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351. Preclinical and Clinical Evidence of Lurbinectedin in Ovarian Cancer: Current Status and Future Perspectives

Author

Musacchio, Lucia, primary, Cicala, Carlo Maria, additional, Salutari, Vanda, additional, Camarda, Floriana, additional, Carbone, Maria Vittoria, additional, Ghizzoni, Viola, additional, Giudice, Elena, additional, Nero, Camilla, additional, Perri, Maria Teresa, additional, Ricci, Caterina, additional, Tronconi, Francesca, additional, Scambia, Giovanni, additional, and Lorusso, Domenica, additional

Published
2022
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353. Additional file 2 of Knowledge and attitudes towards clinical trials among women with ovarian cancer: results of the ACTO study

Author

Mosconi, Paola, Roberto, Anna, Cerana, Nicoletta, Colombo, Nicoletta, Didier, Florence, D’Incalci, Maurizio, Lorusso, Domenica, and Peccatori, Fedro Alessandro

Subjects
endocrine system diseases
Abstract

Additional file 2: Supplementary 2. Knowledge about clinical trials according to education and history of ovarian cancer (% of Yes).

Published
2022
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354. sj-docx-2-tam-10.1177_17588359221126149 – Supplemental material for Quality-adjusted time without symptoms of disease or toxicity and quality-adjusted progression-free survival with niraparib maintenance in first-line ovarian cancer in the PRIMA trial

Author

Barretina-Ginesta, Maria-Pilar, Monk, Bradley J., Han, Sileny, Pothuri, Bhavana, Auranen, Annika, Chase, Dana M., Lorusso, Domenica, Anderson, Charles, Abadie-Lacourtoisie, Sophie, Cloven, Noelle, Braicu, Elena I., Amit, Amnon, Redondo, Andrés, Shah, Ruchit, Kebede, Nehemiah, Hawkes, Carol, Gupta, Divya, Woodward, Tatia, O’Malley, David M., and González-Martín, Antonio

Subjects
110203 Respiratory Diseases, FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, sj-docx-2-tam-10.1177_17588359221126149 for Quality-adjusted time without symptoms of disease or toxicity and quality-adjusted progression-free survival with niraparib maintenance in first-line ovarian cancer in the PRIMA trial by Maria-Pilar Barretina-Ginesta, Bradley J. Monk, Sileny Han, Bhavana Pothuri, Annika Auranen, Dana M. Chase, Domenica Lorusso, Charles Anderson, Sophie Abadie-Lacourtoisie, Noelle Cloven, Elena I. Braicu, Amnon Amit, Andrés Redondo, Ruchit Shah, Nehemiah Kebede, Carol Hawkes, Divya Gupta, Tatia Woodward, David M. O’Malley and Antonio González-Martín in Therapeutic Advances in Medical Oncology

Published
2022
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355. sj-docx-1-tam-10.1177_17588359221126149 – Supplemental material for Quality-adjusted time without symptoms of disease or toxicity and quality-adjusted progression-free survival with niraparib maintenance in first-line ovarian cancer in the PRIMA trial

Author

Barretina-Ginesta, Maria-Pilar, Monk, Bradley J., Han, Sileny, Pothuri, Bhavana, Auranen, Annika, Chase, Dana M., Lorusso, Domenica, Anderson, Charles, Abadie-Lacourtoisie, Sophie, Cloven, Noelle, Braicu, Elena I., Amit, Amnon, Redondo, Andrés, Shah, Ruchit, Kebede, Nehemiah, Hawkes, Carol, Gupta, Divya, Woodward, Tatia, O’Malley, David M., and González-Martín, Antonio

Subjects
110203 Respiratory Diseases, FOS: Clinical medicine, 111702 Aged Health Care, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 111299 Oncology and Carcinogenesis not elsewhere classified
Abstract

Supplemental material, sj-docx-1-tam-10.1177_17588359221126149 for Quality-adjusted time without symptoms of disease or toxicity and quality-adjusted progression-free survival with niraparib maintenance in first-line ovarian cancer in the PRIMA trial by Maria-Pilar Barretina-Ginesta, Bradley J. Monk, Sileny Han, Bhavana Pothuri, Annika Auranen, Dana M. Chase, Domenica Lorusso, Charles Anderson, Sophie Abadie-Lacourtoisie, Noelle Cloven, Elena I. Braicu, Amnon Amit, Andrés Redondo, Ruchit Shah, Nehemiah Kebede, Carol Hawkes, Divya Gupta, Tatia Woodward, David M. O’Malley and Antonio González-Martín in Therapeutic Advances in Medical Oncology

Published
2022
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357. DOMENICA study (GINECO-EN105b/ENGO-Ten13): randomized phase III trial in MMR deficient (MMRd) endometrial cancer (EC) patients comparing chemotherapy (CT) alone versus dostarlimab in first line advanced/metastatic setting (APGOT-EN1).

Author

Chel Hun Choi, Ray-Coquard, Isabelle, Rubio, Maria Jesus, Paoletti, Xavier, Hudson, Emma, Lorusso, Domenica, Hasler-Strub, Ursula, Vardar, Mehmet Ali, Lheureux, Stéphanie, Van Gorp, Toon, Shao Peng Tan, David, Trillsch, Fabian, Eberst, Lauriane, Lescure, Céline, Hardy-Bessard, Anne-Claire, Chaix, Marie, Byoung-Gie Kim, JaeWeon Kim, JeongYeol Park, and Jung-Yun Lee

Subjects
CLINICAL trials, ENDOMETRIAL cancer, ENDOMETRIAL surgery, IMMUNOTHERAPY, ANAPLASTIC thyroid cancer, PROGRESSION-free survival, OVERALL survival, COMBINATION drug therapy
Abstract

Objective: The standard treatment for advanced endometrial cancer (EC) includes platinum-based combination chemotherapy (CT), regardless of the histology, molecular status and the patient's profile. However, EC patients are a particularly frail group of patients, often with co-morbidities. Tolerance of CT can be difficult and induce long-term toxicities. In advanced EC disease, anti-PD1 immunotherapy has shown impressive results amongst mismatch repair deficient (MMRd)/high microsatellite instability (MSI-H) tumors. However, the benefit of adding CT to anti-PD1 is still an opened question. The aim of DOMENICA is to address the question if PD-1 alone has superior efficacy to CT, so that therapy in 1L advanced/recurrent MMRd/MSI-H EC could be de-escalated to avoid CT related toxicities. Methods: DOMENICA is an academic international randomized open-label, phase III trial evaluating the efficacy and safety of dostarlimab versus carboplatin-paclitaxel in patients with MMR deficient (MMRd/MSI-H) relapse or advanced / metastatic EC. Inclusion criteria for the study comprised patients with histologically confirmed EC exhibiting recurrent or advanced disease, including primary stage IIIA to C2 or Stage IV disease, or experiencing their first recurrence of EC without curative treatment, provided they had evaluable disease according to RECIST 1.1 criteria. Additionally, patients with MMRd/MSI-H tumors, determined by institutional MMR immunohistochemistry testing, and those with a performance status (ECOG) of 0-1 were eligible. The primary endpoint is progression-free survival according to RECIST 1.1, assessed by the BICR (Blinded Independent Central Review). Secondary endpoints include overall survival as key secondary endpoint, progression-free survival 2, patients reported outcome, best objective response rate, disease control rate, duration of response rate, safety and tolerability, time to first or second subsequent treatment (TFST, TSST), pharmacokinetics and immunogenicity of dostarlimab. Exploratory objectives include predictive biomarkers, efficacy according to geriatric status. The Study is ongoing in France (GINECO), Spain (GEICO), Italy (MaNGO, MITO), Canada (PMC), Singapore (GCIG), South Korea (KGOG), Japan (GOTIC), Turkey (TRSGO), and UK (NRCI). [ABSTRACT FROM AUTHOR]

Published
2024
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358. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer

Author

Colombo, Nicoletta, primary, Dubot, Coraline, additional, Lorusso, Domenica, additional, Caceres, M. Valeria, additional, Hasegawa, Kosei, additional, Shapira-Frommer, Ronnie, additional, Tewari, Krishnansu S., additional, Salman, Pamela, additional, Usta, Edwin Hoyos, additional, Yañez, Eduardo, additional, Gümüş, Mahmut, additional, Olivera Hurtado de Mendoza, Mivael, additional, Samouëlian, Vanessa, additional, Castonguay, Vincent, additional, Arkhipov, Alexander, additional, Toker, Sarper, additional, Li, Kan, additional, Keefe, Stephen M., additional, and Monk, Bradley J., additional

Published
2022
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359. Quality-adjusted time without symptoms of disease or toxicity and quality-adjusted progression-free survival with niraparib maintenance in first-line ovarian cancer in the PRIMA trial

Author

Barretina-Ginesta, Maria-Pilar, primary, Monk, Bradley J., additional, Han, Sileny, additional, Pothuri, Bhavana, additional, Auranen, Annika, additional, Chase, Dana M., additional, Lorusso, Domenica, additional, Anderson, Charles, additional, Abadie-Lacourtoisie, Sophie, additional, Cloven, Noelle, additional, Braicu, Elena I., additional, Amit, Amnon, additional, Redondo, Andrés, additional, Shah, Ruchit, additional, Kebede, Nehemiah, additional, Hawkes, Carol, additional, Gupta, Divya, additional, Woodward, Tatia, additional, O’Malley, David M., additional, and González-Martín, Antonio, additional

Published
2022
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360. Building a Personalized Medicine Infrastructure for Gynecological Oncology Patients in a High-Volume Hospital

Author

Bizzarri, Nicolò, primary, Nero, Camilla, additional, Sillano, Francesca, additional, Ciccarone, Francesca, additional, D’Oria, Marika, additional, Cesario, Alfredo, additional, Fragomeni, Simona Maria, additional, Testa, Antonia Carla, additional, Fanfani, Francesco, additional, Ferrandina, Gabriella, additional, Lorusso, Domenica, additional, Fagotti, Anna, additional, and Scambia, Giovanni, additional

Published
2021
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361. Gut microbiota and its influence on ovarian cancer carcinogenesis, anticancer therapy and surgical treatment: A literature review

Author

Giudice, Elena, primary, Salutari, Vanda, additional, Ricci, Caterina, additional, Nero, Camilla, additional, Carbone, Maria Vittoria, additional, Ghizzoni, Viola, additional, Musacchio, Lucia, additional, Landolfo, Chiara, additional, Perri, Maria Teresa, additional, Camarda, Floriana, additional, Scambia, Giovanni, additional, and Lorusso, Domenica, additional

Published
2021
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362. Preexisting TP53-Variant Clonal Hematopoiesis and Risk of Secondary Myeloid Neoplasms in Patients With High-grade Ovarian Cancer Treated With Rucaparib

Author

Kwan, Tanya T., primary, Oza, Amit M., additional, Tinker, Anna V., additional, Ray-Coquard, Isabelle, additional, Oaknin, Ana, additional, Aghajanian, Carol, additional, Lorusso, Domenica, additional, Colombo, Nicoletta, additional, Dean, Andrew, additional, Weberpals, Johanne, additional, Severson, Eric, additional, Vo, Lan-Thanh, additional, Goble, Sandra, additional, Maloney, Lara, additional, Harding, Thomas, additional, Kaufmann, Scott H., additional, Ledermann, Jonathan A., additional, Coleman, Robert L., additional, McNeish, Iain A., additional, Lin, Kevin K., additional, and Swisher, Elizabeth M., additional

Published
2021
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363. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer

Author

Colombo, Nicoletta, primary, Dubot, Coraline, additional, Lorusso, Domenica, additional, Caceres, M. Valeria, additional, Hasegawa, Kosei, additional, Shapira-Frommer, Ronnie, additional, Tewari, Krishnansu S., additional, Salman, Pamela, additional, Hoyos Usta, Edwin, additional, Yañez, Eduardo, additional, Gümüş, Mahmut, additional, Olivera Hurtado de Mendoza, Mivael, additional, Samouëlian, Vanessa, additional, Castonguay, Vincent, additional, Arkhipov, Alexander, additional, Toker, Sarper, additional, Li, Kan, additional, Keefe, Stephen M., additional, and Monk, Bradley J., additional

Published
2021
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364. Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: A multicenter, randomized, controlled, open-label phase 3 study (CORAIL)

Author

Gaillard, Stephanie, primary, Oaknin, Ana, additional, Ray-Coquard, Isabelle, additional, Vergote, Ignace, additional, Scambia, Giovanni, additional, Colombo, Nicoletta, additional, Fernandez, Cristian, additional, Alfaro, Vicente, additional, Kahatt, Carmen, additional, Nieto, Antonio, additional, Zeaiter, Ali, additional, Aracil, Miguel, additional, Vidal, Laura, additional, Pardo-Burdalo, Beatriz, additional, Papai, Zsuzsanna, additional, Kristeleit, Rebecca, additional, O'Malley, David M., additional, Benjamin, Ivor, additional, Pautier, Patricia, additional, and Lorusso, Domenica, additional

Published
2021
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365. Population-adjusted indirect treatment comparison of the SOLO1 and PAOLA-1/ENGOT-ov25 trials evaluating maintenance olaparib or bevacizumab or the combination of both in newly diagnosed, advanced BRCA-mutated ovarian cancer

Author

Vergote, Ignace, primary, Ray-Coquard, Isabelle, additional, Anderson, Daniel M., additional, Cantuaria, Guilherme, additional, Colombo, Nicoletta, additional, Garnier-Tixidre, Claire, additional, Gilbert, Lucy, additional, Harter, Philipp, additional, Hettle, Robert, additional, Lorusso, Domenica, additional, Mäenpää, Johanna, additional, Marth, Christian, additional, Matsumoto, Koji, additional, Ouwens, Mario, additional, Poveda, Andrés, additional, Raspagliesi, Francesco, additional, Rhodes, Kirsty, additional, Rubio Pérez, María J., additional, Shapira-Frommer, Ronnie, additional, Shikama, Ayumi, additional, Sikorska, Magdalena, additional, Moore, Kathleen, additional, and DiSilvestro, Paul, additional

Published
2021
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367. 739P Efficacy and safety of maintenance olaparib and bevacizumab (bev) in ovarian cancer (OC) patients (pts) aged ≥65 years (y) from the PAOLA-1/ENGOT-ov25 first-line trial

Author

Sabatier, Renaud, Vicier, Cécile, Garnier, Séverine, Guille, Arnaud, Carbuccia, Nadine, Isambert, Nicolas, Dalenc, Florence, Robert, Marie, Levy, Christelle, Pakradouni, Jihane, Adelaïde, José, Chaffanet, Max, Sfumato, Patrick, Mamessier, Emilie, Bertucci, François, Goncalves, Anthony, Mezni, Essia, Evans, Catherine Karine, Chinot, Olivier, Loschi, Alain, Arnaud, Sylvie, Mellinas, Marie, Bay, Jacques-Olivier, Bouleuc, Carole, Firmin, Nelly, Gandemer, Virginie, Magne, Nicolas, Orbach, Daniel, Penel, Nicolas, Rodrigues, Manuel, Thiery-Vuillemin, Antoine, Wislez, Marie, L’allemain, Gilles, Robert, Jacques, Colombo, Nicoletta, Dubot, Coraline, Lorusso, Domenica, Caceres, M. Valeria, Hasegawa, Kosei, Shapira-Frommer, Ronnie, Tewari, Krishnansu, Salman, Pamela, Hoyos Usta, Edwin, Yañez, Eduardo, Gümüş, Mahmut, Olivera Hurtado de Mendoza, Mivael, Samouëlian, Vanessa, Castonguay, Vincent, Arkhipov, Alexander, Toker, Sarper, Li, Kan, Keefe, Stephen, Monk, Bradley, Oaknin, Ana, Tinker, Anna, Gilbert, Lucy, Mathews, Cara, Brown, Jubilee, Barretina-Ginesta, Maria-Pilar, Moreno, Victor, Gravina, Adriano, Abdeddaim, Cyril, Banerjee, Susana, Guo, Wei, Danaee, Hadi, Im, Ellie, de Nonneville, Alexandre, Zemmour, Christophe, Frank, Sophie, Joly, Florence, Ray-Coquard, Isabelle, Costaz, Hèlène, Classe, Jean-Marc, Floquet, Anne, de La Motte Rouge, Thibault, Colombo, Pierre-Emmanuel, Sauterey, Baptiste, Leblanc, Eric, Pomel, Christophe, Marchal, Frédéric, Barranger, Emmanuel, Savoye, Aude-Marie, Guillemet, Cécile, Petit, Thierry, Pautier, Patricia, Rouzier, Roman, Gladieff, Laurence, Simon, Gaëtane, Courtinard, Coralie, Rousset-Rouviere, Sandrine, Rochigneux, Philippe, Chrétien, Anne-Sophie, Fattori, Stéphane, Gorvel, Laurent, Provansal, Magali, Lambaudie, Eric, Olive, Daniel, Martin, Johan, Guérin, Mathilde, Monneur, Audrey, Tassy, Louis, Tarpin, Carole, Extra, Jean-Marc, Viret, Frédéric, Pierga, Jean-Yves, Curé, Hervé, Abulnaja, Rakan, Bidard, François-Clément, Mari, Roxane, Narducci, Fabrice, Cappiello, Maria-Antonietta, Rousseau, Fréderique, Blache, Guillaume, Birnbaum, Daniel, Cropet, C., Montegut, C., Frindte, J., Cinieri, S., Guerra-Alia, E.M., Bogner, G., Yoshida, H., Vergote, I., Hietanen, S., Largillier, R., Canzler, U., Gratet, A., Marmé, F., Pujade-Lauraine, E., Favier, L., Ray-Coquard, I.L., Department of Medical Oncology, Institut Paoli-Calmettes, 232 Boulevard Sainte Marguerite, 13009 Marseille, France., Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, and Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Oncology, medicine.medical_specialty, Bevacizumab, business.industry, First line, [SDV.CAN]Life Sciences [q-bio]/Cancer, Hematology, medicine.disease, Olaparib, chemistry.chemical_compound, chemistry, Internal medicine, Medicine, business, Ovarian cancer, medicine.drug
Abstract

International audience; 5548 Background: Ovarian cancer is the leading cause of death by gynecological cancer. Complete surgery remains one of the main prognostic factors. Laparoscopic exploration is mandatory to assess surgical resectability at diagnosis or after neoadjuvant chemotherapy. However, there is no clinical or biological marker that can correctly predict resectability and may be able to avoid a second laparoscopic exploration for initially unresectable diseases. Our aim was to assess circulating tumor DNA (ctDNA) value as a predictive non-invasive marker of evolution towards resectability for patients with epithelial ovarian cancer receiving first-line chemotherapy. Methods: We explored in this work one of the secondary objectives of the CIDOC study (NCT03302884). CIDOC is a multicenter prospective study aiming to explore ctDNA value as early marker of disease relapse after first-line treatment for epithelial ovarian cancer. Patients with mucinous histology or early stages not requiring chemotherapy are excluded. Plasma samples are collected at diagnosis, during neoadjuvant chemotherapy, and during follow-up. After DNA extraction, panel-based next generation sequencing is performed on both tumor samples and germline DNA, and somatic mutations of interest are selected for ctDNA monitoring. ctDNA analyses are conducted using droplet digital PCR (BioRad QX200) by measuring the variant allele fraction (VAF) of previously identified mutations. Results: This intermediary analysis has included 47 patients diagnosed between March 2017 and December 2019. Median age was 69 years old (48 – 84). Most of the patients had advanced disease (89.4% stage FIGO III or IV), serous histology (94.8%), and high grade tumor (92.3%). Most of the patients underwent complete interval cytoreductive surgery (76.3% vs 17.4% complete upfront surgery). Most of the tumors had TP53 mutations (85.1%), following by alterations involving DNA repair genes (38.3%). Median cell-free DNA concentration at baseline was 0.38 ng/µL (0 – 12.8). ctDNA was identified in 92.1% of patients at baseline with a median VAF of 1.84% (0 – 42.52%). ctDNA VAF was correlated to the peritoneal dissemination ( p= 0.039) assessed with the peritoneal cancer index. ctDNA clearance after preoperative chemotherapy tended to be correlated to achievement of complete interval surgery for patients receiving neoadjuvant chemotherapy ( p= 0.108). Conclusions: ctDNA may be a promising non-invasive marker to assess peritoneal cancer spreading and to predict surgical resectability after neoadjuvant chemotherapy. If confirmed in larger populations, this may enable to avoid additional surgical explorations for patients who remain ctDNA positive after chemotherapy. Clinical trial information: NCT03302884.

Published
2021

369. Homologous Recombination Repair Gene Mutations to Predict Olaparib Plus Bevacizumab Efficacy in the First-Line Ovarian Cancer PAOLA-1/ENGOT-ov25 Trial.

Author

Pujade-Lauraine, Eric, Brown, Jessica, Barnicle, Alan, Wessen, Jonathan, Lao-Sirieix, Pierre, Criscione, Steven W., du Bois, Andreas, Lorusso, Domenica, Romero, Ignacio, Petru, Edgar, Yoshida, Hiroyuki, Vergote, Ignace, Colombo, Nicoletta, Hietanen, Sakari, Provansal, Magali, Schmalfeldt, Barbara, Pignata, Sandro, Martín Lorente, Cristina, Berton, Dominique, and Runnebaum, Ingo B.

Subjects
BEVACIZUMAB, GENETIC mutation, OLAPARIB, OVARIAN cancer, PROGRESSION-free survival, BRCA genes
Abstract

PURPOSE: The PAOLA-1/ENGOT-ov25 trial of maintenance olaparib plus bevacizumab for newly diagnosed advanced high-grade ovarian cancer demonstrated a significant progression-free survival (PFS) benefit over placebo plus bevacizumab, particularly in patients with homologous recombination deficiency (HRD)–positive tumors. We explored whether mutations in non- BRCA1 or BRCA2 homologous recombination repair (non–BRCA HRRm) genes predicted benefit from olaparib plus bevacizumab in PAOLA-1. METHODS: Eight hundred and six patients were randomly assigned (2:1). Tumors were analyzed using the Myriad MyChoice HRD Plus assay to assess non–BRCA HRRm and HRD status; HRD was based on a genomic instability score (GIS) of ≥ 42. In this exploratory analysis, PFS was assessed in patients harboring deleterious mutations using six non–BRCA HRR gene panels, three devised for this analysis and three previously published. RESULTS: The non–BRCA HRRm prevalence ranged from 30 of 806 (3.7%) to 79 of 806 (9.8%) depending on the gene panel used, whereas 152 of 806 (18.9%) had non‐ BRCA1 or BRCA2 mutation HRD-positive tumors. The majority of tumors harboring non–BRCA HRRm had a low median GIS; however, a GIS of > 42 was observed for tumors with mutations in five HRR genes (BLM , BRIP1 , RAD51C , PALB2 , and RAD51D). Rates of gene-specific biallelic loss were variable (0% to 100%) in non–BRCA HRRm tumors relative to BRCA1 -mutated (99%) or BRCA2 -mutated (86%) tumors. Across all gene panels tested, hazard ratios for PFS (95% CI) ranged from 0.92 (0.51 to 1.73) to 1.83 (0.76 to 5.43). CONCLUSION: Acknowledging limitations of small subgroup sizes, non–BRCA HRRm gene panels were not predictive of PFS benefit with maintenance olaparib plus bevacizumab versus placebo plus bevacizumab in PAOLA-1, irrespective of the gene panel tested. Current gene panels exploring HRRm should not be considered a substitute for HRD determined by BRCA mutation status and genomic instability testing in first-line high-grade ovarian cancer. PAOLA1: nonBRCA HRRm tests not interchangeable with HRD genomic instability to predict olaparib plus bev benefit in 1L OC. [ABSTRACT FROM AUTHOR]

Published
2023
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370. Interviews conducted at the European Society of Gynaecological Oncology 2022 Congress: a ENYGO- IJGC Fellows initiative.

Author

Angeles, Martina Aida, Boria, Felix, Shushkevich, Alexander B., Bizzarri, Nicolò, Theofanakis, Charalampos, Schivardi, Gabriella, Bartnik, Joanna Kacperczyk, Strojna, Aleksandra Natalia, Bilir, Esra, Mahner, Sven, Gultekin, Murat, Cibula, David, Rodolakis, Alexandros, Lorusso, Domenica, Mirza, Mansoor Raza, Fagotti, Anna, Ledermann, Jonathan, Fotopoulou, Christina, and Ramirez, Pedro T.

Published
2023
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371. Indirect Comparison of the Efficacy and Safety of Dostarlimab and Doxorubicin for the Treatment of Advanced and Recurrent Endometrial Cancer.

Author

Mathews, Cara, Lorusso, Domenica, Coleman, Robert L, Boklage, Susan, and Garside, Jamie

Subjects
THERAPEUTIC use of monoclonal antibodies, DRUG efficacy, CONFIDENCE intervals, DOXORUBICIN, CANCER relapse, MONOCLONAL antibodies, COMPARATIVE studies, ENDOMETRIAL tumors, SURVIVAL analysis (Biometry), KAPLAN-Meier estimator, QUALITY of life, DESCRIPTIVE statistics, RESEARCH funding, PROGRESSION-free survival, PROPORTIONAL hazards models, SECONDARY analysis, EVALUATION
Abstract

Background There is no clear standard of care for advanced/recurrent endometrial cancer (EC) following platinum-based therapy. Dostarlimab is approved for patients with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) advanced/recurrent EC. This indirect treatment comparison (ITC) assessed dostarlimab efficacy and safety from the single-arm GARNET (NCT02715284) trial compared with doxorubicin from ZoptEC (NCT01767155). Patients and Methods Patient-level data and study variables from GARNET Cohort A1 (dMMR/MSI-H EC) and the ZoptEC doxorubicin control arm were merged. Patients were matched based on eligibility criteria (main analysis population). Safety population included all patients who received treatment. The primary efficacy comparison outcome, overall survival (OS), was calculated using a Cox proportional hazards model, with adjusted stabilized inverse probability of treatment weighting. Modified assessment-scheduled matching Kaplan--Meier analysis was used for progression-free survival (PFS) and time to deterioration (TTD) in quality of life (QoL). Results In the main analysis population, median (95% CI) OS was not reached (NR; 18.0 months--NR) for dostarlimab (n = 92) and was 11.2 (10.0-13.1) months for doxorubicin (n = 233; HR: 0.41 [95% CI: 0.28-0.61]); median PFS was 12.2 (3.3-NR) and 4.9 (4.1-6.6) months, respectively. Median TTD in QoL was NR (2.5-NR; n = 61) and 4.5 (4.1-5.4; n = 188) months, respectively. Similar rates of adverse events (AEs, 11.6% vs 15.3%) and serious AEs (34.1% vs 30.1%) were observed with dostarlimab (n = 129) and doxorubicin (n = 249). Grade ≥3 AEs occurred in 48.1% vs 78.3%, respectively. Conclusion This ITC suggests a favorable benefit:risk profile for dostarlimab in patients with dMMR/MSI-H advanced/recurrent EC. [ABSTRACT FROM AUTHOR]

Published
2022
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374. Efficacy and Safety of First-line Single-Agent Carboplatin vs Carboplatin Plus Paclitaxel for Vulnerable Older Adult Women With Ovarian Cancer

Author

Falandry, Claire, Rousseau, Frédérique, Mouret-Reynier, Marie-Ange, TINQUAUT, Fabien, Lorusso, Domenica, Herrstedt, Jørn, Savoye, Aude-Marie, Stefani, Laetitia, Bourbouloux, Emmanuelle, Sverdlin, Robert, D’Hondt, Veronique, Lortholary, Alain, Brachet, Pierre-Emmanuel, Zannetti, Alain, Malaurie, Emmanuelle, Venat-Bouvet, Laurence, Trédan, Olivier, Mourey, Loïc, Pujade-Lauraine, Eric, Freyer, Gilles, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), and UNICANCER

Subjects
[SDV]Life Sciences [q-bio], ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2021

376. Randomized phase III trial on niraparib-TSR-042 (dostarlimab) versus physician’s choice chemotherapy in recurrent ovarian, fallopian tube, or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33)

Author

Musacchio, Lucia, primary, Salutari, Vanda, additional, Pignata, Sandro, additional, Braicu, Elena, additional, Cibula, David, additional, Colombo, Nicoletta, additional, Frenel, Jean Sebastien, additional, Zagouri, Flora, additional, Carbone, Vittoria, additional, Ghizzoni, Viola, additional, Giolitto, Serena, additional, Giudice, Elena, additional, Perri, Maria Teresa, additional, Ricci, Caterina, additional, Scambia, Giovanni, additional, and Lorusso, Domenica, additional

Published
2021
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377. ATHENA (GOG-3020/ENGOT-ov45): a randomized, phase III trial to evaluate rucaparib as monotherapy (ATHENA–MONO) and rucaparib in combination with nivolumab (ATHENA–COMBO) as maintenance treatment following frontline platinum-based chemotherapy in ovarian cancer

Author

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

Published
2021
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378. Maintenance treatment with rucaparib for recurrent ovarian carcinoma in ARIEL3, a randomized phase 3 trial: The effects of best response to last platinum‐based regimen and disease at baseline on efficacy and safety

Author

Oaknin, Ana, primary, Oza, Amit M., additional, Lorusso, Domenica, additional, Aghajanian, Carol, 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, Amenedo Gancedo, Margarita, 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, Ledermann, Jonathan A., additional, and Coleman, Robert L., additional

Published
2021
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382. Thromboembolic events and antithrombotic prophylaxis in advanced ovarian cancer patients treated with bevacizumab: secondary analysis of the phase IV MITO-16A/MaNGO-OV2A trial

Author

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

Published
2021
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384. Homologous recombination repair mutation gene panels (excluding BRCA) are not predictive of maintenance olaparib plus bevacizumab efficacy in the first-line PAOLA-1/ENGOT-ov25 trial

Author

Pujade-Lauraine, Eric, primary, Brown, Jessica, additional, Barnicle, Alan, additional, Rowe, Phil, additional, Lao-Sirieix, Pierre, additional, Criscione, Steven, additional, du Bois, Andreas, additional, Lorusso, Domenica, additional, Romero, Ignacio, additional, Petru, Edgar, additional, Yoshida, Hiroyuki, additional, Vergote, Ignace, additional, Colombo, Nicoletta, additional, Hietanen, Sakari, additional, Provansal, Magali, additional, Schmalfeldt, Barbara, additional, Pignata, Sandro, additional, Martin-Lorente, Cristina, additional, Berton, Dominique, additional, Runnebaum, Ingo, additional, and Ray-Coquard, Isabelle, additional

Published
2021
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385. A multicenter, open-label, randomized, phase III study to compare the efficacy and safety of lenvatinib in combination with pembrolizumab versus treatment of physician's choice in patients with advanced endometrial cancer

Author

Makker, Vicky, primary, Colombo, Nicoletta, additional, Herráez, Antonio Casado, additional, Santin, Alessandro, additional, Colomba, Emeline, additional, Miller, David, additional, Fujiwara, Keiichi, additional, Pignata, Sandro, additional, Baron-Hay, Sally, additional, Ray-Coquard, Isabelle, additional, Shapira-Frommer, Ronnie, additional, Ushijima, Kimio, additional, Sakata, Jun, additional, Yonemori, Kan, additional, Kim, Yong Man, additional, Guerra, Eva, additional, Sanli, Ulus, additional, McCormack, Mary, additional, Huang, Jie, additional, Smith, Alan, additional, Keefe, Stephen, additional, Dutta, Lea, additional, Orlowski, Robert, additional, and Lorusso, Domenica, additional

Published
2021
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386. Investigational drugs for recurrent or primary advanced metastatic cervical cancer: what is in the clinical development pipeline?

Author

Vergote, Ignace, Ray-Coquard, Isabelle, Lorusso, Domenica, Oaknin, Ana, Cibula, David, and Van Gorp, Toon

Abstract

ABSTRACTIntroductionRecurrent or primary advanced metastatic cervical cancer (R/M CC) has a poor prognosis with a 5-year-survival rate of 16.5%, demanding novel and improved therapies for the treatment of these patients. The first-line standard of care for R/M CC now benefits from the addition of the immune checkpoint inhibitor, pembrolizumab, to platinum-based chemotherapy with paclitaxel and bevacizumab. Additionally, new options for second-line treatment have become available in recent years.Areas coveredHere, we review current investigational drugs and discuss their relative targets, efficacies, and potential within the R/M CC treatment landscape. This review will focus on recently published data and key ongoing clinical trials in patients with R/M CC, covering multiple modes of action, including immunotherapies, antibody–drug conjugates, and tyrosine kinase inhibitors. We searched clinicaltrials.gov for ongoing trials and pubmed.ncbi.nih.gov for recently published trial data, as well as recent years’ proceedings from the annual conferences of the American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO), European Society of Gynaecological Oncology (ESGO), and the International Gynecologic Cancer Society (IGCS).Expert opinionTherapeutics currently attracting attention include novel immune checkpoint inhibitors, therapeutic vaccinations, antibody–drug conjugates, such as tisotumab vedotin, tyrosine kinase inhibitors targeting HER2, and multitarget synergistic combinations.

Published
2023
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388. Uterine serous carcinoma

Author

Bogani, Giorgio, primary, Ray-Coquard, Isabelle, additional, Concin, Nicole, additional, Ngoi, Natalie Y.L., additional, Morice, Philippe, additional, Enomoto, Takayuki, additional, Takehara, Kazuhiro, additional, Denys, Hannelore, additional, Nout, Remi A., additional, Lorusso, Domenica, additional, Vaughan, Michelle M., additional, Bini, Marta, additional, Takano, Masashi, additional, Provencher, Diane, additional, Indini, Alice, additional, Sagae, Satoru, additional, Wimberger, Pauline, additional, Póka, Robert, additional, Segev, Yakir, additional, Kim, Se Ik, additional, Candido dos Reis, Francisco J., additional, Lopez, Salvatore, additional, Mariani, Andrea, additional, Leitao, Mario M., additional, Raspagliesi, Francesco, additional, Panici, Pieluigi Benedetti, additional, Di Donato, Violante, additional, Muzii, Ludovico, additional, Colombo, Nicoletta, additional, Scambia, Giovanni, additional, Pignata, Sandro, additional, and Monk, Bradley J., additional

Published
2021
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389. Rucaparib maintenance treatment for recurrent ovarian carcinoma: the effects of progression-free interval and prior therapies on efficacy and safety in the randomized phase III trial ARIEL3

Author

Clamp, Andrew R, primary, Lorusso, Domenica, additional, Oza, Amit M, additional, Aghajanian, Carol, additional, Oaknin, Ana, additional, Dean, Andrew, additional, Colombo, Nicoletta, additional, Weberpals, Johanne I, additional, Scambia, Giovanni, additional, Leary, Alexandra, additional, Holloway, Robert W, additional, Amenedo Gancedo, Margarita, 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, Goble, Sandra, additional, Coleman, Robert L, additional, and Ledermann, Jonathan A, additional

Published
2021
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390. Characteristics and outcome of BRCA mutated epithelial ovarian cancer patients in Italy: A retrospective multicenter study (MITO 21)

Author

Artioli, Grazia, primary, Giannone, Gaia, additional, Valabrega, Giorgio, additional, Maggiorotto, Furio, additional, Genta, Sofia, additional, Pignata, Sandro, additional, Lorusso, Domenica, additional, Cormio, Gennaro, additional, Scalone, Simona, additional, Nicoletto, Maria Ornella, additional, Greco, Filippo, additional, Rossi, Emanuela, additional, Spagnoletti, Ilaria, additional, De Giorgi, Ugo, additional, Orditura, Michele, additional, Mosconi, Anna Maria, additional, Kardhashi, Anila, additional, Bogliolo, Stefano, additional, and Borgato, Lucia, additional

Published
2021
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391. Clinical and molecular characteristics of ARIEL3 patients who derived exceptional benefit from rucaparib maintenance treatment for high-grade ovarian cancer (HGOC).

Author

Kwan, Tanya, 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, Maloney, Lara, additional, Goble, Sandra, additional, Ledermann, Jonathan A., additional, and Coleman, Robert L., additional

Published
2021
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392. Tisotumab vedotin versus investigator’s choice chemotherapy in second- or third-line recurrent or metastatic cervical cancer (innovaTV 301/ENGOT-cx12/GOG 3057, trial in progress).

Author

Vergote, Ignace, primary, Monk, Bradley J., additional, Coleman, Robert L., additional, Randall, Leslie M., additional, Fujiwara, Keiichi, additional, Marth, Christian, additional, Woelber, Linn Lena, additional, Van Nieuwenhuysen, Els, additional, Cibula, David, additional, Calvert, Paula, additional, Boere, Ingrid, additional, González-Martín, Antonio, additional, Kalbacher, Elsa, additional, Colombo, Nicoletta, additional, Lorusso, Domenica, additional, Banerjee, Susana N., additional, Maluf, Fernando C., additional, Soumaoro, Ibrahima, additional, and Slomovitz, Brian M., additional

Published
2021
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393. Health-related quality of life (HRQoL) in advanced endometrial cancer (aEC) patients (pts) treated with lenvatinib plus pembrolizumab or treatment of physician’s choice (TPC).

Author

Lorusso, Domenica, primary, Colombo, Nicoletta, additional, Casado Herraez, Antonio, additional, Santin, Alessandro, additional, Colomba, Emeline, additional, Miller, David Scott, additional, Fujiwara, Keiichi, additional, Pignata, Sandro, additional, Baron-Hay, Sally E., additional, Ray-Coquard, Isabelle Laure, additional, Shapira-Frommer, Ronnie, additional, Kim, Yong Man, additional, McCormack, Mary, additional, Bird, Steven, additional, Prabhu, Vimalanand S., additional, Martin Nguyen, Allison, additional, Zhao, Qi, additional, Dutta, Lea, additional, and Makker, Vicky, additional

Published
2021
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394. 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, primary, Musacchio, Lucia, additional, Bartoletti, Michele, additional, Salutari, Vanda, additional, Arenare, Laura, additional, Lorusso, Domenica, additional, Ronzino, Graziana, additional, Lauria, Rossella, additional, Cormio, Gennaro, additional, Naglieri, Emanuele, additional, Scollo, Paolo, additional, Marchetti, Claudia, additional, Raspagliesi, Francesco, additional, Greggi, Stefano, additional, Cinieri, Saverio, additional, Bergamini, Alice, additional, Orditura, Michele, additional, Valabrega, Giorgio, additional, Scambia, Giovanni, additional, Martinelli, Fabio, additional, De Matteis, Elisabetta, additional, Cardalesi, Cinzia, additional, Loizzi, Vera, additional, Perniola, Giorgia, additional, Carella, Claudia, additional, Scandurra, Giuseppa, additional, Giannone, Gaia, additional, and Pignata, Sandro, additional

Published
2021
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395. Efficacy and safety of tisotumab vedotin in previously treated recurrent or metastatic cervical cancer (innovaTV 204/GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study

Author

Coleman, Robert L, primary, Lorusso, Domenica, additional, Gennigens, Christine, additional, González-Martín, Antonio, additional, Randall, Leslie, additional, Cibula, David, additional, Lund, Bente, additional, Woelber, Linn, additional, Pignata, Sandro, additional, Forget, Frederic, additional, Redondo, Andrés, additional, Vindeløv, Signe Diness, additional, Chen, Menghui, additional, Harris, Jeffrey R, additional, Smith, Margaret, additional, Nicacio, Leonardo Viana, additional, Teng, Melinda S L, additional, Laenen, Annouschka, additional, Rangwala, Reshma, additional, Manso, Luis, additional, Mirza, Mansoor, additional, Monk, Bradley J, additional, Vergote, Ignace, additional, Raspagliesi, Francesco, additional, Melichar, Bohuslav, additional, Gaba Garcia, Lydia, additional, Jackson, Amanda, additional, Henry, Stephanie, additional, Kral, Zdenek, additional, Harter, Philipp, additional, De Giorgi, Ugo, additional, Bjurberg, Maria, additional, Gold, Michael, additional, O'Malley, David, additional, Honhon, Brigitte, additional, Vulsteke, Christof, additional, De Cuypere, Eveline, additional, Denys, Hannelore, additional, Baurain, Jean-Francois, additional, Zamagni, Claudio, additional, Tenney, Meaghan, additional, Gordinier, Mary, additional, Bradley, William, additional, Schlumbrecht, Matthew, additional, Spirtos, Nicola, additional, Concin, Nicole, additional, Mahner, Sven, additional, Scambia, Giovanni, additional, Leath, Charles, additional, Farias-Eisner, Robin, additional, Cohen, Joshua, additional, Muller, Carolyn, additional, and Bhatia, Sumeet, additional

Published
2021
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396. Randomized phase III trial on niraparib-TSR-042 (dostarlimab) versus physician's choice chemotherapy in recurrent ovarian, fallopian tube, or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33)

Author

Musacchio, Lucia Salutari, Vanda Pignata, Sandro Braicu, Elena Cibula, David Colombo, Nicoletta Frenel, Jean Sebastien Zagouri, Flora Carbone, Vittoria Ghizzoni, Viola and Giolitto, Serena Giudice, Elena Perri, Maria Teresa and Ricci, Caterina Scambia, Giovanni Lorusso, Domenica

Abstract

Background Platinum-resistant ovarian cancer patients have a poor prognosis and few treatment options are available. Preclinical and clinical data demonstrated that the combination of poly-ADP ribose polymerase inhibitors with immune checkpoint inhibitors could have a synergistic antitumor activity in this setting of patients. Primary Objective The primary objective is to assess the efficacy of niraparib plus dostarlimab compared with chemotherapy in recurrent ovarian cancer patients not suitable for platinum treatment. Study Hypothesis This trial will assess the hypothesis that niraparib plus dostarlimab therapy is effective to increase overall survival, progression--free survival, and time to first subsequent therapy respect to chemotherapy alone, with an acceptable toxicity profile. Trial Design This is a phase III, multicenter trial, where recurrent ovarian cancer patients not eligible for platinum re-treatment will be randomized 1:1 to receive niraparib plus dostarlimab vs physician's choice chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent. The study will be performed according to European Network for Gynaecological Oncological Trial groups (ENGOT) model B and patients will be recruited from 40 sites across MITO, CEEGOG, GINECO, HeCOG, MANGO, and NOGGO groups. Major Inclusion/Exclusion criteria Eligible patients must have recurrent epithelial ovarian cancer not eligible for platinum retreatment. Patients who received previous treatment with poly--ADP ribose polymerase inhibitors and/ or immune checkpoint inhibitors will be eligible. No more than two prior lines of treatment are allowed. Primary Endpoint The primary endpoint is overall survival defined as the time from the randomization to the date of death by any cause. Sample Size 427 patients will be randomized. Estimated Dates for Completing Accrual and Presenting Results June 2024

Published
2021

397. ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma

Author

Concin, Nicole, Matias-Guiu, Xavier, Vergote, Ignace, Cibula, David, Mirza, Mansoor Raza, Marnitz, Simone, Ledermann, Jonathan, Bosse, Tjalling, Chargari, Cyrus, Fagotti, Anna, Fotopoulou, Christina, Gonzalez Martin, Antonio, Lax, Sigurd, Lorusso, Domenica, Marth, Christian, Morice, Philippe, Nout, Remi A., O'Donnell, Dearbhaile, Querleu, Denis, Raspollini, Maria Rosaria, Sehouli, Jalid, Sturdza, Alina, Taylor, Alexandra, Westermann, Anneke, Wimberger, Pauline, Colombo, Nicoletta, Planchamp, Francois, Creutzberg, Carien L., Concin, Nicole, Matias-Guiu, Xavier, Vergote, Ignace, Cibula, David, Mirza, Mansoor Raza, Marnitz, Simone, Ledermann, Jonathan, Bosse, Tjalling, Chargari, Cyrus, Fagotti, Anna, Fotopoulou, Christina, Gonzalez Martin, Antonio, Lax, Sigurd, Lorusso, Domenica, Marth, Christian, Morice, Philippe, Nout, Remi A., O'Donnell, Dearbhaile, Querleu, Denis, Raspollini, Maria Rosaria, Sehouli, Jalid, Sturdza, Alina, Taylor, Alexandra, Westermann, Anneke, Wimberger, Pauline, Colombo, Nicoletta, Planchamp, Francois, and Creutzberg, Carien L.

Abstract

A European consensus conference on endometrial carcinoma was held in 2014 to produce multi-disciplinary evidence-based guidelines on selected questions. Given the large body of literature on the management of endometrial carcinoma published since 2014, the European Society of Gynaecological Oncology (ESGO), the European SocieTy for Radiotherapy and Oncology (ESTRO), and the European Society of Pathology (ESP) jointly decided to update these evidence-based guidelines and to cover new topics in order to improve the quality of care for women with endometrial carcinoma across Europe and worldwide.

Published
2021

398. The role of artificial intelligence in managing multimorbidity and cancer

Author

Cesario, Alfredo, D'Oria, Marika, Calvani, Riccardo, Picca, A., Pietragalla, A., Lorusso, Domenica, Daniele, Gennaro, Lohmeyer, F. M., Boldrini, Luca, Valentini, Vincenzo, Bernabei, Roberto, Auffray, C., Scambia, Giovanni, Cesario A. (ORCID:0000-0003-4687-0709), D'oria M., Calvani R. (ORCID:0000-0001-5472-2365), Lorusso D., Daniele G. (ORCID:0000-0001-5360-1895), Boldrini L., Valentini V. (ORCID:0000-0003-4637-6487), Bernabei R. (ORCID:0000-0002-9197-004X), Scambia G. (ORCID:0000-0003-2758-1063), Cesario, Alfredo, D'Oria, Marika, Calvani, Riccardo, Picca, A., Pietragalla, A., Lorusso, Domenica, Daniele, Gennaro, Lohmeyer, F. M., Boldrini, Luca, Valentini, Vincenzo, Bernabei, Roberto, Auffray, C., Scambia, Giovanni, Cesario A. (ORCID:0000-0003-4687-0709), D'oria M., Calvani R. (ORCID:0000-0001-5472-2365), Lorusso D., Daniele G. (ORCID:0000-0001-5360-1895), Boldrini L., Valentini V. (ORCID:0000-0003-4637-6487), Bernabei R. (ORCID:0000-0002-9197-004X), and Scambia G. (ORCID:0000-0003-2758-1063)

Abstract

Traditional healthcare paradigms rely on the disease-centered approach aiming at reducing human nature by discovering specific drivers and biomarkers that cause the advent and progression of diseases. This reductive approach is not always suitable to understand and manage complex conditions, such as multimorbidity and cancer. Multimorbidity requires considering heterogeneous data to tailor preventing and targeting interventions. Personalized Medicine represents an innovative approach to address the care needs of multimorbid patients considering relevant patient characteristics, such as lifestyle and individual preferences, in opposition to the more traditional “one-size-fits-all” strategy focused on interventions designed at the population level. Integration of omic (e.g., genomics) and non-strictly medical (e.g., lifestyle, the exposome) data is necessary to understand patients’ complexity. Artificial Intelligence can help integrate and manage heterogeneous data through advanced machine learning and bioinformatics algorithms to define the best treatment for each patient with multimorbidity and cancer. The experience of an Italian research hospital, leader in the field of oncology, may help to understand the multifaceted issue of managing multimorbidity and cancer in the framework of Personalized Medicine.

Published
2021

399. Cytoreductive surgery followed by chemotherapy and olaparib maintenance in BRCA 1/2 mutated recurrent ovarian cancer: A retrospective MITO group study

Author

Cecere, S. C., Musacchio, L., Bartoletti, M., Salutari, Vanda, Arenare, L., Lorusso, Domenica, Ronzino, G., Lauria, R., Cormio, G., Naglieri, E., Scollo, P., Marchetti, Claudia, Raspagliesi, F., Greggi, S., Cinieri, S., Bergamini, A., Orditura, M., Valabrega, G., Scambia, Giovanni, Martinelli, F., De Matteis, E., Cardalesi, C., Loizzi, V., Perniola, G., Carella, C., Scandurra, G., Giannone, G., Pignata, S., Salutari V., Lorusso D., Marchetti C. (ORCID:0000-0001-7098-8956), Scambia G. (ORCID:0000-0003-2758-1063), Cecere, S. C., Musacchio, L., Bartoletti, M., Salutari, Vanda, Arenare, L., Lorusso, Domenica, Ronzino, G., Lauria, R., Cormio, G., Naglieri, E., Scollo, P., Marchetti, Claudia, Raspagliesi, F., Greggi, S., Cinieri, S., Bergamini, A., Orditura, M., Valabrega, G., Scambia, Giovanni, Martinelli, F., De Matteis, E., Cardalesi, C., Loizzi, V., Perniola, G., Carella, C., Scandurra, G., Giannone, G., Pignata, S., Salutari V., Lorusso D., Marchetti C. (ORCID:0000-0001-7098-8956), and Scambia G. (ORCID:0000-0003-2758-1063)

Abstract

Introduction The role of cytoreductive surgery in the poly-ADP ribose polymerase inhibitors era is not fully investigated. We evaluated the impact of surgery performed prior to platinum-based chemotherapy followed by olaparib maintenance in platinum-sensitive BRCA-mutated recurrent ovarian cancer. Methods This retrospective study included platinum-sensitive recurrent ovarian cancer BRCA-mutated patients from 13 Multicenter Italian Trials in Ovarian cancer and gynecological malignancies centers treated between September 2015 and May 2019. The primary outcomes were progression-free survival and overall survival. Data on post-progression treatment was also assessed. Results Among 209 patients, 72 patients (34.5%) underwent cytoreductive surgery followed by platinum-based chemotherapy and olaparib maintenance, while 137 patients (65.5%) underwent chemotherapy treatment alone. After a median follow-up of 37.3 months (95% CI: 33.4 to 40.8), median progression-free survival in the surgery group was not reached, compared with 11 months in patients receiving chemotherapy alone (P<0.001). Median overall survival was nearly double in patients undergoing surgery before chemotherapy (55 vs 28 months, P<0.001). Post-progression therapy was assessed in 127 patients: response rate to chemotherapy was 29.2%, 8.8%, and 9.0% in patients with platinum-free interval >12 months, between 6 and 12 months, and <6 months, respectively. Conclusion Cytoreductive surgery performed before platinum therapy and olaparib maintenance was associated with longer progression-free survival and overall survival in BRCA-mutated platinum-sensitive relapsed ovarian cancer patients. In accordance with our preliminary results, the response rate to chemotherapy given after progression during olaparib was associated with platinum-free interval.

Published
2021

400. Efficacy and Safety of First-line Single-Agent Carboplatin vs Carboplatin plus Paclitaxel for Vulnerable Older Adult Women with Ovarian Cancer:A GINECO/GCIG Randomized Clinical Trial

Author

Falandry, Claire, Rousseau, Frédérique, Mouret-Reynier, Marie Ange, Tinquaut, Fabien, Lorusso, Domenica, Herrstedt, Jørn, Savoye, Aude Marie, Stefani, Laetitia, Bourbouloux, Emmanuelle, Sverdlin, Robert, D'Hondt, Veronique, Lortholary, Alain, Brachet, Pierre Emmanuel, Zannetti, Alain, Malaurie, Emmanuelle, Venat-Bouvet, Laurence, Trédan, Olivier, Mourey, Loïc, Pujade-Lauraine, Eric, Freyer, Gilles, Falandry, Claire, Rousseau, Frédérique, Mouret-Reynier, Marie Ange, Tinquaut, Fabien, Lorusso, Domenica, Herrstedt, Jørn, Savoye, Aude Marie, Stefani, Laetitia, Bourbouloux, Emmanuelle, Sverdlin, Robert, D'Hondt, Veronique, Lortholary, Alain, Brachet, Pierre Emmanuel, Zannetti, Alain, Malaurie, Emmanuelle, Venat-Bouvet, Laurence, Trédan, Olivier, Mourey, Loïc, Pujade-Lauraine, Eric, and Freyer, Gilles

Abstract

Importance: Single-agent carboplatin is often proposed instead of a conventional carboplatin-paclitaxel doublet in vulnerable older patients with ovarian cancer. Such an approach could have a detrimental effect on outcomes for these patients. Objective: To compare the feasibility, efficacy, and safety of single-agent carboplatin every 3 weeks, weekly carboplatin-paclitaxel, or conventional every-3-weeks carboplatin-paclitaxel in vulnerable older patients with ovarian cancer. Design, Setting, and Participants: This international, open-label, 3-arm randomized clinical trial screened 447 women 70 years and older with newly diagnosed stage III/IV ovarian cancer by determining their Geriatric Vulnerability Score; 120 patients with a Geriatric Vulnerability Score of 3 or higher were stratified by country and surgical outcome. Enrollment took place at 48 academic centers in France, Italy, Finland, Denmark, Sweden, and Canada from December 11, 2013, to April 26, 2017. Final analysis database lock April 2019. Data analysis was performed from February 1 to December 31, 2019. Interventions: Patients were randomized to receive 6 cycles of (1) carboplatin, area under the curve (AUC) 5 mg/mL·min, plus paclitaxel, 175 mg/m2, every 3 weeks; (2) single-agent carboplatin, AUC 5 mg/mL·min or AUC 6 mg/mL·min, every 3 weeks; or (3) weekly carboplatin, AUC 2 mg/mL·min, plus paclitaxel, 60 mg/m2, on days 1, 8, and 15 every 4 weeks. Main Outcomes and Measures: The primary outcome was treatment feasibility, defined as the ability to complete 6 chemotherapy cycles without disease progression, premature toxic effects-related treatment discontinuation, or death. Results: A total of 120 women were randomized. The mean and median age was 80 (interquartile range, 76-83; range, 70-94) years; 43 (36%) had a Geriatric Vulnerability Score of 4 and 13 (11%) had a Geriatric Vulnerability Score of 5; 40 (33%) had stage IV disease. During its third meeting, the independent data m

Published
2021

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