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1. Deciphering genetic and nongenetic factors underlying tumour dormancy: insights from multiomics analysis of two syngeneic MRD models of melanoma and leukemia

Author

Marie-Océane Laguillaumie, Sofia Titah, Aurélie Guillemette, Bernadette Neve, Frederic Leprêtre, Pascaline Ségard, Faruk Azam Shaik, Dominique Collard, Jean-Claude Gerbedoen, Léa Fléchon, Lama Hasan Bou Issa, Audrey Vincent, Martin Figeac, Shéhérazade Sebda, Céline Villenet, Jérôme Kluza, William Laine, Isabelle Fournier, Jean-Pascal Gimeno, Maxence Wisztorski, Salomon Manier, Mehmet Cagatay Tarhan, Bruno Quesnel, Thierry Idziorek, and Yasmine Touil

Subjects
Tumour dormancy, Leukemia, Melanoma, Syngeneic model, Multiomics analysis, ChIP-seq, Biology (General), QH301-705.5
Abstract

Abstract Background Tumour dormancy, a resistance mechanism employed by cancer cells, is a significant challenge in cancer treatment, contributing to minimal residual disease (MRD) and potential relapse. Despite its clinical importance, the mechanisms underlying tumour dormancy and MRD remain unclear. In this study, we employed two syngeneic murine models of myeloid leukemia and melanoma to investigate the genetic, epigenetic, transcriptomic and protein signatures associated with tumour dormancy. We used a multiomics approach to elucidate the molecular mechanisms driving MRD and identify potential therapeutic targets. Results We conducted an in-depth omics analysis encompassing whole-exome sequencing (WES), copy number variation (CNV) analysis, chromatin immunoprecipitation followed by sequencing (ChIP-seq), transcriptome and proteome investigations. WES analysis revealed a modest overlap of gene mutations between melanoma and leukemia dormancy models, with a significant number of mutated genes found exclusively in dormant cells. These exclusive genetic signatures suggest selective pressure during MRD, potentially conferring resistance to the microenvironment or therapies. CNV, histone marks and transcriptomic gene expression signatures combined with Gene Ontology (GO) enrichment analysis highlighted the potential functional roles of the mutated genes, providing insights into the pathways associated with MRD. In addition, we compared “murine MRD genes” profiles to the corresponding human disease through public datasets and highlighted common features according to disease progression. Proteomic analysis combined with multi-omics genetic investigations, revealed a dysregulated proteins signature in dormant cells with minimal genetic mechanism involvement. Pathway enrichment analysis revealed the metabolic, differentiation and cytoskeletal remodeling processes involved in MRD. Finally, we identified 11 common proteins differentially expressed in dormant cells from both pathologies. Conclusions Our study underscores the complexity of tumour dormancy, implicating both genetic and nongenetic factors. By comparing genomic, transcriptomic, proteomic, and epigenomic datasets, our study provides a comprehensive understanding of the molecular landscape of minimal residual disease. These results provide a robust foundation for forthcoming investigations and offer potential avenues for the advancement of targeted MRD therapies in leukemia and melanoma patients, emphasizing the importance of considering both genetic and nongenetic factors in treatment strategies. Graphical Abstract

Published
2024
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2. Deciphering genetic and nongenetic factors underlying tumour dormancy: insights from multiomics analysis of two syngeneic MRD models of melanoma and leukemia

Author

Laguillaumie, Marie-Océane, Titah, Sofia, Guillemette, Aurélie, Neve, Bernadette, Leprêtre, Frederic, Ségard, Pascaline, Shaik, Faruk Azam, Collard, Dominique, Gerbedoen, Jean-Claude, Fléchon, Léa, Hasan Bou Issa, Lama, Vincent, Audrey, Figeac, Martin, Sebda, Shéhérazade, Villenet, Céline, Kluza, Jérôme, Laine, William, Fournier, Isabelle, Gimeno, Jean-Pascal, Wisztorski, Maxence, Manier, Salomon, Tarhan, Mehmet Cagatay, Quesnel, Bruno, Idziorek, Thierry, and Touil, Yasmine

Published
2024
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3. Impact of a one-year supervised physical activity program on long-term cancer-related fatigue and mediating effects of the gut microbiota in metastatic testicular cancer patients: protocol of the prospective multicentre, randomized controlled phase-III STARTER trial

Author

Hwayoung Noh, Amélie Anota, Rodolf Mongondry, Renaud Meyrand, Carmen Dupuis, Camille Schiffler, Philippe Marijnen, Sabina Rinaldi, Joel Lachuer, Pekka Keski-Rahkonen, Marc J Gunter, Aude Fléchon, Béatrice Fervers, and Olivia Pérol

Subjects
Physical activity, Testicular cancer, Cancer-related fatigue, Health-related quality of life, Cancer-related sequelae, Gut microbiota, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Testicular germ cell tumours (TGCTs) are the most common malignancy in men aged 15–40 years, with increasing incidence worldwide. About 33 ~ 50% of the patients present with metastatic disease at diagnosis. TGCT survivors experience short- and long-term sequelae, including cancer-related fatigue (CRF). Physical activity (PA) has established effects on reducing CRF and other sequelae and improving health-related quality of life (HRQoL). However, its impact on TGCT survivors has so far received little attention. The gut microbiota plays a crucial role in various physiological functions, including cognition and metabolism, and may mediate the effects of PA on CRF and other sequelae, but this has not been investigated in randomized controlled trials. Methods This national, multicentre, phase-III trial will evaluate the impact of a one-year supervised PA program on CRF and other short- and long-term sequelae in metastatic TGCT patients receiving cisplatin-based chemotherapy combined with etoposide+/-bleomycin. It will also investigate potential mediating effects of the gut microbiota and its metabolites involved in the gut-brain axis on the relationship between PA and CRF and other sequelae. A total of 236 men ≥ 18 years of age with metastatic TGCT (seminoma and non-seminoma) will be enrolled before starting first-line chemotherapy in several French hospitals. The primary (CRF) and secondary (cognitive/psychological/metabolic sequelae, HRQoL, etc.) outcomes and gut microbiota and relevant metabolites will be assessed at inclusion, during and at the end of the one-year intervention, and annually until 10 years since inclusion to assess long-term sequelae, more specifically CRF, cardiovascular toxicities, and second primary cancer occurrence in this population. Discussion This trial will provide comprehensive and novel insights into the effects of a long-term supervised PA program on CRF and other sequelae in metastatic TGCT patients receiving first-line chemotherapy. It will also contribute to understanding the potential role of the gut microbiota and its metabolites in mediating the effects of PA on these outcomes. The findings of this study will help the development of effective PA interventions to improve the health of TGCT survivors and may have implications for other cancer populations as well. Trial registration The study was registered on ClinicalTrials.gov (NCT05588700) on 20 Oct. 2022.

Published
2024
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4. MYC dependency in GLS1 and NAMPT is a therapeutic vulnerability in multiple myeloma

Author

Lama Hasan Bou Issa, Léa Fléchon, William Laine, Aicha Ouelkdite, Silvia Gaggero, Adeline Cozzani, Remi Tilmont, Paul Chauvet, Nicolas Gower, Romanos Sklavenitis-Pistofidis, Carine Brinster, Xavier Thuru, Yasmine Touil, Bruno Quesnel, Suman Mitra, Irene M. Ghobrial, Jérôme Kluza, and Salomon Manier

Subjects
Cancer, Metabolomics, Transcriptomics, Science
Abstract

Summary: Multiple myeloma (MM) is an incurable hematological malignancy in which MYC alterations contribute to the malignant phenotype. Nevertheless, MYC lacks therapeutic druggability. Here, we leveraged large-scale loss-of-function screens and conducted a small molecule screen to identify genes and pathways with enhanced essentiality correlated with MYC expression. We reported a specific gene dependency in glutaminase (GLS1), essential for the viability and proliferation of MYC overexpressing cells. Conversely, the analysis of isogenic models, as well as cell lines dataset (CCLE) and patient datasets, revealed GLS1 as a non-oncogenic dependency in MYC-driven cells. We functionally delineated the differential modulation of glutamine to maintain mitochondrial function and cellular biosynthesis in MYC overexpressing cells. Furthermore, we observed that pharmaceutical inhibition of NAMPT selectively affects MYC upregulated cells. We demonstrate the effectiveness of combining GLS1 and NAMPT inhibitors, suggesting that targeting glutaminolysis and NAD synthesis may be a promising strategy to target MYC-driven MM.

Published
2024
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5. Exposure‐response relationship of ramucirumab in RANGE, a randomized phase III trial in advanced urothelial carcinoma refractory to platinum therapy

Author

Wit, Ronald, Powles, Thomas, Castellano, Daniel, Necchi, Andrea, Lee, Jae‐Lyun, Heijden, Michiel S, Matsubara, Nobuaki, Bamias, Aristotelis, Fléchon, Aude, Sternberg, Cora N, Drakaki, Alexandra, Yu, Evan Y, Zimmermann, Annamaria H, Long, Amanda, Walgren, Richard A, Gao, Ling, Bell‐McGuinn, Katherine M, and Petrylak, Daniel P

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Transitional Cell, Docetaxel, Humans, Platinum, Urinary Bladder Neoplasms, exposure-response, overall survival, progression-free survival, ramucirumab, urothelial carcinoma, Pharmacology and Pharmaceutical Sciences, Pharmacology & Pharmacy, Pharmacology and pharmaceutical sciences
Abstract

AimsPatients with advanced urothelial carcinoma (UC) who progress after platinum-based chemotherapy have a poor prognosis, and there is a medical need to improve current treatment options. Ramucirumab plus docetaxel significantly improved progression-free survival but not overall survival (OS) in platinum-refractory advanced UC (RANGE trial; NCT02426125). Here, we report the exposure-response (ER) of ramucirumab plus docetaxel using data from the RANGE trial.MethodsPharmacokinetic (PK) samples were collected (cycle 1-3, 5, 9 [day 1] and 30 days from treatment discontinuation), and PK data were analysed using population PK (popPK) analysis. The minimum ramucirumab concentration after first dose administration (Cmin,1 , or trough concentration immediately prior to the second dose) was derived by popPK analysis and used as the exposure parameter for ER analysis. Cox proportional hazards regression models and matched case-control analyses were used to evaluate the relationship between Cmin,1 and OS. The Cmin,1 relationship with safety was assessed descriptively.ResultsSeveral poor prognostic factors (ECOG 1, haemoglobin concentration

Published
2022

7. Corridor for new mobility Aachen-D\'usseldorf: Methods and concepts of the research project ACCorD

Author

Kloeker, Laurent, Kloeker, Amarin, Thomsen, Fabian, Erraji, Armin, Eckstein, Lutz, Lamberty, Serge, Fazekas, Adrian, Kalló, Eszter, Oeser, Markus, Fléchon, Charlotte, Lohmiller, Jochen, Pfeiffer, Pascal, Sommer, Martin, and Winter, Helen

Subjects
Computer Science - Computers and Society, Computer Science - Computer Vision and Pattern Recognition
Abstract

With the Corridor for New Mobility Aachen - D\"usseldorf, an integrated development environment is created, incorporating existing test capabilities, to systematically test and validate automated vehicles in interaction with connected Intelligent Transport Systems Stations (ITS-Ss). This is achieved through a time- and cost-efficient toolchain and methodology, in which simulation, closed test sites as well as test fields in public transport are linked in the best possible way. By implementing a digital twin, the recorded traffic events can be visualized in real-time and driving functions can be tested in the simulation based on real data. In order to represent diverse traffic scenarios, the corridor contains a highway section, a rural area, and urban areas. First, this paper outlines the project goals before describing the individual project contents in more detail. These include the concepts of traffic detection, driving function development, digital twin development, and public involvement.

Published
2021

8. Genomic profiling of mycosis fungoides identifies patients at high risk of disease progression

Author

Fléchon, Léa, Arib, Inès, Dutta, Ankit K., Hasan Bou Issa, Lama, Sklavenitis-Pistofidis, Romanos, Tilmont, Rémi, Stewart, Chip, Dubois, Romain, Poulain, Stéphanie, Copin, Marie-Christine, Javed, Sahir, Nudel, Morgane, Cavalieri, Doriane, Escure, Guillaume, Gower, Nicolas, Chauvet, Paul, Gazeau, Nicolas, Saade, Cynthia, Thiam, Marietou Binta, Ouelkite-Oumouchal, Aïcha, Gaggero, Silvia, Cailliau, Émeline, Faiz, Sarah, Carpentier, Olivier, Duployez, Nicolas, Idziorek, Thierry, Mortier, Laurent, Figeac, Martin, Preudhomme, Claude, Quesnel, Bruno, Mitra, Suman, Morschhauser, Franck, Getz, Gad, Ghobrial, Irene M., and Manier, Salomon

Published
2024
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11. TROPHY-U-01, a phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors: updated safety and efficacy outcomes

Author

Loriot, Y., Petrylak, D.P., Rezazadeh Kalebasty, A., Fléchon, A., Jain, R.K., Gupta, S., Bupathi, M., Beuzeboc, P., Palmbos, P., Balar, A.V., Kyriakopoulos, C.E., Pouessel, D., Sternberg, C.N., Tonelli, J., Sierecki, M., Zhou, H., Grivas, P., Barthélémy, P., and Tagawa, S.T.

Published
2024
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12. Perioperative dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin in muscle-invasive bladder cancer (VESPER): survival endpoints at 5 years in an open-label, randomised, phase 3 study

Author

PIGNOT, Géraldine, FENDLER, Jean Philippe, GUY, Laurent, VERHOEST, Grégory, MOTTET, Nicolas, DOERFLER, Arnaud, ABADIE LACOURTOISIE, Sophie, AZZOUZI, Abde Rahmene, MONGIAT, Pierre, GEOFFROIS, Lionnel, ESCHWEGE, Pascal, DI FIORE, Frédéric, ROUBAUD, Guilhem, HOEPFFNER, Jean Luc, BARTHELEMY, Philippe, LANG, Hervé, VOOG, Eric, MANDRON, Eric, TOURANI, Jean Marc, SERRATE, Camille, COLAU, Alexandre, SALDANA, Carolina, DE LA TAILLE, Alexandre, NGUYEN, Thierry, KLEINCLAUSS, François, LORIOT, Yohan, IRANI, Jacques, EYMARD, Jean Christophe, LARRE, Stéphane, HUILLARD, Olivier, ZERBIB, Marc, ROLLAND, Frédéric, RIGAUD, Jérôme, HOUEDE, Nadine, DROUPY, Stéphane, MALOUF, Georgina, ROUPRET, Morgan, VIEILLOT, Sabine, LETANG, Nicolas, LHARIDON, Tiffen, GASCHIGNARD, Nicolas, HILGERS, Werner, DAVIN, Jean Louis, Pfister, Christian, Gravis, Gwenaelle, Flechon, Aude, Chevreau, Christine, Mahammedi, Hakim, Laguerre, Brigitte, Guillot, Aline, Joly, Florence, Soulie, Michel, Allory, Yves, Harter, Valentin, and Culine, Stéphane

Published
2024
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14. Bone Metastases in Non-Seminomatous Germ Cell Tumors: A 20-Year Retrospective Analysis

Author

Romane Gille, Benoît Allignet, Floriane Izarn, Patrice Peyrat, Helen Boyle, and Aude Fléchon

Subjects
bone metastases, non-seminomatous germ cell tumor, testicular cancer, prognosis, chemotherapy, Medicine
Abstract

Background: Non-seminomatous germ cell tumors (NSGCTs) represent a rare yet the most prevalent malignancy among young men. Bone metastases (BMs) are exceedingly uncommon in this neoplasm, and available data regarding the initial disease presentation, survival outcomes, and prognostic significance of BMs are limited. Methods: We conducted a retrospective analysis of 40 NSGCT patients with BMs treated between 2001 and 2021 in our tertiary care center. The cohort was stratified into synchronous (n = 29) and metachronous (n = 11) groups based on the presence of BM at diagnosis or only at relapse, respectively. We assessed overall survival (OS), progression-free survival (PFS), disease presentation, and treatments. Results: After a median follow-up of 93 months, the 5-year PFS and OS rates were 37.6% and 53.9% in the synchronous group and 18.2% and 36.4% in the metachronous group, respectively. At the initial diagnosis, most patients were classified into the IGCCCG poor prognostic group (n = 34, 85%). BMs were mostly asymptomatic (n = 23, 57.5%), involved the spine (n = 37, 92.5%), and could become visible only after disease response (n = 4, 10%). A pathological examination of resected bone lesions after first-line treatment revealed necrosis (n = 5, 71.4%), teratoma, or seminoma (both n = 1, 14.3%). At first relapse, eight patients in the synchronous group did not experience bone recurrence, while eight patients experienced recurrence at the initial affected bone site. Conclusions: In NSGCT patients, BMs often present asymptomatically and may initially be unnoticed. However, these patients may have a poorer prognosis compared to those in the IGCCCG poor prognostic group. Further studies including control groups are needed to assess the independent prognostic significance of BMs.

Published
2024
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15. Small myeloid subclones are present at diagnosis of multiple myeloma in patients who develop secondary myelodysplastic syndromes

Author

Guillaume Escure, Elise Fournier, Cynthia Saade, Lama Hasan Bou Issa, Inès Arib, Rémi Tilmont, Nicolas Gazeau, Binta M. Thiam, Morgane Chovet, Maxime Delforge, Nicolas Gower, Léa Fléchon, Doriane Cavalieri, Paul Chauvet, Morgane Nudel, Laure Goursaud, Céline Berthon, Bruno Quesnel, Thierry Facon, Claude Preudhomme, Nicolas Duployez, and Salomon Manier

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Published
2023
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16. Long term activity of vemurafenib in cancers with BRAF mutations: the ACSE basket study for advanced cancers other than BRAFV600-mutated melanoma

Author

Blay, J.Y., Cropet, C., Mansard, S., Loriot, Y., De La Fouchardière, C., Haroche, J., Topart, D., Tougeron, D., You, B., Italiano, A., Le Brun-Ly, V., Ferrero, J.M., Penel, N., Fabbro, M., Troussard, X., Malka, D., Ray-Coquard, I., Leboulleux, S., Fléchon, A., Maubec, E., Charles, J., Dalle, S., Taieb, S., Garcia, G.C.T.E., Mandache, A.M., Colignon, N., Gavrel, M., Nowak, F., Hoog Labouret, N., Mahier Aït Oukhatar, C., and Gomez-Roca, C.

Published
2023
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19. Gemcitabine plus platinum-based chemotherapy in combination with bevacizumab for kidney metastatic collecting duct and medullary carcinomas: Results of a prospective phase II trial (BEVABEL-GETUG/AFU24)

Author

Thibault, Constance, Fléchon, Aude, Albiges, Laurence, Joly, Charlotte, Barthelemy, Philippe, Gross-Goupil, Marine, Chevreau, Christine, Coquan, Elodie, Rolland, Frédéric, Laguerre, Brigitte, Gravis, Gwenaelle, Pécuchet, Nicolas, Elaidi, Réza-Thierry, Timsit, Marc-Olivier, Brihoum, Meryem, Auclin, Edouard, de Reyniès, Aurélien, Allory, Yves, and Oudard, Stéphane

Published
2023
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21. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial.

Author

Petrylak, Daniel, de Wit, Ronald, Chi, Kim, Drakaki, Alexandra, Sternberg, Cora, Nishiyama, Hiroyuki, Castellano, Daniel, Hussain, Syed, Fléchon, Aude, Bamias, Aristotelis, Yu, Evan, van der Heijden, Michiel, Matsubara, Nobuaki, Alekseev, Boris, Necchi, Andrea, Géczi, Lajos, Ou, Yen-Chuan, Coskun, Hasan, Su, Wen-Pin, Bedke, Jens, Gakis, Georgios, Percent, Ivor, Lee, Jae-Lyun, Tucci, Marcello, Semenov, Andrey, Laestadius, Fredrik, Peer, Avivit, Tortora, Giampaolo, Safina, Sufia, Garcia Del Muro, Xavier, Rodriguez-Vida, Alejo, Cicin, Irfan, Harputluoglu, Hakan, Tagawa, Scott, Vaishampayan, Ulka, Aragon-Ching, Jeanny, Hamid, Oday, Liepa, Astra, Wijayawardana, Sameera, Russo, Francesca, Walgren, Richard, Zimmermann, Annamaria, Hozak, Rebecca, Bell-McGuinn, Katherine, and Powles, Thomas

Subjects
Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Transitional Cell, Docetaxel, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Invasiveness, Neoplasm Metastasis, Platinum, Prognosis, Salvage Therapy, Survival Rate, Urologic Neoplasms, Ramucirumab
Abstract

BACKGROUND: Ramucirumab-an IgG1 vascular endothelial growth factor receptor 2 antagonist-plus docetaxel was previously reported to improve progression-free survival in platinum-refractory, advanced urothelial carcinoma. Here, we report the secondary endpoint of overall survival results for the RANGE trial. METHODS: We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy. Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries. Previous treatment with one immune checkpoint inhibitor was permitted. Patients were randomly assigned (1:1) using an interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m2 (60 mg/m2 in Korea, Taiwan, and Japan) on day 1 of a 21-day cycle. Treatment continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Randomisation was stratified by geographical region, Eastern Cooperative Oncology Group performance status at baseline, and visceral metastasis. Progression-free survival (the primary endpoint) and overall survival (a key secondary endpoint) were assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02426125; patient enrolment is complete and the last patient on treatment is being followed up for safety issues. FINDINGS: Between July 20, 2015, and April 4, 2017, 530 patients were randomly allocated to ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267) and comprised the intention-to-treat population. At database lock (March 21, 2018) for the final overall survival analysis, median follow-up was 7·4 months (IQR 3·5-13·9). In our sensitivity analysis of investigator-assessed progression-free survival at the overall survival database lock, median progression-free survival remained significantly improved with ramucirumab compared with placebo (4·1 months [95% CI 3·3-4·8] vs 2·8 months [2·6-2·9]; HR 0·696 [95% CI 0·573-0·845]; p=0·0002). Median overall survival was 9·4 months (95% CI 7·9-11·4) in the ramucirumab group versus 7·9 months (7·0-9·3) in the placebo group (stratified HR 0·887 [95% CI 0·724-1·086]; p=0·25). Grade 3 or worse treatment-related treatment-emergent adverse events in 5% or more of patients and with an incidence more than 2% higher with ramucirumab than with placebo were febrile neutropenia (24 [9%] of 258 patients in the ramucirumab group vs 16 [6%] of 265 patients in the placebo group) and neutropenia (17 [7%] of 258 vs six [2%] of 265). Serious adverse events were similar between groups (112 [43%] of 258 patients in the ramucirumab group vs 107 [40%] of 265 patients in the placebo group). Adverse events related to study treatment and leading to death occurred in eight (3%) patients in the ramucirumab group versus five (2%) patients in the placebo group. INTERPRETATION: Additional follow-up supports that ramucirumab plus docetaxel significantly improves progression-free survival, without a significant improvement in overall survival, for patients with platinum-refractory advanced urothelial carcinoma. Clinically meaningful benefit might be restricted in an unselected population. FUNDING: Eli Lilly and Company.

Published
2020

22. Frontline immune checkpoint inhibitor-based combination therapy in metastatic renal cell carcinoma patients with poor performance status

Author

Carril-Ajuria, Lucía, Colomba, Emeline, Romero-Ferreiro, Carmen, Cerbone, Luigi, Ratta, Raffaele, Barthelemy, Philippe, Vindry, Clarisse, Fléchon, Aude, Cherifi, François, Boughalem, Elouen, Linassier, Claude, Fornarini, Giuseppe, Rebuzzi, Sara E., Gross-Goupil, Marine, Saldana, Carolina, Martin-Soberón, Maricruz, de Velasco, Guillermo, Manneh, Ray, Pernaut, Cristina, Sanchez de Torre, Ana, Flippot, Ronan, Escudier, Bernard, and Albiges, Laurence

Published
2023
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23. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial

Author

Cascallar, Diana Vera, Varela, Mirta, Lazzaro, Mauricio Fernandez, Kaen, Diego Lucas, Gatica, Gabriela, Flores, David Hugo, Falco, Agustin, Molina, Matias, Van Aelst, Filip, Vulsteke, Christof, Sautois, Brieuc, Machiels, Jean-Pascal, Schallier, Denis, Brust, Leandro, Rapatoni, Liane, Azevedo, Sergio J, Marinho, Gisele, Soares, Joao Paulo Holanda, Dzik, Carlos, Almeida Silva, Jamile, Fay, Andre Poisl, Gingerich, Joel, Fradet, Yves, Ferrario, Cristiano, Potvin, Kylea, Vanhuyse, Marie, Abdelsalam, Mahmoud, Cheng, Susanna, Caglevic, Christian, Reyes, Felipe, Leal, Jose Luis, Francisco, Francisco, Ibanez, Carolina, Joly, Florence, Laguerre, Brigitte, Ladoire, Sylvain, Flechon, Aude, Topart, Delphine, Huillard, Olivier, Oudard, Stéphane, Gross-Goupil, Marine, Culine, Stephane, Loriot, Yohann, Gravis, Gwenaelle, Reichardt, Peter, Retz, Margitta, Herden, Jan, Pfister, David, Ohlman, Carsten, Stoeckle, Michael, Wirth, Manfred, Lorch, Anja, Niegisch, Guenter, Goebell, Peter J, Boegemann, Martin, Merseburger, Axel, Gakis, Georgios, Bedke, Jens, Neisius, Andreas, Thomas, Christian, Hoefner, Thomas, Telekes, Andras, Kosa, Judit Erzsebet, Revesz, Janos, Bodoky, Gyorgy, Csoszi, Tibor, Csejtei, Andras, Geczi, Lajos, Ruzsa, Agnes, Kolonics, Zsuzsanna, Erfan, Jozsef, McDermott, Ray, Bambury, Richard, Sella, Avishay, Frank, Stephen Jay, Kejzman, Daniel, Goldman, Olesya, Rosenbaum, Eli, Peer, Avivit, Berger, Raanan, Rouvinov, Keren, Sarid, David, Fukasawa, Satoshi, Arai, Gaku, Yamaguchi, Akito, Yokomizo, Akira, Takayama, Tatsuya, Kinoshita, Hidefumi, Kikuchi, Eiji, Mizuno, Ryuichi, Fujii, Yasuhisa, Sassa, Naoto, Matsukawa, Yoshihisa, Fujimoto, Kiyohide, Matsubara, Nobuaki, Tanikawa, Toshiki, Tomita, Yoshihiko, Nishimura, Kazuo, Tsujihata, Masao, Oyama, Masafumi, Masumori, Naoya, Kanayama, Hiroomi, Takano, Toshimi, Miura, Yuji, Miyazaki, Jun, Joraku, Akira, Kimura, Tomokazu, Yamamoto, Yoshiaki, Kobayashi, Kazuki, De Wit, Ronald, Aarts, Maureen, Gerritsen, Winald, Los, Maartje, Beerepoot, Laurens, Izmailov, Adel, Gorelov, Sergey Igorevich, Alekseev, Boris Yakovlevich, Semenov, Andrey, Kostorov, Vladimir Anatolyevich, Alekseev, Sergey M, Zyryanov, Alexander, Oschepkov, Vasiliy Nikolaevich, Shidin, Vladimir Aleksandrovich, Vladimirov, Vladimir Ivanovich, Gafanov, Rustem Airatovich, Karlov, Petr Alexandrovich, Anderson, David Brian, Shepherd, Lucinda, Cohen, Graham Lawrence, Rapoport, Bernardo Louis, Ruff, Paul, Lee, Nari, Bae, Woo Kyun, Lee, Hyo Jin, Herranz, Urbano Anido, Rodriguez-Vida, Alejo, Morales Barrera, Rafael, Grande, Enrique, Alonso Gordoa, Teresa, Guma Padro, Josep, Gauna, Daniel Castellano, Arranz, Jose Angel, Munoz Langa, Jose, Sarrio, Regina Girones, Montesa Pino, Alvaro, Juan Fita, Maria Jose, Su, Yu-Li, Lin, Yung-Chang, Su, Wen-Pin, Shen, Ying-Chun, Chang, Yen-Hwa, Huang, Yi-Hsiu, Sriuranpong, Virote, Chansriwong, Phichai, Srimuninnimit, Vichien, Danchaivijitr, Pongwut, Abali, Huseyin, Yavuz, Sinan, Ozyilkan, Ozgur, Sendur, Mehmet Ali Nahit, Ekenel, Meltem, Ozguroglu, Mustafa, Arslan, Cagatay, Gunduz, Seyda, Ozdogan, Mustafa, Birtle, Alison, Powles, Thomas, Huddart, Robert, de Santis, Maria, Zarkar, Anjali, Evans, Linda, Hussain, Syed, DiSimone, Christopher, Muina, Antonio F, Schlegel, Peter, Jhangiani, Haresh S, Harrison, Michael, Slater, Dennis E, Wright, David, Percent, Ivor J, Lin, Jianqing, Hwang, Clara, Mamtani, Ronac, Gupta, Sumati, Bajaj, Madhuri, Galamaga, Robert, Eklund, John, Wallace, James, Shtivelband, Mikhail, Suh, Jason Jung-Gon, Burhani, Nafisa, Eadens, Matthew, Gunturu, Krishna, Burgess, Earle, Wong, John, Chaudhry, Arvind, Van Veldhuizen, Peter, Graff, Stephanie, Thomas, Christian A, Schnadig, Ian D, Carneiro, Benedito, Hussain, Maha, Morgans, Alicia, Fitzharris, John T, Oliff, Ira A, Vuky, Jacqueline, Hauke, Ralph, Baron, Ari, Joshi, Monika, Bolemon, Britt H, Jiang, Peter, Mega, Anthony E, Markus, Maurice, Pfanzelter, Nicklas, Lawler, William Eyre, Cobb, Patrick Wayne, Courtright, Jay G, Jain, Sharad, Doshi, Gurjyot, Gunuganti, Vijay K, Sartor, Oliver Alton, Cole, Scott W, Babiker, Hani, Uchio, Edward M, Drakaki, Alexandra, Mannuel, Heather D, Alva, Ajjai, Guancial, Elizabeth, Fung, Chunkit, Charles, Anthony, Amato, Robert J, Arriaga, Yull, Bowman, Isaac, Ades, Steven, Dreicer, Robert, Yu, Evan, Quinn, David I, Fleming, Mark, Csőszi, Tibor, Özgüroğlu, Mustafa, Géczi, Lajos, Cheng, Susanna Y-S, Oudard, Stephane, Fléchon, Aude, Yu, Evan Y, Nam, Kijoeng, Imai, Kentaro, and Homet Moreno, Blanca

Published
2021
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24. Activity of Lutetium-177 Prostate-specific Membrane Antigen and Determinants of Outcomes in Patients with Metastatic Castration-resistant Prostate Cancer Previously Treated with Cabazitaxel: The PACAP Study

Author

Flippot, Ronan, primary, Telli, Tugce, additional, Velev, Maud, additional, Fléchon, Aude, additional, De Vries-Brilland, Manon, additional, Turpin, Léa, additional, Bergman, Andries, additional, Turco, Fabio, additional, Mahammedi, Hakim, additional, Fendler, Wolfgang P., additional, Giraudet, Anne-Laure, additional, Josset, Quentin, additional, Montravers, Françoise, additional, Vogel, Wouter, additional, Gillessen, Silke, additional, Berardi Vilei, Simona, additional, Herrmann, Ken, additional, Kryza, David, additional, Paone, Gaetano, additional, Hadaschik, Boris, additional, Merlin, Charles, additional, Dufour, Pierre-Alban, additional, Bernard-Tessier, Alice, additional, Naoun, Natacha, additional, Patrikidou, Anna, additional, Garcia, Camilo, additional, Foulon, Stéphanie, additional, Pagès, Arnaud, additional, and Fizazi, Karim, additional

Published
2024
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25. Safety and efficacy of nivolumab, an anti-PD1 immunotherapy, in patients with advanced basal cell carcinoma, after failure or intolerance to sonic Hedgehog inhibitors: UNICANCER AcSé NIVOLUMAB trial

Author

Véron, Marie, Chevret, Sylvie, Grob, Jean-Jacques, Beylot-Barry, Marie, Saiag, Philippe, Fléchon, Aude, You, Benoit, Maubec, Eve, Jouary, Thomas, Toulemonde, Elise, Jamme, Philippe, Gambotti, Laëtitia, Lamrani-Ghaouti, Assia, Dupuy, Alain, Lebbe, Céleste, Seguin, Nicole Basset, Houede, Nadine, Leccia, Marie-Thérèse, Le Du, Fanny, de Pontville, Michel, Gaudy-Marquestre, Caroline, Guillot, Bernard, Simon, Clotilde, Marabelle, Aurélien, and Mortier, Laurent

Published
2022
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29. Patient-reported outcomes with olaparib plus abiraterone versus placebo plus abiraterone for metastatic castration-resistant prostate cancer: a randomised, double-blind, phase 2 trial

Author

Saad, Fred, Thiery-Vuillemin, Antoine, Wiechno, Pawel, Alekseev, Boris, Sala, Nuria, Jones, Robert, Kocak, Ivo, Chiuri, Vincenzo Emanuele, Jassem, Jacek, Fléchon, Aude, Redfern, Charles, Kang, Jinyu, Burgents, Joseph, Gresty, Christopher, Degboe, Arnold, and Clarke, Noel W

Published
2022
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30. The GETUG SEMITEP Trial: De-escalating Chemotherapy in Good-prognosis Seminoma Based on Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography

Author

Loriot, Yohann, Texier, Matthieu, Culine, Stéphane, Fléchon, Aude, Thiery-Vuillemin, Antoine, Gravis, Gwenaëlle, Geoffrois, Lionel, Chevreau, Christine, Gross-Goupil, Marine, Barthelemy, Philippe, Bompas, Emmanuelle, Mahammedi, Hakim, Laguerre, Brigitte, Lacourtoisie, Sophie Abadie, Helissey, Carole, Ladoire, Sylvain, Abraham, Christine, Massard, Christophe, Grimaldi, Serena, and Fizazi, Karim

Published
2022
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31. Intra-articular botulinum toxin A injection for painful base-of-thumb osteoarthritis: a double-blind, randomised, controlled, phase 3 trial (RHIBOT)

Author

Nguyen, Christelle, Abdoul, Hendy, Campagna, Raphaël, Guerini, Henri, Jilet, Léa, Bedin, Catherine, Chagny, Franck, Couraud, Gaëlle, Daste, Camille, Drapé, Jean-Luc, Fléchon, Rémy, Gil, Charlotte, Guérin, Corinne, Lefèvre-Colau, Marie-Martine, Poiraudeau, Serge, Randriamampandry, Estelle, Roren, Alexandra, Feydy, Antoine, and Rannou, François

Published
2022
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33. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design

Author

Fizazi, Karim, Foulon, Stéphanie, Carles, Joan, Roubaud, Guilhem, McDermott, Ray, Fléchon, Aude, Tombal, Bertrand, Supiot, Stéphane, Berthold, Dominik, Ronchin, Philippe, Kacso, Gabriel, Gravis, Gwenaëlle, Calabro, Fabio, Berdah, Jean-François, Hasbini, Ali, Silva, Marlon, Thiery-Vuillemin, Antoine, Latorzeff, Igor, Mourey, Loïc, Laguerre, Brigitte, Abadie-Lacourtoisie, Sophie, Martin, Etienne, El Kouri, Claude, Escande, Anne, Rosello, Alvar, Magne, Nicolas, Schlurmann, Friederike, Priou, Frank, Chand-Fouche, Marie-Eve, Freixa, Salvador Villà, Jamaluddin, Muhammad, Rieger, Isabelle, and Bossi, Alberto

Published
2022
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35. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial

Author

Parnis, Francis, Joshua, Anthony M., Horvath, Lisa G., Steer, Christopher, Marx, Gavin, Sandhu, Shahneen, Gurney, Howard, Ferguson, Thomas, Van Bruwaene, Siska, Luyten, Daisy, Schatteman, Peter, Lumen, Nicolaas, Dirix, Luc, Goeminne, Jean-Charles, Gil, Thierry, Seront, Emmanuel, Vulsteke, Christof, Kussumoto, Celio, Franke, Fabio A., Martinelli de Oliveira, Fabricio Augusto, Pereira de Santana Gomes, Andrea Juliana, Pinczowski, Hélio, Preto, Daniel D'Almeida, Zucca, Luis Eduardo, Borges, Giuliano Santos, Murad, Andre M., Saad, Fred, Chi, Kim N., Fradet, Yves, Fleshner, Neil E., Emmenegger, Urban, Brasso, Klaus, Fizazi, Karim, Culine, Stephane, Thiery-Vuillemin, Antoine, Joly, Florence, Fléchon, Aude, Hilgers, Werner, Eymard, Jean-Christophe, Borchiellini, Delphine, Barthélémy, Philippe, Berger, Raanan, Leibowitz-Amit, Raya, Mermershtain, Wilmosh, Rouvinov, Keren, Peer, Avivit, Kovel, Svetlana, Sella, Avishay, Lolkema, Martijn P., van den Eertwegh, Alfonsus J.M., Voortman, Johannes, Aarts, Maureen J., Gietema, Jourik A., Kim, Choung-Soo, Choi, Young-Deuk, Chung, Byung-Ha, Gafanov, Rustem A., Kopyltsov, Evgeniy, Usynin, Evgeny A., Carles, Joan, Mellado, Begoña, Maroto, José Pablo, García-Donás, Jesús, Rodríguez Moreno, Juan Francisco, Durán, Ignacio, Pérez-Valderrama, Begoña, Castro, Elena, Olmos, David, Méndez-Vidal, María José, Estellés, David Lorente, Sarrió, Regina Gironés, Muñoz-Langa, José, Herranz, Urbano Anido, Puente Vázquez, Javier, Castellanos, Enrique, Hellström, Martin, Widmark, Anders, Lissbrant, Ingela Franck, Jellvert, Åsa, Külich, Cecilia, Blom, René, Ståhl, Olof, Chiang, Po-Hui, Kang, Chih-Hsiung, Ou, Yen-Chuan, Wang, Shian-Shiang, Wu, Hsi-Chin, Lu, Yu-Chuan, Attard, Gerhardt, Khoo, Vincent, Bahl, Amit, Kellati, Prasad, Parikh, Omi, Srinivasan, Rajaguru, Lester, Jason F., Staffurth, John N., Cheng, Heather H., Efstathiou, Eleni, Pilié, Patrick G., George, Daniel J., Karsh, Lawrence I., Kelly, W. Kevin, Danila, Daniel C., Sieber, Paul R., Smith, Matthew R., Heath, Elisabeth I., Vaishampayan, Ulka N., Flaig, Thomas W., Emamekhoo, Hamid, Pinski, Jacek K., Kalebasty, Arash Rezazadeh, Maly, Joseph J., Moon, Helen, Smith, Matthew R, Scher, Howard I, Lara, Primo N, Jr, Yu, Evan Y, George, Daniel J, Chi, Kim N, Danila, Daniel C, Mason, Gary E, Espina, Byron M, Zhao, Xin, Urtishak, Karen A, Francis, Peter, and Lopez-Gitlitz, Angela

Published
2022
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36. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study

Author

Necchi, Andrea, Loriot, Yohann, Park, Se Hoon, Tagawa, Scott, Flechon, Aude, Alexeev, Boris, Varlamov, Sergey, Huddart, Robert, Burgess, Earle, Rezazadeh, Arash, Siefker-Radtke, Arlene, Vano, Yann, Gasparro, Donatello, Hamzaj, Alketa, Kopyltsov, Eugeniy, Gracia Donas, Jesus, Mellado, Begona, Parikh, Omi, Schatteman, Peter, Culine, Stephane, Houédé, Nadine, Zanetta, Sylvie, Facchini, Gaetano, Scagliotti, Giorgio, Schinzari, Giovanni, Lee, Jae Lyun, Shkolnik, Mikhail, Fleming, Mark, Joshi, Monica, O'Donnell, Peter, Stöger, Herbert, Decaestecker, Karel, Dirix, Luc, Machiels, Jean Pascal, Borchiellini, Dephine, Delva, Remy, Rolland, Frederic, Hadaschik, Boris, Retz, Margitta, Rosenbaum, Eli, Basso, Umberto, Mosca, Alessandra, Lee, Hyo Jin, Shin, Dong Bok, Cebotaru, Cristina, Duran, Ignacio, Moreno, Victor, Perez Gracia, Jose Luis, Pinto, Alvaro, Su, Wen-Pin, Wang, Shian-Shiang, Hainsworth, John, Schnadig, Ian, Srinivas, Sandhya, Vogelzang, Nicholas, Loidl, Wolfgang, Meran, Johannes, Gross Goupil, Marine, Joly, Florence, Imkamp, Florian, Klotz, Theodor, Krege, Susanne, May, Matthias, Schultze-Seemann, Wolfgang, Strauss, Arne, Zimmermann, Uwe, Keizman, Daniel, Peer, Avivit, Sella, Avishai, Berardi, Rossana, De Giorgi, Ugo, Sternberg, Cora Nanette, Rha, Sun Young, Bulat, Iurie, Izmailov, Adel, Matveev, Vsevolod, Vladimirov, Vladimir, Carles, Joan, Font, Albert, Saez, Maribel, Syndikus, Isabel, Tarver, Kathryn, Appleman, Leonard, Burke, John, Dawson, Nancy, Jain, Sharad, Zakharia, Yousef, Siefker-Radtke, Arlene O, García-Donas, Jesús, Huddart, Robert A, Burgess, Earle F, Fleming, Mark T, Rezazadeh Kalebasty, Arash, Mellado, Begoña, Varlamov, Sergei, Joshi, Monika, Tagawa, Scott T, Akapame, Sydney, Santiago-Walker, Ademi E, Monga, Manish, and O'Hagan, Anne

Published
2022
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37. Domestic use of pesticides during early periods of development and risk of testicular germ cell tumors in adulthood: a French nationwide case-control study

Author

Aurélie M. N. Danjou, Olivia Pérol, Astrid Coste, Elodie Faure, Rémi Béranger, Helen Boyle, Elodie Belladame, Lény Grassot, Matthieu Dubuis, Johan Spinosi, Liacine Bouaoun, Aude Fléchon, Louis Bujan, Véronique Drouineaud, Florence Eustache, Isabelle Berthaut, Jeanne Perrin, Florence Brugnon, Barbara Charbotel, Joachim Schüz, Béatrice Fervers, and For the TESTIS study group

Subjects
Case-control study, Domestic use, Epidemiology, Environment, Pesticides, Testicular germ cell tumor, Industrial medicine. Industrial hygiene, RC963-969, Public aspects of medicine, RA1-1270
Abstract

Abstract Background Testicular germ cell tumours (TGCT) are the most frequent cancers in young men in developed countries and their incidence rate has doubled worldwide over the past 40 years. Early life exposures to pesticides are suspected to increase TGCT risk. Our research aimed at estimating adult TGCT risk associated with parental domestic use of pesticides during early periods of child development. Methods We conducted a case-control study of 304 TGCT cases, aged 18–45 years old, recruited in 20 French university hospitals, and 274 controls frequency-matched on hospital and birth year. Participants’ mothers provided information on their domestic use of pesticides from 1 year before start of pregnancy to 1 year after their son’s birth, for gardening activities, treatment of indoor plants, pets, wood and mold, and pest control. Odds ratios (OR) for TGCT (overall and by histological subtype) and 95% confidence intervals (CI) were estimated using conditional logistic regression. Results Prevalence of reported domestic use of pesticides was 77.3% for insecticides, 15.9% for fungicides and 12.1% for herbicides. While no association was found for any use of insecticides (OR = 1.27, CI = 0.80–2.01) or herbicides (OR = 1.15, CI = 0.67–2.00), elevated risks of TGCT overall (OR = 1.73, CI = 1.04–2.87) and non-seminoma subtype (OR = 2.44, CI = 1.26–4.74) were observed for any use of fungicides. When specific purposes were examined, using fungicides and/or insecticides for woodwork (OR = 2.35, CI = 1.06–5.20) and using insecticides on cats and dogs (OR = 1.95, CI = 1.12–3.40) were associated with increased risk of non-seminoma subtype. We found no association for seminoma subtype. Conclusions Although recall bias may partially explain the elevated ORs, our study provides some evidence of a positive association between domestic use of pesticides during early periods of development, particularly fungicides and risk of adult TGCT and non-seminoma. Given the common domestic use of pesticides in France, further research on TGCT risk is warranted.

Published
2021
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38. How to improve adherence of guidelines for localized testicular cancer surveillance: A Delphi consensus study

Author

Angélique Da Silva, Aude Fléchon, Elodie Coquan, François Planchamp, Stéphane Culine, Thibaut Murez, Arnaud Méjean, David Pasquier, Christine Chevreau, Karim Fizazi, Antoine Thiery-Vuilemin, and Florence Joly

Subjects
consensus, de-escalation, delphy method, surveillance, testicular germ cell cancer, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Stage-I testicular germ-cell tumor (TGCT) has excellent cure rates. Surveillance is fully included in patient’s management, particularly during the first years of follow-up. Surveillance guidelines differ between the academic societies, mainly concerning imaging frequency and long-term follow-up. We evaluated surveillance practice and schedules followed by French specialists and set up a DELPHI method to obtain a consensual surveillance program with an optimal schedule for patients with localized TGCT. First, an online survey on surveillance practice of stage-I TGCT based on clinical-cases was conducted among urologists, radiation-oncologists and medical-oncologists. These results were compared to ESMO/EAU and AFU guidelines. Then a panel of experts assessed surveillance proposals following a Delphi-CM. Statements were drafted after analysis of the previous survey and systematic literature review, with 2 successive rounds to reach a consensus. The study was conducted between July 2018 and May 2019. Concerning the first step: 61 participated to the survey (69% medical-oncologists, 15% urologists, 16% radiation-oncologists). About 65% of practitioners followed clinico-biological guidelines concerning 1 to 5 years of follow-up, but only 25% stopped surveillance after the 5th-year. No physician followed the EAU/ESMO guidelines of de-escalation chest imaging. Concerning the second step: 32 experts (78% medical-oncologists, 16% urologists, 6% radiation-oncologists) participated to the Delphi-CM. Thanks to Delphi-CM, a consensus was reached for 26 of the 38 statements. Experts agreed on clinico-biological surveillance modalities and end of surveillance after the 5th-year of follow-up. For seminoma, abdominal ultrasound was proposed as an option to the abdominopelvic (AP) scan for the 4th-year of follow-up. No consensus was reached regarding de-escalation of chest imaging. To conclude, the survey proved that French TGCT-specialists do not follow current guidelines. With Delphi-CM, a consensus was obtained for frequency of clinico-biological surveillance, discontinuation of surveillance after the 5th-year, stop of AP scan on the 4th-year of follow-up for seminoma. Questions remains concerning type and frequency of chest imaging.

Published
2022
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39. Chemotherapy for Muscle-invasive Bladder Cancer: Impact of Cisplatin Delivery on Renal Function and Local Control Rate in the Randomized Phase III VESPER (GETUG-AFU V05) Trial

Author

Culine, Stéphane, Harter, Valentin, Gravis, Gwenaelle, Fléchon, Aude, Chevreau, Christine, Mahammedi, Hakim, Laguerre, Brigitte, Guillot, Aline, Joly, Florence, Abadie-Lacourtoisie, Sophie, Geoffrois, Lionnel, Fiore, Frédéric Di, Roubaud, Guilhem, Barthélémy, Philippe, Voog, Eric, Emambux, Sheik, Serrate, Camille, Saldana, Carolina, Nguyen-Tan-Hon, Thierry, Loriot, Yohann, Eymard, Jean-Christophe, Huillard, Olivier, Rolland, Frédéric, Houédé, Nadine, Spano, Jean-Philippe, Demery, Mounira El, Vieillot, Sabine, L'Haridon, Tifenn, Hilgers, Werner, Allory, Yves, and Pfister, Christian

Published
2021
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40. Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer

Author

Powles, Thomas, primary, Valderrama, Begoña P., additional, Gupta, Shilpa, additional, Bedke, Jens, additional, Kikuchi, Eiji, additional, Hoffman-Censits, Jean, additional, Iyer, Gopa, additional, Vulsteke, Christof, additional, Park, Se Hoon, additional, Shin, Sang Joon, additional, Castellano, Daniel, additional, Fornarini, Giuseppe, additional, Li, Jian-Ri, additional, Gümüş, Mahmut, additional, Mar, Nataliya, additional, Loriot, Yohann, additional, Fléchon, Aude, additional, Duran, Ignacio, additional, Drakaki, Alexandra, additional, Narayanan, Sujata, additional, Yu, Xuesong, additional, Gorla, Seema, additional, Homet Moreno, Blanca, additional, and van der Heijden, Michiel S., additional

Published
2024
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41. MYC dependency in GLS1 and NAMPT is a therapeutic vulnerability in multiple myeloma

Author

Bou Issa, Lama Hasan, primary, Fléchon, Léa, additional, Laine, William, additional, Ouelkdite, Aicha, additional, Gaggero, Silvia, additional, Cozzani, Adeline, additional, Tilmont, Remi, additional, Chauvet, Paul, additional, Gower, Nicolas, additional, Pistofidis, Romanos Sklavenitis, additional, Brinster, Carine, additional, Thuru, Xavier, additional, Touil, Yasmine, additional, Quesnel, Bruno, additional, Mitra, Suman, additional, Ghobrial, Irene M., additional, Kluza, Jérôme, additional, and Manier, Salomon, additional

Published
2024
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43. Sacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3

Author

Grivas, Petros, primary, Pouessel, Damien, additional, Park, Chandler H., additional, Barthelemy, Philippe, additional, Bupathi, Manojkumar, additional, Petrylak, Daniel P., additional, Agarwal, Neeraj, additional, Gupta, Sumati, additional, Fléchon, Aude, additional, Ramamurthy, Chethan, additional, Davis, Nancy B., additional, Recio-Boiles, Alejandro, additional, Sternberg, Cora N., additional, Bhatia, Astha, additional, Pichardo, Cabilia, additional, Sierecki, Mitch, additional, Tonelli, Julia, additional, Zhou, Huafeng, additional, Tagawa, Scott T., additional, and Loriot, Yohann, additional

Published
2024
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44. Impact of a one-year supervised physical activity program on long-term cancer-related fatigue and mediating effects of the gut microbiota in metastatic testicular cancer patients: protocol of the prospective multicentre, randomized controlled phase-III STARTER trial

Author

Noh, Hwayoung, primary, Anota, Amélie, additional, Mongondry, Rodolf, additional, Meyrand, Renaud, additional, Dupuis, Carmen, additional, Schiffler, Camille, additional, Marijnen, Philippe, additional, Rinaldi, Sabina, additional, Lachuer, Joel, additional, Keski-Rahkonen, Pekka, additional, Gunter, Marc J, additional, Fléchon, Aude, additional, Fervers, Béatrice, additional, and Pérol, Olivia, additional

Published
2024
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45. A Risk-benefit Analysis of Prophylactic Anticoagulation for Patients with Metastatic Germ Cell Tumours Undergoing First-line Chemotherapy

Author

Fankhauser, Christian Daniel, Tran, Ben, Pedregal, Manuel, Ruiz-Morales, José Manuel, Gonzalez-Billalabeitia, Egon, Patrikidou, Anna, Amir, Eitan, Seidel, Christoph, Bokemeyer, Carsten, Hermanns, Thomas, Rumyantsev, Alexey, Tryakin, Alexey, Brito, Margarida, Fléchon, Aude, Kwan, Edmon M., Cheng, Tina, Castellano, Daniel, del Muro, Xavier Garcia, Hamid, Anis A., Ottaviano, Margaret, Palmieri, Giovanella, Kitson, Robert, Reid, Alison, Heng, Daniel Y.C., Bedard, Philippe L., Sweeney, Christopher J., and Connors, Jean M.

Published
2021
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46. Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin With or Without Panitumumab in Patients With Advanced Urothelial Carcinoma: Multicenter, Randomized, French Unicancer GETUG/AFU 19 Study

Author

Culine, Stéphane, Fléchon, Aude, Gravis, Gwenaelle, Roubaud, Guilhem, Loriot, Yohann, Joly, Florence, Barthélémy, Philippe, Assaf, Elias, Mahammedi, Hakim, Beuzeboc, Philippe, Houédé, Nadine, Rolland, Frédéric, Guillot, Aline, Gross-Goupil, Marine, Spano, Jean-Philippe, Tartas, Sophie, Deblock, Mathilde, Chevreau, Christine, Serrate, Camille, Manduzio, Hélène, Habibian, Muriel, Thézénas, Simon, and Allory, Yves

Published
2021
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47. Nivolumab plus rucaparib for metastatic castration-resistant prostate cancer: results from the phase 2 CheckMate 9KD trial

Author

Jun Li, Stefanie Zschäbitz, Daniel P Petrylak, Margitta Retz, Prabhu Bhagavatheeswaran, Marc-Oliver Grimm, Jose Perez-Gracia, Gwenaelle Gravis, Karim Fizazi, Jeffrey C Goh, Mauricio Burotto, Daniel Castellano, Fred Saad, Andrew J Armstrong, HAKIM MAHAMMEDI, Russell K Pachynski, Louis Lacombe, Diogo Assed Bastos, Steven L McCune, Juan Carlos Vázquez Limón, Edmond M Kwan, Aude Fléchon, David R Shaffer, Neha P Amin, Keziban Ünsal-Kaçmaz, Xuya Wang, and Andrea Loehr

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background CheckMate 9KD (NCT03338790) is a non-randomized, multicohort, phase 2 trial of nivolumab plus other anticancer treatments for metastatic castration-resistant prostate cancer (mCRPC). We report results from cohorts A1 and A2 of CheckMate 9KD, specifically evaluating nivolumab plus rucaparib.Methods CheckMate 9KD enrolled adult patients with histologically confirmed mCRPC, ongoing androgen deprivation therapy, and an Eastern Cooperative Oncology Group performance status of 0–1. Cohort A1 included patients with postchemotherapy mCRPC (1–2 prior taxane-based regimens) and ≤2 prior novel hormonal therapies (eg, abiraterone, enzalutamide, apalutamide); cohort A2 included patients with chemotherapy-naïve mCRPC and prior novel hormonal therapy. Patients received nivolumab 480 mg every 4 weeks plus rucaparib 600 mg two times per day (nivolumab dosing ≤2 years). Coprimary endpoints were objective response rate (ORR) per Prostate Cancer Clinical Trials Working Group 3 and prostate-specific antigen response rate (PSA50-RR; ≥50% PSA reduction) in all-treated patients and patients with homologous recombination deficiency (HRD)-positive tumors, determined before enrollment. Secondary endpoints included radiographic progression-free survival (rPFS), overall survival (OS), and safety.Results Outcomes (95% CI) among all-treated, HRD-positive, and BRCA1/2-positive populations for cohort A1 were confirmed ORR: 10.3% (3.9–21.2) (n=58), 17.2% (5.8–35.8) (n=29), and 33.3% (7.5–70.1) (n=9); confirmed PSA50-RR: 11.9% (5.9–20.8) (n=84), 18.2% (8.2–32.7) (n=44), and 41.7% (15.2–72.3) (n=12); median rPFS: 4.9 (3.7–5.7) (n=88), 5.8 (3.7–8.4) (n=45), and 5.6 (2.8–15.7) (n=12) months; and median OS: 13.9 (10.4–15.8) (n=88), 15.4 (11.4–18.2) (n=45), and 15.2 (3.0–not estimable) (n=12) months. For cohort A2 they were confirmed ORR: 15.4% (5.9–30.5) (n=39), 25.0% (8.7–49.1) (n=20), and 33.3% (7.5–70.1) (n=9); confirmed PSA50-RR: 27.3% (17.0–39.6) (n=66), 41.9 (24.5–60.9) (n=31), and 84.6% (54.6–98.1) (n=13); median rPFS: 8.1 (5.6–10.9) (n=71), 10.9 (6.7–12.0) (n=34), and 10.9 (5.6–12.0) (n=15) months; and median OS: 20.2 (14.1–22.8) (n=71), 22.7 (14.1–not estimable) (n=34), and 20.2 (11.1–not estimable) (n=15) months. In cohorts A1 and A2, respectively, the most common any-grade and grade 3–4 treatment-related adverse events (TRAEs) were nausea (40.9% and 40.8%) and anemia (20.5% and 14.1%). Discontinuation rates due to TRAEs were 27.3% and 23.9%, respectively.Conclusions Nivolumab plus rucaparib is active in patients with HRD-positive postchemotherapy or chemotherapy-naïve mCRPC, particularly those harboring BRCA1/2 mutations. Safety was as expected, with no new signals identified. Whether the addition of nivolumab incrementally improves outcomes versus rucaparib alone cannot be determined from this trial.Trial registration number NCT03338790.

Published
2022
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48. An adaptive, biomarker-directed platform study of durvalumab in combination with targeted therapies in advanced urothelial cancer

Author

Powles, Thomas, Carroll, Danielle, Chowdhury, Simon, Gravis, Gwenaelle, Joly, Florence, Carles, Joan, Fléchon, Aude, Maroto, Pablo, Petrylak, Daniel, Rolland, Frederic, Cook, Natalie, Balar, Arjun V., Sridhar, Srikala S., Galsky, Matthew D., Grivas, Petros, Ravaud, Alain, and Jones, Robert

Subjects
Oncology, Experimental, Gene mutations -- Research, Metastasis -- Drug therapy -- Genetic aspects, Cancer -- Research, Molecular targeted therapy -- Research, Biological markers -- Research, Urinary tract cancer -- Drug therapy -- Genetic aspects, Biological sciences, Health
Abstract

Durvalumab is a programmed death-ligand 1 (PD-L1) inhibitor with clinical activity in advanced urothelial cancer (AUC).sup.1. AUC is characterized by several recurrent targetable genomic alterations.sup.2-5. This study (NCT02546661, BISCAY) combined durvalumab with relevant targeted therapies in biomarker-selected chemotherapy-refractory AUC populations including: (1) fibroblast growth factor receptor (FGFR) inhibitors in tumors with FGFR DNA alterations (FGFRm); (2) pharmacological inhibitor of the enzyme poly-ADP ribose polymerase (PARP) in tumors with and without DNA homologous recombination repair deficiency (HRRm); and (3) TORC1/2 inhibitors in tumors with DNA alteration to the mTOR/PI3K pathway.sup.3-5.This trial adopted a new, biomarker-driven, multiarm adaptive design. Safety, efficacy and relevant biomarkers were evaluated. Overall, 391 patients were screened of whom 135 were allocated to one of six study arms. Response rates (RRs) ranged 9-36% across the study arms, which did not meet efficacy criteria for further development. Overall survival (OS) and progression-free survival (PFS) were similar in the combination arms and durvalumab monotherapy arm. Biomarker analysis showed a correlation between circulating plasma-based DNA (ctDNA) and tissue for FGFRm. Sequential circulating tumor DNA analysis showed that changes to FGFRm correlated with clinical outcome. Our data support the clinical activity of FGFR inhibition and durvalumab monotherapy but do not show increased activity for any of the combinations. These findings question the targeted/immune therapy approach in AUC. The adaptive, biomarker-driven BISCAY trial evaluating durvalumab with targeted agents in patients with metastatic urothelial carcinoma based on tumor genomic alterations finds no added clinical benefit over durvalumab monotherapy., Author(s): Thomas Powles [sup.1] , Danielle Carroll [sup.2] , Simon Chowdhury [sup.3] , Gwenaelle Gravis [sup.4] , Florence Joly [sup.5] , Joan Carles [sup.6] , Aude Fléchon [sup.7] , Pablo [...]

Published
2021
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49. Very Long‐Term Complete Remission Can Be Achieved in Men With High‐Risk Localized Prostate Cancer and a Very High PSA Value: An Analysis of the GETUG 12 Phase 3 Trial

Author

Orlando, Valentina, Drubay, Damien, Lavaud, Pernelle, Faivre, Laura, Lesaunier, François, Delva, Remy, Gravis, Gwenaëlle, Rolland, Frédéric, Priou, Frank, Ferrero, Jean-Marc, Houede, Nadine, Mourey, Loic, Theodore, Christine, Krakowski, Ivan, Berdah, Jean-François, Baciuchka, Marjorie, Laguerre, Brigitte, Fléchon, Aude, Grosse-Goupil, Marine, Cojean-Zelek, Isabelle, Oudard, Stéphane, Labourey, Jean-Luc, Chinet-Charrot, Paule, Legouffe, Eric, Lagrange, Jean-Léon, Linassier, Claude, Deplanque, Gaël, Beuzeboc, Philippe, Davin, Jean-Louis, Martin, Anne-Laure, Brihoum, Meryem, Culine, Stéphane, Teuff, Gwénaël Le, and Fizazi, Karim

Published
2023
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50. Immune checkpoint inhibitor treatment of a first cancer is associated with a decreased incidence of second primary cancer

Author

Heudel, P., Chabaud, S., Perol, D., Flechon, A., Fayette, J., Combemale, P., Tredan, O., Desseigne, F., de la Fouchardiere, C., Boyle, H., Perol, M., Bachelot, T., Cassier, P., Avrillon, V., Terret, C., Michallet, A.-S., Neidhardt-Berard, E.-M., Nicolas-Virelizier, E., Dufresne, A., Belhabri, A., Brahmi, M., Lebras, L., Nicolini, F., Sarabi, M., Rey, P., Bonneville-Levard, A., Rochefort, P., Provensal, A.-M., Eberst, L., Assaad, S., Swalduz, A., Saintigny, P., Toussaint, P., Guillermin, Y., Castets, M., Coutzac, C., Meeus, P., Dupré, A., Durand, T., Crochet, H., Fervers, B., Gomez, F., Rivoire, M., Gregoire, V., Claude, L., Chassagne-Clement, C., Pilleul, F., Mognetti, T., Russias, B., Soubirou, J.-L., Lasset, C., Chvetzoff, G., Mehlen, P., Beaupère, S., Zrounba, P., Ray-Coquard, I., and Blay, J.-Y.

Published
2021
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