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460 results on '"Leary, Alexandra"'

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. The CD47/TSP-1 axis: a promising avenue for ovarian cancer treatment and biomarker research

Author

Moniot, Aurélie, Schneider, Christophe, Chardin, Laure, Yaniz-Galende, Elisa, Genestie, Catherine, Etiennot, Marion, Henry, Aubéri, Drelon, Coralie, Le Formal, Audrey, Langlois, Benoit, Venat, Laurence, Louvet, Christophe, Favier, Laure, Lortholary, Alain, Berton-Rigaud, Dominique, Dohollou, Nadine, Desauw, Christophe, Fabbro, Michel, Malaurie, Emmanuelle, Dubot, Coraline, Kurtz, Jean Emmanuel, Bonichon Lamichhane, Nathalie, Pujade-Lauraine, Éric, Jeanne, Albin, Leary, Alexandra, and Dedieu, Stéphane

Published
2024
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3. 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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4. 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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7. Clinical research in endometrial cancer: consensus recommendations from the Gynecologic Cancer InterGroup

Author

Barretina-Ginesta, Pilar, Bennett, Katherine, Berek, Jonathan, Berger, Regina, Bjørge, Line, Boere, Ingrid, Brennan, Donal, Bruchim, Ilan, Chang, Ting-Chang, Chavez Blanco, Adriana, Chen, Xiaojun, Colombo, Nicoletta, Crosbie, Emma, Denys, Hannelore, Duska, Linda, Fruehauf, Filip, Gomez Garcia, Eva Maria, van Gorp, Toon, Grimm, Christoph, Guitmann, Gustavo, Han, Kathy, Hanker, Lars, Harano, Kenichi, Hasegawa, Kosei, Herrington, C Simon, Ip, Philip, Joly, Florence, Khaw, Pearly, Kohn, Elise, Kristeleit, Rebecca, Kroep, Judith, Leary, Alexandra, Lee, Jung-Yun, Lheureux, Stephanie, Liu, Jihong, Mackay, Helen, Mahner, Sven, Mariani, Andrea, McAlpine, Jessica, Mikami, Yoshiki, Mirza, Mansoor Raza, Mukhopadhyay, Asima, Nagao, Shoji, Ng, Joseph, Nogueira-Rodrigues, Angelica, Novák, Zoltán, O'Donnell, Jennifer, Osborne, Sherill, Perez-Fidalgo, J. Alejandro, Romeo Marin, Margarita, Roy Chowdhury, Rahul, Sadozye, Azmat, Safra, Tamar, Scott, Claire, Sehouli, Jalid, Slomovitz, Brian, Tan, David, Taylor, Alexandra, Valabrega, Giorgio, Veneziani, Ana, Verhoeven, Karen, Vetter, Marcus, Wampfler, Julian, Westin, Shannon, Wimberger, Pauline, Zola, Paolo, Creutzberg, Carien L, Kim, Jae-Weon, Eminowicz, Gemma, Allanson, Emma, Eberst, Lauriane, Kim, Se Ik, Nout, Remi A, Park, Jeong-Yeol, Lorusso, Domenica, Mileshkin, Linda, Ottevanger, Petronella B, Brand, Alison, Mezzanzanica, Delia, Oza, Amit, Gebski, Val, Pothuri, Bhavana, Batley, Tania, Gordon, Carol, Mitra, Tina, White, Helen, Howitt, Brooke, Matias-Guiu, Xavier, Ray-Coquard, Isabelle, Gaffney, David, Small, William, Jr, Miller, Austin, Concin, Nicole, Powell, Matthew A, Stuart, Gavin, and Bookman, Michael A

Published
2024
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8. Lurbinectedin in patients with pretreated endometrial cancer: results from a phase 2 basket clinical trial and exploratory translational study

Author

Kristeleit, Rebecca, Leary, Alexandra, Delord, Jean Pierre, Moreno, Victor, Oaknin, Ana, Castellano, Daniel, Shappiro, Geoffrey I., Fernández, Cristian, Kahatt, Carmen, Alfaro, Vicente, Siguero, Mariano, Rueda, Daniel, Zeaiter, Ali, Awada, Ahmad, Santaballa, Ana, Zaman, Khalil, Sehouli, Jalid, and Subbiah, Vivek

Published
2023
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9. Prognostic impact and causality of age on oncological outcomes in women with endometrial cancer: a multimethod analysis of the randomised PORTEC-1, PORTEC-2, and PORTEC-3 trials

Author

Wakkerman, Famke C, Wu, Jiqing, Putter, Hein, Jürgenliemk-Schulz, Ina M, Jobsen, Jan J, Lutgens, Ludy C H W, Haverkort, Marie A D, de Jong, Marianne A, Mens, Jan Willem M, Wortman, Bastiaan G, Nout, Remi A, Léon-Castillo, Alicia, Powell, Melanie E, Mileshkin, Linda R, Katsaros, Dionyssios, Alfieri, Joanne, Leary, Alexandra, Singh, Naveena, de Boer, Stephanie M, Nijman, Hans W, Smit, Vincent T H B M, Bosse, Tjalling, Koelzer, Viktor H, Creutzberg, Carien L, and Horeweg, Nanda

Published
2024
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13. Molecular and Clinicopathologic Characterization of Mismatch Repair-Deficient Endometrial Carcinoma Not Related to MLH1 Promoter Hypermethylation

Author

Kaya, Merve, Post, Cathalijne C.B., Tops, Carli M., Nielsen, Maartje, Crosbie, Emma J., Leary, Alexandra, Mileshkin, Linda R., Han, Kathy, Bessette, Paul, de Boer, Stephanie M., Jürgenliemk-Schulz, Ina M., Lutgens, Ludy, Jobsen, Jan J., Haverkort, Marie A.D., Nout, Remi A., Kroep, Judith, Creutzberg, Carien L., Smit, Vincent T.H.B.M., Horeweg, Nanda, van Wezel, Tom, and Bosse, Tjalling

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

Author

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

Published
2024
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17. Prognostic refinement of NSMP high-risk endometrial cancers using oestrogen receptor immunohistochemistry

Author

Vermij, Lisa, Jobsen, Jan J., León-Castillo, Alicia, Brinkhuis, Mariel, Roothaan, Suzan, Powell, Melanie E., de Boer, Stephanie M., Khaw, Pearly, Mileshkin, Linda R., Fyles, Anthony, Leary, Alexandra, Genestie, Catherine, Jürgenliemk-Schulz, Ina M., Crosbie, Emma J., Mackay, Helen J., Nijman, Hans. W., Nout, Remi A., Smit, Vincent T. H. B. M., Creutzberg, Carien L., Horeweg, Nanda, and Bosse, Tjalling

Published
2023
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18. 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

19. 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

21. A RAD51 functional assay as a candidate test for homologous recombination deficiency in ovarian cancer

Author

Blanc-Durand, Félix, Yaniz-Galende, Elisa, Llop-Guevara, Alba, Genestie, Catherine, Serra, Violeta, Herencia-Ropero, Andrea, Klein, Christophe, Berton, Dominique, Lortholary, Alain, Dohollou, Nadine, Desauw, Christophe, Fabbro, Michel, Malaurie, Emmanuelle, Bonichon-Lamaichhane, Nathalie, Dubot, Coraline, Kurtz, Jean Emmanuel, de Rauglaudre, Gaëtan, Raban, Nadia, Chevalier-Place, Annick, Ferron, Gwenael, Kaminsky, Marie-Christine, Kramer, Claire, Rouleau, Etienne, and Leary, Alexandra

Published
2023
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22. Interpretable deep learning model to predict the molecular classification of endometrial cancer from haematoxylin and eosin-stained whole-slide images: a combined analysis of the PORTEC randomised trials and clinical cohorts

Author

Fremond, Sarah, Andani, Sonali, Barkey Wolf, Jurriaan, Dijkstra, Jouke, Melsbach, Sinéad, Jobsen, Jan J, Brinkhuis, Mariel, Roothaan, Suzan, Jurgenliemk-Schulz, Ina, Lutgens, Ludy C H W, Nout, Remi A, van der Steen-Banasik, Elzbieta M, de Boer, Stephanie M, Powell, Melanie E, Singh, Naveena, Mileshkin, Linda R, Mackay, Helen J, Leary, Alexandra, Nijman, Hans W, Smit, Vincent T H B M, Creutzberg, Carien L, Horeweg, Nanda, Koelzer, Viktor H, and Bosse, Tjalling

Published
2023
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23. p53 immunohistochemistry in endometrial cancer: clinical and molecular correlates in the PORTEC-3 trial

Author

Vermij, Lisa, Léon-Castillo, Alicia, Singh, Naveena, Powell, Melanie E., Edmondson, Richard J., Genestie, Catherine, Khaw, Pearly, Pyman, Jan, McLachlin, C. Meg, Ghatage, Prafull, de Boer, Stephanie M., Nijman, Hans W., Smit, Vincent T. H. B. M., Crosbie, Emma J., Leary, Alexandra, Creutzberg, Carien L., Horeweg, Nanda, and Bosse, Tjalling

Published
2022
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25. Low probability of disease cure in advanced ovarian carcinomas before the PARP inhibitor era

Author

You, Benoit, Van Wagensveld, Lilian, Tod, Michel, Sonke, Gabe S., Horlings, Hugo M., Kruitwagen, R. F. P. M., Du Bois, Andreas, Selle, Frédéric, Perren, Timothy, Pfisterer, Jacobus, Joly, Florence, Cook, Adrian, Kaminsky, Marie Christine, Wollschlaeger, Kerstin, Lortholary, Alain, Tome, Oliver, Leary, Alexandra, Freyer, Gilles, Van Der Aa, Maaike, and Colomban, Olivier

Published
2022
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28. Tertiary lymphoid structures critical for prognosis in endometrial cancer patients

Author

Horeweg, Nanda, Workel, Hagma H., Loiero, Dominik, Church, David N., Vermij, Lisa, Léon-Castillo, Alicia, Krog, Ricki T., de Boer, Stephanie M., Nout, Remi A., Powell, Melanie E., Mileshkin, Linda R., MacKay, Helen, Leary, Alexandra, Singh, Naveena, Jürgenliemk-Schulz, Ina M., Smit, Vincent T. H. B. M., Creutzberg, Carien L., Koelzer, Viktor H., Nijman, Hans W., Bosse, Tjalling, and de Bruyn, Marco

Published
2022
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29. Clinical utility of comprehensive liquid molecular profiling in patients with advanced endometrial cancer.

Author

Blanc‐Durand, Félix, Camilleri, Geraldine M., Bayle, Arnaud, Aldea, Mihaela, Vasseur, Damien, Ouali, Kaissa, Michels, Judith, Pautier, Patricia, Nicotra, Claudio, Ngo‐Camus, Maud, Lacroix, Ludovic, Rouleau, Etienne, Ponce‐Aix, Santiago, Italiano, Antoine, and Leary, Alexandra

Subjects
CANCER patients, ENDOMETRIAL cancer, CELL-free DNA, MEDICAL societies, DRUG target
Abstract

Background: Molecular characterization has significantly improved the management of advanced endometrial cancer (EC). It distinguishes four molecular subclasses associated with prognosis and personalized therapeutic strategies. This study assesses the clinical utility of cell‐free DNA (cfDNA) profiling in EC to identify targetable alterations. Methods: Women with metastatic or recurrent EC were prospectively recruited within the framework of the STING trial (NCT04932525), during which cfDNA was analyzed. Genomic alterations were identified with the FoundationOne CDx assay. Each molecular report underwent review by a molecular tumor board. Alterations were categorized via the European Society of Medical Oncology Scale for Clinical Actionability of Molecular Targets (ESCAT). Results: A total of 61 patients were enrolled. The median age was 66.9 years, with 43% presenting frontline metastatic disease. All histologic subgroups were represented. Notably, 89% of patients yielded informative cfDNA analysis. Six tumors were classified with deficient mismatch repair/microsatellite instability (11%) and 37 as TP53 gene mutant (67%), and 12 had nonspecific molecular profiles (22%). Molecular classification based on liquid biopsy showed 87.5% accuracy in correlating with tissue results. Moreover, 65% of cases exhibited ≥1 actionable alteration, including 25% ESCAT I alterations and 13% ESCAT II alterations. Consequently, 16% of patients received a molecularly matched therapy, and presented with a 56% response rate and median progression‐free survival of 7.7 months. Conclusions: cfDNA sequencing in EC is a feasible approach that produces informative results in 89% of cases and accurately categorizes patients into the main molecular subclasses. It also reveals multiple actionable alterations, which offers the potential for personalized therapeutic strategies. Cell‐free DNA sequencing is a highly feasible assay that allows an accurate molecular characterization of patients with advanced endometrial cancer while detecting multiple actionable alterations. It serves as a valuable tool for tailoring the management of patients with metastatic endometrial cancer. [ABSTRACT FROM AUTHOR]

Published
2024
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30. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Banerjee, Susana, Moore, Kathleen N, Colombo, Nicoletta, Scambia, Giovanni, Kim, Byoung-Gie, Oaknin, Ana, Friedlander, Michael, Lisyanskaya, Alla, Floquet, Anne, Leary, Alexandra, Sonke, Gabe S, Gourley, Charlie, Oza, Amit, González-Martín, Antonio, Aghajanian, Carol, Bradley, William H, Holmes, Eileen, Lowe, Elizabeth S, and DiSilvestro, Paul

Published
2021
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34. Overall Survival With Maintenance Olaparib at a 7-Year Follow-up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial

Author

DiSilvestro, Paul, Banerjee, Susana, Colombo, Nicoletta, Scambia, Giovanni, Kim, Byoung-Gie, Oaknin, Ana, Friedlander, Michael, Lisyanskaya, Alla, Floquet, Anne, Leary, Alexandra, Sonke, Gabe S., Gourley, Charlie, Oza, Amit, González-Martín, Antonio, Aghajanian, Carol, Bradley, William, Mathews, Cara, Liu, Joyce, McNamara, John, Lowe, Elizabeth S., Ah-See, Mei-Lin, and Moore, Kathleen N.

Published
2023
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35. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study

Author

Pujade-Lauraine, Eric, Fujiwara, Keiichi, Ledermann, Jonathan A, Oza, Amit M, Kristeleit, Rebecca, Ray-Coquard, Isabelle-Laure, Richardson, Gary E, Sessa, Cristiana, Yonemori, Kan, Banerjee, Susana, Leary, Alexandra, Tinker, Anna V, Jung, Kyung Hae, Madry, Radoslaw, Park, Sang-Yoon, Anderson, Charles K, Zohren, Fabian, Stewart, Ross A, Wei, Caimiao, Dychter, Samuel S, and Monk, Bradley J

Published
2021
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36. Long-Term Toxicity and Health-Related Quality of Life After Adjuvant Chemoradiation Therapy or Radiation Therapy Alone for High-Risk Endometrial Cancer in the Randomized PORTEC-3 Trial

Author

Post, Cathalijne C.B., de Boer, Stephanie M., Powell, Melanie E., Mileshkin, Linda, Katsaros, Dionyssios, Bessette, Paul, Haie-Meder, Christine, Ottevanger, Nelleke (P.) B., Ledermann, Jonathan A., Khaw, Pearly, D'Amico, Romerai, Fyles, Anthony, Baron, Marie Hélène, Kitchener, Henry C., Nijman, Hans W., Lutgens, Ludy C.H.W., Brooks, Susan, Jürgenliemk-Schulz, Ina M., Feeney, Amanda, Goss, Geraldine, Fossati, Roldano, Ghatage, Prafull, Leary, Alexandra, Do, Viet, Lissoni, Andrea A., McCormack, Mary, Nout, Remi A., Verhoeven-Adema, Karen W., Smit, Vincent T.H.B.M., Putter, Hein, and Creutzberg, Carien L.

Published
2021
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38. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Coleman, Robert L, Oza, Amit M, Lorusso, Domenica, Aghajanian, Carol, Oaknin, Ana, Dean, Andrew, Colombo, Nicoletta, Weberpals, Johanne I, Clamp, Andrew, Scambia, Giovanni, Leary, Alexandra, Holloway, Robert W, Gancedo, Margarita Amenedo, Fong, Peter C, Goh, Jeffrey C, O'Malley, David M, Armstrong, Deborah K, Garcia-Donas, Jesus, Swisher, Elizabeth M, Floquet, Anne, Konecny, Gottfried E, McNeish, Iain A, Scott, Clare L, Cameron, Terri, Maloney, Lara, Isaacson, Jeff, Goble, Sandra, Grace, Caroline, Harding, Thomas C, Raponi, Mitch, Sun, James, Lin, Kevin K, Giordano, Heidi, Ledermann, Jonathan A, investigators, ARIEL3, Buck, M, Dean, A, Friedlander, ML, Goh, JC, Harnett, P, Kichenadasse, G, Scott, CL, Denys, H, Dirix, L, Vergote, I, Elit, L, Ghatage, P, Oza, AM, Plante, M, Provencher, D, Weberpals, JI, Welch, S, Floquet, A, Gladieff, L, Joly, F, Leary, A, Lortholary, A, Lotz, J, Medioni, J, Tredan, O, You, B, El-Balat, A, Hänle, C, Krabisch, P, Neunhöffer, T, Pölcher, M, Wimberger, P, Amit, A, Kovel, S, Leviov, M, Safra, T, Shapira-Frommer, R, Stemmer, S, Bologna, A, Colombo, N, Lorusso, D, Pignata, S, Sabbatini, RF, Scambia, G, Tamberi, S, Zamagni, C, Fong, PC, O'Donnell, A, Gancedo, M Amenedo, Herraez, A Casado, Garcia-Donas, J, Guerra, EM, Oaknin, A, Palacio, I, Romero, I, Sanchez, A, Banerjee, SN, Clamp, A, Drew, Y, Gabra, HG, Jackson, D, Ledermann, JA, McNeish, IA, Parkinson, C, and Powell, M

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Orphan Drug, Clinical Research, Cancer, Genetics, Clinical Trials and Supportive Activities, Ovarian Cancer, Rare Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Aged, Disease-Free Survival, Double-Blind Method, Female, Follow-Up Studies, Humans, Indoles, Internationality, Maintenance Chemotherapy, Middle Aged, Molecular Targeted Therapy, Neoplasm Recurrence, Local, Ovarian Neoplasms, Poly(ADP-ribose) Polymerase Inhibitors, Risk Assessment, Survival Rate, Treatment Outcome, ARIEL3 investigators, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundRucaparib, a poly(ADP-ribose) polymerase inhibitor, has anticancer activity in recurrent ovarian carcinoma harbouring a BRCA mutation or high percentage of genome-wide loss of heterozygosity. In this trial we assessed rucaparib versus placebo after response to second-line or later platinum-based chemotherapy in patients with high-grade, recurrent, platinum-sensitive ovarian carcinoma.MethodsIn this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients from 87 hospitals and cancer centres across 11 countries. Eligible patients were aged 18 years or older, had a platinum-sensitive, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube carcinoma, had received at least two previous platinum-based chemotherapy regimens, had achieved complete or partial response to their last platinum-based regimen, had a cancer antigen 125 concentration of less than the upper limit of normal, had a performance status of 0-1, and had adequate organ function. Patients were ineligible if they had symptomatic or untreated central nervous system metastases, had received anticancer therapy 14 days or fewer before starting the study, or had received previous treatment with a poly(ADP-ribose) polymerase inhibitor. We randomly allocated patients 2:1 to receive oral rucaparib 600 mg twice daily or placebo in 28 day cycles using a computer-generated sequence (block size of six, stratified by homologous recombination repair gene mutation status, progression-free interval after the penultimate platinum-based regimen, and best response to the most recent platinum-based regimen). Patients, investigators, site staff, assessors, and the funder were masked to assignments. The primary outcome was investigator-assessed progression-free survival evaluated with use of an ordered step-down procedure for three nested cohorts: patients with BRCA mutations (carcinoma associated with deleterious germline or somatic BRCA mutations), patients with homologous recombination deficiencies (BRCA mutant or BRCA wild-type and high loss of heterozygosity), and the intention-to-treat population, assessed at screening and every 12 weeks thereafter. This trial is registered with ClinicalTrials.gov, number NCT01968213; enrolment is complete.FindingsBetween April 7, 2014, and July 19, 2016, we randomly allocated 564 patients: 375 (66%) to rucaparib and 189 (34%) to placebo. Median progression-free survival in patients with a BRCA-mutant carcinoma was 16·6 months (95% CI 13·4-22·9; 130 [35%] patients) in the rucaparib group versus 5·4 months (3·4-6·7; 66 [35%] patients) in the placebo group (hazard ratio 0·23 [95% CI 0·16-0·34]; p

Published
2017

39. 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

41. Predicting tumor response and outcome of second-look surgery with 18F-FDG PET/CT: insights from the GINECO CHIVA phase II trial of neoadjuvant chemotherapy plus nintedanib in stage IIIc-IV FIGO ovarian cancer

Author

Aide, Nicolas, Fauchille, Pauline, Coquan, Elodie, Ferron, Gwenael, Combe, Pierre, Meunier, Jérome, Alexandre, Jerôme, Berton, Dominique, Leary, Alexandra, De Rauglaudre, Gaétan, Bonichon, Nathalie, Pujade Lauraine, Eric, and Joly, Florence

Published
2021
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43. Characterization of patients with long-term responses to rucaparib treatment in recurrent ovarian cancer

Author

Swisher, Elizabeth M., Kristeleit, Rebecca S., Oza, Amit M., Tinker, Anna V., Ray-Coquard, Isabelle, Oaknin, Ana, Coleman, Robert L., Burris, Howard A., Aghajanian, Carol, O'Malley, David M., Leary, Alexandra, Welch, Stephen, Provencher, Diane, Shapiro, Geoffrey I., Chen, Lee-may, Shapira-Frommer, Ronnie, Kaufmann, Scott H., Goble, Sandra, Maloney, Lara, Kwan, Tanya, Lin, Kevin K., and McNeish, Iain A.

Published
2021
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50. Comparative analysis of predictive values of the kinetics of 11 circulating miRNAs and of CA125 in ovarian cancer during first line treatment (a GINECO study)

Author

Robelin, Patrick, Tod, Michel, Colomban, Olivier, Lachuer, Joel, Ray-Coquard, Isabelle, Rauglaudre, Gaëtan De, Joly, Florence, Chevalier-Place, Annick, Combe, Pierre, Lortholary, Alain, Hamizi, Salima, Raban, Nadia, Ferron, Gwénaël, Meunier, Jérôme, Berton-Rigaud, Dominique, Alexandre, Jérôme, Kaminsky, Marie-Christine, Dubot, Coraline, Leary, Alexandra, Malaurie, Emmanuelle, and You, Benoit

Published
2020
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