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42 results on '"Ronzino, Graziana"'

1. Stereotactic Body Radiation Therapy for Oligoprogressive Ovarian Cancer Patients Treated During Poly(ADP-Ribose)-Polymerase Inhibitor Maintenance: Efficacy and Adverse Events From the Epimetheo Retrospective Study

Author

Macchia, Gabriella, Pezzulla, Donato, Campitelli, Maura, Russo, Donatella, Ronzino, Graziana, Lucci, Simona, Salutari, Vanda, Di Stefano, Aida, Balcet, Vittoria, Epifani, Valeria, Perrucci, Elisabetta, Marchetti, Claudia, Distefano, Maria Grazia, Palluzzi, Eleonora, Autorino, Rosa, De Luca, Viola, Giannini, Roberta, Rinaldi, Raffaella, Russo, Silvio Andrea, Cilla, Savino, Fagotti, Anna, Gambacorta, Maria Antonietta, Scambia, Giovanni, Deodato, Francesco, and Ferrandina, Gabriella

Published
2025
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2. 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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3. Post hoc analysis of progression-free survival (PFS) and overall survival (OS) by mechanism of mismatch repair (MMR) protein loss in patients with endometrial cancer (EC) treated with dostarlimab plus chemotherapy in the RUBY trial.

Author

Mirza, Mansoor Raza, primary, Sharma, Sudarshan, additional, Roed, Henrik, additional, Landrum, Lisa M., additional, Gilbert, Lucy, additional, Gold, Michael A., additional, Novák, Zoltán, additional, Edelson, Mitchell, additional, Meirovitz, Mihai, additional, Diaz, John Paul, additional, Huygh, Greet, additional, Buscema, Joseph, additional, Pothuri, Bhavana, additional, Eshed, Helen Dinkelspiel, additional, Coleman, Robert L., additional, Slomovitz, Brian M., additional, Kostadinov, Rumen, additional, Stevens, Shadi, additional, Ronzino, Graziana, additional, and Powell, Matthew A., additional

Published
2024
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4. Impact of COVID-19 on medical treatment patterns in gynecologic oncology: a MITO group survey

Author

Cioffi, Raffaella, Sabetta, Giulia, Rabaiotti, Emanuela, Bergamini, Alice, Bocciolone, Luca, Candotti, Giorgio, Candiani, Massimo, Valabrega, Giorgio, Mangili, Giorgia, Pignata, Sandro, Sambataro, Daniela, Mammoliti, Serafina, Breda, Enrico, D’Alessio, Antonietta, Rondello, Giacomo, Arcangeli, Valentina, Messina, Carlo, Artioli, Grazia, Maneschi, Francesco, Andreetta, Claudia, Raspagliesi, Francesco, Stefano, Aida Di, Ditto, Antonino, Garassino, Isabella Maria Giovanna, Carella, Claudia, Ferrandina, Maria Gabriella, Narducci, Filomena, Cirigliano, Giovanna, Corrado, Giacomo, Borghesi, Simona, Legge, Francesco, Bartoletti, Michele, De Giorgi, Ugo, Festi, Anna, Ronzino, Graziana, Scandurra, Giusy, Kardhashi, Anila, Zamagni, Claudio, Petrella, Maria Cristina, Mosconi, Anna Maria, Pinto, Giancarlo Di, Savarese, Antonella, Perin, Alessandra, Palma, Teresa Di, Rubino, Daniela, Zanaboni, Flavia, Vertechy, Laura, Roccio, Marianna, Palaia, Innocenza, Giovannoni, Sara, Cassani, Chiara, Sergi, Domenico, Scotto, Giulia, Lauria, Rossella, Perrone, Anna Myriam, Danese, Saverio, and Scarfone, Giovanna

Published
2021
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5. Cytoreductive surgery followed by chemotherapy and olaparib maintenance in BRCA 1/2 mutated recurrent ovarian cancer: a retrospective MITO group study

Author

Cecere, Sabrina Chiara, Musacchio, Lucia, Bartoletti, Michele, Salutari, Vanda, Arenare, Laura, Lorusso, Domenica, Ronzino, Graziana, Lauria, Rossella, Cormio, Gennaro, Naglieri, Emanuele, Scollo, Paolo, Marchetti, Claudia, Raspagliesi, Francesco, Greggi, Stefano, Cinieri, Saverio, Bergamini, Alice, Orditura, Michele, Valabrega, Giorgio, Scambia, Giovanni, Martinelli, Fabio, De Matteis, Elisabetta, Cardalesi, Cinzia, Loizzi, Vera, Perniola, Giorgia, Carella, Claudia, Scandurra, Giuseppa, Giannone, Gaia, and Pignata, Sandro

Published
2021
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6. Safety of dostarlimab in combination with chemotherapy in patients with primary advanced or recurrent endometrial cancer in a phase III, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY).

Author

Auranen, Annika, Powell, Matthew A., Sukhin, Vladyslav, Landrum, Lisa M., Ronzino, Graziana, Buscema, Joseph, Bauerschlag, Dirk, Lalisang, Roy, Bender, David, Gilbert, Lucy, Armstrong, Amy, Safra, Tamar, Nevadunsky, Nicole, Sebastianelli, Alexandra, Slomovitz, Brian, Ring, Kari, Coleman, Robert, Podzielinski, Iwona, Stuckey, Ashley, and Teneriello, Michael

Abstract

Background: In Part 1 of the phase III RUBY trial (NCT03981796) in patients with primary advanced or recurrent endometrial cancer (EC), dostarlimab plus carboplatin–paclitaxel (CP) significantly improved progression-free survival and overall survival compared with CP alone. Limited safety data have been reported for the combination of immunotherapies plus chemotherapy in this setting. Objectives: The objective of this analysis was to identify the occurrence of treatment-related adverse events (TRAEs) and immune-related adverse events (irAEs) and to describe irAE management in Part 1 of the RUBY trial. Design: RUBY is a phase III, randomized, double-blind, multicenter study of dostarlimab plus CP compared with CP alone in patients with primary advanced or recurrent EC. Methods: Patients were randomized 1:1 to dostarlimab 500 mg, or placebo, plus CP every 3 weeks for 6 cycles, followed by dostarlimab 1000 mg, or placebo, every 6 weeks for up to 3 years. Adverse events (AEs) were assessed according to Common Terminology Criteria for Adverse Events, version 4.03. Results: The safety population included 487 patients who received ⩾1 dose of treatment (241 dostarlimab plus CP; 246 placebo plus CP). Treatment-emergent AEs were experienced by 100% of patients in both arms. TRAEs occurred in 97.9% of the dostarlimab arm and 98.8% of the placebo arm. The most common TRAEs occurred at similar rates between arms and were mostly low grade. IrAEs occurred in 58.5% of patients in the dostarlimab arm and 37.0% of patients in the placebo arm. Dostarlimab- or placebo-related irAEs were reported in 40.7% of patients in the dostarlimab arm and 16.3% of the placebo arm. Conclusion: The safety profile of dostarlimab plus CP was generally consistent with that of the individual components. Dostarlimab plus CP has a favorable benefit–risk profile and is a new standard of care for patients with primary advanced or recurrent EC. Trial registration: NCT03981796. Plain language summary: Safety of dostarlimab plus carboplatin-paclitaxel compared with carboplatin-paclitaxel in primary advanced or recurrent endometrial cancer For many years, patients with primary advanced or recurrent endometrial cancer were treated with chemotherapy, specifically with a combination of carboplatin and paclitaxel. Recently, new treatments called immune checkpoint inhibitors have been used to treat endometrial cancer. Dostarlimab, an immune checkpoint inhibitor, is being tested to treat many types of cancer, including endometrial cancer. In the RUBY trial, a combination of dostarlimab plus chemotherapy was compared with chemotherapy alone as treatment for primary advanced or recurrent endometrial cancer. Results showed that patients treated with dostarlimab plus chemotherapy had a lower risk of their cancer becoming worse and a lower risk of dying. Results in this article describe the safety of dostarlimab plus chemotherapy compared with chemotherapy alone. All patients in the RUBY trial experienced at least one adverse event (an undesired effect that happens while receiving treatment or shortly after stopping treatment); most were determined to be caused by the cancer treatments. No differences in the frequency of the overall cancer treatment-related adverse events were seen in patients who received dostarlimab plus chemotherapy compared with those patients who received chemotherapy alone. Some patients experienced an immune-related adverse event. These are a specific type of undesired effect that can occur when patients are treated with immune checkpoint inhibitors. Immune-related adverse events occurred more frequently in patients who received dostarlimab plus chemotherapy than in those who received chemotherapy alone. Physicians were generally able to treat the immune-related adverse events, and only a low percentage of patients discontinued treatment because they experienced an immune-related adverse event. The types of adverse events seen were similar to a combination of those seen in patients who received dostarlimab alone or patients who received chemotherapy alone as treatment for endometrial cancer. Dostarlimab plus chemotherapy is a new standard of care for patients with primary advanced or recurrent endometrial cancer. [ABSTRACT FROM AUTHOR]

Published
2024
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7. HYPERTHERMIC INTRAPERITONEAL CHEMOTHERAPY (HIPEC) WITH A CLOSED CO2 RECIRCULATION DEVICE IN PERITONEAL CARCINOMATOSIS FROM ADVANCED EPITHELIAL OVARIAN/TUBAL CANCER AFTER INTERVAL DEBULKING SURGERY (IDS): A FEASIBILITY SINGLE CENTER STUDY

Author

Legge, Francesco, Carone, Vito, Leone, Luca, Murgia, Ferdinando, Surico, Giammarco, Minicucci, Valentina, Di Benedetto, Francesca, Lombardi, Francesca, Madaro, Andrea, Calbi, Roberto, Fuoco, Valentina, Bruno, Isabella, Cristofano, Antonella, Ronzino, Graziana, Troia, Michele, Natalicchio, Maria Iole, Milano, Angela, and Laera, Letizia

Published
2025
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8. Olaparib as maintenance therapy in patients with BRCA 1–2 mutated recurrent platinum sensitive ovarian cancer: Real world data and post progression outcome

Author

Cecere, Sabrina Chiara, Giannone, Gaia, Salutari, Vanda, Arenare, Laura, Lorusso, Domenica, Ronzino, Graziana, Lauria, Rossella, Cormio, Gennaro, Carella, Claudia, Scollo, Paolo, Ghizzoni, Viola, Raspagliesi, Francesco, Di Napoli, Marilena, Mazzoni, Enrica, Marchetti, Claudia, Bergamini, Alice, Orditura, Michele, Valabrega, Giorgio, Scambia, Giovanni, Maltese, Giuseppa, De Matteis, Elisabetta, Cardalesi, Cinzia, Loizzi, Vera, Boccia, Serena, Naglieri, Emanuele, Scandurra, Giuseppa, and Pignata, Sandro

Published
2020
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9. Sharing real-world experiences to optimize the management of olaparib toxicities: a practical guidance from an Italian expert panel

Author

Lorusso, Domenica, Bologna, Alessandra, Cecere, Sabrina Chiara, De Matteis, Elisabetta, Scandurra, Giusy, Zamagni, Claudio, Arcangeli, Valentina, Artioli, Fabrizio, Bella, Mariangela, Blanco, Giusi, Cardalesi, Cinzia, Casartelli, Clelia, De Vivo, Rocco, Di Napoli, Marilena, Gisone, Emanuele Baldo, Lauria, Rossella, Lissoni, Alberto Andrea, Loizzi, Vera, Maccaroni, Elena, Mangili, Giorgia, Marchetti, Claudia, Martella, Francesca, Naglieri, Emanuele, Parolin, Veronica, Ricciardi, Giusy, Ronzino, Graziana, Salutari, Vanda, Scarfone, Giovanna, Secondino, Simona, Spagnoletti, Ilaria, Tasca, Giulia, Tognon, Germana, and Guarneri, Valentina

Published
2020
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10. Prevalence and spectrum of germline BRCA1 and BRCA2 in a cohort of ovarian cancer patients from the Salento peninsula (Southern Italy): a matter of preventive health

Author

De Matteis, Elisabetta, primary, Tumolo, Maria Rosaria, additional, Tarantino, Paolo, additional, Ciccarese, Mariangela, additional, Grassi, Tiziana, additional, Bagordo, Francesco, additional, De Giorgio, Maria Rita, additional, Rizzo, Emanuele, additional, and Ronzino, Graziana, additional

Published
2024
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11. 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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12. Patient-reported outcomes (PROs) in patients (pts) with primary advanced or recurrent endometrial cancer (pA/rEC) treated with dostarlimab (D) plus carboplatin/paclitaxel (CP) compared with CP in the ENGOT-EN6/GOG3031/RUBY trial.

Author

Mirza, Mansoor Raza, primary, Shahin, Mark S., additional, Powell, Matthew A., additional, Lundgren, Caroline, additional, Sukhin, Vladyslav, additional, Pothuri, Bhavana, additional, Gilbert, Lucy, additional, Gill, Sarah, additional, Ronzino, Graziana, additional, Nevadunsky, Nicole Suzanne, additional, Kommoss, Stefan, additional, Willmott, Lyndsay, additional, Boere, Ingrid, additional, Mathews, Cara Amanda, additional, Buscema, Joseph, additional, Teneriello, Michael, additional, Meyers, Oren, additional, Garside, Jamie, additional, Coleman, Robert L., additional, and Slomovitz, Brian M., additional

Published
2023
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13. 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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14. #540 Safety of dostarlimab in combination with chemotherapy in patients with primary advanced or recurrent endometrial cancer in a phase 3, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY)

Author

Auranen, Annika, primary, Black, Destin, additional, Sukhin, Vladyslav, additional, Sharma, Sudarshan, additional, Ronzino, Graziana, additional, Landrum, Lisa M, additional, Bauerschlag, Dirk, additional, Willmott, Lyndsay, additional, Lalisang, Roy, additional, Buscema, Joseph, additional, Gilbert, Lucy, additional, Coleman, Robert L, additional, Bender, David, additional, Armstrong, Amy, additional, Nevadunsky, Nicole, additional, Powell, Matthew A, additional, Dabrowski, Christine, additional, Stevens, Shadi, additional, Mirza, Mansoor Raza, additional, and Fleming, Evelyn, additional

Published
2023
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15. Consensus statements and treatment algorithm to guide clinicians in the selection of maintenance therapy for patients with newly diagnosed, advanced ovarian carcinoma: Results of a Delphi study

Author

Colombo, Nicoletta, primary, Gadducci, Angiolo, additional, Landoni, Fabio, additional, Lorusso, Domenica, additional, Sabbatini, Roberto, additional, Artioli, Grazia, additional, Berardi, Rossana, additional, Ceccherini, Rita, additional, Cecere, Sabrina Chiara, additional, Cormio, Gennaro, additional, De Angelis, Carmine, additional, Legge, Francesco, additional, Lissoni, Andrea, additional, Mammoliti, Serafina, additional, Mangili, Giorgia, additional, Naglieri, Emanuele, additional, Petrella, Maria Cristina, additional, Ricciardi, Giuseppina Rosaria Rita, additional, Ronzino, Graziana, additional, Salutari, Vanda, additional, Sambataro, Daniela, additional, Savarese, Antonella, additional, Scandurra, Giuseppa, additional, Tasca, Giulia, additional, Tomao, Federica, additional, Valabrega, Giorgio, additional, Zavallone, Laura, additional, and Pignata, Sandro, additional

Published
2023
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17. Consensus statements and treatment algorithm to guide clinicians in the selection of maintenance therapy for patients with newly diagnosed, advanced ovarian carcinoma: Results of a Delphi study

Author

Colombo, N, Gadducci, A, Landoni, F, Lorusso, D, Sabbatini, R, Artioli, G, Berardi, R, Ceccherini, R, Cecere, S, Cormio, G, De Angelis, C, Legge, F, Lissoni, A, Mammoliti, S, Mangili, G, Naglieri, E, Petrella, M, Ricciardi, G, Ronzino, G, Salutari, V, Sambataro, D, Savarese, A, Scandurra, G, Tasca, G, Tomao, F, Valabrega, G, Zavallone, L, Pignata, S, Colombo, Nicoletta, Gadducci, Angiolo, Landoni, Fabio, Lorusso, Domenica, Sabbatini, Roberto, Artioli, Grazia, Berardi, Rossana, Ceccherini, Rita, Cecere, Sabrina Chiara, Cormio, Gennaro, De Angelis, Carmine, Legge, Francesco, Lissoni, Andrea, Mammoliti, Serafina, Mangili, Giorgia, Naglieri, Emanuele, Petrella, Maria Cristina, Ricciardi, Giuseppina Rosaria Rita, Ronzino, Graziana, Salutari, Vanda, Sambataro, Daniela, Savarese, Antonella, Scandurra, Giuseppa, Tasca, Giulia, Tomao, Federica, Valabrega, Giorgio, Zavallone, Laura, Pignata, Sandro, Colombo, N, Gadducci, A, Landoni, F, Lorusso, D, Sabbatini, R, Artioli, G, Berardi, R, Ceccherini, R, Cecere, S, Cormio, G, De Angelis, C, Legge, F, Lissoni, A, Mammoliti, S, Mangili, G, Naglieri, E, Petrella, M, Ricciardi, G, Ronzino, G, Salutari, V, Sambataro, D, Savarese, A, Scandurra, G, Tasca, G, Tomao, F, Valabrega, G, Zavallone, L, Pignata, S, Colombo, Nicoletta, Gadducci, Angiolo, Landoni, Fabio, Lorusso, Domenica, Sabbatini, Roberto, Artioli, Grazia, Berardi, Rossana, Ceccherini, Rita, Cecere, Sabrina Chiara, Cormio, Gennaro, De Angelis, Carmine, Legge, Francesco, Lissoni, Andrea, Mammoliti, Serafina, Mangili, Giorgia, Naglieri, Emanuele, Petrella, Maria Cristina, Ricciardi, Giuseppina Rosaria Rita, Ronzino, Graziana, Salutari, Vanda, Sambataro, Daniela, Savarese, Antonella, Scandurra, Giuseppa, Tasca, Giulia, Tomao, Federica, Valabrega, Giorgio, Zavallone, Laura, and Pignata, Sandro

Abstract

Introduction: Standard treatment of newly diagnosed, advanced ovarian carcinoma (OC) consists of cytoreductive surgery followed by platinum-based chemotherapy with or without bevacizumab. Maintenance therapy with PARP inhibitors and olaparib-bevacizumab has recently shown to significantly improve progression-free survival in the first-line setting. Some practical aspects of maintenance therapy, however, are still poorly defined. Aim of the study: To provide guidance to clinicians in the selection of maintenance therapy for newly diagnosed, advanced ovarian carcinoma. Methods: A board of six gynecologic oncologists with expertise in the treatment of OC in Italy convened to address issues related to the new options for maintenance treatment. Based on scientific evidences, the board produced practice-oriented statements. Consensus was reached via a modified Delphi study that involved a panel of 22 experts from across Italy. Results: Twenty-seven evidence- and consensus-based statements are presented, covering the following areas of interest: use of biomarkers (BRCA mutations and presence of homologous recombination deficiency); timing and outcomes of surgery; selection of patients eligible for bevacizumab; definition of response to treatment; toxicity and contraindications; evidence of synergy of bevacizumab plus PARP inhibitor. Two treatment algorithms are also included, for selecting maintenance therapy based on timing and outcomes of surgery, response to platinum-based chemotherapy and biomarker status. A score for the assessment of response to chemotherapy is proposed, but its validation is ongoing. Conclusions: We provide here consensus statements and treatment algorithms to guide clinicians in the selection of appropriate and personalized maintenance therapy in the first-line setting of advanced OC management.

Published
2023

18. 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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19. First‐line cetuximab + platinum‐based therapy for recurrent/metastatic head and neck squamous cell carcinoma: A real‐world observational study— ENCORE

Author

Le Tourneau, Christophe, primary, Ghiani, Massimo, additional, Cau, Maria Chiara, additional, Depenni, Roberta, additional, Ronzino, Graziana, additional, Bonomo, Pierluigi, additional, Montesarchio, Vincenzo, additional, Leo, Luigi, additional, Schulten, Jeltje, additional, Salmio, Satu, additional, Messinger, Diethelm, additional, Sbrana, Andrea, additional, Borcoman, Edith, additional, and Ghi, Maria Grazia, additional

Published
2023
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20. Consensus statements and treatment algorithm to guide clinicians in the selection of maintenance therapy for patients with newly diagnosed, advanced ovarian carcinoma: Results of a Delphi study

Author

Colombo, Nicoletta, Gadducci, Angiolo, Landoni, Fabio, Lorusso, Domenica, Sabbatini, Roberto, Artioli, Grazia, Berardi, Rossana, Ceccherini, Rita, Cecere, Sabrina Chiara, Cormio, Gennaro, De Angelis, Carmine, Legge, Francesco, Lissoni, Andrea, Mammoliti, Serafina, Mangili, Giorgia, Naglieri, Emanuele, Petrella, Maria Cristina, Ricciardi, Giuseppina Rosaria Rita, Ronzino, Graziana, Salutari, Vanda, Sambataro, Daniela, Savarese, Antonella, Scandurra, Giuseppa, Tasca, Giulia, Tomao, Federica, Valabrega, Giorgio, Zavallone, Laura, Pignata, Sandro, Colombo, N, Gadducci, A, Landoni, F, Lorusso, D, Sabbatini, R, Artioli, G, Berardi, R, Ceccherini, R, Cecere, S, Cormio, G, De Angelis, C, Legge, F, Lissoni, A, Mammoliti, S, Mangili, G, Naglieri, E, Petrella, M, Ricciardi, G, Ronzino, G, Salutari, V, Sambataro, D, Savarese, A, Scandurra, G, Tasca, G, Tomao, F, Valabrega, G, Zavallone, L, and Pignata, S

Subjects
Bevacizumab, Olaparib, PARP inhibitor, HRD, Advanced ovarian cancer, BRCA, Maintenance therapy, Niraparib
Abstract

Introduction: Standard treatment of newly diagnosed, advanced ovarian carcinoma (OC) consists of cytoreductive surgery followed by platinum-based chemotherapy with or without bevacizumab. Maintenance therapy with PARP inhibitors and olaparib-bevacizumab has recently shown to significantly improve progression-free survival in the first-line setting. Some practical aspects of maintenance therapy, however, are still poorly defined. Aim of the study: To provide guidance to clinicians in the selection of maintenance therapy for newly diagnosed, advanced ovarian carcinoma. Methods: A board of six gynecologic oncologists with expertise in the treatment of OC in Italy convened to address issues related to the new options for maintenance treatment. Based on scientific evidences, the board produced practice-oriented statements. Consensus was reached via a modified Delphi study that involved a panel of 22 experts from across Italy. Results: Twenty-seven evidence- and consensus-based statements are presented, covering the following areas of interest: use of biomarkers (BRCA mutations and presence of homologous recombination deficiency); timing and outcomes of surgery; selection of patients eligible for bevacizumab; definition of response to treatment; toxicity and contraindications; evidence of synergy of bevacizumab plus PARP inhibitor. Two treatment algorithms are also included, for selecting maintenance therapy based on timing and outcomes of surgery, response to platinum-based chemotherapy and biomarker status. A score for the assessment of response to chemotherapy is proposed, but its validation is ongoing. Conclusions: We provide here consensus statements and treatment algorithms to guide clinicians in the selection of appropriate and personalized maintenance therapy in the first-line setting of advanced OC management.

Published
2023

21. O025/#522 Maintenance olaparib rechallenge in patients with ovarian cancer previously treated with a parp inhibitor: patient-reported outcomes from the phase IIIB OReO/engot-ov38 trial

Author

Redondo, Andrés, primary, Follana, Philippe, additional, Scambia, Giovanni, additional, Asselain, Bernard, additional, Marmé, Frederik, additional, Mirza, Mansoor, additional, Laudani, Maria Elena, additional, Mądry, Radosław, additional, Glasspool, Rosalind, additional, You, Benoit, additional, Rubio-Perez, María Jesús, additional, Zamagni, Claudio, additional, El-Balat, Ahmed, additional, Hardy-Bessard, Anne Claire, additional, Oaknin, Ana, additional, Ronzino, Graziana, additional, Shaw, Bob, additional, Nakamura, Hitomi, additional, Berton, Dominique, additional, and Pujade-Lauraine, Eric, additional

Published
2022
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22. 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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23. 2022-RA-1290-ESGO Maintenance olaparib rechallenge in patients with ovarian cancer previously treated with a PARP inhibitor: detailed safety results from the Phase IIIb OReO/ENGOT-ov38 trial

Author

Salutari, Vanda, primary, Lotz, Jean-Pierre, additional, Manso, Luis, additional, Asselain, Bernard, additional, Marmé, Frederik, additional, Lindemann, Kristina, additional, Tognon, Germana, additional, Mądry, Radosław, additional, Glasspool, Ros, additional, Medioni, Jacques, additional, Márquez-Aragones, Antonia, additional, Ronzino, Graziana, additional, de Gregorio, Nikolaus, additional, Joly, Florence, additional, Romero, Ignacio, additional, Raspagliesi, Francesco, additional, Bashir, Zahid, additional, Shaw, Bob, additional, Fabbro, Michel, additional, and Pujade-Lauraine, Eric, additional

Published
2022
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24. 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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25. The impact of locoregional treatment on response to nivolumab in advanced platinum refractory head and neck cancer: The need trial.

Author

Botticelli, Andrea, primary, Mezi, Silvia, additional, Pomati, Giulia, additional, Sciattella, Paolo, additional, Roberto, Michela, additional, Cirillo, Alessio, additional, Mammone, Giulia, additional, Cassano, Alessandra, additional, Di Dio, Carmela, additional, Cortellini, Alessio, additional, Pizzuti, Laura, additional, Ronzino, Graziana, additional, Salati, Massimiliano, additional, Vici, Patrizia, additional, Merlano, Marco Carlo, additional, Nuti, Marianna, additional, and Marchetti, Paolo, additional

Published
2020
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26. A new founder BRCA1 haplotype identified in the Puglia region is associated with a specific age-related cancer onset in three unrelated families

Author

Capoluongo, Ettore, primary, De Matteis, Elisabetta, additional, Cucinotto, Iole, additional, Ronzino, Graziana, additional, Santonocito, Concetta, additional, Tornesello, Assunta, additional, De Giorgio, Maria Rita, additional, Lucci Cordisco, Emanuela, additional, Minucci, Angelo, additional, and Genuardi, Maurizio, additional

Published
2020
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29. Selection of systemic therapy in patients with locally advanced and recurrent/metastatic head and neck cancer: RAND-based expert opinion by an Italian multidisciplinary panel

Author

Benasso, Marco, primary, Bonomo, Pierluigi, additional, Buglione, Michela, additional, Ghi, Maria Grazia, additional, Licitra, Lisa, additional, Magrini, Stefano Maria, additional, Merlano, Marco Carlo, additional, Presutti, Livio, additional, Ronzino, Graziana, additional, and Ferrari, Daris, additional

Published
2019
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31. A new founder BRCA1 haplotype identified in the Puglia region is associated with a specific age-related cancer onset in three unrelated families.

Author

Capoluongo, Ettore, De Matteis, Elisabetta, Cucinotto, Iole, Ronzino, Graziana, Santonocito, Concetta, Tornesello, Assunta, De Giorgio, Maria Rita, Lucci Cordisco, Emanuela, Minucci, Angelo, and Genuardi, Maurizio

Subjects
BRCA genes, AGE factors in cancer, HAPLOTYPES, GENETIC databases, HEAD & neck cancer, FAMILIES, CANCER genes
Abstract

Keywords: BRCA1/2; founder mutation; HBOC; novel mutations EN BRCA1/2 founder mutation HBOC novel mutations e95 e98 4 02/06/21 20210301 NES 210301 To the Editor, Inherited pathogenic variants (PVs) in cancer susceptibility genes account for approximately 5%-10% of all breast (BC) and ovarian cancers (OvCa), with a large proportion of mutations found in families with several affected patients over multiple generations [[1]], [[2]], [[3]]. Graph: Figure 1: Family pedigree by cancer gene software BRCAPRO v6.The proband is indicated with an arrow. [Extracted from the article]

Published
2021
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32. Neo-adjuvant platinum-based chemotherapy followed by chemoradiation and radical surgery in locally advanced cervical cancer (Lacc) patients: A phase II study

Author

Ferrandina, Gabriella, primary, Palluzzi, Eleonora, additional, Gallotta, Valerio, additional, Gambacorta, Maria Antonietta, additional, Autorino, Rosa, additional, Turco, Luigi Carlo, additional, Macchia, Gabriella, additional, Cosentino, Francesco, additional, Gui, Benedetta, additional, Mattoli, Maria Vittoria, additional, Ronzino, Graziana, additional, Valentini, Vincenzo, additional, and Scambia, Giovanni, additional

Published
2018
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33. Neo-adjuvant platinum-based chemotherapy followed by chemoradiation and radical surgery in locally advanced cervical cancer (Lacc) patients: A phase II study

Author

Ferrandina, Maria Gabriella, Palluzzi, Eleonora, Gallotta, Valerio, Gambacorta, Maria Antonietta, Autorino, Rosa, Turco, Luigi Carlo, Macchia, Gabriella, Cosentino, Francesco, Gui, Benedetta, Mattoli, Maria Vittoria, Ronzino, Graziana, Valentini, Vincenzo, Scambia, Giovanni, Ferrandina, Gabriella (ORCID:0000-0003-4672-4197), Gambacorta, Maria Antonietta (ORCID:0000-0001-5455-8737), Macchia, Gabriella (ORCID:0000-0002-0529-201X), Valentini, Vincenzo (ORCID:0000-0003-4637-6487), Scambia, Giovanni (ORCID:0000-0003-2758-1063), Ferrandina, Maria Gabriella, Palluzzi, Eleonora, Gallotta, Valerio, Gambacorta, Maria Antonietta, Autorino, Rosa, Turco, Luigi Carlo, Macchia, Gabriella, Cosentino, Francesco, Gui, Benedetta, Mattoli, Maria Vittoria, Ronzino, Graziana, Valentini, Vincenzo, Scambia, Giovanni, Ferrandina, Gabriella (ORCID:0000-0003-4672-4197), Gambacorta, Maria Antonietta (ORCID:0000-0001-5455-8737), Macchia, Gabriella (ORCID:0000-0002-0529-201X), Valentini, Vincenzo (ORCID:0000-0003-4637-6487), and Scambia, Giovanni (ORCID:0000-0003-2758-1063)

Abstract

Purpose: The aim of this Phase II, non-randomized study was to assess activity and safety of neoadjuvant chemotherapy (NACT) before chemoradiation (CT/RT) followed by radical surgery (RS) in locally advanced cervical cancer (LACC) patients. Methods and materials: The primary end point was rate of pathologic complete response (pCR). FIGO Stage IB2-IVA patients were administered NACT chemotherapy (paclitaxel 80 mg/m2, carboplatin AUC 2), for 6 weeks, followed by Intensity Modulated Radiotherapy plus simultaneous boost (total dose of 50.4 Gy to CTV1, and 39.6 Gy to CTV2). Clinical response was assessed according to RECIST criteria. Responsive patients were triaged to RS. The regimen would be considered active if >20 pCRs were registered in 39 patients. Results: 45 patients were enrolled into the study; 25 patients (55.5%) were FIGO stage IIB, 9 cases (20.0%) had stage III disease. At work up, pelvic lymph node involvement was documented in 38 (84.4%) patients; pCR was documented in 18 out of 40 patients (45.0%). Grade 3–4 hematological toxicity after NACT occurred in 4 patients; CT/RT associated grade 3 toxicity was found in 7 patients. Early and late postoperative complications were detected in 16, and 11 cases, respectively. Three-year PFS and OS were 66.0% and 86.0%, respectively. Conclusions: NACT followed by CT/RT by IMRT and RS, is feasible and safe; failure to achieve the primary endpoint has to be recognized; however, enrollment of a higher rate of poor prognosis patients compared to historical data used to calculate sample size, could have resulted in reduced activity.

Published
2018

34. Palbociclib versus placebo in combination with letrozole for patients with advanced or recurrent endometrial cancer: The NSGO ENGOT-EN3/PALEO trial.

Author

Mirza, Mansoor Raza, primary, Salutari, Vanda, additional, Mendiola, Cesar, additional, Sehouli, Jalid, additional, Christensen, Rene dePont, additional, Bjorge, Line, additional, Pignata, Sandro, additional, Gil-Martin, Marta, additional, Chekerov, Radoslav, additional, Nyvang, Gitte-Betina, additional, Lorusso, Domenica, additional, Barretina-Ginesta, Maria Pilar, additional, Marme, Frederic, additional, Ronzino, Graziana, additional, Rubio, M Jesus, additional, Runnebaum, Ingo B., additional, Juhler-Nøttrup, Trine, additional, Løhndorf, Joan, additional, and Auranen, Annika, additional

Published
2017
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35. Selection of systemic therapy in patients with locally advanced and recurrent/metastatic head and neck cancer: RAND-based expert opinion by an Italian multidisciplinary panel

Author

Benasso, Marco, Bonomo, Pierluigi, Buglione, Michela, Ghi, Maria Grazia, Licitra, Lisa, Magrini, Stefano Maria, Merlano, Marco Carlo, Presutti, Livio, Ronzino, Graziana, and Ferrari, Daris

Abstract

Background: Head and neck squamous cell carcinoma (HNSCC) is a heterogeneous disease often presenting at an already advanced stage. Cisplatin chemoradiotherapy is the standard treatment for locally advanced disease, although its efficacy varies according to different studies. Thus, treatment selection is a challenge, especially in older patients, who frequently have several comorbidities. Moreover, the majority of patients with recurrent and/or metastatic disease are unsuitable for local treatment, either surgery or radiation therapy. The only treatment option for them is systemic therapy, but prognosis remains poor, with a median overall survival of less than 12 months.Methods: A group of Italian key opinion leaders in the field of HNSCC gathered several times in 2018 in order to retrieve a set of statements to help clinicians in their daily decision-making process for the treatment of patients with different scenarios of HNSCC.Results and Conclusion: The panel agreed on 22 statements that were identified as “good clinical points” based on the available literature or after discussion of the most relevant aspect of the underlying diseases when no international consensus was available. The panel identified a number of possible scenarios (namely 71) in which these statements may be helpful to guide decision-making for the best treatment selection.

Published
2020
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36. Patient-reported outcomes (PROs) in primary advanced or recurrent endometrial cancer (pA/rEC) for patients (pts) treated with dostarlimab plus carboplatin/paclitaxel (CP) as compared to CP in the ENGOT-EN6/GOG3031/RUBY trial.

Author

Mirza, Mansoor Raza, Powell, Matthew A., Lundgren, Caroline, Sukhin, Vladyslav, Pothuri, Bhavana, Gilbert, Lucy, Gill, Sarah, Ronzino, Graziana, Nevadunsky, Nicole, Kommoss, Stefan, Willmott, Lyndsay, Boere, Ingrid, Mathews, Cara Amanda, Buscema, Joseph, Teneriello, Michael, Shahin, Mark S., Meyers, Oren, Garside, Jamie, Coleman, Robert L., and Slomovitz, Brian M.

Published
2023
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37. Benefit of chemotherapy after third line and evaluation of post-progression survival (PPS) in metastatic breast cancer (MBC): A single institution study.

Author

Forcignano, Rosachiara, primary, Ciccarese, Mariangela, additional, Chiuri, Vincenzo Emanuele, additional, Cairo, Giuseppe, additional, Lupo, Laura Isabella, additional, Petrucelli, Luciana, additional, Gambino, Abbondanza, additional, Ronzino, Graziana, additional, Licchetta, Antonella, additional, Gnoni, Antonio, additional, and Giannarelli, Diana, additional

Published
2013
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38. Feasibility and Safety of High Dose Chemoradiation in Locally Advanced Cervical Cancer: A Preliminary Experience of Gynecologic Oncology Management Italian Team

Author

Russo, Donatella, primary, Ronzino, Graziana, additional, Papaleo, Antonella, additional, Cavalera, Elisa, additional, Leone, Angela, additional, Giampaglia, Marianna, additional, Caretto, Simona, additional, Aprile, Fabrizio Totaro, additional, De Marzi, Alex Cristiano, additional, Santantonio, Mario, additional, Perrone, Antonio, additional, and Tinelli, Andrea, additional

Published
2013
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40. The Impact of Locoregional Treatment on Response to Nivolumab in Advanced Platinum Refractory Head and Neck Cancer: The Need Trial.

Author

Botticelli, Andrea, Mezi, Silvia, Pomati, Giulia, Sciattella, Paolo, Cerbelli, Bruna, Roberto, Michela, Mammone, Giulia, Cirillo, Alessio, Cassano, Alessandra, Di Dio, Carmela, Cortellini, Alessio, Pizzuti, Laura, Ronzino, Graziana, Salati, Massimiliano, Vici, Patrizia, Polimeni, Antonella, Merlano, Marco Carlo, Nuti, Marianna, and Marchetti, Paolo

Subjects
HEAD & neck cancer, PLATINUM, SQUAMOUS cell carcinoma, NECK dissection, LYMPHATICS
Abstract

Background: Previous locoregional treatment could affect the response to nivolumab in platinum-refractory recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The aim of this study is to evaluate the impact of the clinicopathological characteristics and previous treatment in predicting early progression to nivolumab in a real-world population. Methods: This is an observational, multicenter retrospective/prospective study including patients (pts) with platinum refractory R/M HNSCC who received nivolumab 240 mg every 2 weeks from October 2018 to October 2019. We analyzed the association between previous treatment, clinicopathological characteristics, and early progression (within 3 months). Results: Data from 61 pts were reviewed. Median age was 67 years (30–82). Forty-two pts (69%) received previous locoregional treatment. Early progression to nivolumab occurred in 36 pts (59%), while clinical benefit (stable disease and partial response) was achieved in 25 pts (41%). Early progression to nivolumab was significantly associated to previous locoregional treatment both at univariate and multivariate analysis (p = 0.005 and p = 0.048, respectively). Conclusion: nivolumab in R/M HNSCC is burdened with a high early progression rate. Previous wide neck dissection and high dose radiotherapy may compromise the efficacy of nivolumab, distorting the anatomy of the local lymphatic system and hindering the priming of immune response. [ABSTRACT FROM AUTHOR]

Published
2020
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41. Olaparib as maintenance therapy in patients with BRCA 1-2 mutated recurrent platinum sensitive ovarian cancer: Real world data and post progression outcome

Author

Graziana Ronzino, Cinzia Cardalesi, Viola Ghizzoni, Vera Loizzi, Giuseppa Scandurra, Giovanni Scambia, Giorgio Valabrega, Paolo Scollo, Vanda Salutari, Elisabetta De Matteis, Gennaro Cormio, Rossella Lauria, Alice Bergamini, Sabrina Chiara Cecere, Emanuele Naglieri, Gaia Giannone, Laura Arenare, Marilena Di Napoli, Sandro Pignata, Claudia Marchetti, Domenica Lorusso, Enrica Mazzoni, Serena Maria Boccia, Michele Orditura, Claudia Carella, Francesco Raspagliesi, Giuseppa Maltese, Cecere, Sabrina Chiara, Giannone, Gaia, Salutari, Vanda, Arenare, Laura, Lorusso, Domenica, Ronzino, Graziana, Lauria, Rossella, Cormio, Gennaro, Carella, Claudia, Scollo, Paolo, Ghizzoni, Viola, Raspagliesi, Francesco, Di Napoli, Marilena, Mazzoni, Enrica, Marchetti, Claudia, Bergamini, Alice, Orditura, Michele, Valabrega, Giorgio, Scambia, Giovanni, Maltese, Giuseppa, De Matteis, Elisabetta, Cardalesi, Cinzia, Loizzi, Vera, Boccia, Serena, Naglieri, Emanuele, Scandurra, Giuseppa, and Pignata, Sandro

Subjects
0301 basic medicine, Oncology, Organoplatinum Compounds, endocrine system diseases, medicine.medical_treatment, Genes, BRCA2, Genes, BRCA1, Piperazines, chemistry.chemical_compound, 0302 clinical medicine, Olaparib, Maintenance therapy, Ovarian Neoplasms, BRCA1 Protein, Obstetrics and Gynecology, Real world, Middle Aged, Progression-Free Survival, female genital diseases and pregnancy complications, Local, 030220 oncology & carcinogenesis, Female, medicine.medical_specialty, Maintenance, Ovarian cancer, Post progression, Antineoplastic Agents, BRCA2 Protein, Germ-Line Mutation, Humans, Maintenance Chemotherapy, Neoplasm Recurrence, Local, Phthalazines, Retrospective Studies, 03 medical and health sciences, Pharmacotherapy, Internal medicine, medicine, Progression-free survival, Chemotherapy, Settore MED/06 - ONCOLOGIA MEDICA, business.industry, Retrospective cohort study, medicine.disease, BRCA1, BRCA2, Discontinuation, 030104 developmental biology, Neoplasm Recurrence, Settore MED/40 - GINECOLOGIA E OSTETRICIA, chemistry, Genes, business
Abstract

Objectives Olaparib is approved as maintenance therapy in patients with BRCA mutated platinum sensitive (PS) recurrent ovarian cancer (OC) after response to last platinum based therapy. Few data are available regarding the use out of the registration trials and on response to further treatments after progression. Materials ad methods In this non interventional, retrospective study, patients treated with olaparib in 13 centers, according to the label, have been collected and analyzed. Primary objectives of the study are to describe effectiveness and safety of olaparib in a real world setting with a focus on post progression treatments and response. Results 234 patients were analyzed. All patients were BRCA mutated and most of them had germline mutations. Around 50% of the patients received olaparib after 3 or more lines of platinum based chemotherapy achieving a radiologic complete (CR) or partial response. 12.4% patients with stable disease were also included. Median PFS was 14.7 months (95% CI:12.6–18), with statistically longer PFS in patients with normal serum Ca125 at baseline, a CR after last platinum based therapy and that received olaparib after second platinum based therapy. Median OS was not reached. Most frequent G3-G4 toxicity was anaemia (6%) with dose discontinuation and dose reduction in 11 (4.7%) and 49 (20.9%) of cases, respectively. Among 66 patients receiving further treatment after olaparib progression and evaluable for response, ORR was 22.2, 11.1% and 9.5% in patients with Platinum Free interval (PFI) of more than 12 months, between 6 and 12 months and less than 6 months, respectively. Conclusions Olaparib is effective and safe in real world setting. Data on post-progression treatments seem to suggest cross resistance with chemotherapy and need to be confirmed in larger studies because of the potential importance in clinical practice decisions.

Published
2020

42. Paclitaxel for second-line treatment of squamous cell carcinoma of the head and neck: A multicenter retrospective Italian study.

Author

Fasano M, Pirozzi M, Vitale P, Damiano V, Ronzino G, Farese S, Carfora V, Ciccarelli G, Di Giovanni I, Facchini S, Cennamo G, Caraglia M, Ciardiello F, and Addeo R

Abstract

Background: Squamous cell carcinoma of the head and neck (SCCHN) accounts for 3% of all malignant tumors in Italy. Immune checkpoint inhibitors combined with chemotherapy is first-line treatment for SCCHN; however, second-line treatment options are limited. Taxanes are widely used for combination therapy of SCCHN, as clinical trials have shown their efficacy in patients with this disease, particularly in patients with prior therapy., Aim: To perform a multicenter retrospective study on the efficacy and safety of weekly paclitaxel for SCCHN., Methods: All patients were previously treated with at least one systemic therapy regimen, which included platinum-based therapy in the vast majority. No patient received prior immunotherapy., Results: Median progression-free survival (mPFS) was 3.4 months and median overall survival (mOS) was 6.5 months. Subgroup analysis was performed according to three principal prognostic factors: Smoking, alcohol consumption, and body mass index. Analysis demonstrated reduced survival, both mOS and mPFS, in the unfavorable prognostic groups, with the biggest deltas observed in mOS., Conclusion: Weekly paclitaxel provided favorable survival and disease control rates, with low severe adverse events. Paclitaxel is a safe and valid therapeutic option for patients with SCCHN who received prior therapy., Competing Interests: Conflict-of-interest statement: The authors have no conflicts of interest to declare., (©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.)

Published
2024
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