment of Relapsed Ovarian Cancer after Maintenance Therapy with PARP Inhibitors—A Multicenter Italian Trial in Ovarian Cancer Observational Case-Control Study

Author

Turinetto, Margherita, primary, Ricotti, Andrea, additional, Marchetti, Claudia, additional, Pisano, Carmela, additional, Zamagni, Claudio, additional, Cassani, Chiara, additional, Malaguti, Paola, additional, Baldoni, Alessandra, additional, Scollo, Paolo, additional, Scandurra, Giuseppa, additional, Parisi, Alessandro, additional, Artioli, Grazia, additional, Palaia, Innocenza, additional, Vertechy, Laura, additional, Bergamini, Alice, additional, Picardo, Elisa, additional, Tuninetti, Valentina, additional, Scotto, Giulia, additional, Scambia, Giovanni, additional, Pignata, Sandro, additional, and Valabrega, Giorgio, additional

Published
2023
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15. Updated progression-free survival and final overall survival with maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed advanced ovarian cancer in the phase III PAOLA-1/ENGOT-ov25 trial.

Author

Lorusso, Domenica, Mouret-Reynier, Marie-Ange, Harter, Philipp, Cropet, Claire, Caballero, Cristina, Wolfrum-Ristau, Pia, Satoh, Toyomi, Vergote, Ignace, Parma, Gabriella, Nøttrup, Trine J., Lebreton, Coriolan, Fasching, Peter A., Pisano, Carmela, Manso, Luis, Bourgeois, Hugues, Runnebaum, Ingo, Zamagni, Claudio, Hardy-Bessard, Anne-Claire, Schnelzer, Andreas, and Fabbro, Michel

Published
2024
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16. Management of metastatic endometrial cancer: physicians' choices beyond the first line after approval of checkpoint inhibitors.

Author

Arezzo, Francesca, Giannone, Gaia, Castaldo, Daniele, Scotto, Giulia, Tuninetti, Valentina, Turinetto, Margherita, Bartoletti, Michele, Mammoliti, Serafina, Artioli, Grazia, Mangili, Giorgia, Salutari, Vanda, Lorusso, Domenica, Cormio, Gennaro, Loizzi, Vera, Zamagni, Claudio, Savarese, Antonella, Di Maio, Massimo, Ronzino, Graziana, Pisano, Carmela, and Pignata, Sandro

Subjects
ENDOMETRIAL cancer, PHYSICIANS, IMMUNE checkpoint inhibitors, METASTASIS, OVARIAN cancer, THERAPEUTICS, IPILIMUMAB, PEMETREXED
Abstract

Introduction: Endometrial cancer (EC) represents 3.4% of all newly diagnosed cancer cases and is responsible for 2.1% of all cancer-related deaths. Approximately 10%-15% of women with EC are diagnosed with advancedstage disease, resulting in a reported 5-year survival rate of only 17% for those with distant metastases. A better understanding of its molecular features has ushered in a new era of immunotherapy for the treatment of EC, allowing for alternative therapeutic approaches, even in cases of advanced disease. Methods: We administered a multi-choice online survey for Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITO) members. The questionnaire was available for 2 months, starting in October 2022. Our objective was to evaluate the current attitude of incorporating molecular characterization of EC into routine clinical practice, appraise the implementation of newly available therapies, and compare the outcomes with the previous survey conducted in April-May 2021 to ascertain the actual changes that have transpired during this recent time period. Results: The availability of molecular classification in Italian centers has changed in 1 year. Seventy-five percent of centers performed the molecular classification compared with 55.6% of the previous survey. Although this percentage has increased, only 18% performed all the tests. Significant changes have occurred in the administration of new treatments in EC patients in MITO centers. In 2022, 82.1% of the centers administrated dostarlimab in recurrent or advanced MMRdeficient (dMMR) EC experiencing disease progression after platinum-based chemotherapy regimens, compared to only 24.4% in 2021. In 2022, 85.7% of the centers already administrated the pembrolizumab plus lenvatinib combination as a second-line therapy for MMR-proficient (pMMR) patients with advanced or recurrent EC who had progressed from first-line platinumbased therapy. Conclusion: Both the therapeutic and diagnostic scenarios have changed over the last couple of years in MITO centers, with an increased prescription of immune checkpoint inhibitors and use of the molecular classification. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Effect of bevacizumab in advanced low grade serous ovarian cancer: Data from the MITO 22 trial

Author

Musacchio, Lucia, Turinetto, Margherita, Arenare, Laura, Bartoletti, Michele, Califano, Daniela, Tuninetti, Valentina, Marchetti, Claudia, Cormio, Gennaro, Loizzi, Vera, Pisano, Carmela, Salutari, Vanda, Valabrega, Giorgio, Priolo, Domenico, Cecere, Sabrina Chiara, Ventriglia, Jole, Raspagliesi, Francesco, Perrone, Francesco, Fagotti, Anna, Lorusso, Domenica, Scambia, Giovanni, and Pignata, Sandro

Subjects
MITO 22 trial, Settore MED/40 - GINECOLOGIA E OSTETRICIA, serous ovarian cance, varian cancer, Oncology, advanced low grade, MITO 22, Obstetrics and Gynecology, bevacizumab, advanced low grade, serous ovarian cance, MITO 22, trial, trial, bevacizumab
Published
2023

20. Management of metastatic endometrial cancer: physicians’ choices beyond the first line after approval of checkpoint inhibitors

Author

Arezzo, Francesca, primary, Giannone, Gaia, additional, Castaldo, Daniele, additional, Scotto, Giulia, additional, Tuninetti, Valentina, additional, Turinetto, Margherita, additional, Bartoletti, Michele, additional, Mammoliti, Serafina, additional, Artioli, Grazia, additional, Mangili, Giorgia, additional, Salutari, Vanda, additional, Lorusso, Domenica, additional, Cormio, Gennaro, additional, Loizzi, Vera, additional, Zamagni, Claudio, additional, Savarese, Antonella, additional, Di Maio, Massimo, additional, Ronzino, Graziana, additional, Pisano, Carmela, additional, Pignata, Sandro, additional, and Valabrega, Giorgio, additional

Published
2023
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21. Thromboembolic events and antithrombotic prophylaxis in advanced ovarian cancer patients treated with bevacizumab: secondary analysis of the phase IV MITO-16A/MaNGO-OV2A trial

Author

Di Liello, Raimondo, Arenare, Laura, Raspagliesi, Francesco, Scambia, Giovanni, Pisano, Carmela, Colombo, Nicoletta, Frezzini, Simona, Tognon, Germana, Artioli, Grazia, Gadducci, Angiolo, Lauria, Rossella, Ferrero, Annamaria, Cinieri, Saverio, De Censi, Andrea, Breda, Enrico, Scollo, Paolo, De Giorgi, Ugo, Lissoni, Andrea Alberto, Katsaros, Dionyssios, Lorusso, Domenica, Salutari, Vanda, Cecere, Sabrina Chiara, Lapresa, Mariateresa, Nardin, Margherita, Bogani, Giorgio, Distefano, Mariagrazia, Greggi, Stefano, Gargiulo, Piera, Schettino, Clorinda, Gallo, Ciro, Daniele, Gennaro, Califano, Daniela, Perrone, Francesco, Pignata, Sandro, and Piccirillo, Maria Carmela

Published
2021
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22. MITO39: Efficacy and Tolerability of Pegylated Liposomal Doxorubicin (PLD)–Trabectedin in the Treatment of Relapsed Ovarian Cancer after Maintenance Therapy with PARP Inhibitors—A Multicenter Italian Trial in Ovarian Cancer Observational Case-Control Study

Author

Turinetto, Margherita, Ricotti, Andrea, Marchetti, Claudia, Pisano, Carmela, Zamagni, Claudio, Cassani, Chiara, Malaguti, Paola, Baldoni, Alessandra, Scollo, Paolo, Scandurra, Giuseppa, Parisi, Alessandro, Artioli, Grazia, Palaia, Innocenza, Vertechy, Laura, Bergamini, Alice, Picardo, Elisa, Tuninetti, Valentina, Scotto, Giulia, Scambia, Giovanni, and Pignata, Sandro

Subjects
THERAPEUTIC use of antineoplastic agents, DRUG efficacy, RESEARCH, DISEASE progression, HAND-foot syndrome, OVARIAN tumors, SCIENTIFIC observation, CONFIDENCE intervals, DOXORUBICIN, RESEARCH methodology, CASE-control method, RETROSPECTIVE studies, GASTROINTESTINAL diseases, PLATINUM, BLOOD diseases, DESCRIPTIVE statistics, RESEARCH funding, FATIGUE (Physiology), ENZYME inhibitors, EVALUATION
Abstract

Simple Summary: This multicenter, retrospective analysis had the objective of comparing the efficacy of PLD-Trabectedin in patients who had already been treated with PARP-I (cases) before vs. PARPi-naïve patients (controls). Data from 166 patients were collected, composed of 109 cases and 57 controls. In total, 135 patients were included in our analyses, composing 46 controls and 89 cases. We found a median PFS of 11 months (95% IC 10–12) in the control group vs. 8 months (95% IC 6–9) in the case group (p value 0.0017). The clinical benefit rate was evaluated, with an HR for progression of 2.55 (1.28–5.06) for the case group (p value 0.008) persisting when adjusted for BRCA mutation. The study showed a statistically significant difference in terms of PFS, suggesting that a previous exposure to PARP-i might inhibit the efficacy of PLD-Trabectedin. Regarding tolerability, no remarkable disparity was noted. Objective: While PLD-Trabectedin is an approved treatment for relapsed platinum-sensitive ovarian cancer, its efficacy and tolerability has so far not been tested extensively in patients who progress after poly ADP-ribose polymerase inhibitor (PARPi) treatment. Methodology: This multicenter, retrospective analysis had the objective of comparing patients receiving PLD-Trabectedin after being treated with PARP-I (cases) with PARPi-naïve patients. Descriptive and survival analyses were performed for each group. Results: Data from 166 patients were collected, composed of 109 cases and 57 controls. In total, 135 patients were included in our analyses, composing 46 controls and 89 cases. The median PFS was 11 months (95% IC 10–12) in the control group vs. 8 months (95% IC 6–9) in the case group (p value 0.0017). The clinical benefit rate was evaluated, with an HR for progression of 2.55 (1.28–5.06) for the case group (p value 0.008), persisting when adjusted for BRCA and line with treatment. We compared hematological toxicity, gastro-intestinal toxicity, hand–foot syndrome (HFS), fatigue, and liver toxicity, and no statistically significant disparity was noted, except for HFS with a p value of 0.006. The distribution of G3 and G4 toxicities was also equally represented. Conclusion: The MITO39 study showed a statistically significant difference in terms of PFS, suggesting that previous exposure to PARPi might inhibit the efficacy of PLD-Trabectedin. Regarding tolerability, no remarkable disparity was noted; PLD-Trabectedin was confirmed to be a well-tolerated scheme in both groups. To our knowledge, these are the first data regarding this topic, which we deem to be of great relevance in the current landscape. [ABSTRACT FROM AUTHOR]

Published
2024
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23. Machine Learning Application Identifies Germline Markers of Hypertension in Ovarian Cancer Patients Treated with Carboplatin, Taxane and Bevacizumab

Author

Polano, Maurizio, primary, Bedon, Luca, additional, Bo, Michele Dal, additional, Sorio, Roberto, additional, Bartoletti, Michele, additional, De Mattia, Elena, additional, Cecchin, Erika, additional, Pisano, Carmela, additional, Lorusso, Domenica, additional, Lissoni, Andrea Alberto, additional, De Censi, Andrea, additional, Cecere, Sabrina Chiara, additional, Scollo, Paolo, additional, Marchini, Sergio, additional, Arenare, Laura, additional, De Giorgi, Ugo, additional, Califano, Daniela, additional, Biagioli, Elena, additional, Chiodini, Paolo, additional, Perrone, Francesco, additional, Pignata, Sandro, additional, and Toffoli, Giuseppe, additional

Published
2023
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24. Prospective evaluation of the tolerability and efficacy of niraparib dosing based on baseline body weight and platelet count: Results from the PRIMA/ENGOT‐OV26/GOG‐3012 trial

Author

Mirza, Mansoor R., primary, González‐Martín, Antonio, additional, Graybill, Whitney S., additional, O’Malley, David M., additional, Gaba, Lydia, additional, Stephanie Yap, Oi Wah, additional, Guerra, Eva M., additional, Rose, Peter G., additional, Baurain, Jean‐François, additional, Ghamande, Sharad A., additional, Denys, Hannelore, additional, Prendergast, Emily, additional, Pisano, Carmela, additional, Follana, Philippe, additional, Baumann, Klaus, additional, Calvert, Paula M., additional, Korach, Jacob, additional, Li, Yong, additional, Malinowska, Izabela A., additional, Gupta, Divya, additional, and Monk, Bradley J., additional

Published
2023
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25. Carboplatin and paclitaxel plus avelumab compared with carboplatin and paclitaxel in advanced or recurrent endometrial cancer (MITO END-3): a multicentre, open-label, randomised, controlled, phase 2 trial

Author

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

Published
2023
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26. Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase 3 trial

Author

Oaknin, Ana, Gladieff, Laurence, Martínez-García, Jerónimo, Villacampa, Guillermo, Takekuma, Munetaka, De Giorgi, Ugo, Lindemann, Kristina, Woelber, Linn, Colombo, Nicoletta, Duska, Linda, Leary, Alexandra, Godoy-Ortiz, Ana, Nishio, Shin, Angelergues, Antoine, Rubio, Maria Jesús, Fariñas-Madrid, Lorena, Yamaguchi, Satoshi, Lorusso, Domenica, Ray-Coquard, Isabelle, Manso, Luis, Joly, Florence, Alarcón, Jesús, Follana, Philippe, Romero, Ignacio, Lebreton, Coriolan, Pérez-Fidalgo, J Alejandro, Yunokawa, Mayu, Dahlstrand, Hanna, D'Hondt, Véronique, Randall, Leslie M, Abadie-Lacourtoisie, Sophie, Andreetta, Claudia, Anzizar, Nerea, Aoki, Daiseuke, Barretina-Ginesta, Maria-Pilar, Battista, Marco, Bellier, Charlotte, Bentzen, Anne Gry, Berton, Dominique, Billemont, Bertrand, Bjørge, Line, Bjurberg, Maria, Black, Destin, Bologna, Alessandra, Braicu, Elena Ioana, Casanova, Claudia, Chekerov, Radoslav, Chevalier, Annick, Cueva, Juan Fernando, Czogalla, Bastian, Delanoy, Nicolas, Denschlag, Dominik, Derke, Oscar, Eichbaum, Michael, Enomoto, Takayuki, Esteban, Carmen, Fabbro, Michel, Fehm, Tanja, Ferrero, Annamaria, Fleisch, Markus, Floquet, Anne, Frassoldati, Antonio, Gaba, Lydia, Gadducci, Angiolo, García, Yolanda, Geuna, Elena, Guerra, Eva, Hanker, Lars, Hardy-Bessard, Anne-Claire, Harter, Philipp, Hasegawa, Kosei, Hellman, Kristina, Herrero, Ana, Hilpert, Felix, Katsaros, Dionyssios, Koegel, Matthias, Koliadi, Anthoula, Kurtz, Jean-Emmanuel, Lampe, Bjoern, Lissoni, Andrea Alberto, Lortholary, Alain, Mangili, Giorgia, Mansi, Laura, Marmé, Frederik, Mathews, Cara, Mina, William, Minobe, Shinichiro, Moxley, Katherine, Nagao, Shoji, Nicoletto, Ornella, Nishino, Koji, Nishio, Hiroshi, Nishio, Shin, Oaknin, Ana, Onstad, Michaela, Pardo, Beatriz, Pérez-Fidalgo, J Alejandro, Pisano, Carmela, Poveda, Andrés, Radosa, Julia, Randall, Leslie M., Ray-Coquard, Isabelle, Redondo, Andrés, Richardson, Debra, Romero, Ignacio, Ronzino, Graziana, Rubio, Maria Jesús, Selle, Frederic, Takekuma, Munetaka, Takeshima, Nobuhiro, Tasca, Giulia, Tewari, Krishnansu, Todo, Yukiharu, Valabrega, Giorgio, Wimberger, Pauline, Woelber, Linn, Yamaguchi, Satoshi, You, Benoît, and Yunokawa, Mayu

Abstract

The GOG240 trial established bevacizumab with chemotherapy as standard first-line therapy for metastatic or recurrent cervical cancer. In the BEATcc trial (ENGOT-Cx10–GEICO 68-C–JGOG1084–GOG-3030), we aimed to evaluate the addition of an immune checkpoint inhibitor to this standard backbone.

Published
2024
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27. Machine Learning Application Identifies Germline Markers of Hypertension in Patients With Ovarian Cancer Treated With Carboplatin, Taxane, and Bevacizumab.

Author

Polano, Maurizio, Bedon, Luca, Dal Bo, Michele, Sorio, Roberto, Bartoletti, Michele, De Mattia, Elena, Cecchin, Erika, Pisano, Carmela, Lorusso, Domenica, Lissoni, Andrea Alberto, De Censi, Andrea, Cecere, Sabrina Chiara, Scollo, Paolo, Marchini, Sergio, Arenare, Laura, De Giorgi, Ugo, Califano, Daniela, Biagioli, Elena, Chiodini, Paolo, and Perrone, Francesco

Subjects
OVARIAN cancer, CANCER patients, MACHINE learning, HYPERTENSION, BEVACIZUMAB, GENETIC variation, PRECISION farming
Abstract

Pharmacogenomics studies how genes influence a person's response to treatment. When complex phenotypes are influenced by multiple genetic variations with little effect, a single piece of genetic information is often insufficient to explain this variability. The application of machine learning (ML) in pharmacogenomics holds great potential — namely, it can be used to unravel complicated genetic relationships that could explain response to therapy. In this study, ML techniques were used to investigate the relationship between genetic variations affecting more than 60 candidate genes and carboplatin‐induced, taxane‐induced, and bevacizumab‐induced toxicities in 171 patients with ovarian cancer enrolled in the MITO‐16A/MaNGO‐OV2A trial. Single‐nucleotide variation (SNV, formerly SNP) profiles were examined using ML to find and prioritize those associated with drug‐induced toxicities, specifically hypertension, hematological toxicity, nonhematological toxicity, and proteinuria. The Boruta algorithm was used in cross‐validation to determine the significance of SNVs in predicting toxicities. Important SNVs were then used to train eXtreme gradient boosting models. During cross‐validation, the models achieved reliable performance with a Matthews correlation coefficient ranging from 0.375 to 0.410. A total of 43 SNVs critical for predicting toxicity were identified. For each toxicity, key SNVs were used to create a polygenic toxicity risk score that effectively divided individuals into high‐risk and low‐risk categories. In particular, compared with low‐risk individuals, high‐risk patients were 28‐fold more likely to develop hypertension. The proposed method provided insightful data to improve precision medicine for patients with ovarian cancer, which may be useful for reducing toxicities and improving toxicity management. [ABSTRACT FROM AUTHOR]

Published
2023
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28. The way to precision medicine in gynecologic cancers: The first case report of an exceptional response to alpelisib in a PIK3CA-mutated endometrial cancer

Author

Passarelli, Anna, primary, Ventriglia, Jole, additional, Pisano, Carmela, additional, Cecere, Sabrina Chiara, additional, Napoli, Marilena Di, additional, Rossetti, Sabrina, additional, Tambaro, Rosa, additional, Tarotto, Luca, additional, Fiore, Francesco, additional, Farolfi, Alberto, additional, Bartoletti, Michele, additional, and Pignata, Sandro, additional

Published
2023
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29. Efficacy and safety of trabectedin for the treatment of advanced uterine or ovarian carcinosarcoma: Results of a phase II multicenter clinical trial (MITO-26)

Author

Lorusso, Domenica, primary, Pignata, Sandro, additional, Tamberi, Stefano, additional, Mangili, Giorgia, additional, Bologna, Alessandra, additional, Nicoloso, Milena Sabrina, additional, Giolitto, Serena, additional, Salutari, Vanda, additional, Mantero, Mara, additional, Pisano, Carmela, additional, Bergamini, Alice, additional, Musacchio, Lucia, additional, Ronzulli, Dominique, additional, Raspagliesi, Francesco, additional, and Scambia, Giovanni, additional

Published
2022
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30. 2022-RA-1623-ESGO Effect of bevacizumab and complete cytoreductive surgery in advanced low grade serous ovarian cancer: a secondary analysis of MITO 22

Author

Musacchio, Lucia, primary, Turinetto, Margherita, additional, Bartoletti, Michele, additional, Arenare, Laura, additional, Califano, Daniela, additional, Tuninetti, Valentina, additional, Cormio, Gennaro, additional, Pisano, Carmela, additional, Valabrega, Giorgio, additional, Marchetti, Claudia, additional, Cecere, Sabrina Chiara, additional, Greggi, Stefano, additional, Raspagliesi, Francesco, additional, Perrone, Francesco, additional, Fagotti, Anna, additional, Lorusso, Domenica, additional, Scambia, Giovanni, additional, and Pignata, Sandro, additional

Published
2022
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32. Targeting immunometabolism mediated by the IDO1 Pathway: A new mechanism of immune resistance in endometrial cancer

Author

Passarelli, Anna, primary, Pisano, Carmela, additional, Cecere, Sabrina Chiara, additional, Di Napoli, Marilena, additional, Rossetti, Sabrina, additional, Tambaro, Rosa, additional, Ventriglia, Jole, additional, Gherardi, Federica, additional, Iannacone, Eva, additional, Venanzio, Sergio Setola, additional, Fiore, Francesco, additional, Bartoletti, Michele, additional, Scognamiglio, Giosuè, additional, Califano, Daniela, additional, and Pignata, Sandro, additional

Published
2022
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33. Analysis of A Disintegrin and Metalloprotease 17 (ADAM17) Expression as a Prognostic Marker in Ovarian Cancer Patients Undergoing First-Line Treatment Plus Bevacizumab

Author

Fabbi, Marina, primary, Costa, Delfina, additional, Russo, Daniela, additional, Arenare, Laura, additional, Gaggero, Gabriele, additional, Signoriello, Simona, additional, Scambia, Giovanni, additional, Pisano, Carmela, additional, Colombo, Nicoletta, additional, Losito, Nunzia Simona, additional, Filaci, Gilberto, additional, Spina, Anna, additional, Califano, Daniela, additional, Scognamiglio, Giosuè, additional, Gadducci, Angiolo, additional, Mezzanzanica, Delia, additional, Bagnoli, Marina, additional, Ferrini, Silvano, additional, Canzonieri, Vincenzo, additional, Chiodini, Paolo, additional, Perrone, Francesco, additional, and Pignata, Sandro, additional

Published
2022
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34. Management of Metastatic Endometrial Cancer: Physicians’ Choices Beyond the First Line. A MITO Survey

Author

Giannone, Gaia, primary, Castaldo, Daniele, additional, Tuninetti, Valentina, additional, Scotto, Giulia, additional, Turinetto, Margherita, additional, Valsecchi, Anna Amela, additional, Bartoletti, Michele, additional, Mammoliti, Serafina, additional, Artioli, Grazia, additional, Mangili, Giorgia, additional, Salutari, Vanda, additional, Lorusso, Domenica, additional, Cormio, Gennaro, additional, Zamagni, Claudio, additional, Savarese, Antonella, additional, Di Maio, Massimo, additional, Ronzino, Graziana, additional, Pisano, Carmela, additional, Pignata, Sandro, additional, and Valabrega, Giorgio, additional

Published
2022
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35. Biological Role of Tumor/Stromal CXCR4-CXCL12-CXCR7 in MITO16A/MaNGO-OV2 Advanced Ovarian Cancer Patients

Author

D’Alterio, Crescenzo, primary, Spina, Anna, additional, Arenare, Laura, additional, Chiodini, Paolo, additional, Napolitano, Maria, additional, Galdiero, Francesca, additional, Portella, Luigi, additional, Simeon, Vittorio, additional, Signoriello, Simona, additional, Raspagliesi, Francesco, additional, Lorusso, Domenica, additional, Pisano, Carmela, additional, Colombo, Nicoletta, additional, Zannoni, Gian Franco, additional, Losito, Nunzia Simona, additional, De Cecio, Rossella, additional, Scognamiglio, Giosuè, additional, Califano, Daniela, additional, Russo, Daniela, additional, Tuninetti, Valentina, additional, Piccirillo, Maria Carmela, additional, Gargiulo, Piera, additional, Perrone, Francesco, additional, Pignata, Sandro, additional, and Scala, Stefania, additional

Published
2022
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36. MITO END-3: A Randomized Phase II Trial of Avelumab Plus Carboplatin and Paclitaxel Compared to Carboplatin and Paclitaxel in Advanced or Recurrent Endometrial Cancer

Author

Pignata, Sandro, primary, Scambia, Giovanni, additional, Schettino, Clorinda, additional, Arenare, Laura, additional, Pisano, Carmela, additional, Lombardi, Davide, additional, De Giorgi, Ugo, additional, Andreetta, Claudia, additional, Cinieri, Saverio, additional, De Angelis, Carmine, additional, Priolo, Domenico, additional, Casanova, Claudia, additional, Rosati, Marta, additional, Greco, Filippo, additional, Zafarana, Elena, additional, Schiavetto, Ilaria, additional, Mammoliti, Serafina, additional, Cecere, Sabrina Chiara, additional, Salutari, Vanda, additional, Scalone, Simona, additional, Farolfi, Alberto, additional, Di Napoli, Marilena, additional, Lo Russo, Domenica, additional, Gargiulo, Piera, additional, Califano, Daniela, additional, Russo, Daniela, additional, Spina, Anna, additional, De Cecio, Rossella, additional, Chiodini, Paolo, additional, and Perrone, Francesco, additional

Published
2022
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37. Oligometastatic prostate cancer treatment

Author

Rossetti, Sabrina, primary, Di Napoli, Marilena, additional, Pisano, Carmela, additional, C Cecere, Sabrina, additional, Tambaro, Rosa, additional, Ventriglia, Jole, additional, Passarelli, Anna, additional, Iovane, Gelsomina, additional, Feroce, Florinda, additional, Lastoria, Secondo, additional, Di Gennaro, Francesca, additional, Muto, Paolo, additional, Borzillo, Valentina, additional, Di Franco, Rossella, additional, Perdonà, Sisto, additional, Quarto, Giuseppe, additional, and Pignata, Sandro, additional

Published
2021
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38. Biological Role of Tumor/Stromal CXCR4-CXCL12-CXCR7 in MITO16A/MaNGO-OV2 Advanced Ovarian Cancer Patients.

Author

D'Alterio, Crescenzo, Spina, Anna, Arenare, Laura, Chiodini, Paolo, Napolitano, Maria, Galdiero, Francesca, Portella, Luigi, Simeon, Vittorio, Signoriello, Simona, Raspagliesi, Francesco, Lorusso, Domenica, Pisano, Carmela, Colombo, Nicoletta, Zannoni, Gian Franco, Losito, Nunzia Simona, De Cecio, Rossella, Scognamiglio, Giosuè, Califano, Daniela, Russo, Daniela, and Tuninetti, Valentina

Subjects
OVARIAN tumors, STROMAL cells, CANCER patients, TUMOR markers
Abstract

Simple Summary: Despite rapid progress in the research on epithelial ovarian cancer (EOC), it is usually diagnosed during the advanced stage with only 30% of patients surviving longer than 5 years. This is the first study in which the whole CXCR4-CXCL12-CXCR7 axis was systematically evaluated in tumor and stromal cells, through rigorous statistical methods in a prospective clinical trial. CXCL12 expression in cancer cells is associated with worse progression-free survival in stage III EOC patients, and deserves further attention as a potential prognostic and therapeutic target. This study investigated the prognostic role of the CXCR4-CXCL12-CXCR7 axis in advanced epithelial ovarian cancer (EOC) patients receiving first-line treatment within the MITO16A/MaNGO-OV2 phase-IV trial. CXCR4-CXCL12-CXCR7 expression was evaluated in the epithelial and stromal component of 308 EOC IHC-stained tumor samples. The statistical analysis focused on biomarkers' expression, their association with other variables and prognostic value. Zero-inflated tests, shrinkage, bootstrap procedures, and multivariable models were applied. The majority of EOC (75.0%) expressed CXCR4 and CXCR7, 56.5% expressed the entire CXCR4-CXCL12-CXCR7 axis, while only 4.6% were negative for CXCL12 and its cognate receptors, in regard to the epithelial component. Stromal CXCL12 and CXCR7, expressed in 11.2% and 65.5%, respectively, were associated with the FIGO stage. High CXCL12 in epithelial cancer cells was associated with shorter progression-free and overall survival. However, after adjusting for overfitting due to best cut-off multiplicity testing, the significance was lost. This is a wide-ranging, prospective study in which CXCR4-CXCL12-CXCR7 were systematically evaluated in epithelial and stromal components, in selected stage III-IV EOC. Although CXCL12 was not prognostic, epithelial expression identified high-risk FIGO stage III patients for PFS. These data suggest that it might be worth studying the CXCL12 axis as a therapeutic target to improve treatment efficacy in EOC patients. [ABSTRACT FROM AUTHOR]

Published
2022
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39. Analysis of A Disintegrin and Metalloprotease 17 (ADAM17) Expression as a Prognostic Marker in Ovarian Cancer Patients Undergoing First-Line Treatment Plus Bevacizumab

Author

Marina Fabbi, Delfina Costa, Daniela Russo, Laura Arenare, Gabriele Gaggero, Simona Signoriello, Giovanni Scambia, Carmela Pisano, Nicoletta Colombo, Nunzia Simona Losito, Gilberto Filaci, Anna Spina, Daniela Califano, Giosuè Scognamiglio, Angiolo Gadducci, Delia Mezzanzanica, Marina Bagnoli, Silvano Ferrini, Vincenzo Canzonieri, Paolo Chiodini, Francesco Perrone, Sandro Pignata, Fabbi, Marina, Costa, Delfina, Russo, Daniela, Arenare, Laura, Gaggero, Gabriele, Signoriello, Simona, Scambia, Giovanni, Pisano, Carmela, Colombo, Nicoletta, Losito, Nunzia Simona, Filaci, Gilberto, Spina, Anna, Califano, Daniela, Scognamiglio, Giosuè, Gadducci, Angiolo, Mezzanzanica, Delia, Bagnoli, Marina, Ferrini, Silvano, Canzonieri, Vincenzo, Chiodini, Paolo, Perrone, Francesco, Pignata, Sandro, Fabbi, M, Costa, D, Russo, D, Arenare, L, Gaggero, G, Signoriello, S, Scambia, G, Pisano, C, Colombo, N, Losito, N, Filaci, G, Spina, A, Califano, D, Scognamiglio, G, Gadducci, A, Mezzanzanica, D, Bagnoli, M, Ferrini, S, Canzonieri, V, Chiodini, P, Perrone, F, and Pignata, S

Subjects
ADAM17, ovarian cancer, bevacizumab treatment, Clinical Biochemistry, immunohistochemistry, prognostic biomarker
Abstract

To find prognostic factors for advanced ovarian cancer patients undergoing first-line therapy with carboplatin, paclitaxel and bevacizumab, we investigated the expression of a disintegrin and metalloprotease 17 (ADAM17) in cancer tissues. ADAM17 has been involved in ovarian cancer development, progression and cell resistance to cisplatin. Tissue microarrays from 309 ovarian cancer patients enrolled in the MITO16A/MANGO-OV2 clinical trial were analyzed by immunohistochemistry for ADAM17 protein expression. Intensity and extent of staining were combined into a semi-quantitative visual grading system (H score) which was related to clinicopathological characteristics of cases and the clinical outcome of patients by univariate and multivariate Cox regression models. ADAM17 immunostaining was detected in most samples, mainly localized in the tumor cells, with variable intensity across the cohort. Kaplan–Meier survival curves, generated according to the best cut-off value for the ADAM17 H score, showed that high ADAM17 expression was associated with worse prognosis for PFS and OS. However, after the application of a shrinkage procedure to adjust for overfitting hazard ratio estimates, the ADAM17 value as prognostic factor was lost. As subgroup analysis suggested that ADAM17 expression could be prognostically relevant in cases with no residual disease at baseline, further studies in this patient category may be worth planning.

Published
2022

40. Clinical characteristics and molecular aspects of low-grade serous ovarian and peritoneal cancer: a multicenter, observational, retrospective analysis of MITO Group (MITO 22)

Author

Lucia Musacchio, Daniela Califano, Michele Bartoletti, Laura Arenare, Domenica Lorusso, Nunzia Simona Losito, Gennaro Cormio, Stefano Greggi, Francesco Raspagliesi, Giorgio Valabrega, Vanda Salutari, Carmela Pisano, Anna Spina, Daniela Russo, Michele Del Sesto, Vincenzo Canzonieri, Francesco Ferraù, Gian Franco Zannoni, Vera Loizzi, Viola Ghizzoni, Claudia Casanova, Valentina Tuninetti, Monika Ducceschi, Vittoria Del Vecchio, Simona Scalone, Domenico Priolo, Francesco Perrone, Giovanni Scambia, Sandro Pignata, Musacchio, Lucia, Califano, Daniela, Bartoletti, Michele, Arenare, Laura, Lorusso, Domenica, Losito, Nunzia Simona, Cormio, Gennaro, Greggi, Stefano, Raspagliesi, Francesco, Valabrega, Giorgio, Salutari, Vanda, Pisano, Carmela, Spina, Anna, Russo, Daniela, Del Sesto, Michele, Canzonieri, Vincenzo, Ferraù, Francesco, Zannoni, Gian Franco, Loizzi, Vera, Ghizzoni, Viola, Casanova, Claudia, Tuninetti, Valentina, Ducceschi, Monika, Del Vecchio, Vittoria, Scalone, Simona, Priolo, Domenico, Perrone, Francesco, Scambia, Giovanni, and Pignata, Sandro

Subjects
Ovarian Neoplasms, Proto-Oncogene Proteins B-raf, Cancer Research, therapy, peritoneal cancer, multicenter, retrospective analysis, serous ovarian, serous ovarian cancer, Cystadenocarcinoma, Serous, Proto-Oncogene Proteins p21(ras), Oncology, MITO Group (MITO 22), Humans, Female, Prospective Studies, observational, serous ovarian, peritoneal cancer, multicenter, observational, retrospective analysis, MITO Group (MITO 22), Peritoneal Neoplasms, Retrospective Studies
Abstract

Low-grade serous ovarian and peritoneal cancer (LGSC) is a rare disease and few data on the clinical and genomic landscape have been published.A retrospective analysis of patients diagnosed with LGSC between 1996 and 2019 was conducted in MITO centers. Objective Response Rate (ORR) to treatments, progression-free survival (PFS) and overall survival (OS) were assessed. Additionally, the tumor molecular profile of 56 patients was evaluated using the Next Generation Sequencing (NGS) FoundationOne CDX (Foundation Medicine®).A total of 128 patients with complete clinical data and pathologically confirmed diagnosis of LGSC were identified. ORR to first and subsequent therapies were 23.7% and 33.7%, respectively. PFS was 43.9 months (95% CI:32.4-53.1) and OS was 105.4 months (95% CI: 82.7-not reached). The most common gene alterations were: KRAS (n = 12, 21%), CDKN2A/B (n = 11, 20%), NRAS (n = 8, 14%), FANCA (n = 8, 14%), NF1 (n = 7, 13%) and BRAF (n = 6, 11%). Unexpectedly, pathogenetic BRCA1 (n = 2, 4%), BRCA2 (n = 1, 2%) and PALB2 (n = 1, 2%) mutations were found.MITO 22 suggests that LGSC is an heterogenous disease for both its clinical behavior in response to standard therapies and its molecular alterations. Future prospective studies should test treatments according to biological and molecular tumor's characteristics.This study is registered under NCT02408536 on ClinicalTrials.gov .

Published
2022

41. Niraparib Population Pharmacokinetics and Exposure-Response Relationships in Patients With Newly Diagnosed Advanced Ovarian Cancer.

Author

Monk BJ, Romero I, Graybill W, Churruca C, O'Malley DM, Knudsen AØ, Yap OWS, Baurain JF, Rose PG, Denys H, Ghamande S, Pisano C, Fabbro M, Braicu EI, Calvert PM, Amit A, Prendergast E, Taylor A, Kheibarshekan L, Zhang ZY, Zajic S, Jewell RC, Gupta D, and González-Martín A

Abstract

Purpose: Niraparib is a poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitor approved for the maintenance treatment of advanced ovarian cancer (OC). Niraparib was originally approved in recurrent OC at a fixed starting dose (FSD) of 300 mg once daily (QD). This analysis characterized the population pharmacokinetics (PK) of niraparib and evaluated the relationships between exposure, efficacy, and safety to support clinical use of an individualized dosing strategy, in which the starting dose of niraparib was adjusted based on patient characteristics to improve the benefit-risk profile., Methods: A population PK model was developed by pooling data from four niraparib clinical trials (PN001 [n = 104], QUADRA [n = 455], NOVA [n = 403], and PRIMA [n = 480]) in patients with solid tumors, including OC. Exposure-response analyses were conducted to explore the relationships of niraparib exposure with progression-free survival (PFS) and adverse events in the PRIMA study. A multivariate logistic regression model was also developed to estimate the probability of grade ≥3 thrombocytopenia, using data from patients enrolled in PRIMA and NOVA. The impact of an individualized starting dose (ISD) regimen (200 mg QD in patients with body weight [BW] <77 kg or platelet count [PLT] <150,000/µL, or 300 mg QD in patients with BW ≥77 kg and PLT ≥150,000/µL) on systemic exposure, efficacy, and safety was assessed., Findings: Niraparib disposition was best described by a 3-compartment model with linear elimination. Key covariates included baseline creatinine clearance, BW, albumin, and age, all of which had minor effects on niraparib exposure. Comparable model-predicted exposure up to the time of disease progression/death or censoring in the 300-mg FSD and 200-/300-mg ISD groups was consistent with the lower rate of dose reduction in the ISD groups. No consistent niraparib exposure-response relationship was observed for efficacy in all PRIMA patients (first-line OC), and no statistically significant difference was seen in PFS curves for patients receiving a niraparib dose of 200 mg versus 300 mg. In the multivariate regression model, performed using combined data from PRIMA and NOVA, higher niraparib exposure (area under the concentration-time curve at steady-state [AUC ss ]), lower BW, and lower PLT were associated with an increased risk of grade ≥3 thrombocytopenia., Implications: Population PK and exposure-response analyses support use of an ISD to improve the safety profile of niraparib, including reducing the rate of grade ≥3 thrombocytopenia, without compromising efficacy., Clinical Trial Registration: ClinicalTrials.gov, NCT01847274 (NOVA), NCT00749502 (PN001), NCT02655016 (PRIMA), NCT02354586 (QUADRA), www., Clinicaltrials: gov., Competing Interests: Declaration of competing interest Bradley J. Monk is an Associate Editor for Annals of Oncology and was not involved in the editorial review or the decision to publish this article. The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Bradley J. Monk reports consulting fees from Agenus, Akeso Biopharma, Amgen, Aravive, Bayer, Elevar, EMD Merck, Genmab/Seagen, GOG Foundation, Gradalis, ImmunoGen, Iovance, Karyopharm, MacroGenics, Mersana, Myriad, Novartis, Novocure, Pfizer, Puma, Regeneron, Sorrento, US Oncology Research, and VBL and speakers’ bureau honoraria from AstraZeneca, Clovis, Eisai, Merck, Roche/Genentech, and Tesaro/GSK. Ignacio Romero reports consulting or advisory role at AstraZeneca, Clovis, GSK, MSD, and Roche; speakers bureau at AstraZeneca, GSK, PharmaMar, and Roche; research funding from AstraZeneca and Roche; and travel expenses from AstraZeneca, Clovis, GSK, MSD, PharmaMar, and Roche. Whitney Graybill reports personal fees from GSK. David M. O'Malley reports personal fees from Agenus, Eisai, GSK, and Immunogen; consultant/advisory board for AbbVie, Ambry, Amgen, Array Biopharma, Clovis, EMD Serono, Ergomed, Janssen/J&J, Myriad Genetics, Novocure, Regeneron, Tarveda, and VentiRx; steering committee for Genentech/Roche and Merck; institutional funding from Ajinomoto, BMS, Cerulean Pharma, GOG Foundation, INC Research, InVentiv Health Clinical, Iovance Biotherapeutics, Ludwig Cancer Research, New Mexico Cancer Care Alliance, PRA International, Serono, Stemcentrx, Tracon Pharmaceuticals, and Yale University. Hannelore Denys reports consulting or advisory role at Amgen, AstraZeneca, Eli Lilly, Gilead, GSK, MSD, Novartis, Pfizer, PharmaMar, and Seagen; institutional research funding from Gilead; and travel expenses from AstraZeneca, Gilead, GSK, Pfizer, PharmaMar, Roche, and Teva. Sharad Ghamande reports consulting fees from Seattle Genetics; speakers bureau fees from GSK; and institutional grants from AbbVie, Advaxis, BMS, Clovis, Genentech, GSK, Merck, Roche, Seattle Genetics, Takeda, and Tesaro. Carmela Pisano reports speakers’ bureau fee and advisory role from AstraZeneca, GSK, and MSD. Michel Fabbro reports honoraria from GSK. Elena Iona Braicu reports honoraria from AstraZeneca, GSK, and Merck; consulting or advisory roles at AstraZeneca and GSK; institutional research funding from AstraZeneca, Bayer, Clovis, Eisai, GSK, Merck, and Resolve; travel support from AstraZeneca; and relationship with medical director of the North Eastern German Society of Gynecological Oncology (NOGGO). Paula M. Calvert reports an educational grant for meeting attendance, flights, and accommodations from MSD. Emily Prendergast reports consulting or advisory role at AstraZeneca and Merck. Adekemi Taylor reports being an employee of Certara (a biosimulation company) and, as a Certara employee, provided consulting services to GSK and Tesaro for this analysis and also provides consulting services to various pharmaceutical and biotech companies. Zhi-Yi Zhang was an employee of GSK when these analyses were undertaken and held shares/stock options in GSK. Stefan Zajic is an employee of GSK and holds shares/stock in GSK. Roxanne C. Jewell is an employee of GSK and holds shares/stock in GSK. Divya Gupta was an employee of GSK when these analyses were undertaken and held shares/stock options in GSK. Antonio González-Martín reports consulting fees from Alkermes, Amgen, AstraZeneca, Clovis, Daichii ,Genmab, GSK, Hedera DX, Illumina, Immunogen, Incyte, Kartos, Karyopharm, Mersana, MSD, Novartis, Novocure, Oncoinvent, Pharma&, PharmaMar, Roche, Seagen SOTIO, Sutro, Takeda, and Tubulis; grants or contracts from Asociación Española Contra el Cáncer, GSK, Instituto de Salud Carlos III, and Roche; payment or honoraria for lectures, presentations, or speakers bureau from AstraZeneca, Clovis, GSK, Immunogen, Mersana, MSD, Novocure, PharmaMar, Roche, Takeda, Seagen, and Zai Lab; and travel support from AstraZeneca, Clovis, GSK, Immunogen, Mersana, MSD, Novocure, PharmaMar, Roche, and Takeda. Peter G. Rose, Amnon Amit, Leila Kheibarshekan, Cristina Churruca, Anja Ør Knudsen, Oi Wah Stephanie Yap, and Jean-François Baurain have nothing to disclose., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Published
2024
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42. Nivolumab-ipilimumab in renal cell carcinoma metastatic to the bones: A case report.

Author

Di Napoli M, Pisano C, Setola SV, Perdonà S, Feroce F, and Pignata S

Subjects
Antineoplastic Combined Chemotherapy Protocols therapeutic use, Humans, Ipilimumab adverse effects, Nivolumab therapeutic use, Carcinoma, Renal Cell drug therapy, Kidney Neoplasms drug therapy, Kidney Neoplasms pathology
Abstract

In the last recent years, the introduction in the clinical setting of treatment combinations having immune checkpoint inhibitors as the backbone has dramatically improved the outcomes of patients suffering from advanced/metastatic renal cell carcinoma (RCC). Here we report the clinical course of a patient with a rapid and bulky bone recurrence of RCC after nephrectomy, experiencing long-term benefit from nivolumab-ipilimumab administered as first-line treatment.

Published
2022
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