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1. PARP inhibition with rucaparib alone followed by combination with atezolizumab: Phase Ib COUPLET clinical study in advanced gynaecological and triple-negative breast cancers

Author

Kristeleit, Rebecca, Leary, Alexandra, Oaknin, Ana, Redondo, Andres, George, Angela, Chui, Stephen, Seiller, Aicha, Liste-Hermoso, Mario, Willis, Jenna, Shemesh, Colby S., Xiao, Jim, Lin, Kevin K., Molinero, Luciana, Guan, Yinghui, Ray-Coquard, Isabelle, and Mileshkin, Linda

Published
2024
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2. Correction: ENDOLUNG trial. A phase 1/2 study of the Akt/mTOR inhibitor and autophagy inducer Ibrilatazar (ABTL0812) in combination with paclitaxel/carboplatin in patients with advanced/recurrent endometrial cancer: Alexandra Leary

Author

Leary, Alexandra, Estévez-García, Purificación, Sabatier, Renaud, Ray-Coquard, Isabelle, Romeo, Margarita, Barretina-Ginesta, Pilar, Gil-Martin, Marta, Garralda, Elena, Bosch-Barrera, Joaquim, Morán, Teresa, Martin-Martorell, Paloma, Nadal, Ernest, Gascón, Pere, Rodon, Jordi, Lizcano, Jose M, Muñoz-Guardiola, Pau, Fierro-Durán, Gemma, Pedrós-Gámez, Oriol, Pérez-Montoyo, Héctor, Yeste-Velasco, Marc, Cortal, Marc, Pérez-Campos, Antonio, Alfon, Jose, Domenech, Carles, Pérez-Fidalgo, Alejandro, and Oaknin, Ana

Published
2024
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3. ENDOLUNG trial. A phase 1/2 study of the Akt/mTOR inhibitor and autophagy inducer Ibrilatazar (ABTL0812) in combination with paclitaxel/carboplatin in patients with advanced/recurrent endometrial cancer

Author

Leary, Alexandra, Estévez-García, Purificación, Sabatier, Renaud, Ray-Coquard, Isabelle, Romeo, Margarita, Barretina-Ginesta, Pilar, Gil-Martin, Marta, Garralda, Elena, Bosch-Barrera, Joaquim, Morán, Teresa, Martin-Martorell, Paloma, Nadal, Ernest, Gascón, Pere, Rodon, Jordi, Lizcano, Jose M, Muñoz-Guardiola, Pau, Fierro-Durán, Gemma, Pedrós-Gámez, Oriol, Pérez-Montoyo, Héctor, Yeste-Velasco, Marc, Cortal, Marc, Pérez-Campos, Antonio, Alfon, Jose, Domenech, Carles, Pérez-Fidalgo, Alejandro, and Oaknin, Ana

Published
2024
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4. Neoadjuvant and adjuvant pembrolizumab in advanced high-grade serous carcinoma: the randomized phase II NeoPembrOV clinical trial

Author

Ray-Coquard, Isabelle L., Savoye, Aude-Marie, Schiffler, Camille, Mouret-Reynier, Marie-Ange, Derbel, Olfa, Kalbacher, Elsa, LeHeurteur, Marianne, Martinez, Alejandra, Cornila, Corina, Martinez, Mathilde, Bengrine Lefevre, Leila, Priou, Frank, Cloarec, Nicolas, Venat, Laurence, Selle, Frédéric, Berton, Dominique, Collard, Olivier, Coquan, Elodie, Le Saux, Olivia, Treilleux, Isabelle, Gouerant, Sophie, Angelergues, Antoine, Joly, Florence, and Tredan, Olivier

Published
2024
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5. Immunomic longitudinal profiling of the NeoPembrOv trial identifies drivers of immunoresistance in high-grade ovarian carcinoma

Author

Le Saux, Olivia, Ardin, Maude, Berthet, Justine, Barrin, Sarah, Bourhis, Morgane, Cinier, Justine, Lounici, Yasmine, Treilleux, Isabelle, Just, Pierre-Alexandre, Bataillon, Guillaume, Savoye, Aude-Marie, Mouret-Reynier, Marie-Ange, Coquan, Elodie, Derbel, Olfa, Jeay, Louis, Bouizaguen, Suliman, Labidi-Galy, Intidhar, Tabone-Eglinger, Séverine, Ferrari, Anthony, Thomas, Emilie, Ménétrier-Caux, Christine, Tartour, Eric, Galy-Fauroux, Isabelle, Stern, Marc-Henri, Terme, Magali, Caux, Christophe, Dubois, Bertrand, and Ray-Coquard, Isabelle

Published
2024
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8. Netrin-1 blockade inhibits tumor associated Myeloid-derived suppressor cells, cancer stemness and alleviates resistance to chemotherapy and immune checkpoint inhibitor

Author

Ducarouge, Benjamin, Redavid, Anna-Rita, Victoor, Camille, Chira, Ruxanda, Fonseca, Aurélien, Hervieu, Maëva, Bergé, Roméo, Lengrand, Justine, Vieugué, Pauline, Neves, David, Goddard, Isabelle, Richaud, Mathieu, Laval, Pierre-Alexandre, Rama, Nicolas, Goldschneider, David, Paradisi, Andrea, Gourdin, Nicolas, Chabaud, Sylvie, Treilleux, Isabelle, Gadot, Nicolas, Ray-Coquard, Isabelle, Depil, Stéphane, Decaudin, Didier, Némati, Fariba, Marangoni, Elisabetta, Mery-Lamarche, Eliane, Génestie, Catherine, Tabone-Eglinger, Séverine, Devouassoux-Shisheboran, Mojgan, Moore, Kathryn J., Gibert, Benjamin, Mehlen, Patrick, and Bernet, Agnes

Published
2023
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9. Netrin-1 blockade inhibits tumour growth and EMT features in endometrial cancer

Author

Cassier, Philippe A., Navaridas, Raul, Bellina, Melanie, Rama, Nicolas, Ducarouge, Benjamin, Hernandez-Vargas, Hector, Delord, Jean-Pierre, Lengrand, Justine, Paradisi, Andrea, Fattet, Laurent, Garin, Gwenaële, Gheit, Hanane, Dalban, Cecile, Pastushenko, Ievgenia, Neves, David, Jelin, Remy, Gadot, Nicolas, Braissand, Nicolas, Léon, Sophie, Degletagne, Cyril, Matias-Guiu, Xavier, Devouassoux-Shisheboran, Mojgan, Mery-Lamarche, Eliane, Allard, Justine, Zindy, Egor, Decaestecker, Christine, Salmon, Isabelle, Perol, David, Dolcet, Xavi, Ray-Coquard, Isabelle, Blanpain, Cédric, Bernet, Agnès, and Mehlen, Patrick

Published
2023
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10. Clinical, pathological, and comprehensive molecular analysis of the uterine clear cell carcinoma: a retrospective national study from TMRG and GINECO network

Author

Nigon, Elsa, Lefeuvre-Plesse, Claudia, Martinez, Alejandra, Chauleur, Céline, Lortholary, Alain, Favier, Laure, Bats, Anne-Sophie, Guille, Arnaud, AdélaÏde, José, Finetti, Pascal, de Casteljac, Victoire, Provansal, Magali, Mamessier, Emilie, Bertucci, François, Ray-Coquard, Isabelle, and Sabatier, Renaud

Published
2023
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11. Management of patients with rare adult solid cancers: objectives and evaluation of European reference networks (ERN) EURACAN

Author

Blay, Jean-Yves, Casali, Paolo, Ray-Coquard, Isabelle, Seckl, Michael J., Gietema, Jourik, de Herder, Wouter W., Caplin, Martyn, Klümpen, Heinz-Josef, Glehen, Olivier, Wyrwicz, Lucjan, Peeters, Robin, Licitra, Lisa, Girard, Nicolas, Piperno-Neumann, Sophie, Kapiteijn, Ellen, Idbaih, Ahmed, Franceschi, Enrico, Trama, Annalisa, Frezza, Anna-Maria, Hohenberger, Peter, Hindi, Nadia, Martin-Broto, Javier, Schell, Johanna, Rogasik, Muriel, Lejeune, Stephane, Oliver, Kathy, de Lorenzo, Francesco, and Weinman, Ariane

Published
2024
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12. Population exposure-efficacy and exposure-safety analyses for rucaparib in patients with recurrent ovarian carcinoma from Study 10 and ARIEL2

Author

Konecny, Gottfried E, Oza, Amit M, Tinker, Anna V, Oaknin, Ana, Shapira-Frommer, Ronnie, Ray-Coquard, Isabelle, Aghajanian, Carol, Coleman, Robert L, O'Malley, David M, Leary, Alexandra, Chen, Lee-May, Provencher, Diane, Ma, Ling, Brenton, James D, Castro, Cesar, Green, Michelle, Simmons, Andrew D, Beltman, Jeri, Harding, Thomas, Lin, Kevin K, Goble, Sandra, Maloney, Lara, Kristeleit, Rebecca S, McNeish, Iain A, Swisher, Elizabeth M, and Xiao, Jim J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Ovarian Cancer, Orphan Drug, Rare Diseases, Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Administration, Oral, Aged, Area Under Curve, BRCA1 Protein, Carcinoma, Ovarian Epithelial, Dose-Response Relationship, Drug, Female, Humans, Indoles, Middle Aged, Neoplasm Recurrence, Local, Ovarian Neoplasms, Platinum, Efficacy, Exposure, Ovarian carcinoma, Pharmacokinetics, Rucaparib, Safety, Paediatrics and Reproductive Medicine, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis, Reproductive medicine
Abstract

ObjectiveTo evaluate correlations between rucaparib exposure and selected efficacy and safety endpoints in patients with recurrent ovarian carcinoma using pooled data from Study 10 and ARIEL2.MethodsEfficacy analyses were limited to patients with carcinomas harboring a deleterious BRCA1 or BRCA2 mutation who had received ≥2 prior lines of chemotherapy. Safety was evaluated in all patients who received ≥1 rucaparib dose. Steady-state daily area under the concentration-time curve (AUCss) and maximum concentration (Cmax,ss) for rucaparib were calculated for each patient and averaged by actual dose received over time (AUCavg,ss and Cmax,avg,ss) using a previously developed population pharmacokinetic model.ResultsRucaparib exposure was dose-proportional and not associated with baseline patient weight. In the exposure-efficacy analyses (n = 121), AUCavg,ss was positively associated with independent radiology review-assessed RECIST response in the subgroup of patients with platinum-sensitive recurrent disease (n = 75, p = 0.017). In the exposure-safety analyses (n = 393, 40 mg once daily to 840 mg twice daily [BID] starting doses), most patients received a 600 mg BID rucaparib starting dose, with 27% and 21% receiving 1 or ≥2 dose reductions, respectively. Cmax,ss was significantly correlated with grade ≥2 serum creatinine increase, grade ≥3 alanine transaminase/aspartate transaminase increase, platelet decrease, fatigue/asthenia, and maximal hemoglobin decrease (p

Published
2021

13. Molecular and clinical determinants of response and resistance to rucaparib for recurrent ovarian cancer treatment in ARIEL2 (Parts 1 and 2).

Author

Swisher, Elizabeth M, Kwan, Tanya T, Oza, Amit M, Tinker, Anna V, Ray-Coquard, Isabelle, Oaknin, Ana, Coleman, Robert L, Aghajanian, Carol, Konecny, Gottfried E, O'Malley, David M, Leary, Alexandra, Provencher, Diane, Welch, Stephen, Chen, Lee-May, Wahner Hendrickson, Andrea E, Ma, Ling, Ghatage, Prafull, Kristeleit, Rebecca S, Dorigo, Oliver, Musafer, Ashan, Kaufmann, Scott H, Elvin, Julia A, Lin, Douglas I, Chambers, Setsuko K, Dominy, Erin, Vo, Lan-Thanh, Goble, Sandra, Maloney, Lara, Giordano, Heidi, Harding, Thomas, Dobrovic, Alexander, Scott, Clare L, Lin, Kevin K, and McNeish, Iain A

Subjects
Humans, Ovarian Neoplasms, Neoplasm Recurrence, Local, Platinum, Indoles, DNA-Binding Proteins, BRCA1 Protein, BRCA2 Protein, Antineoplastic Agents, DNA Methylation, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Promoter Regions, Genetic, Poly(ADP-ribose) Polymerase Inhibitors, Carcinoma, Ovarian Epithelial
Abstract

ARIEL2 (NCT01891344) is a single-arm, open-label phase 2 study of the PARP inhibitor (PARPi) rucaparib in relapsed high-grade ovarian carcinoma. In this post hoc exploratory biomarker analysis of pre- and post-platinum ARIEL2 samples, RAD51C and RAD51D mutations and high-level BRCA1 promoter methylation predict response to rucaparib, similar to BRCA1/BRCA2 mutations. BRCA1 methylation loss may be a major cross-resistance mechanism to platinum and PARPi. Genomic scars associated with homologous recombination deficiency are irreversible, persisting even as platinum resistance develops, and therefore are predictive of rucaparib response only in platinum-sensitive disease. The RAS, AKT, and cell cycle pathways may be additional modulators of PARPi sensitivity.

Published
2021

14. Comparison between exclusive (chemo)radiation and surgery or induction chemotherapy as first curative treatment for localized or locally advanced head and neck squamous cell carcinomas (L(A)-HNSCC): Sub-analysis of the EPOCKS study

Author

Gauduchon, Coauthor(s) Thibault, Dalban, Cécile, Philippe, Zrounba, Racadot, Séverine, Chabaud, Sylvie, Reyt, Emile, Poupart, Marc, Prades, Jean Michel, Burgy, Michael, Cellier, Dominique, Ceruse, Philippe, Leval, Jacques, Muller, Philippe, Manipoud, Patrick, Ray-Coquard, Isabelle, and Fayette, Jérôme

Published
2023
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15. Development and Validation of the Gene Expression Predictor of High-grade Serous Ovarian Carcinoma Molecular SubTYPE (PrOTYPE)

Author

Talhouk, Aline, George, Joshy, Wang, Chen, Budden, Timothy, Tan, Tuan Zea, Chiu, Derek S, Kommoss, Stefan, San Leong, Huei, Chen, Stephanie, Intermaggio, Maria P, Gilks, Blake, Nazeran, Tayyebeh M, Volchek, Mila, Elatre, Wafaa, Bentley, Rex C, Senz, Janine, Lum, Amy, Chow, Veronica, Sudderuddin, Hanwei, Mackenzie, Robertson, Leong, Samuel CY, Liu, Geyi, Johnson, Dustin, Chen, Billy, Group, AOCS, Alsop, Jennifer, Banerjee, Susana N, Behrens, Sabine, Bodelon, Clara, Brand, Alison H, Brinton, Louise, Carney, Michael E, Chiew, Yoke-Eng, Cushing-Haugen, Kara L, Cybulski, Cezary, Ennis, Darren, Fereday, Sian, Fortner, Renée T, García-Donas, Jesús, Gentry-Maharaj, Aleksandra, Glasspool, Rosalind, Goranova, Teodora, Greene, Casey S, Haluska, Paul, Harris, Holly R, Hendley, Joy, Hernandez, Brenda Y, Herpel, Esther, Jimenez-Linan, Mercedes, Karpinskyj, Chloe, Kaufmann, Scott H, Keeney, Gary L, Kennedy, Catherine J, Köbel, Martin, Koziak, Jennifer M, Larson, Melissa C, Lester, Jenny, Lewsley, Liz-Anne, Lissowska, Jolanta, Lubiński, Jan, Luk, Hugh, Macintyre, Geoff, Mahner, Sven, McNeish, Iain A, Menkiszak, Janusz, Nevins, Nikilyn, Osorio, Ana, Oszurek, Oleg, Palacios, José, Hinsley, Samantha, Pearce, Celeste L, Pike, Malcolm C, Piskorz, Anna M, Ray-Coquard, Isabelle, Rhenius, Valerie, Rodriguez-Antona, Cristina, Sharma, Raghwa, Sherman, Mark E, De Silva, Dilrini, Singh, Naveena, Sinn, Peter, Slamon, Dennis, Song, Honglin, Steed, Helen, Stronach, Euan A, Thompson, Pamela J, Tołoczko, Aleksandra, Trabert, Britton, Traficante, Nadia, Tseng, Chiu-Chen, Widschwendter, Martin, Wilkens, Lynne R, Winham, Stacey J, Winterhoff, Boris, Beeghly-Fadiel, Alicia, Benitez, Javier, Berchuck, Andrew, Brenton, James D, Brown, Robert, and Chang-Claude, Jenny

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Orphan Drug, Genetics, Ovarian Cancer, Women's Health, Cancer Genomics, Precision Medicine, Cancer, Human Genome, 4.2 Evaluation of markers and technologies, Good Health and Well Being, Aged, Algorithms, Cystadenoma, Serous, Female, Gene Expression Regulation, Neoplastic, Humans, Lymphocytes, Tumor-Infiltrating, Middle Aged, Neoplasm Grading, Neoplasm Proteins, Neoplasm, Residual, Ovarian Neoplasms, Transcriptome, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeGene expression-based molecular subtypes of high-grade serous tubo-ovarian cancer (HGSOC), demonstrated across multiple studies, may provide improved stratification for molecularly targeted trials. However, evaluation of clinical utility has been hindered by nonstandardized methods, which are not applicable in a clinical setting. We sought to generate a clinical grade minimal gene set assay for classification of individual tumor specimens into HGSOC subtypes and confirm previously reported subtype-associated features.Experimental designAdopting two independent approaches, we derived and internally validated algorithms for subtype prediction using published gene expression data from 1,650 tumors. We applied resulting models to NanoString data on 3,829 HGSOCs from the Ovarian Tumor Tissue Analysis consortium. We further developed, confirmed, and validated a reduced, minimal gene set predictor, with methods suitable for a single-patient setting.ResultsGene expression data were used to derive the predictor of high-grade serous ovarian carcinoma molecular subtype (PrOTYPE) assay. We established a de facto standard as a consensus of two parallel approaches. PrOTYPE subtypes are significantly associated with age, stage, residual disease, tumor-infiltrating lymphocytes, and outcome. The locked-down clinical grade PrOTYPE test includes a model with 55 genes that predicted gene expression subtype with >95% accuracy that was maintained in all analytic and biological validations.ConclusionsWe validated the PrOTYPE assay following the Institute of Medicine guidelines for the development of omics-based tests. This fully defined and locked-down clinical grade assay will enable trial design with molecular subtype stratification and allow for objective assessment of the predictive value of HGSOC molecular subtypes in precision medicine applications.See related commentary by McMullen et al., p. 5271.

Published
2020

16. The KAT6B::KANSL1 Fusion Defines a New Uterine Sarcoma With Hybrid Endometrial Stromal Tumor and Smooth Muscle Tumor Features

Author

Trecourt, Alexis, Azmani, Rhiab, Hostein, Isabelle, Blanchard, Larry, Le Loarer, François, Bourdon, Aurelien, Alame, Melissa, Nadaud, Béatrice, Mayer, Laetitia, Rebier, Flora, Larmonier, Claire, Moura, Madalena Souto, Soubeyran, Isabelle, Hartog, Cécile, Ray-Coquard, Isabelle, Treilleux, Isabelle, Devouassoux-Shisheboran, Mojgan, and Croce, Sabrina

Published
2023
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19. Olaparib Addition to Maintenance Bevacizumab Therapy in Ovarian Carcinoma With BRCA-Like Genomic Aberrations

Author

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

Published
2024
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21. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial

Author

Swisher, Elizabeth M, Lin, Kevin K, Oza, Amit M, Scott, Clare L, Giordano, Heidi, Sun, James, Konecny, Gottfried E, Coleman, Robert L, Tinker, Anna V, O'Malley, David M, Kristeleit, Rebecca S, Ma, Ling, Bell-McGuinn, Katherine M, Brenton, James D, Cragun, Janiel M, Oaknin, Ana, Ray-Coquard, Isabelle, Harrell, Maria I, Mann, Elaina, Kaufmann, Scott H, Floquet, Anne, Leary, Alexandra, Harding, Thomas C, Goble, Sandra, Maloney, Lara, Isaacson, Jeff, Allen, Andrew R, Rolfe, Lindsey, Yelensky, Roman, Raponi, Mitch, and McNeish, Iain A

Subjects
Rare Diseases, Genetics, Cancer, Ovarian Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Good Health and Well Being, Aged, Antineoplastic Agents, BRCA1 Protein, BRCA2 Protein, Carcinoma, Ovarian Epithelial, Drug Resistance, Neoplasm, Fallopian Tube Neoplasms, Female, Follow-Up Studies, Germ-Line Mutation, Humans, Indoles, International Agencies, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Neoplasms, Glandular and Epithelial, Ovarian Neoplasms, Peritoneal Neoplasms, Platinum, Poly(ADP-ribose) Polymerase Inhibitors, Poly(ADP-ribose) Polymerases, Prognosis, Prospective Studies, Salvage Therapy, Survival Rate, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundPoly(ADP-ribose) polymerase (PARP) inhibitors have activity in ovarian carcinomas with homologous recombination deficiency. Along with BRCA1 and BRCA2 (BRCA) mutations genomic loss of heterozygosity (LOH) might also represent homologous recombination deficiency. In ARIEL2, we assessed the ability of tumour genomic LOH, quantified with a next-generation sequencing assay, to predict response to rucaparib, an oral PARP inhibitor.MethodsARIEL2 is an international, multicentre, two-part, phase 2, open-label study done at 49 hospitals and cancer centres in Australia, Canada, France, Spain, the UK, and the USA. In ARIEL2 Part 1, patients with recurrent, platinum-sensitive, high-grade ovarian carcinoma were classified into one of three predefined homologous recombination deficiency subgroups on the basis of tumour mutational analysis: BRCA mutant (deleterious germline or somatic), BRCA wild-type and LOH high (LOH high group), or BRCA wild-type and LOH low (LOH low group). We prespecified a cutoff of 14% or more genomic LOH for LOH high. Patients began treatment with oral rucaparib at 600 mg twice per day for continuous 28 day cycles until disease progression or any other reason for discontinuation. The primary endpoint was progression-free survival. All patients treated with at least one dose of rucaparib were included in the safety analyses and all treated patients who were classified were included in the primary endpoint analysis. This trial is registered with ClinicalTrials.gov, number NCT01891344. Enrolment into ARIEL2 Part 1 is complete, although an extension (Part 2) is ongoing.Findings256 patients were screened and 206 were enrolled between Oct 30, 2013, and Dec 19, 2014. At the data cutoff date (Jan 18, 2016), 204 patients had received rucaparib, with 28 patients remaining in the study. 192 patients could be classified into one of the three predefined homologous recombination deficiency subgroups: BRCA mutant (n=40), LOH high (n=82), or LOH low (n=70). Tumours from 12 patients were established as BRCA wild-type, but could not be classified for LOH, because of insufficient neoplastic nuclei in the sample. The median duration of treatment for the 204 patients was 5·7 months (IQR 2·8-10·1). 24 patients in the BRCA mutant subgroup, 56 patients in the LOH high subgroup, and 59 patients in the LOH low subgroup had disease progression or died. Median progression-free survival after rucaparib treatment was 12·8 months (95% CI 9·0-14·7) in the BRCA mutant subgroup, 5·7 months (5·3-7·6) in the LOH high subgroup, and 5·2 months (3·6-5·5) in the LOH low subgroup. Progression-free survival was significantly longer in the BRCA mutant (hazard ratio 0·27, 95% CI 0·16-0·44, p

Published
2017

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

Author

Schouten, P, Schmidt, S, Becker, K, Thiele, H, Nürnberg, P, Richters, L, Ernst, C, Treilleux, I, Medioni, J, Heitz, F, Pisano, C, Garcia, Y, Petru, E, Hietanen, S, Colombo, N, Vergote, I, Nagao, S, Linn, S, Pujade-Lauraine, E, Ray-Coquard, I, Harter, P, Hahnen, E, Schmutzler, R, Schouten, Philip C, Schmidt, Sandra, Becker, Kerstin, Thiele, Holger, Nürnberg, Peter, Richters, Lisa, Ernst, Corinna, Treilleux, Isabelle, Medioni, Jacques, Heitz, Florian, Pisano, Carmela, Garcia, Yolanda, Petru, Edgar, Hietanen, Sakari, Colombo, Nicoletta, Vergote, Ignace, Nagao, Shoji, Linn, Sabine C, Pujade-Lauraine, Eric, Ray-Coquard, Isabelle, Harter, Philipp, Hahnen, Eric, Schmutzler, Rita K, Schouten, P, Schmidt, S, Becker, K, Thiele, H, Nürnberg, P, Richters, L, Ernst, C, Treilleux, I, Medioni, J, Heitz, F, Pisano, C, Garcia, Y, Petru, E, Hietanen, S, Colombo, N, Vergote, I, Nagao, S, Linn, S, Pujade-Lauraine, E, Ray-Coquard, I, Harter, P, Hahnen, E, Schmutzler, R, Schouten, Philip C, Schmidt, Sandra, Becker, Kerstin, Thiele, Holger, Nürnberg, Peter, Richters, Lisa, Ernst, Corinna, Treilleux, Isabelle, Medioni, Jacques, Heitz, Florian, Pisano, Carmela, Garcia, Yolanda, Petru, Edgar, Hietanen, Sakari, Colombo, Nicoletta, Vergote, Ignace, Nagao, Shoji, Linn, Sabine C, Pujade-Lauraine, Eric, Ray-Coquard, Isabelle, Harter, Philipp, Hahnen, Eric, and Schmutzler, Rita K

Abstract

Importance: Testing for homologous recombination deficiency is required for the optimal treatment of high-grade epithelial ovarian cancer. The search for accurate biomarkers is ongoing. Objective: To investigate whether progression-free survival (PFS) and overall survival (OS) of patients with high-grade epithelial ovarian cancer treated with maintenance olaparib or placebo differed between patients with a tumor BRCA-like genomic profile and patients without a tumor BRCA-like profile. Design, Setting, and Participants: This cohort study was a secondary analysis of the PAOLA-1 randomized clinical trial that compared olaparib plus bevacizumab with placebo plus bevacizumab as maintenance treatment in patients with advanced high-grade ovarian cancer after a good response to first-line platinum with taxane chemotherapy plus bevacizumab, irrespective of germline or tumor BRCA1/2 mutation status. All patients with available tumor DNA were included in the analysis. The current analysis tested for an interaction between BRCA-like status and olaparib treatment on survival outcomes. The original trial was conducted between July 2015 and September 2017; at the time of data extraction for analysis in March 2022, a median follow-up of 54.1 months (IQR, 28.5-62.2 months) and a total follow-up time of 21711 months was available, with 336 PFS and 245 OS events. Exposures: Tumor homologous recombination deficiency was assessed using the BRCA-like copy number aberration profile classifier. Myriad MyChoice CDx was previously measured. The trial was randomized between the olaparib and bevacizumab and placebo plus bevacizumab groups. Main Outcomes and Measures: This secondary analysis assessed hazard ratios (HRs) of olaparib vs placebo among biomarker strata and tested for interaction between BRCA-like status and olaparib treatment on PFS and OS, using Cox proportional hazards regression. Results: A total of 469 patients (median age, 60 [range 26-80] years) were included in this study. T

Published
2024

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

Author

Oaknin, A, Gladieff, L, Martínez-García, J, Villacampa, G, Takekuma, M, De Giorgi, U, Lindemann, K, Woelber, L, Colombo, N, Duska, L, Leary, A, Godoy-Ortiz, A, Nishio, S, Angelergues, A, Rubio, M, Fariñas-Madrid, L, Yamaguchi, S, Lorusso, D, Ray-Coquard, I, Manso, L, Joly, F, Alarcón, J, Follana, P, Romero, I, Lebreton, C, Pérez-Fidalgo, J, Yunokawa, M, Dahlstrand, H, D'Hondt, V, Randall, L, Oaknin, Ana, Gladieff, Laurence, Martínez-García, Jerónimo, Villacampa, Guillermo, Takekuma, Munetaka, De Giorgi, Ugo, Lindemann, Kristina, Woelber, Linn, Colombo, Nicoletta, Duska, Linda, Leary, Alexandra, Godoy-Ortiz, Ana, Nishio, Shin, Angelergues, Antoine, Rubio, Maria Jesús, Fariñas-Madrid, Lorena, Yamaguchi, Satoshi, Lorusso, Domenica, Ray-Coquard, Isabelle, Manso, Luis, Joly, Florence, Alarcón, Jesús, Follana, Philippe, Romero, Ignacio, Lebreton, Coriolan, Pérez-Fidalgo, J Alejandro, Yunokawa, Mayu, Dahlstrand, Hanna, D'Hondt, Véronique, Randall, Leslie M, Oaknin, A, Gladieff, L, Martínez-García, J, Villacampa, G, Takekuma, M, De Giorgi, U, Lindemann, K, Woelber, L, Colombo, N, Duska, L, Leary, A, Godoy-Ortiz, A, Nishio, S, Angelergues, A, Rubio, M, Fariñas-Madrid, L, Yamaguchi, S, Lorusso, D, Ray-Coquard, I, Manso, L, Joly, F, Alarcón, J, Follana, P, Romero, I, Lebreton, C, Pérez-Fidalgo, J, Yunokawa, M, Dahlstrand, H, D'Hondt, V, Randall, L, Oaknin, Ana, Gladieff, Laurence, Martínez-García, Jerónimo, Villacampa, Guillermo, Takekuma, Munetaka, De Giorgi, Ugo, Lindemann, Kristina, Woelber, Linn, Colombo, Nicoletta, Duska, Linda, Leary, Alexandra, Godoy-Ortiz, Ana, Nishio, Shin, Angelergues, Antoine, Rubio, Maria Jesús, Fariñas-Madrid, Lorena, Yamaguchi, Satoshi, Lorusso, Domenica, Ray-Coquard, Isabelle, Manso, Luis, Joly, Florence, Alarcón, Jesús, Follana, Philippe, Romero, Ignacio, Lebreton, Coriolan, Pérez-Fidalgo, J Alejandro, Yunokawa, Mayu, Dahlstrand, Hanna, D'Hondt, Véronique, and Randall, Leslie M

Abstract

Background: The GOG240 trial established bevacizumab with chemotherapy as standard first-line therapy for metastatic or recurrent cervical cancer. In the BEATcc trial (ENGOT-Cx10–GEICO 68-C–JGOG1084–GOG-3030), we aimed to evaluate the addition of an immune checkpoint inhibitor to this standard backbone. Methods: In this investigator-initiated, randomised, open-label, phase 3 trial, patients from 92 sites in Europe, Japan, and the USA with metastatic (stage IVB), persistent, or recurrent cervical cancer that was measurable, previously untreated, and not amenable to curative surgery or radiation were randomly assigned 1:1 to receive standard therapy (cisplatin 50 mg/m2 or carboplatin area under the curve of 5, paclitaxel 175 mg/m2, and bevacizumab 15 mg/kg, all on day 1 of every 3-week cycle) with or without atezolizumab 1200 mg. Treatment was continued until disease progression, unacceptable toxicity, patient withdrawal, or death. Stratification factors were previous concomitant chemoradiation (yes vs no), histology (squamous cell carcinoma vs adenocarcinoma including adenosquamous carcinoma), and platinum backbone (cisplatin vs carboplatin). Dual primary endpoints were investigator-assessed progression-free survival according to Response Evaluation Criteria in Solid Tumours version 1.1 and overall survival analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT03556839, and is ongoing. Findings: Between Oct 8, 2018, and Aug 20, 2021, 410 of 519 patients assessed for eligibility were enrolled. Median progression-free survival was 13·7 months (95% CI 12·3–16·6) with atezolizumab and 10·4 months (9·7–11·7) with standard therapy (hazard ratio [HR]=0·62 [95% CI 0·49–0·78]; p<0·0001); at the interim overall survival analysis, median overall survival was 32·1 months (95% CI 25·3–36·8) versus 22·8 months (20·3–28·0), respectively (HR 0·68 [95% CI 0·52–0·88]; p=0·0046). Grade 3 or worse adverse events occurred in 79% of patient

Published
2024

25. Management of patients with rare adult solid cancers:objectives and evaluation of European reference networks (ERN) EURACAN

Author

Blay, Jean Yves, Casali, Paolo, Ray-Coquard, Isabelle, Seckl, Michael J., Gietema, Jourik, de Herder, Wouter W., Caplin, Martyn, Klümpen, Heinz Josef, Glehen, Olivier, Wyrwicz, Lucjan, Peeters, Robin, Licitra, Lisa, Girard, Nicolas, Piperno-Neumann, Sophie, Kapiteijn, Ellen, Idbaih, Ahmed, Franceschi, Enrico, Trama, Annalisa, Frezza, Anna Maria, Hohenberger, Peter, Hindi, Nadia, Martin-Broto, Javier, Schell, Johanna, Rogasik, Muriel, Lejeune, Stephane, Oliver, Kathy, de Lorenzo, Francesco, Weinman, Ariane, Blay, Jean Yves, Casali, Paolo, Ray-Coquard, Isabelle, Seckl, Michael J., Gietema, Jourik, de Herder, Wouter W., Caplin, Martyn, Klümpen, Heinz Josef, Glehen, Olivier, Wyrwicz, Lucjan, Peeters, Robin, Licitra, Lisa, Girard, Nicolas, Piperno-Neumann, Sophie, Kapiteijn, Ellen, Idbaih, Ahmed, Franceschi, Enrico, Trama, Annalisa, Frezza, Anna Maria, Hohenberger, Peter, Hindi, Nadia, Martin-Broto, Javier, Schell, Johanna, Rogasik, Muriel, Lejeune, Stephane, Oliver, Kathy, de Lorenzo, Francesco, and Weinman, Ariane

Abstract

About 500,000 patients with rare adult solid cancers (RASC) are diagnosed yearly in Europe. Delays and unequal quality of management impact negatively their survival. Since 2017, European reference networks (ERN) aim to improve the quality of care of patients with rare disease. The steering committee of EURACAN, including physicians, researchers and patients review here the previous actions, present objectives of the ERN EURACAN dedicated to RASC. EURACAN promoted management in reference centres, and equal implementation of excellence and innovation in Europe and developed 22 clinical practice guidelines (CPGs). Additionally, fourteen information brochures translated in 24 EU languages were developed in collaboration with patient advocacy groups (ePAGs) and seventeen training session were organized. Nevertheless, connections to national networks in the 26 participating countries (106 centres), simplification of cross-border healthcare, international multidisciplinary tumour boards, registries and monitoring of the quality of care are still required. In this Health Policy, evaluation criteria of the performances of the network and of health care providers are proposed.

Published
2024

26. Beyond the map: evidencing the spatial dimension of health inequalities

Author

Fayet Yohan, Praud Delphine, Fervers Béatrice, Ray-Coquard Isabelle, Blay Jean-Yves, Ducimetiere Françoise, Fagherazzi Guy, and Faure Elodie

Subjects
Health inequalities, Environment, Social deprivation, Health care access, Geography, Public health, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

Abstract Background Spatial inequalities in health result from different exposures to health risk factors according to the features of geographical contexts, in terms of physical environment, social deprivation, and health care accessibility. Using a common geographical referential, which combines indices measuring these contextual features, could improve the comparability of studies and the understanding of the spatial dimension of health inequalities. Methods We developed the Geographical Classification for Health studies (GeoClasH) to distinguish French municipalities according to their ability to influence health outcomes. Ten contextual scores measuring physical and social environment as well as spatial accessibility of health care have been computed and combined to classify French municipalities through a K-means clustering. Age-standardized mortality rates according to the clusters of this classification have been calculated to assess its effectiveness. Results Significant lower mortality rates compared to the mainland France population were found in the Wealthy Metropolitan Areas (SMR = 0.868, 95% CI 0.863–0.873) and in the Residential Outskirts (SMR = 0.971, 95% CI 0.964–0.978), while significant excess mortality were found for Precarious Population Districts (SMR = 1.037, 95% CI 1.035–1.039), Agricultural and Industrial Plains (SMR = 1.066, 95% CI 1.063–1.070) and Rural Margins (SMR = 1.042, 95% CI 1.037–1.047). Conclusions Our results evidence the comprehensive contribution of the geographical context in the constitution of health inequalities. To our knowledge, GeoClasH is the first nationwide classification that combines social, environmental and health care access scores at the municipality scale. It can therefore be used as a proxy to assess the geographical context of the individuals in public health studies.

Published
2020
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29. Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2

Author

Monk, Bradley J, Poveda, Andrés, Vergote, Ignace, Raspagliesi, Francesco, Fujiwara, Keiichi, Bae, Duk-Soo, Oaknin, Ana, Ray-Coquard, Isabelle, Provencher, Diane M, Karlan, Beth Y, Lhommé, Catherine, Richardson, Gary, Rincón, Dolores Gallardo, Coleman, Robert L, Marth, Christian, Brize, Arija, Fabbro, Michel, Redondo, Andrés, Bamias, Aristotelis, Ma, Haijun, Vogl, Florian D, Bach, Bruce A, and Oza, Amit M

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Rare Diseases, Ovarian Cancer, Clinical Research, Cancer, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Ascites, Disease-Free Survival, Double-Blind Method, Female, Humans, Middle Aged, Neoplasm Recurrence, Local, Ovarian Neoplasms, Paclitaxel, Recombinant Fusion Proteins, Trebananib, TRINOVA-1, Recurrent epithelial ovarian cancer, Overall survival, Time to second disease progression, Paediatrics and Reproductive Medicine, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis, Reproductive medicine
Abstract

PurposeTrebananib, a peptibody that blocks binding of angiopoietin-1 and -2 to Tie2, significantly prolonged progression-free survival (PFS) in patients with recurrent epithelial ovarian cancer in the phase 3 TRINOVA-1 study. We report overall survival (OS) in the intent-to-treat population and clinically relevant subgroups and time to second disease progression (PFS-2).Patients and methodsWomen with recurrent disease (platinum-free interval

Published
2016

30. Determinants of the access to remote specialised services provided by national sarcoma reference centres

Author

Fayet, Yohan, Tétreau, Raphaël, Honoré, Charles, Le Nail, Louis-Romée, Dalban, Cécile, Gouin, François, Causeret, Sylvain, Piperno-Neumann, Sophie, Mathoulin-Pelissier, Simone, Karanian, Marie, Italiano, Antoine, Chaigneau, Loïc, Gantzer, Justine, Bertucci, François, Ropars, Mickael, Saada-Bouzid, Esma, Cordoba, Abel, Ruzic, Jean-Christophe, Varatharajah, Sharmini, Ducimetière, Françoise, Chabaud, Sylvie, Dubray-Longeras, Pascale, Fiorenza, Fabrice, De Percin, Sixtine, Lebbé, Céleste, Soibinet, Pauline, Michelin, Paul, Rios, Maria, Farsi, Fadila, Penel, Nicolas, Bompas, Emmanuelle, Duffaud, Florence, Chevreau, Christine, Le Cesne, Axel, Blay, Jean-Yves, Le Loarer, François, and Ray-Coquard, Isabelle

Published
2021
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32. “Chronic fatigue, quality of life and long-term side-effects of chemotherapy in patients treated for non-epithelial ovarian cancer: national case-control protocol study of the GINECO-Vivrovaire rare tumors INCa French network for rare malignant ovarian tumors”

Author

Gernier, François, Ahmed-Lecheheb, Djihane, Pautier, Patricia, Floquet, Anne, Nadeau, Cédric, Frank, Sophie, Alexandre, Jérôme, Selle, Frédéric, Berton-Rigaud, Dominique, Kalbacher, Elsa, Orfeuvre, Hubert, Lortholary, Alain, Augereau, Paule, Labombarda, Fabien, Perrier, Lionel, Grellard, Jean-Michel, Licaj, Idlir, Clarisse, Bénédicte, Savoye, Aude-Marie, Bourien, Héloise, De La Motte Rouge, Thibaut, Kurtz, Jean-Emmanuel, Kerdja, Katia, Lelaidier, Anaïs, Charreton, Amandine, Ray-Coquard, Isabelle, and Joly, Florence

Published
2021
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33. Anti-Angiopoietin Therapy With Trebananib for Recurrent Ovarian Cancer (TRINOVA-1)

Author

Monk, Bradley J, Poveda, Andrés, Vergote, Ignace, Raspagliesi, Francesco, Fujiwara, Keiichi, Bae, Duk-Soo, Oaknin, Ana, Ray-Coquard, Isabelle, Provencher, Diane M, Karlan, Beth Y, Lhommé, Catherine, Richardson, Gary, Rincón, Dolores Gallardo, Coleman, Robert L, Herzog, Thomas J, Marth, Christian, Brize, Arija, Fabbro, Michel, Redondo, Andrés, Bamias, Aristotelis, Tassoudji, Marjan, Navale, Lynn, Warner, Douglas J, and Oza, Amit M

Subjects
Clinical Trials and Supportive Activities, Rare Diseases, Ovarian Cancer, Patient Safety, Cancer, Clinical Research, 5.1 Pharmaceuticals, 6.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Evaluation of treatments and therapeutic interventions, Paediatrics and Reproductive Medicine, Obstetrics & Reproductive Medicine
Published
2014

34. Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial

Author

Monk, Bradley J, Poveda, Andrés, Vergote, Ignace, Raspagliesi, Francesco, Fujiwara, Keiichi, Bae, Duk-Soo, Oaknin, Ana, Ray-Coquard, Isabelle, Provencher, Diane M, Karlan, Beth Y, Lhommé, Catherine, Richardson, Gary, Rincón, Dolores Gallardo, Coleman, Robert L, Herzog, Thomas J, Marth, Christian, Brize, Arija, Fabbro, Michel, Redondo, Andrés, Bamias, Aristotelis, Tassoudji, Marjan, Navale, Lynn, Warner, Douglas J, and Oza, Amit M

Subjects
Digestive Diseases, Clinical Trials and Supportive Activities, Ovarian Cancer, Rare Diseases, Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Angiogenesis Inhibitors, Angiopoietin-1, Angiopoietin-2, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Ovarian Epithelial, Disease-Free Survival, Double-Blind Method, Edema, Female, Humans, Middle Aged, Neoplasm Recurrence, Local, Neoplasms, Glandular and Epithelial, Ovarian Neoplasms, Paclitaxel, Recombinant Fusion Proteins, Withholding Treatment, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundAngiogenesis is a valid target in the treatment of epithelial ovarian cancer. Trebananib inhibits the binding of angiopoietins 1 and 2 to the Tie2 receptor, and thereby inhibits angiogenesis. We aimed to assess whether the addition of trebananib to single-agent weekly paclitaxel in patients with recurrent epithelial ovarian cancer improved progression-free survival.MethodsFor this randomised, double-blind phase 3 study undertaken between Nov 10, 2010, and Nov 19, 2012, we enrolled women with recurrent epithelial ovarian cancer from 32 countries. Patient eligibility criteria included having been treated with three or fewer previous regimens, and a platinum-free interval of less than 12 months. We enrolled patients with a computerised interactive voice response system, and patients were randomly assigned using a permuted block method (block size of four) in a 1:1 ratio to receive weekly intravenous paclitaxel (80 mg/m(2)) plus either weekly masked intravenous placebo or trebananib (15 mg/kg). Patients were stratified on the basis of platinum-free interval (≥0 and ≤6 months vs >6 and ≤12 months), presence or absence of measurable disease, and region (North America, western Europe and Australia, or rest of world). The sponsor, investigators, site staff, and patients were masked to the treatment assignment. The primary endpoint was progression-free survival assessed in the intention-to-treat population. The trial is registered with ClinicalTrials.gov, NCT01204749, and is no longer accruing patients.Findings919 patients were enrolled, of whom 461 were randomly assigned to the trebananib group and 458 to the placebo group. Median progression-free survival was significantly longer in the trebananib group than in the placebo group (7·2 months [5·8-7·4] vs 5·4 months [95% CI 4·3-5·5], respectively, hazard ratio 0·66, 95% CI 0·57-0·77, p

Published
2014

35. Low-Grade Uterine Leiomyosarcoma Is Highly Sensitive to Hormonal Treatment

Author

Sanfilippo, Roberta, primary, Sbaraglia, Marta, additional, Fabbroni, Chiara, additional, Croce, Sabrina, additional, Ray-Coquard, Isabelle, additional, Guermazi, Fatma Valentina, additional, Paolini, Biagio, additional, Blanc-Durand, Félix, additional, Lecesne, Axel, additional, Chiappa, Valentina, additional, Dei Tos, Angelo Paolo, additional, and Casali, Paolo Giovanni, additional

Published
2023
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37. Molecular Results and Potential Biomarkers Identified from the Phase 3 MILO/ENGOT-ov11 Study of Binimetinib versus Physician Choice of Chemotherapy in Recurrent Low-Grade Serous Ovarian Cancer

Author

Grisham, Rachel N., primary, Vergote, Ignace, additional, Banerjee, Susana, additional, Drill, Esther, additional, Kalbacher, Elsa, additional, Mirza, Mansoor Raza, additional, Romero, Ignacio, additional, Vuylsteke, Peter, additional, Coleman, Robert L., additional, Hilpert, Felix, additional, Oza, Amit M., additional, Westermann, Anneke, additional, Oehler, Martin K., additional, Pignata, Sandro, additional, Aghajanian, Carol, additional, Colombo, Nicoletta, additional, Cibula, David, additional, Moore, Kathleen N., additional, del Campo, Josep M., additional, Berger, Regina, additional, Marth, Christian, additional, Sehouli, Jalid, additional, O'Malley, David M., additional, Churruca, Cristina, additional, Kristensen, Gunnar, additional, Clamp, Andrew, additional, Farley, John, additional, Iyer, Gopa, additional, Ray-Coquard, Isabelle, additional, and Monk, Bradley J., additional

Published
2023
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38. 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, Van Gorp, Toon, Institut Català de la Salut, [Vergote I, Van Gorp T] Department of Gynecology and Obstetrics, Gynecologic Oncology, Leuven Cancer Institute, Catholic University Leuven, Leuven, Belgium, Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Leuven, Belgium, European Union. [Ray-Coquard I] Medical Oncology Department, Centre Léon Bérard and University Claude Bernard Lyon 1, GINECO, Lyon, France. [Lorusso D] Gynecologic Oncology Unit, Catholic University of Sacred Heart and Fondazione Policlinico Gemelli IRCCS, Rome, Italy. [Oaknin A] Gynecologic Cancer Program, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Cibula D] Department of Obstetrics and Gynaecology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic. Central and Eastern European Gynecologic Oncology Group (CEEGOG), Prague, Czech Republic, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Pharmacology, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::globulinas séricas::inmunoglobulinas::anticuerpos::inmunoconjugados [COMPUESTOS QUÍMICOS Y DROGAS], Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Serum Globulins::Immunoglobulins::Antibodies::Immunoconjugates [CHEMICALS AND DRUGS], General Medicine, Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms, Female::Uterine Neoplasms::Uterine Cervical Neoplasms [DISEASES], Other subheadings::Other subheadings::/drug therapy [Other subheadings], Coll uterí - Càncer - Tractament, Farmàcia - Investigació, Pharmaceutical Preparations::Drugs, Investigational [CHEMICALS AND DRUGS], preparados farmacéuticos::fármacos en investigación [COMPUESTOS QUÍMICOS Y DROGAS], Pharmacology (medical), Immunoglobulines, neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales femeninos::neoplasias uterinas::neoplasias del cuello uterino [ENFERMEDADES]
Abstract

Recurrent cervical cancer; Combination therapy; Immunotherapy Cáncer cervical recurrente; Terapia de combinación; Inmunoterapia Càncer cervical recurrent; Teràpia combinada; Immunoteràpia Introduction: Recurrent 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 covered: Here, 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 opinion: Therapeutics 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

39. Sorafenib in Molecularly Selected Cancer Patients: Final Analysis of the MOST-Plus Sorafenib Cohort

Author

Trédan, Olivier, primary, Toulmonde, Maud, additional, Le Tourneau, Christophe, additional, Montane, Laure, additional, Italiano, Antoine, additional, Ray-Coquard, Isabelle, additional, De La Fouchardière, Christelle, additional, Bertucci, François, additional, Gonçalves, Anthony, additional, Gomez-Roca, Carlos, additional, You, Benoit, additional, Attignon, Valéry, additional, Boyault, Sandrine, additional, Cassier, Philippe A., additional, Dufresne, Armelle, additional, Tabone-Eglinger, Séverine, additional, Viari, Alain, additional, Sohier, Emilie, additional, Kamal, Maud, additional, Garin, Gwenaël, additional, Blay, Jean-Yves, additional, and Pérol, David, additional

Published
2023
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40. Development of the NOGGO GIS v1 Assay, a Comprehensive Hybrid-Capture-Based NGS Assay for Therapeutic Stratification of Homologous Repair Deficiency Driven Tumors and Clinical Validation

Author

Willing, Eva-Maria, primary, Vollbrecht, Claudia, additional, Vössing, Christine, additional, Weist, Peggy, additional, Schallenberg, Simon, additional, Herbst, Johanna M., additional, Schatz, Stefanie, additional, Jóri, Balázs, additional, Bataillon, Guillaume, additional, Harter, Philipp, additional, Salutari, Vanda, additional, Martin, Antonio Gonzáles, additional, Vergote, Ignace, additional, Colombo, Nicoletta, additional, Roeper, Julia, additional, Berg, Tobias, additional, Berger, Regina, additional, Kah, Bettina, additional, Noettrup, Trine Jakobi, additional, Falk, Markus, additional, Arndt, Kathrin, additional, Polten, Andreas, additional, Ray-Coquard, Isabelle, additional, Selzam, Franziska, additional, Pirngruber, Judith, additional, Schmidt, Stefanie, additional, Hummel, Michael, additional, Tiemann, Markus, additional, Horst, David, additional, Sehouli, Jalid, additional, Pujade-Lauraine, Eric, additional, Tiemann, Katharina, additional, Braicu, Elena Ioana, additional, and Heukamp, Lukas C., additional

Published
2023
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42. Development of a disease-specific graded prognostic assessment index for the management of sarcoma patients with brain metastases (Sarcoma-GPA)

Author

Patrikidou, Anna, Chaigneau, Loic, Isambert, Nicolas, Kitikidou, Kyriaki, Shanley, Ryan, Ray-Coquard, Isabelle, Valentin, Thibaud, Malivoir, Bettina, Laigre, Maryline, Bay, Jacques-Olivier, Moureau-Zabotto, Laurence, Bompas, Emmanuelle, Piperno-Neumann, Sophie, Penel, Nicolas, Alcindor, Thierry, Guillemet, Cécile, Duffaud, Florence, Hügli, Anne, Le Pechoux, Cécile, Dhermain, Frédéric, Blay, Jean-Yves, Sperduto, Paul W., and Le Cesne, Axel

Published
2020
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43. Maintenance olaparib plus bevacizumab in patients with newly diagnosed advanced high-grade ovarian cancer: Main analysis of second progression-free survival in the phase III PAOLA-1/ENGOT-ov25 trial

Author

González-Martín, Antonio, Desauw, Christophe, Heitz, Florian, Cropet, Claire, Gargiulo, Piera, Berger, Regina, Ochi, Hiroyuki, Vergote, Ignace, Colombo, Nicoletta, Mirza, Mansoor R, Tazi, Youssef, Canzler, Ulrich, Zamagni, Claudio, Guerra-Alia, Eva M, Levaché, Charles B, Marmé, Frederik, Bazan, Fernando, de Gregorio, Nikolaus, Dohollou, Nadine, Fasching, Peter A, Scambia, Giovanni, Rubio-Pérez, María J, Milenkova, Tsveta, Costan, Cristina, Pautier, Patricia, Ray-Coquard, Isabelle, PAOLA1/ENGOT-ov25 investigators, Gonzalez-Martin, A, Desauw, C, Heitz, F, Cropet, C, Gargiulo, P, Berger, R, Ochi, H, Vergote, I, Colombo, N, Mirza, M, Tazi, Y, Canzler, U, Zamagni, C, Guerra-Alia, E, Levache, C, Marme, F, Bazan, F, de Gregorio, N, Dohollou, N, Fasching, P, Scambia, G, Rubio-Perez, M, Milenkova, T, Costan, C, Pautier, P, and Ray-Coquard, I

Subjects
Ovarian Neoplasms, Cancer Research, Science & Technology, Antineoplastic Agents, Carcinoma, Ovarian Epithelial, Poly(ADP-ribose) Polymerase Inhibitors, Piperazines, Progression-Free Survival, Bevacizumab, Settore MED/40 - GINECOLOGIA E OSTETRICIA, PARP inhibitor, Olaparib, Antiangiogenic agent, Second progression-free survival, Double-Blind Method, Oncology, Ovarian cancer, Antineoplastic Combined Chemotherapy Protocols, Humans, Phthalazines, Female, Life Sciences & Biomedicine
Abstract

BACKGROUND: PAOLA-1/ENGOT-ov25 (NCT02477644) demonstrated a significant progression-free survival (PFS) benefit with maintenance olaparib plus bevacizumab versus placebo plus bevacizumab in newly diagnosed, advanced ovarian cancer. We report the prespecified main second progression-free survival (PFS2) analysis for PAOLA-1. METHODS: This randomised, double-blind, phase III trial was conducted in 11 countries. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were in response after first-line platinum-based chemotherapy plus bevacizumab. Patients were randomised 2:1 to olaparib (300 mg twice daily) or placebo for up to 24 months; all patients received bevacizumab (15 mg/kg every 3 weeks) for up to 15 months. Primary PFS end-point was reported previously. Time from randomisation to second disease progression or death was a key secondary end-point included in the hierarchical-testing procedure. RESULTS: After a median follow-up of 35.5 months and 36.5 months, respectively, median PFS2 was 36.5 months (olaparib plus bevacizumab) and 32.6 months (placebo plus bevacizumab), hazard ratio 0.78; 95% confidence interval (CI) 0.64-0.95; P = 0.0125. Median time to second subsequent therapy or death was 38.2 months (olaparib plus bevacizumab) and 31.5 months (placebo plus bevacizumab), hazard ratio 0.78; 95% CI 0.64-0.95; P = 0.0115. Seventy-two (27%) patients in the placebo plus bevacizumab group received a poly(ADP-ribose) polymerase inhibitor as first subsequent therapy. No new safety signals were observed for olaparib plus bevacizumab. CONCLUSION: In newly diagnosed, advanced ovarian cancer, maintenance olaparib plus bevacizumab provided continued benefit beyond first progression, with a significant PFS2 improvement and a time to second subsequent therapy or death delay versus placebo plus bevacizumab. ispartof: EUROPEAN JOURNAL OF CANCER vol:174 pages:221-231 ispartof: location:England status: published

Published
2022

44. HE4 and CA-125 kinetics to predict outcome in patients with recurrent epithelial ovarian carcinoma: the META4 clinical trial.

Author

Fabbro, Michel, Lamy, Pierre-Jean, Touraine, Célia, Floquet, Anne, Ray-Coquard, Isabelle, and Mollevi, Caroline

Subjects
CLINICAL trials, PROGRESSION-free survival, PROGNOSIS, OVARIAN epithelial cancer, MULTIVARIATE analysis, MEDICAL screening, OVARIAN cancer
Abstract

HE4 and CA-125 are used for epithelial ovarian cancer (EOC) screening, diagnosis, and follow-up. Our objective was to study HE4 and CA-125 kinetics in patients treated for recurrent EOC. Serum samples were prospectively collected before the first chemotherapy cycle and every 3 months until disease progression. Data from 89/101 patients could be analyzed. At baseline, the median CA-125 and HE4 concentrations were 210 IU/L (7-10,310) and 184 pM (31-4,836). Among the 12 patients (13%) with normal CA-125 (<35 IU/L) concentration, eight had HE4 concentration ≥75 pM, and among the 16 patients with normal HE4 concentration (18%), 12 had increased CA-125 concentration. The median nadir concentrations were 31 IU/L (3-8,744) for CA-125 and 75 pM (20-4,836) for HE4. The median times to nadir were 14 (0-130) weeks for CA- 125 and 12 (0-52) weeks for HE4. In multivariate analysis, CA-125 and HE4 nadir concentrations (<35 IU/L, HR 0.35, 95% CI: 0.17-0.72 and<75 pM, HR 0.40, 95% CI: 0.20-0.79) and time to CA-125 and HE4 nadir (>14 weeks, HR 0.37, 95% CI: 0.20-0.70 and >12 weeks, HR 0.43, 95% CI: 0.23-0.83) were prognostic factors of progression-free survival. More investigations on HE4 kinetics could help to better monitor patients with CA-125 concentration within normal values. [ABSTRACT FROM AUTHOR]

Published
2024
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46. Dissecting the origin of heterogeneity in uterine and ovarian carcinosarcomas

Author

Sertier, Anne-Sophie, primary, Ferrari, Anthony, additional, Pommier, Roxane M., additional, Treilleux, Isabelle, additional, Boyault, Sandrine, additional, Devouassoux-Shisheboran, Mojgan, additional, Kielbassa, Janice, additional, Thomas, Emilie, additional, Tonon, Laurie, additional, Le Texier, Vincent, additional, Charreton, Amandine, additional, Morel, Anne-Pierre, additional, Floquet, Anne, additional, Joly, Florence, additional, Berton-Rigaud, Dominique, additional, Ferron, Gwenaël, additional, Arnould, Laurent, additional, Croce, Sabrina, additional, Bataillon, Guillaume, additional, Saintigny, Pierre, additional, Mery-Lamarche, Eliane, additional, Sagan, Christine, additional, Senaratne, Aruni P., additional, Gut, Ivo G., additional, Calvo, Fabien, additional, Viari, Alain, additional, Ouzounova, Maria, additional, Ray-Coquard, Isabelle, additional, and Puisieux, Alain, additional

Published
2023
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47. Abstract CT058: TROPION-PanTumor03: Phase 2, multicenter study of datopotamab deruxtecan (Dato-DXd) as monotherapy and in combination with anticancer agents in patients (pts) with advanced/metastatic solid tumors

Author

Meric-Bernstam, Funda, primary, Janjigian, Yelena, additional, Lang, Joshua, additional, Ciombor, Kristen K., additional, Ray-Coquard, Isabelle, additional, Oza, Amit, additional, Yonemori, Kan, additional, Xu, Ruihua, additional, Zhao, Jimmy L., additional, Gajavelli, Srikanth, additional, Filant, Justyna, additional, Hovey, Tina, additional, and Oaknin, Ana, additional

Published
2023
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48. Pembrolizumab in Lymphopenic Metastatic Breast Cancer Patients Treated with Metronomic Cyclophosphamide: A Clinical and Translational Prospective Study

Author

Mery, Benoîte, primary, Ménétrier-Caux, Christine, additional, Montané, Laure, additional, Heudel, Pierre-Etienne, additional, Ray-Coquard, Isabelle, additional, Bachelot, Thomas, additional, Derbel, Olfa, additional, Augereau, Paule, additional, Treilleux, Isabelle, additional, Berthet, Justine, additional, Nkodia, Axelle, additional, Bardin-Dit-Courageot, Christine, additional, Attignon, Valery, additional, Ferrari, Anthony, additional, Garin, Gwenaele, additional, Perol, David, additional, Caux, Christophe, additional, Dubois, Bertrand, additional, and Trédan, Olivier, additional

Published
2023
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50. Efficacy and Safety of Adjuvant Radiotherapy in Re-excised Soft-tissue Sarcoma After Unplanned Resection

Author

Allignet, Benoît, primary, Pou, Paul, additional, Izarn, Floriane, additional, Ray-Coquard, Isabelle, additional, Blay, Jean-Yves, additional, Dufresne, Armelle, additional, Brahmi, Mehdi, additional, Bouhamama, Amine, additional, Meeus, Pierre, additional, Vaz, Gualter, additional, Gouin, Francois, additional, Meurgey, Alexandra, additional, Karanian, Marie, additional, Moncharmont, Coralie, additional, Waissi, Waisse, additional, and Sunyach, Marie-Pierre, additional

Published
2023
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