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1,579 results on '"Lorusso, Domenica"'

451. Past, present and future of adjuvant HIPEC in patients at high risk for colorectal peritoneal metastases

Author

Baratti, Dario, primary, Sammartino, Paolo, additional, Kusamura, Shigeki, additional, Deraco, Marcello, additional, Ansaloni, Luca, additional, Asero, Salvatore, additional, Baiocchi, Gianluca, additional, Bagnoli, Pietro, additional, Cavaliere, Davide, additional, Framarini, Massimo, additional, Cirocchi, Roberto, additional, Coccolini, Federico, additional, Decian, Franco, additional, Delrio, Paolo, additional, Sassaroli, Cinzia, additional, De Simone, Michele, additional, Robella, Manuela, additional, Vaira, Marco, additional, Di Giorgio, Andrea, additional, Fagotti, Anna, additional, Lorusso, Domenica, additional, Federici, Orietta, additional, Fiorentini, Giammaria, additional, Fambrini, Massimiliano, additional, Scaringi, Stefano, additional, Garofalo, Alfredo, additional, Valle, Mario, additional, Gelmini, Roberta, additional, Cabry, Francesca, additional, Cautero, Nicola, additional, Sorrentino, Lorena, additional, Graziosi, Luigina, additional, Guaglio, Marcello, additional, Montenovo, Matteo, additional, Bartolini, Valentina, additional, Lippolis, Piero Vincenzo, additional, Macrì, Antonio, additional, Pasqual, Enrico Maria, additional, Roviello, Francesco, additional, Marrelli, Daniele, additional, Orsenigo, Elena, additional, and Sommariva, Antonio, additional

Published
2020
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452. Rucaparib for patients with platinum-sensitive, recurrent ovarian carcinoma (ARIEL3): post-progression outcomes and updated safety results from a randomised, placebo-controlled, phase 3 trial

Author

Ledermann, Jonathan A, primary, Oza, Amit M, additional, Lorusso, Domenica, additional, Aghajanian, Carol, additional, Oaknin, Ana, additional, Dean, Andrew, additional, Colombo, Nicoletta, additional, Weberpals, Johanne I, additional, Clamp, Andrew R, additional, Scambia, Giovanni, additional, Leary, Alexandra, additional, Holloway, Robert W, additional, Gancedo, Margarita Amenedo, additional, Fong, Peter C, additional, Goh, Jeffrey C, additional, O'Malley, David M, additional, Armstrong, Deborah K, additional, Banerjee, Susana, additional, García-Donas, Jesus, additional, Swisher, Elizabeth M, additional, Cameron, Terri, additional, Maloney, Lara, additional, Goble, Sandra, additional, and Coleman, Robert L, additional

Published
2020
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454. Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study

Author

Brewer, Molly, primary, Angioli, Roberto, additional, Scambia, Giovani, additional, Lorusso, Domenica, additional, Terranova, Corrado, additional, Panici, Pierluigi Benedetti, additional, Raspagliesi, Francesco, additional, Scollo, Paolo, additional, Plotti, Francessco, additional, Ferrandina, Gabriella, additional, Salutari, Vanda, additional, Ricci, Caterina, additional, Braly, Patricia, additional, Holloway, Robert, additional, Method, Michael, additional, Madiyalakan, Madi, additional, Bayever, Eliel, additional, and Nicodemus, Christopher, additional

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

Author

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

Published
2020
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457. 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, primary, Giannone, Gaia, additional, Salutari, Vanda, additional, Arenare, Laura, additional, Lorusso, Domenica, additional, Ronzino, Graziana, additional, Lauria, Rossella, additional, Cormio, Gennaro, additional, Carella, Claudia, additional, Scollo, Paolo, additional, Ghizzoni, Viola, additional, Raspagliesi, Francesco, additional, Di Napoli, Marilena, additional, Mazzoni, Enrica, additional, Marchetti, Claudia, additional, Bergamini, Alice, additional, Orditura, Michele, additional, Valabrega, Giorgio, additional, Scambia, Giovanni, additional, Maltese, Giuseppa, additional, De Matteis, Elisabetta, additional, Cardalesi, Cinzia, additional, Loizzi, Vera, additional, Boccia, Serena, additional, Naglieri, Emanuele, additional, Scandurra, Giuseppa, additional, and Pignata, Sandro, additional

Published
2020
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460. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer

Author

Ray-Coquard, Isabelle, primary, Pautier, Patricia, additional, Pignata, Sandro, additional, Pérol, David, additional, González-Martín, Antonio, additional, Berger, Regina, additional, Fujiwara, Keiichi, additional, Vergote, Ignace, additional, Colombo, Nicoletta, additional, Mäenpää, Johanna, additional, Selle, Frédéric, additional, Sehouli, Jalid, additional, Lorusso, Domenica, additional, Guerra Alía, Eva M., additional, Reinthaller, Alexander, additional, Nagao, Shoji, additional, Lefeuvre-Plesse, Claudia, additional, Canzler, Ulrich, additional, Scambia, Giovanni, additional, Lortholary, Alain, additional, Marmé, Frederik, additional, Combe, Pierre, additional, de Gregorio, Nikolaus, additional, Rodrigues, Manuel, additional, Buderath, Paul, additional, Dubot, Coraline, additional, Burges, Alexander, additional, You, Benoît, additional, Pujade-Lauraine, Eric, additional, and Harter, Philipp, additional

Published
2019
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461. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

Author

González-Martín, Antonio, primary, Pothuri, Bhavana, additional, Vergote, Ignace, additional, DePont Christensen, René, additional, Graybill, Whitney, additional, Mirza, Mansoor R., additional, McCormick, Colleen, additional, Lorusso, Domenica, additional, Hoskins, Paul, additional, Freyer, Gilles, additional, Baumann, Klaus, additional, Jardon, Kris, additional, Redondo, Andrés, additional, Moore, Richard G., additional, Vulsteke, Christof, additional, O’Cearbhaill, Roisin E., additional, Lund, Bente, additional, Backes, Floor, additional, Barretina-Ginesta, Pilar, additional, Haggerty, Ashley F., additional, Rubio-Pérez, Maria J., additional, Shahin, Mark S., additional, Mangili, Giorgia, additional, Bradley, William H., additional, Bruchim, Ilan, additional, Sun, Kaiming, additional, Malinowska, Izabela A., additional, Li, Yong, additional, Gupta, Divya, additional, and Monk, Bradley J., additional

Published
2019
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463. Advances in laparoscopic surgery for cervical cancer

Author

Bogani, Giorgio, primary, Maggiore, Umberto Leone Roberti, additional, Rossetti, Diego, additional, Ditto, Antonino, additional, Martinelli, Fabio, additional, Chiappa, Valentina, additional, Ferla, Stefano, additional, Indini, Alice, additional, Sabatucci, Ilaria, additional, Lorusso, Domenica, additional, and Raspagliesi, Francesco, additional

Published
2019
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464. Celio_Supplementary_Table_2 – Supplemental material for Short-course olanzapine to prevent delayed emesis following carboplatin/paclitaxel for gynecologic cancer: a randomised study

Author

Celio, Luigi, Saibene, Gabriella, Lepori, Stefano, Festinese, Fabrizio, Niger, Monica, Raspagliesi, Francesco, and Lorusso, Domenica

Subjects
Medicine
Abstract

Supplemental material, Celio_Supplementary_Table_2 for Short-course olanzapine to prevent delayed emesis following carboplatin/paclitaxel for gynecologic cancer: a randomised study by Luigi Celio, Gabriella Saibene, Stefano Lepori, Fabrizio Festinese, Monica Niger, Francesco Raspagliesi and Domenica Lorusso in Tumori Journal

Published
2019
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466. BRCA1/2 molecular assay for ovarian cancer patients: A survey through Italian departments of oncology and molecular and genomic diagnostic laboratories

Author

Capoluongo, E, Verde, N, Barberis, M, Bella, M, Buttitta, F, Carrera, P, Colombo, N, Cortesi, L, Gion, M, Guarneri, V, Lorusso, D, Marchetti, A, Marchetti, P, Normanno, N, Pasini, B, Pensabene, M, Pignata, S, Radice, P, Ricevuto, E, Sapino, A, Tagliaferri, P, Tassone, P, Trevisiol, C, Truini, M, Varesco, L, Russo, A, Gori, S, Capoluongo, Ettore, Verde, Nicla La, Barberis, Massimo, Bella, Maria Angela, Buttitta, Fiamma, Carrera, Paola, Colombo, Nicoletta, Cortesi, Laura, Gion, Massimo, Guarneri, Valentina, Lorusso, Domenica, Marchetti, Antonio, Marchetti, Paolo, Normanno, Nicola, Pasini, Barbara, Pensabene, Matilde, Pignata, Sandro, Radice, Paolo, Ricevuto, Enrico, Sapino, Anna, Tagliaferri, Pierosandro, Tassone, Pierfrancesco, Trevisiol, Chiara, Truini, Mauro, Varesco, Liliana, Russo, Antonio, Gori, Stefania, Capoluongo, E, Verde, N, Barberis, M, Bella, M, Buttitta, F, Carrera, P, Colombo, N, Cortesi, L, Gion, M, Guarneri, V, Lorusso, D, Marchetti, A, Marchetti, P, Normanno, N, Pasini, B, Pensabene, M, Pignata, S, Radice, P, Ricevuto, E, Sapino, A, Tagliaferri, P, Tassone, P, Trevisiol, C, Truini, M, Varesco, L, Russo, A, Gori, S, Capoluongo, Ettore, Verde, Nicla La, Barberis, Massimo, Bella, Maria Angela, Buttitta, Fiamma, Carrera, Paola, Colombo, Nicoletta, Cortesi, Laura, Gion, Massimo, Guarneri, Valentina, Lorusso, Domenica, Marchetti, Antonio, Marchetti, Paolo, Normanno, Nicola, Pasini, Barbara, Pensabene, Matilde, Pignata, Sandro, Radice, Paolo, Ricevuto, Enrico, Sapino, Anna, Tagliaferri, Pierosandro, Tassone, Pierfrancesco, Trevisiol, Chiara, Truini, Mauro, Varesco, Liliana, Russo, Antonio, and Gori, Stefania

Abstract

In Italy, 5200 new ovarian cancers were diagnosed in 2018, highlighting an increasing need to test women for BRCA1/2. The number of labs offering this test is continuously increasing. The aim of this study was to show the results coming from the intersociety survey coordinated by four different Clinical and Laboratory Italian Scientific Societies (AIOM, SIAPEC-IAP, SIBIOC, and SIGU). A multidisciplinary team belonging to the four scientific societies drew up two different questionnaires: One was targeted toward all Italian Departments of Medical Oncology, and the second toward laboratories of clinical molecular biology. This survey was implemented from September 2017 to March 2018. Seventy-seven out of 305 (25%) Departments of Medical Oncology filled our survey form. Indeed, 59 molecular laboratories were invited. A total of 41 laboratories (70%) filled in the questionnaire. From 2014 to 2017, 16 new molecular laboratories were activated. A total of 12,559 tests were performed in the year 2016, with a mean of 339 tests and a median of 254 tests per laboratory, showing a glimpse of an extreme low number of tests performed per year by some laboratories. In terms of the type and number of professionals involved in the pre- and post-test counseling, results among the onco-genetic team were heterogeneous. Our data show that the number of laboratories providing BRCA1/2 germline assays is significantly increased with further implementation of the somatic test coming soon. The harmonization of the complete laboratory diagnostic path should be encouraged, particularly in order to reduce the gap between laboratories with high and low throughput.

Published
2019

467. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer.

Author

UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'oncologie médicale, Ray-Coquard, Isabelle, Pautier, Patricia, Pignata, Sandro, Pérol, David, González-Martín, Antonio, Berger, Regina, Fujiwara, Keiichi, Vergote, Ignace, Colombo, Nicoletta, Mäenpää, Johanna, Selle, Frédéric, Sehouli, Jalid, Lorusso, Domenica, Guerra Alía, Eva M, Reinthaller, Alexander, Nagao, Shoji, Lefeuvre-Plesse, Claudia, Canzler, Ulrich, Scambia, Giovanni, Lortholary, Alain, Marmé, Frederik, Combe, Pierre, de Gregorio, Nikolaus, Rodrigues, Manuel, Buderath, Paul, Dubot, Coraline, Burges, Alexander, You, Benoît, Pujade-Lauraine, Eric, Harter, Philipp, PAOLA-1 Investigators, D'Hondt, Lionel, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'oncologie médicale, Ray-Coquard, Isabelle, Pautier, Patricia, Pignata, Sandro, Pérol, David, González-Martín, Antonio, Berger, Regina, Fujiwara, Keiichi, Vergote, Ignace, Colombo, Nicoletta, Mäenpää, Johanna, Selle, Frédéric, Sehouli, Jalid, Lorusso, Domenica, Guerra Alía, Eva M, Reinthaller, Alexander, Nagao, Shoji, Lefeuvre-Plesse, Claudia, Canzler, Ulrich, Scambia, Giovanni, Lortholary, Alain, Marmé, Frederik, Combe, Pierre, de Gregorio, Nikolaus, Rodrigues, Manuel, Buderath, Paul, Dubot, Coraline, Burges, Alexander, You, Benoît, Pujade-Lauraine, Eric, Harter, Philipp, PAOLA-1 Investigators, and D'Hondt, Lionel

Abstract

Olaparib has shown significant clinical benefit as maintenance therapy in women with newly diagnosed advanced ovarian cancer with a mutation. The effect of combining maintenance olaparib and bevacizumab in patients regardless of mutation status is unknown. We conducted a randomized, double-blind, international phase 3 trial. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum-taxane chemotherapy plus bevacizumab. Patients were eligible regardless of surgical outcome or mutation status. Patients were randomly assigned in a 2:1 ratio to receive olaparib tablets (300 mg twice daily) or placebo for up to 24 months; all the patients received bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks for up to 15 months in total. The primary end point was the time from randomization until investigator-assessed disease progression or death. Of the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo. After a median follow-up of 22.9 months, the median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P<0.001). The hazard ratio (olaparib group vs. placebo group) for disease progression or death was 0.33 (95% CI, 0.25 to 0.45) in patients with tumors positive for homologous-recombination deficiency (HRD), including tumors that had mutations (median progression-free survival, 37.2 vs. 17.7 months), and 0.43 (95% CI, 0.28 to 0.66) in patients with HRD-positive tumors that did not have mutations (median progression-free survival, 28.1 vs. 16.6 months). Adverse events were consistent with the established safety profiles of olaparib and bevacizumab. In patients with advanced ovarian cancer receiving first-line standard therapy including bevacizumab, the addition of maintenan

Published
2019

468. Carboplatin-paclitaxel compared to Carboplatin-Paclitaxel-Bevacizumab in advanced or recurrent endometrial cancer: MITO END-2 - A randomized phase II trial

Author

Lorusso, Domenica, Ferrandina, Maria Gabriella, Colombo, N., Pignata, S., Pietragalla, A., Sonetto, C., Pisano, C., Lapresa, M. T., Savarese, A., Tagliaferri, P., Lombardi, Debora Benedetta, Cinieri, S., Breda, E., Sabatucci, I., Sabbatini, R., Conte, C., Cecere, S. C., Maltese, G., Scambia, Giovanni, Lorusso D., Ferrandina G. (ORCID:0000-0003-4672-4197), Lombardi D., Scambia G. (ORCID:0000-0003-2758-1063), Lorusso, Domenica, Ferrandina, Maria Gabriella, Colombo, N., Pignata, S., Pietragalla, A., Sonetto, C., Pisano, C., Lapresa, M. T., Savarese, A., Tagliaferri, P., Lombardi, Debora Benedetta, Cinieri, S., Breda, E., Sabatucci, I., Sabbatini, R., Conte, C., Cecere, S. C., Maltese, G., Scambia, Giovanni, Lorusso D., Ferrandina G. (ORCID:0000-0003-4672-4197), Lombardi D., and Scambia G. (ORCID:0000-0003-2758-1063)

Abstract

Objective: Increased Vascular Endothelial Growth Factor Receptor (VEGF) expression in endometrial cancer (EC) is associated with a poor prognosis. Preliminary clinical data reported Bevacizumab effectiveness in EC both as single agent and in combination with chemotherapy. Methods: In a phase II trial, patients with advanced (FIGO stage III-IV) or recurrent EC were randomized to receive Carboplatin-Paclitaxel standard dose for 6–8 cycles vs Carboplatin-Paclitaxel and Bevacizumab 15 mg/kg in combination with chemotherapy and maintenance until disease progression or unacceptable toxicity. The primary endpoint was progression free survival (PFS). Results: 108 patients were randomized; PFS (10.5 vs 13.7 months, HR 0.84 p = 0.43), overall response rate (ORR 53.1% vs 74.4%) and overall survival (OS) (29.7 vs 40.0 months, HR 0.71 p = 0.24) resulted in a non-significant increase in Bevacizumab treated patients. The PFS increase became significant when an exploratory analysis with the Breslow test was used. Moreover, patients treated with Bevacizumab experienced a significant increase in 6-month disease control rate (70.4% vs 90.7%). Cardiovascular events were more frequent in the experimental arm (“de novo” grade ≥2 hypertension 21% vs 0% and grade ≥2 thromboembolic events 11% vs 2% in the Bevacizumab vs standard treatment arm, respectively). Conclusions: Bevacizumab combined with chemotherapy in the treatment of advanced/recurrent EC failed to demonstrate a significant increase in PFS in the MITO END-2 trial. Nevertheless, these preliminary data suggests some effectiveness of the antiangiogenic agent which merits further exploration in a larger population with a better molecular characterization.

Published
2019

470. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer

Author

Ray-Coquard, I, Pautier, P, Pignata, S, Pérol, D, González-Martín, A, Berger, R, Fujiwara, K, Vergote, I, Colombo, N, Mäenpää, J, Selle, F, Sehouli, J, Lorusso, D, Guerra Alía, E, Reinthaller, A, Nagao, S, Lefeuvre-Plesse, C, Canzler, U, Scambia, G, Lortholary, A, Marmé, F, Combe, P, de Gregorio, N, Rodrigues, M, Buderath, P, Dubot, C, Burges, A, You, B, Pujade-Lauraine, E, Harter, P, Ray-Coquard, Isabelle, Pautier, Patricia, Pignata, Sandro, Pérol, David, González-Martín, Antonio, Berger, Regina, Fujiwara, Keiichi, Vergote, Ignace, Colombo, Nicoletta, Mäenpää, Johanna, Selle, Frédéric, Sehouli, Jalid, Lorusso, Domenica, Guerra Alía, Eva M, Reinthaller, Alexander, Nagao, Shoji, Lefeuvre-Plesse, Claudia, Canzler, Ulrich, Scambia, Giovanni, Lortholary, Alain, Marmé, Frederik, Combe, Pierre, de Gregorio, Nikolaus, Rodrigues, Manuel, Buderath, Paul, Dubot, Coraline, Burges, Alexander, You, Benoît, Pujade-Lauraine, Eric, Harter, Philipp, Ray-Coquard, I, Pautier, P, Pignata, S, Pérol, D, González-Martín, A, Berger, R, Fujiwara, K, Vergote, I, Colombo, N, Mäenpää, J, Selle, F, Sehouli, J, Lorusso, D, Guerra Alía, E, Reinthaller, A, Nagao, S, Lefeuvre-Plesse, C, Canzler, U, Scambia, G, Lortholary, A, Marmé, F, Combe, P, de Gregorio, N, Rodrigues, M, Buderath, P, Dubot, C, Burges, A, You, B, Pujade-Lauraine, E, Harter, P, Ray-Coquard, Isabelle, Pautier, Patricia, Pignata, Sandro, Pérol, David, González-Martín, Antonio, Berger, Regina, Fujiwara, Keiichi, Vergote, Ignace, Colombo, Nicoletta, Mäenpää, Johanna, Selle, Frédéric, Sehouli, Jalid, Lorusso, Domenica, Guerra Alía, Eva M, Reinthaller, Alexander, Nagao, Shoji, Lefeuvre-Plesse, Claudia, Canzler, Ulrich, Scambia, Giovanni, Lortholary, Alain, Marmé, Frederik, Combe, Pierre, de Gregorio, Nikolaus, Rodrigues, Manuel, Buderath, Paul, Dubot, Coraline, Burges, Alexander, You, Benoît, Pujade-Lauraine, Eric, and Harter, Philipp

Abstract

BACKGROUND: Olaparib has shown significant clinical benefit as maintenance therapy in women with newly diagnosed advanced ovarian cancer with a BRCA mutation. The effect of combining maintenance olaparib and bevacizumab in patients regardless of BRCA mutation status is unknown. METHODS: We conducted a randomized, double-blind, international phase 3 trial. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum-taxane chemotherapy plus bevacizumab. Patients were eligible regardless of surgical outcome or BRCA mutation status. Patients were randomly assigned in a 2:1 ratio to receive olaparib tablets (300 mg twice daily) or placebo for up to 24 months; all the patients received bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks for up to 15 months in total. The primary end point was the time from randomization until investigator-assessed disease progression or death. RESULTS: Of the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo. After a median follow-up of 22.9 months, the median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P<0.001). The hazard ratio (olaparib group vs. placebo group) for disease progression or death was 0.33 (95% CI, 0.25 to 0.45) in patients with tumors positive for homologous-recombination deficiency (HRD), including tumors that had BRCA mutations (median progression-free survival, 37.2 vs. 17.7 months), and 0.43 (95% CI, 0.28 to 0.66) in patients with HRD-positive tumors that did not have BRCA mutations (median progression-free survival, 28.1 vs. 16.6 months). Adverse events were consistent with the established safety profiles of olaparib and bevacizumab. CONCLUSIONS: In patients with advanced ovarian cancer receiving first-li

Published
2019

471. Prognostic role of chemotherapy-induced neutropenia in first-line treatment of advanced ovarian cancer. A pooled analysis of MITO2 and MITO7 trials

Author

Daniele, Gennaro, Arenare, Laura, Scambia, Giovanni, Pisano, Carmela, Sorio, Roberto, Breda, Enrico, De Placido, Sabino, Savarese, Antonella, Ferrandina, Maria Gabriella, Raspagliesi, Francesco, Panici, Pierluigi Benedetti, Ferro, Antonella, Rimanti, Anita, Cormio, Gennaro, Lorusso, Domenica, Cecere, Sabrina Chiara, Scalone, Simona, Marsico, Valentina Angela, Cardalesi, Cinzia, Cognetti, Francesco, Salutari, Vanda, Attademo, Laura, Guizzaro, Lorenzo, Schettino, Clorinda, Piccirillo, Maria Carmela, Perrone, Francesco, Gallo, Ciro, Pignata, Sandro, Scambia, Giovanni (ORCID:0000-0003-2758-1063), Ferrandina, Gabriella (ORCID:0000-0003-4672-4197), Daniele, Gennaro, Arenare, Laura, Scambia, Giovanni, Pisano, Carmela, Sorio, Roberto, Breda, Enrico, De Placido, Sabino, Savarese, Antonella, Ferrandina, Maria Gabriella, Raspagliesi, Francesco, Panici, Pierluigi Benedetti, Ferro, Antonella, Rimanti, Anita, Cormio, Gennaro, Lorusso, Domenica, Cecere, Sabrina Chiara, Scalone, Simona, Marsico, Valentina Angela, Cardalesi, Cinzia, Cognetti, Francesco, Salutari, Vanda, Attademo, Laura, Guizzaro, Lorenzo, Schettino, Clorinda, Piccirillo, Maria Carmela, Perrone, Francesco, Gallo, Ciro, Pignata, Sandro, Scambia, Giovanni (ORCID:0000-0003-2758-1063), and Ferrandina, Gabriella (ORCID:0000-0003-4672-4197)

Abstract

Background: Chemotherapy-induced neutropenia (CIN) has been associated with improved prognosis in several cancer conditions. Contrasting data have been produced in ovarian cancer.

Published
2019

472. A randomized trial of lymphadenectomy in patients with advanced ovarian neoplasms

Author

Harter, Philipp, Sehouli, Jalid, Lorusso, Domenica, Reuss, Alexander, Vergote, Ignace, Marth, Christian, Kim, Jae-Weon, Raspagliesi, Fran-Cesco, Lampe, Björn, Aletti, Giovanni, Meier, Werner, Cibula, David, Mustea, Alexander, Mahner, Sven, Runnebaum, Ingo B., Schmalfeldt, Barbara, Burges, Alexander, Kimmig, Rainer, Scambia, Giovanni, Greggi, Stefano, Hilpert, Felix, Hasenburg, Annette, Hillemanns, Peter, Giorda, Giorgio, Von Leffern, Ingo, Schade-Brittinger, Carmen, Wagner, Uwe, Du Bois, Andreas, Scambia, Giovanni (ORCID:0000-0003-2758-1063), Harter, Philipp, Sehouli, Jalid, Lorusso, Domenica, Reuss, Alexander, Vergote, Ignace, Marth, Christian, Kim, Jae-Weon, Raspagliesi, Fran-Cesco, Lampe, Björn, Aletti, Giovanni, Meier, Werner, Cibula, David, Mustea, Alexander, Mahner, Sven, Runnebaum, Ingo B., Schmalfeldt, Barbara, Burges, Alexander, Kimmig, Rainer, Scambia, Giovanni, Greggi, Stefano, Hilpert, Felix, Hasenburg, Annette, Hillemanns, Peter, Giorda, Giorgio, Von Leffern, Ingo, Schade-Brittinger, Carmen, Wagner, Uwe, Du Bois, Andreas, and Scambia, Giovanni (ORCID:0000-0003-2758-1063)

Abstract

BACKGROUND Systematic pelvic and paraaortic lymphadenectomy has been widely used in the surgical treatment of patients with advanced ovarian cancer, although supporting evidence from randomized clinical trials has been limited. METHODS We intraoperatively randomly assigned patients with newly diagnosed advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage IIB through IV) who had undergone macroscopically complete resection and had normal lymph nodes both before and during surgery to either undergo or not undergo lymphadenectomy. All centers had to qualify with regard to surgical skills before participation in the trial. The primary end point was overall survival. RESULTS A total of 647 patients underwent randomization from December 2008 through January 2012, were assigned to undergo lymphadenectomy (323 patients) or not undergo lymphadenectomy (324), and were included in the analysis. Among patients who underwent lymphadenectomy, the median number of removed nodes was 57 (35 pelvic and 22 paraaortic nodes). The median overall survival was 69.2 months in the no-lymphadenectomy group and 65.5 months in the lymphadenectomy group (hazard ratio for death in the lymphadenectomy group, 1.06; 95% confidence interval [CI], 0.83 to 1.34; P=0.65), and median progression-free survival was 25.5 months in both groups (hazard ratio for progression or death in the lymphadenectomy group, 1.11; 95% CI, 0.92 to 1.34; P=0.29). Serious postoperative complications occurred more frequently in the lymphadenectomy group (e.g., incidence of repeat laparotomy, 12.4% vs. 6.5% [P=0.01]; mortality within 60 days after surgery, 3.1% vs. 0.9% [P=0.049]). CONCLUSIONS Systematic pelvic and paraaortic lymphadenectomy in patients with advanced ovarian cancer who had undergone intraabdominal macroscopically complete resection and had normal lymph nodes both before and during surgery was not associated with longer overall or progression-free survival than no lymphadenectom

Published
2019

473. Incorporation of anti-PD1 or anti PD-L1 agents to platinum-based chemotherapy for the primary treatment of advanced or recurrent endometrial cancer. A meta-analysis.

Author

Bartoletti, Michele, Montico, Marcella, Lorusso, Domenica, Mazzeo, Roberta, Oaknin, Ana, Musacchio, Lucia, Scambia, Giovanni, Puglisi, Fabio, and Pignata, Sandro

Abstract

• Immune checkpoints inhibitors enhance the efficacy of platinum-based chemotherapy in advanced endometrial cancer. • The benefit in progression-free survival is more pronounced among patients with microsatellite unstable disease. • For DNA mismatch repair proficient tumors, the benefit is limited to the use of anti-PD1 agents. Various randomized trials have explored the efficacy of combining immune checkpoint inhibitors (ICIs) with first-line chemotherapy in advanced endometrial cancer. We aimed to summarize available data and clarify the benefit of adding immunotherapy according to the DNA mismatch repair status (deficient, dMMR or proficient, pMMR) and the specific type of agent used (anti-PD1 or anti-PD-L1). To assess whether the addition of ICIs to standard platinum-based chemotherapy enhances progression-free survival (PFS) for patients with advanced endometrial cancer both overall and based on DNA mismatch repair status. Electronic databases (PubMed, Embase and Cochrane Library) and conference proceedings were searched for first line, randomized and controlled trials integrating ICIs with chemotherapy for the treatment of advanced endometrial cancer published or presented by November 1, 2023. Five studies, comprising 2456 patients (1308 received ICIs with chemotherapy and 1148 treated with chemotherapy alone) met the selection criteria and were included in the analysis. Experimental arms included pembrolizumab, dostarlimab (anti-PD1) and durvalumab, atezolizumab and avelumab (anti-PD-L1) combined with standard three-weekly carboplatin-paclitaxel chemotherapy backbone. Endometrial carcinosarcoma were included in 3 out of 5 trials. For comparison of PFS outcomes, extrapolation of hazard ratios (HRs), 95% confidence intervals (CI) and PFS events was performed for each included study in the overall population and according to subgroups. Data analysis was conducted using a random-effects model. The addition of ICIs to chemotherapy improved PFS compared to chemotherapy alone in the overall population (pooled HR, 0.63; 95 % CI, 0.52––0.76; P <.001). In the dMMR subgroup the benefit was more pronounced (pooled HR, 0.34; 95 % CI, 0.27––0.44; P <.001) and not affected by drugs used with pooled HRs of 0.39 (95 % CI, 0.28––0.55; P <.001) and 0.34 (95 % CI, 0.27––0.44; P <.001) for PD-L1 and PD1 inhibitors, respectively. For pMMR patients, a statistically significant benefit in terms of PFS was confirmed only when anti-PD1 were used (anti-PD-1: HR 0.64, 95 % CI: 0.46–0.90, P =.010 vs anti-PD-L1: HR 0.87, 95 % CI: 0.73–1.03, P =.104) This meta -analysis confirmed the advantage in terms of PFS of adding ICIs to standard platinum-based chemotherapy. While dMMR patients benefit from the incorporation of both anti PD-1 or anti PD-L1, this benefit is confined to the association of anti-PD1 agents in pMMR patients. Updated analysis of trials is awaited to clarify the impact of immunotherapy on overall survival. [ABSTRACT FROM AUTHOR]

Published
2024
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474. Spotlight on olaparib in the treatment of BRCA-mutated ovarian cancer: design, development and place in therapy

Author

Lorusso,Domenica, Tripodi,Elisa, Maltese,Giuseppa, Lepori,Stefano, Sabatucci,Ilaria, Bogani,Giorgio, and Raspagliesi,Francesco

Subjects
Drug Design, Development and Therapy
Abstract

Domenica Lorusso, Elisa Tripodi, Giuseppa Maltese, Stefano Lepori, Ilaria Sabatucci, Giorgio Bogani, Francesco Raspagliesi Gynecologic Oncology Unit, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy Abstract: Epithelial ovarian cancer is the sixth most common cancer among women worldwide and the first cause of death among gynecological malignancies. Most of the patients present recurrent disease and unfortunately cannot be cured. The unsatisfactory results obtained with salvage chemotherapy have elicited investigators to search for novel biological agents capable of achieving a better control of the disease. In the setting of homologous recombination deficiency, the DNA errors that occur cannot be accurately repaired, and the treatment with poly(ADP-ribose) polymerase (PARP) inhibition results in definitive cell death in a process called synthetic lethality. As a result of two positive clinical trials, Olaparib was approved in 2014 by U.S. Food and Drug Administration and European Medicines Agency as the first-in-class PARP inhibitor. Olaparib is effective and well tolerated in homologous recombination deficient patients. Several studies with Olaparib have been conducted in the recurrent setting either as maintenance in platinum-responsive patients or as a single agent. Ongoing trials are focused on the use of olaparib as maintenance in the first-line ovarian cancer setting alone or in combination with antiangiogenic agents. Future perspectives will probably investigate the association of olaparib with novel agents as check-point inhibitors and PI3K-AKT inhibitors. The PARP inhibitor era is just at the beginning. Keywords: olaparib, ovarian cancer, PARP inhibitors, homologous recombination deficiency, BRCA mutation

Published
2018

475. Chemotherapy plus or minus bevacizumab for platinum-sensitive ovarian cancer patients recurring after a bevacizumab containing first line treatment: The randomized phase 3 trial MITO16B-MaNGO OV2B-ENGOT OV17

Author

Pignata, Sandro Lorusso, Domenica Joly, Florence Gallo, Ciro and Colombo, Nicoletta Sessa, Cristiana Bamias, Aristotelis and Pisano, Carmela Selle, Frederic Zaccarelli, Eleonora and Scambia, Giovanni Pautier, Patricia Nicoletto, Maria Ornella and De Giorgi, Ugo Dubot, Coraline Bologna, Alessandra Orditura, Michele Ray-Coquard, Isabelle Laure Perrone, Francesco and Daniele, Gennaro

Published
2018

477. Recommendations for the implementation of BRCA testing in ovarian cancer patients and their relatives

Author

Gori, Stefania, primary, Barberis, Massimo, additional, Bella, Maria Angela, additional, Buttitta, Fiamma, additional, Capoluongo, Ettore, additional, Carrera, Paola, additional, Colombo, Nicoletta, additional, Cortesi, Laura, additional, Genuardi, Maurizio, additional, Gion, Massimo, additional, Guarneri, Valentina, additional, Incorvaia, Lorena, additional, La Verde, Nicla, additional, Lorusso, Domenica, additional, Marchetti, Antonio, additional, Marchetti, Paolo, additional, Normanno, Nicola, additional, Pasini, Barbara, additional, Pensabene, Matilde, additional, Pignata, Sandro, additional, Radice, Paolo, additional, Ricevuto, Enrico, additional, Sapino, Anna, additional, Tagliaferri, Pierosandro, additional, Tassone, Pierfrancesco, additional, Trevisiol, Chiara, additional, Truini, Mauro, additional, Varesco, Liliana, additional, and Russo, Antonio, additional

Published
2019
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478. Prognostic role of chemotherapy-induced neutropenia in first-line treatment of advanced ovarian cancer. A pooled analysis of MITO2 and MITO7 trials

Author

Daniele, Gennaro, primary, Arenare, Laura, additional, Scambia, Giovanni, additional, Pisano, Carmela, additional, Sorio, Roberto, additional, Breda, Enrico, additional, De Placido, Sabino, additional, Savarese, Antonella, additional, Ferrandina, Gabriella, additional, Raspagliesi, Francesco, additional, Panici, Pierluigi Benedetti, additional, Ferro, Antonella, additional, Rimanti, Anita, additional, Cormio, Gennaro, additional, Lorusso, Domenica, additional, Cecere, Sabrina Chiara, additional, Scalone, Simona, additional, Marsico, Valentina Angela, additional, Cardalesi, Cinzia, additional, Cognetti, Francesco, additional, Salutari, Vanda, additional, Attademo, Laura, additional, Guizzaro, Lorenzo, additional, Schettino, Clorinda, additional, Piccirillo, Maria Carmela, additional, Perrone, Francesco, additional, Gallo, Ciro, additional, and Pignata, Sandro, additional

Published
2019
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479. Abstract CT158: ATHENA (GOG-3020/ENGOT-ov45): a randomized, double-blind, placebo-controlled, Phase III study of rucaparib + nivolumab following front-line platinum-based chemotherapy in ovarian cancer

Author

Westin, Shannon N., primary, Kristeleit, Rebecca S., additional, Coleman, Robert L., additional, Fujiwara, Keiichi, additional, Oza, Amit M., additional, O’Malley, David M., additional, Herzog, Thomas J., additional, Marmé, Frederik, additional, Oaknin, Ana, additional, Eskander, Ramez, additional, Lorusso, Domenica, additional, Safra, Tamar, additional, Korach, Jacob, additional, Lin, Kevin K., additional, Shih, Danny, additional, Caunt, Lisa, additional, Goble, Sandra, additional, Hume, Stephanie, additional, Maloney, Lara, additional, McNeish, Iain, additional, and Monk, Bradley J., additional

Published
2019
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480. The MITO CERV-2 trial: A randomized phase II study of cetuximab plus carboplatin and paclitaxel, in advanced or recurrent cervical cancer

Author

Pignata, Sandro, primary, Scambia, Giovanni, additional, Lorusso, Domenica, additional, De Giorgi, Ugo, additional, Nicoletto, Maria Ornella, additional, Lauria, Rossella, additional, Mosconi, Anna Maria, additional, Sacco, Cosimo, additional, Omarini, Claudia, additional, Tagliaferri, Pierosandro, additional, Ferrandina, Gabriella, additional, Cinieri, Saverio, additional, Savarese, Antonella, additional, Valabrega, Giorgio, additional, Pisano, Carmela, additional, Salutari, Vanda, additional, Raspagliesi, Francesco, additional, Kopf, Barbara, additional, Cecere, Sabrina Chiara, additional, Amadio, Giulia, additional, Maltese, Giuseppa, additional, Di Napoli, Marilena, additional, Greggi, Stefano, additional, Signoriello, Simona, additional, Daniele, Gennaro, additional, Sacco, Alessandra, additional, Losito, Simona, additional, Normanno, Nicola, additional, Perrone, Francesco, additional, Gallo, Ciro, additional, and Piccirillo, Maria Carmela, additional

Published
2019
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481. RECIST 1.1 criteria predict recurrence-free survival in advanced ovarian cancer submitted to neoadjuvant chemotherapy

Author

Bogani, Giorgio, primary, Matteucci, Laura, additional, Tamberi, Stefano, additional, Ditto, Antonino, additional, Sabatucci, Ilaria, additional, Murgia, Ferdinando, additional, Arcangeli, Valentina, additional, Maltese, Giuseppa, additional, Comerci, Giuseppe, additional, Stefanetti, Marco, additional, Sonetto, Cristina, additional, Calareso, Giuseppina, additional, Marchiano, Alfonso, additional, Chiappa, Valentina, additional, Lorusso, Domenica, additional, and Raspagliesi, Francesco, additional

Published
2019
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482. Surveillance in stage I MOGCTs (malignant ovarian germ cell tumors): A MITO prospective study (multicenter Italian trials in ovarian cancer).

Author

Bergamini, Alice, primary, Giorda, Giorgio, additional, Ferrandina, Gabriella, additional, Cormio, Gennaro, additional, Lorusso, Domenica, additional, Cassani, Chiara, additional, Raspagliesi, Francesco, additional, Marinaccio, Marco, additional, Bertone, Elena, additional, Frigerio, Luigi, additional, Scarfone, Giovanna, additional, Perrone, Myriam, additional, Bocciolone, Luca, additional, Savarese, Antonella, additional, Pignata, Sandro, additional, and Mangili, Giorgia, additional

Published
2019
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483. Exploratory analysis of the effect of maintenance rucaparib on postprogression outcomes in patients (pts) with platinum-sensitive recurrent ovarian carcinoma (OC) and updated safety data from the phase 3 study ARIEL3.

Author

Coleman, Robert L., primary, Oza, Amit M., additional, Lorusso, Domenica, additional, Aghajanian, Carol, additional, Oaknin, Ana, additional, Dean, Andrew Peter, additional, Colombo, Nicoletta, additional, Weberpals, Johanne I, additional, Clamp, Andrew R., additional, Scambia, Giovanni, additional, Leary, Alexandra, additional, Holloway, Robert W., additional, Amenedo, Margarita, additional, Fong, Peter C.C., additional, Goh, Jeffrey C., additional, O'Malley, David M., additional, Cameron, Teresa, additional, Maloney, Lara, additional, Goble, Sandra, additional, and Ledermann, Jonathan A., additional

Published
2019
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484. EUDARIO/ENGOTov-48: A European multicenter randomised phase II trial on the combination of the HSP90 inhibitor ganetespib with carboplatin followed by maintenance treatment with niraparib (+/- ganetespib) compared to platinum-based combination-chemotherapy followed by niraparib in relapsed platinum-sensitive ovarian cancer patients.

Author

Concin, Nicole, primary, Lorusso, Domenica, additional, Braicu, Ioana, additional, Ray-Coquard, Isabelle Laure, additional, Joly, Florence, additional, Harter, Philipp, additional, Wimberger, Pauline, additional, Lotz, Jean-Pierre, additional, Zeimet, Alain G, additional, Scambia, Giovanni, additional, Schmalfeldt, Barbara, additional, Zamagni, Claudio, additional, Raspagliesi, Francesco, additional, Mustea, Alexander, additional, Ulmer, Hanno, additional, Kramer, Daniela, additional, Dobbelstein, Matthias, additional, Pujade-Lauraine, Eric, additional, Sehouli, Jalid, additional, and Vergote, Ignace, additional

Published
2019
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485. EWOC-1: A randomized trial to evaluate the feasibility of three different first-line chemotherapy regimens for vulnerable elderly women with ovarian cancer (OC): A GCIG-ENGOT-GINECO study.

Author

Falandry, Claire, primary, Savoye, Aude Marie, additional, Stefani, Laetitia, additional, Tinquaut, Fabien, additional, Lorusso, Domenica, additional, Herrstedt, Jorn, additional, Bourbouloux, Emmanuelle, additional, Floquet, Anne, additional, Brachet, Pierre Emmanuel, additional, Zannetti, Alain, additional, Mouret-Reynier, Marie-Ange, additional, Sverdlin, Robert, additional, D'hondt, Veronique, additional, Guillem, Olivier, additional, Cojocarasu, Oana, additional, Venat-Bouvet, Laurence, additional, Rousseau, Frederique, additional, Lortholary, Alain, additional, Pujade-Lauraine, Eric, additional, and Freyer, Gilles, additional

Published
2019
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488. A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms

Author

Harter, Philipp, primary, Sehouli, Jalid, additional, Lorusso, Domenica, additional, Reuss, Alexander, additional, Vergote, Ignace, additional, Marth, Christian, additional, Kim, Jae-Weon, additional, Raspagliesi, Francesco, additional, Lampe, Björn, additional, Aletti, Giovanni, additional, Meier, Werner, additional, Cibula, David, additional, Mustea, Alexander, additional, Mahner, Sven, additional, Runnebaum, Ingo B., additional, Schmalfeldt, Barbara, additional, Burges, Alexander, additional, Kimmig, Rainer, additional, Scambia, Giovanni, additional, Greggi, Stefano, additional, Hilpert, Felix, additional, Hasenburg, Annette, additional, Hillemanns, Peter, additional, Giorda, Giorgio, additional, von Leffern, Ingo, additional, Schade-Brittinger, Carmen, additional, Wagner, Uwe, additional, and du Bois, Andreas, additional

Published
2019
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493. Minimally invasive surgery improves short-term outcomes of nerve-sparing radical hysterectomy in patients with cervical cancer: a propensity-matched analysis with open abdominal surgery

Author

Bogani, Giorgio, primary, Rossetti, Diego, additional, Ditto, Antonino, additional, Martinelli, Fabio, additional, Chiappa, Valentina, additional, Leone, Chiara, additional, Leone Roberti Maggiore, Umberto, additional, Lorusso, Domenica, additional, and Raspagliesi, Francesco, additional

Published
2019
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495. Treatment Outcomes and Sensitivity to Hormone Therapy of Aggressive Angiomyxoma: A Multicenter, International, Retrospective Study

Author

Fucà, Giovanni, primary, Hindi, Nadia, additional, Ray-Coquard, Isabelle, additional, Colia, Vittoria, additional, Dei Tos, Angelo Paolo, additional, Martin-Broto, Javier, additional, Brahmi, Mehdi, additional, Collini, Paola, additional, Lorusso, Domenica, additional, Raspagliesi, Francesco, additional, Pantaleo, Maria Abbondanza, additional, Vincenzi, Bruno, additional, Fumagalli, Elena, additional, Gronchi, Alessandro, additional, Casali, Paolo Giovanni, additional, and Sanfilippo, Roberta, additional

Published
2018
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498. Surgical Efforts Might Mitigate Difference in Response to Neoadjuvant Chemotherapy in Stage IIIC–IV Unresectable Ovarian Cancer: A Case-Control Multi-institutional Study

Author

Raspagliesi, Francesco, primary, Bogani, Giorgio, additional, Matteucci, Laura, additional, Casarin, Jvan, additional, Sabatucci, Ilaria, additional, Tamberi, Stefano, additional, Arcangeli, Valentina, additional, Maltese, Giuseppa, additional, Lepori, Stefano, additional, Comerci, Giuseppe, additional, Stefanetti, Marco, additional, Ditto, Antonino, additional, Martinelli, Fabio, additional, Chiappa, Valentina, additional, and Lorusso, Domenica, additional

Published
2018
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499. Phase I Study of Rucaparib in Combination with Bevacizumab in Ovarian Cancer Patients: Maximum Tolerated Dose and Pharmacokinetic Profile.

Author

Lorusso, Domenica, Maltese, Giuseppa, Sabatucci, Ilaria, Cresta, Sara, Matteo, Cristina, Ceruti, Tommaso, D'Incalci, Maurizio, Zucchetti, Massimo, Raspagliesi, Francesco, Sonetto, Cristina, Sinno, Valentina, Ronzulli, Dominique, Giolitto, Serena, and de Braud, Filippo

Abstract

Background: Targeted agents, such as antiangiogenic drugs (e.g., bevacizumab) and poly(ADP-ribose) polymerase inhibitors (e.g., rucaparib), have been shown to improve outcomes in patients with newly diagnosed or recurrent ovarian cancer. Evidence suggests that combinations of these two classes of targeted agents may result in synergistic antitumor activity. Objective: The phase I portion of MITO 25 was designed to determine the maximum tolerated dose, pharmacokinetics, and the safety profile of rucaparib when administered in combination with bevacizumab as maintenance treatment for patients with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer. Methods: This was a single-arm, phase I dose-escalation study. Cohorts of three patients were recruited to receive increasing rucaparib doses of 400 mg, 500 mg, or 600 mg twice daily for 28 days. Bevacizumab 15 mg/kg was administered at day 1 every 21 days. Results: We enrolled nine patients. Two patients in the rucaparib 600-mg group had four grade 3 treatment-emergent adverse events: increased in alanine aminotransferase and aspartate aminotransferase levels, depression, and hallucinations. These were deemed to be dose-limiting toxicities related to rucaparib. Because these dose-limiting toxicities occurred in the 600-mg group and affected more than one in three patients, the maximum tolerated dose for rucaparib was considered 500 mg twice daily when combined with bevacizumab 15 mg/kg at day 1 every 21 days. There were no new safety concerns from using the combination. No substantial difference in pharmacokinetic parameters was found between the cohorts or in the pharmacokinetic profiles of rucaparib administered alone or with bevacizumab with respect to historical controls. Conclusions: The maximum tolerated dose of rucaparib is 500 mg twice daily when co-administered with bevacizumab. The plasma concentration–time profiles of rucaparib in combination with bevacizumab suggest no pharmacokinetic interactions between the drugs. The randomized phase II portion of MITO 25 will further investigate rucaparib maintenance treatment with or without bevacizumab in patients with newly diagnosed stage III–IV ovarian cancer who responded to carboplatin-paclitaxel chemotherapy with or without bevacizumab. Trial Registration: ClinicalTrials.gov identifier NCT03462212; registered March 2018. [ABSTRACT FROM AUTHOR]

Published
2021
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500. Validation of the modified Glasgow Prognostic Score (mGPS) in recurrent ovarian cancer (ROC) : Analysis of patients enrolled in the GCIG Symptom Benefit Study (SBS)

Author

Roncolato, Felicia T, Berton-Rigaud, Dominique, O'Connell, Rachel, Lanceley, Anne, Sehouli, Jalid, Buizen, Luke, Okamoto, Aikou, Aotani, Eriko, Lorusso, Domenica, Donnellan, Paul, Oza, Amit, Åvall-Lundqvist, Elisabeth, Berek, Jonathan, Hilpert, Felix, Ledermann, Jonathan A, Kaminsky, Marie Christine, Stockler, Martin R, King, Madeleine T, Friedlander, Michael, Roncolato, Felicia T, Berton-Rigaud, Dominique, O'Connell, Rachel, Lanceley, Anne, Sehouli, Jalid, Buizen, Luke, Okamoto, Aikou, Aotani, Eriko, Lorusso, Domenica, Donnellan, Paul, Oza, Amit, Åvall-Lundqvist, Elisabeth, Berek, Jonathan, Hilpert, Felix, Ledermann, Jonathan A, Kaminsky, Marie Christine, Stockler, Martin R, King, Madeleine T, and Friedlander, Michael

Abstract

BACKGROUND: Modified Glasgow Prognostic Score (mGPS) is predictive of survival in many advanced cancers, but has not been evaluated in recurrent ovarian cancer (ROC). The aim was to determine validity of mGPS in ROC, investigate its associations with health related quality of life (HRQL) and ECOG performance status (PS). METHODS: mGPS is based on serum C reactive protein (CRP) and albumin, with scores ranging from 0 (least) to 2 (most). HRQL was measured with EORTC QLQ C-30 and OV-28. χ2 tests for trend were used to examine the relationship between HRQL, PS and mGPS. Cox proportional hazards regression was used to assess associations between mGPS, HRQL, clinicopathological factors, and overall survival (OS). RESULTS: Inflammatory markers were available in 516 of 948 patients in GCIG SBS. 200(39%) had potentially platinum sensitive ROC with ≥3 lines of chemotherapy, 316(61%) had platinum resistant ROC. 282(55%), 123(24%), 111(22%) had mGPS of 0, 1, 2, respectively. Median OS (months) was 18.1, 9.6, and 6.6 for mGPS 0, 1, and 2 respectively. mGPS was an independent predictor of OS after adjusting for PS and platinum sensitivity (p<0.001). mGPS remained a predictor of OS after adjusting for physical function, role function, global health status, abdominal/GI symptoms, and multiple clinicopathologic factors (p=0.02). Worse PS and higher mGPS were associated with poorer HRQL (p<0.001). Higher mGPS was associated with worse HRQL, independent of PS. CONCLUSION: The mGPS is an independent predictor of OS in ROC after adjusting for HRQL and clinicopathological factors. Higher mGPS is associated with worse HRQL independent of PS. mGPS is simple, inexpensive and may be suitable for clinical practice, clinical trial patient selection and stratification.

Published
2018
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