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1. Results of TRIO-15, a multicenter, open-label, phase II study of the efficacy and safety of ganitumab in patients with recurrent platinum-sensitive ovarian cancer.

Author

Davidson, T, Lebreton, C, Hendricksen, A, Atkinson, H, Larson, M, Oberg, A, Provencher, D, Glaspy, J, Ray-Coquard, I, Slamon, D, Konecny, Gottfried, and Karlan, Beth

Subjects
AMG 479, Ganitumab, IGFR1 inhibitor, Insulin-like growth factor, Ovarian cancer, Targeted therapy, Humans, Female, Antibodies, Monoclonal, Humanized, Antibodies, Monoclonal, Ovarian Neoplasms
Abstract

BACKGROUND: IGF signaling has been implicated in the pathogenesis and progression of ovarian carcinoma (OC). Single agent activity and safety of ganitumab (AMG 479), a fully human monoclonal antibody against IGF1R that blocks binding of IGF1 and IGF2, were evaluated in patients with platinum-sensitive recurrent OC. METHODS: Patients with CA125 progression (GCIG criteria) or measurable disease per RECIST following primary platinum-based therapy received 18 mg/kg of ganitumab q3w. The primary endpoint was objective response rate (ORR) assessed per RECIST 1.1 by an independent radiology review committee (IRC) and/or GCIG CA125 criteria. Secondary endpoints included clinical benefit rate (CBR), progression free survival (PFS) and overall survival (OS). RESULTS: 61 pts. were accrued. Objective responses were seen in 5/61 patients (ORR 8.2%, 95% CI, 3.1-18.8) with 1 partial response (PR) by RECIST and 2 complete responses (CR) as well as 2 PR by CA125 criteria. CBR was 80.3% (95% CI, 67.8-89.0%). The median PFS according to RECIST by IRC was 2.1 months (95% CI, 2.0-3.1). The median PFS per RECIST IRC and/or CA125 was 2.0 months (95% CI, 1.8-2.2). The median OS was 21 months (95% CI, 19.5-NA). The most common overall adverse events were fatigue (36.1%) and hypertension (34.4%). Grade 1/2 hyperglycemia occurred in 30.4% of patients. Hypertension (11.5%) and hypersensitivity (8.2%) were the most frequent grade 3 adverse events. CONCLUSIONS: IGF1R inhibition with ganitumab was well-tolerated, however, our results do not support further study of ganitumab as a single agent in unselected OC patients.

Published
2023

3. Improved nationwide survival of sarcoma patients with a network of reference centers

Author

Blay, J.Y., Penel, N., Valentin, T., Anract, P., Duffaud, F., Dufresne, A., Verret, B., Cordoba, A., Italiano, A., Brahmi, M., Henon, C., Amouyel, T., Ray-Coquard, I., Ferron, G., Boudou-Rouquette, P., Tlemsani, C., Salas, S., Rochwerger, R., Faron, M., Bompas, E., Ducassou, A., Gangloff, D., Gouin, F., Firmin, N., Piperno-Neumann, S., Rios, M., Ropars, M., Kurtz, J.E., Le Nail, L.R., Bertucci, F., Carrere, S., Llacer, C., Watson, S., Bonvalot, S., Leroux, A., Perrin, C., Gantzer, J., Pracht, M., Narciso, B., Monneur, A., Lebbe, C., Hervieu, A., Saada-Bouzid, E., Dubray-Longeras, P., Fiorenza, F., Chaigneau, L., Nevieres, Z.-M., Soibinet, P., Bouché, O., Guillemet, C., Spano, J.P., Ruzic, J.C., Isambert, N., Vaz, G., Meeus, P., Karanian, M., Ngo, C., Coindre, J.M., De Pinieux, G., Le Loarer, F., Ducimetiere, F., Chemin, C., Morelle, M., Toulmonde, M., and Le Cesne, A.

Published
2024
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4. ESGO–ESMO–ESP consensus conference recommendations on ovarian cancer: pathology and molecular biology and early, advanced and recurrent disease

Author

Ledermann, J.A., Matias-Guiu, X., Amant, F., Concin, N., Davidson, B., Fotopoulou, C., González-Martin, A., Gourley, C., Leary, A., Lorusso, D., Banerjee, S., Chiva, L., Cibula, D., Colombo, N., Croce, S., Eriksson, A.G., Falandry, C., Fischerova, D., Harter, P., Joly, F., Lazaro, C., Lok, C., Mahner, S., Marmé, F., Marth, C., McCluggage, W.G., McNeish, I.A., Morice, P., Nicum, S., Oaknin, A., Pérez-Fidalgo, J.A., Pignata, S., Ramirez, P.T., Ray-Coquard, I., Romero, I., Scambia, G., Sehouli, J., Shapira-Frommer, R., Sundar, S., Tan, D.S.P., Taskiran, C., van Driel, W.J., Vergote, I., Planchamp, F., Sessa, C., and Fagotti, A.

Published
2024
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5. A randomized study of 6 versus 3 years of adjuvant imatinib in patients with localized GIST at high risk of relapse

Author

Blay, J.-Y., Schiffler, C., Bouché, O., Brahmi, M., Duffaud, F., Toulmonde, M., Landi, B., Lahlou, W., Pannier, D., Bompas, E., Bertucci, F., Chaigneau, L., Collard, O., Pracht, M., Henon, C., Ray-Coquard, I., Armoun, K., Salas, S., Spalato-Ceruso, M., Adenis, A., Verret, B., Penel, N., Moreau-Bachelard, C., Italiano, A., Dufresne, A., Metzger, S., Chabaud, S., Perol, D., and Le Cesne, A.

Published
2024
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6. 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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7. Maintenance olaparib rechallenge in patients with platinum-sensitive relapsed ovarian cancer previously treated with a PARP inhibitor (OReO/ENGOT-ov38): a phase IIIb trial

Author

Pujade-Lauraine, E., Selle, F., Scambia, G., Asselain, B., Marmé, F., Lindemann, K., Colombo, N., Mądry, R., Glasspool, R., Vergote, I., Korach, J., Lheureux, S., Dubot, C., Oaknin, A., Zamagni, C., Heitz, F., Gladieff, L., Rubio-Pérez, M.J., Scollo, P., Blakeley, C., Shaw, B., Ray-Coquard, I., and Redondo, A.

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

Author

Mery B, Ménétrier-Caux C, Montané L, Heudel PE, Ray-Coquard I, Bachelot T, Derbel O, Augereau P, Treilleux I, Berthet J, Nkodia A, Bardin-Dit-Courageot C, Attignon V, Ferrari A, Garin G, Perol D, Caux C, Dubois B, and Trédan O

Subjects
metastatic breast cancer, lymphopenia, immunotherapy, chemotherapy, immunomonitoring, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Benoîte Mery,1,2,* Christine Ménétrier-Caux,2,3,* Laure Montané,4 Pierre-Etienne Heudel,1 Isabelle Ray-Coquard,1 Thomas Bachelot,1 Olfa Derbel,5 Paule Augereau,6 Isabelle Treilleux,2,7 Justine Berthet,2,3 Axelle Nkodia,3 Christine Bardin-Dit-Courageot,3 Valery Attignon,8 Anthony Ferrari,9 Gwenaele Garin,4 David Perol,4 Christophe Caux,2,3 Bertrand Dubois,2,3,* Olivier Trédan1,2,* 1Department of Medical Oncology, Centre Léon Bérard, Lyon, France; 2Inserm U1052, CNRS 5286, Cancer Research Center of Lyon, Université Claude Bernard Lyon 1, Lyon, France; 3Laboratory of Cancer Immunotherapy of LYON (LICL), Centre Léon Bérard, Lyon, France; 4Clinical Research Platform (DRCI), Centre Léon Bérard, Lyon, France; 5Department of Medical Oncology, Hôpital Privé Jean-Mermoz, Lyon, France; 6Department of Medical Oncology, Institut de Cancérologie de L’ouest- Paul Papin, Angers, France; 7Biopathology Department, Centre Léon Bérard, Lyon, France; 8Genomic of Cancer Platform, Centre Léon Bérard, Lyon, France; 9Gilles Thomas Bioinformatics Platform, Synergie Lyon Cancer Foundation, Centre Léon Bérard, Lyon, France*These authors contributed equally to this workCorrespondence: Benoîte Mery, Department of Medical Oncology, Centre Léon Bérard, 28 Rue Laennec, Lyon, 69008, France, Tel +33 4 78 78 26 44, Fax +33 4 78 78 27 15, Email Benoite.mery@lyon.unicancer.frPurpose: Metastatic endocrine-resistant breast cancer (MBC) is a disease with poor prognosis and few treatment options. Low lymphocyte count is associated with limited overall survival. In a prospective cohort of lymphopenic patients with HER-2 negative MBC, we assessed the clinical and biological impact of pembrolizumab combined with metronomic cyclophosphamide.Experimental Design: This multicenter Phase II study evaluated the safety and clinical activity of pembrolizumab (intravenous (IV), 200mg, every 3 weeks) combined with metronomic cyclophosphamide (50mg/day, per os) in lymphopenic adult patients with HER2-negative MBC previously treated by at least one line of chemotherapy in this setting according to a Simon’s minimax two-stage design. Blood and tumor samples were collected to assess the impact of the combined treatment on circulating immune cells and the tumor immune microenvironment through multiparametric flow cytometry and multiplex immunofluorescence analyses. Primary endpoint was the clinical benefit rate at 6 months of treatment (CBR-6M). Secondary endpoints were objective response rate (ORR), duration of response, progression free survival (PFS), and overall survival (OS).Results: Two out of the twenty treated patients presented clinical benefit (one Tumor Mutational Burden (TMB)-high patient with complete response (CR) and one patient with objective response (OR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) associated with a strong increase of cytokine-producing and proliferating CD4+ T cells and higher CD8+ T cells to macrophage ratios in the tumor. This impact on CD4+ and CD8+ T cell polyfunctionality was still observed more than one year for the patient with CR. A decreased in their absolute number of CD4+ and CD8+ memory T cells was observed in other patients.Conclusion: Pembrolizumab combined with metronomic cyclophosphamide was well tolerated, and displayed limited anti-tumoral activity in lymphopenic MBC. Correlative translational data of our trial advocates for additional studies with other chemotherapy combinations.Keywords: metastatic breast cancer, lymphopenia, immunotherapy, chemotherapy, immunomonitoring

Published
2023

10. Prognostic gene expression signature for high-grade serous ovarian cancer.

Author

Millstein, J, Budden, T, Goode, EL, Anglesio, MS, Talhouk, A, Intermaggio, MP, Leong, HS, Chen, S, Elatre, W, Gilks, B, Nazeran, T, Volchek, M, Bentley, RC, Wang, C, Chiu, DS, Kommoss, S, Leung, SCY, Senz, J, Lum, A, Chow, V, Sudderuddin, H, Mackenzie, R, George, J, AOCS Group, Fereday, S, Hendley, J, Traficante, N, Steed, H, Koziak, JM, Köbel, M, McNeish, IA, Goranova, T, Ennis, D, Macintyre, G, Silva De Silva, D, Ramón Y Cajal, T, García-Donas, J, Hernando Polo, S, Rodriguez, GC, Cushing-Haugen, KL, Harris, HR, Greene, CS, Zelaya, RA, Behrens, S, Fortner, RT, Sinn, P, Herpel, E, Lester, J, Lubiński, J, Oszurek, O, Tołoczko, A, Cybulski, C, Menkiszak, J, Pearce, CL, Pike, MC, Tseng, C, Alsop, J, Rhenius, V, Song, H, Jimenez-Linan, M, Piskorz, AM, Gentry-Maharaj, A, Karpinskyj, C, Widschwendter, M, Singh, N, Kennedy, CJ, Sharma, R, Harnett, PR, Gao, B, Johnatty, SE, Sayer, R, Boros, J, Winham, SJ, Keeney, GL, Kaufmann, SH, Larson, MC, Luk, H, Hernandez, BY, Thompson, PJ, Wilkens, LR, Carney, ME, Trabert, B, Lissowska, J, Brinton, L, Sherman, ME, Bodelon, C, Hinsley, S, Lewsley, LA, Glasspool, R, Banerjee, SN, Stronach, EA, Haluska, P, Ray-Coquard, I, Mahner, S, Winterhoff, B, Slamon, D, Levine, DA, Kelemen, LE, Benitez, J, and Chang-Claude, J

Subjects
AOCS Group, Humans, Cystadenocarcinoma, Serous, Ovarian Neoplasms, Prognosis, Proportional Hazards Models, Survival Analysis, Female, Transcriptome, formalin-fixed paraffin-embedded, gene expression, high-grade serous ovarian cancer, overall survival, prognosis, Rare Diseases, Genetic Testing, Cancer, Ovarian Cancer, Genetics, 4.4 Population screening, 4.2 Evaluation of markers and technologies, Oncology & Carcinogenesis, Oncology and Carcinogenesis
Abstract

BackgroundMedian overall survival (OS) for women with high-grade serous ovarian cancer (HGSOC) is ∼4 years, yet survival varies widely between patients. There are no well-established, gene expression signatures associated with prognosis. The aim of this study was to develop a robust prognostic signature for OS in patients with HGSOC.Patients and methodsExpression of 513 genes, selected from a meta-analysis of 1455 tumours and other candidates, was measured using NanoString technology from formalin-fixed paraffin-embedded tumour tissue collected from 3769 women with HGSOC from multiple studies. Elastic net regularization for survival analysis was applied to develop a prognostic model for 5-year OS, trained on 2702 tumours from 15 studies and evaluated on an independent set of 1067 tumours from six studies.ResultsExpression levels of 276 genes were associated with OS (false discovery rate < 0.05) in covariate-adjusted single-gene analyses. The top five genes were TAP1, ZFHX4, CXCL9, FBN1 and PTGER3 (P < 0.001). The best performing prognostic signature included 101 genes enriched in pathways with treatment implications. Each gain of one standard deviation in the gene expression score conferred a greater than twofold increase in risk of death [hazard ratio (HR) 2.35, 95% confidence interval (CI) 2.02-2.71; P < 0.001]. Median survival [HR (95% CI)] by gene expression score quintile was 9.5 (8.3 to -), 5.4 (4.6-7.0), 3.8 (3.3-4.6), 3.2 (2.9-3.7) and 2.3 (2.1-2.6) years.ConclusionThe OTTA-SPOT (Ovarian Tumor Tissue Analysis consortium - Stratified Prognosis of Ovarian Tumours) gene expression signature may improve risk stratification in clinical trials by identifying patients who are least likely to achieve 5-year survival. The identified novel genes associated with the outcome may also yield opportunities for the development of targeted therapeutic approaches.

Published
2020

12. ESGO–ESMO–ESP consensus conference recommendations on ovarian cancer: pathology and molecular biology and early, advanced and recurrent disease

Author

Ledermann, J, Matias-Guiu, X, Amant, F, Concin, N, Davidson, B, Fotopoulou, C, González-Martin, A, Gourley, C, Leary, A, Lorusso, D, Banerjee, S, Chiva, L, Cibula, D, Colombo, N, Croce, S, Eriksson, A, Falandry, C, Fischerova, D, Harter, P, Joly, F, Lazaro, C, Lok, C, Mahner, S, Marmé, F, Marth, C, Mccluggage, W, Mcneish, I, Morice, P, Nicum, S, Oaknin, A, Pérez-Fidalgo, J, Pignata, S, Ramirez, P, Ray-Coquard, I, Romero, I, Scambia, G, Sehouli, J, Shapira-Frommer, R, Sundar, S, Tan, D, Taskiran, C, van Driel, W, Vergote, I, Planchamp, F, Sessa, C, Fagotti, A, Ledermann J. A., Matias-Guiu X., Amant F., Concin N., Davidson B., Fotopoulou C., González-Martin A., Gourley C., Leary A., Lorusso D., Banerjee S., Chiva L., Cibula D., Colombo N., Croce S., Eriksson A. G., Falandry C., Fischerova D., Harter P., Joly F., Lazaro C., Lok C., Mahner S., Marmé F., Marth C., McCluggage W. G., McNeish I. A., Morice P., Nicum S., Oaknin A., Pérez-Fidalgo J. A., Pignata S., Ramirez P. T., Ray-Coquard I., Romero I., Scambia G., Sehouli J., Shapira-Frommer R., Sundar S., Tan D. S. P., Taskiran C., van Driel W. J., Vergote I., Planchamp F., Sessa C., Fagotti A., Ledermann, J, Matias-Guiu, X, Amant, F, Concin, N, Davidson, B, Fotopoulou, C, González-Martin, A, Gourley, C, Leary, A, Lorusso, D, Banerjee, S, Chiva, L, Cibula, D, Colombo, N, Croce, S, Eriksson, A, Falandry, C, Fischerova, D, Harter, P, Joly, F, Lazaro, C, Lok, C, Mahner, S, Marmé, F, Marth, C, Mccluggage, W, Mcneish, I, Morice, P, Nicum, S, Oaknin, A, Pérez-Fidalgo, J, Pignata, S, Ramirez, P, Ray-Coquard, I, Romero, I, Scambia, G, Sehouli, J, Shapira-Frommer, R, Sundar, S, Tan, D, Taskiran, C, van Driel, W, Vergote, I, Planchamp, F, Sessa, C, Fagotti, A, Ledermann J. A., Matias-Guiu X., Amant F., Concin N., Davidson B., Fotopoulou C., González-Martin A., Gourley C., Leary A., Lorusso D., Banerjee S., Chiva L., Cibula D., Colombo N., Croce S., Eriksson A. G., Falandry C., Fischerova D., Harter P., Joly F., Lazaro C., Lok C., Mahner S., Marmé F., Marth C., McCluggage W. G., McNeish I. A., Morice P., Nicum S., Oaknin A., Pérez-Fidalgo J. A., Pignata S., Ramirez P. T., Ray-Coquard I., Romero I., Scambia G., Sehouli J., Shapira-Frommer R., Sundar S., Tan D. S. P., Taskiran C., van Driel W. J., Vergote I., Planchamp F., Sessa C., and Fagotti A.

Abstract

The European Society of Gynaecological Oncology, the European Society for Medical Oncology (ESMO) and the European Society of Pathology held a consensus conference (CC) on ovarian cancer on 15-16 June 2022 in Valencia, Spain. The CC panel included 44 experts in the management of ovarian cancer and pathology, an ESMO scientific advisor and a methodologist. The aim was to discuss new or contentious topics and develop recommendations to improve and harmonise the management of patients with ovarian cancer. Eighteen questions were identified for discussion under four main topics: (i) pathology and molecular biology, (ii) early-stage disease and pelvic mass in pregnancy, (iii) advanced stage (including older/frail patients) and (iv) recurrent disease. The panel was divided into four working groups (WGs) to each address questions relating to one of the four topics outlined above, based on their expertise. Relevant scientific literature was reviewed in advance. Recommendations were developed by the WGs and then presented to the entire panel for further discussion and amendment before voting. This manuscript focuses on the recommendation statements that reached a consensus, their voting results and a summary of evidence supporting each recommendation.

Published
2024

13. Clinical evaluation of a low-coverage whole-genome test for detecting homologous recombination deficiency in ovarian cancer

Author

Boidot, R, Blum, M, Wissler, M, Gottin, C, Ruzicka, J, Chevrier, S, Delhomme, T, Audoux, J, Jeanniard, A, Just, P, Harter, P, Pignata, S, Gonzalez-Martin, A, Marth, C, Maenpaa, J, Colombo, N, Vergote, I, Fujiwara, K, Duforet-Frebourg, N, Bertrand, D, Philippe, N, Ray-Coquard, I, Pujade-Lauraine, E, Boidot R., Blum M. G. B., Wissler M. -P., Gottin C., Ruzicka J., Chevrier S., Delhomme T. M., Audoux J., Jeanniard A., Just P. -A., Harter P., Pignata S., Gonzalez-Martin A., Marth C., Maenpaa J., Colombo N., Vergote I., Fujiwara K., Duforet-Frebourg N., Bertrand D., Philippe N., Ray-Coquard I., Pujade-Lauraine E., Boidot, R, Blum, M, Wissler, M, Gottin, C, Ruzicka, J, Chevrier, S, Delhomme, T, Audoux, J, Jeanniard, A, Just, P, Harter, P, Pignata, S, Gonzalez-Martin, A, Marth, C, Maenpaa, J, Colombo, N, Vergote, I, Fujiwara, K, Duforet-Frebourg, N, Bertrand, D, Philippe, N, Ray-Coquard, I, Pujade-Lauraine, E, Boidot R., Blum M. G. B., Wissler M. -P., Gottin C., Ruzicka J., Chevrier S., Delhomme T. M., Audoux J., Jeanniard A., Just P. -A., Harter P., Pignata S., Gonzalez-Martin A., Marth C., Maenpaa J., Colombo N., Vergote I., Fujiwara K., Duforet-Frebourg N., Bertrand D., Philippe N., Ray-Coquard I., and Pujade-Lauraine E.

Abstract

Background: The PAOLA-1/ENGOT-ov25 trial showed that maintenance olaparib plus bevacizumab increases survival of advanced ovarian cancer patients with homologous recombination deficiency (HRD). However, decentralized solutions to test for HRD in clinical routine are scarce. The goal of this study was to retrospectively validate on tumor samples from the PAOLA-1 trial, the decentralized SeqOne assay, which relies on shallow Whole Genome Sequencing (sWGS) to capture genomic instability and targeted sequencing to determine BRCA status. Methods: The study comprised 368 patients from the PAOLA-1 trial. The SeqOne assay was compared to the Myriad MyChoice HRD test (Myriad Genetics), and results were analyzed with respect to Progression-Free Survival (PFS). Results: We found a 95% concordance between the HRD status of the two tests (95% Confidence Interval (CI); 92%−97%). The Positive Percentage Agreement (PPA) of the sWGS test was 95% (95% CI; 91%−97%) like its Negative Percentage Agreement (NPA) (95% CI; 89%−98%). In patients with HRD-positive tumors treated with olaparib plus bevacizumab, the PFS Hazard Ratio (HR) was 0.38 (95% CI; 0.26–0.54) with SeqOne assay and 0.32 (95% CI; 0.22–0.45) with the Myriad assay. In patients with HRD-negative tumors, HR was 0.99 (95% CI; 0.68–1.42) and 1.05 (95% CI; 0.70–1.57) with SeqOne and Myriad assays. Among patients with BRCA-wildtype tumors, those with HRD-positive tumors, benefited from olaparib plus bevacizumab maintenance, with HR of 0.48 (95% CI: 0.29–0.79) and of 0.38 (95% CI: 0.23 to 0.63) with the SeqOne and Myriad assay. Conclusion: The SeqOne assay offers a clinically validated approach to detect HRD.

Published
2024

14. Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial

Author

Ray-Coquard, I., Leary, A., Pignata, S., Cropet, C., González-Martín, A., Marth, C., Nagao, S., Vergote, I., Colombo, N., Mäenpää, J., Selle, F., Sehouli, J., Lorusso, D., Guerra Alia, E.M., Bogner, G., Yoshida, H., Lefeuvre-Plesse, C., Buderath, P., Mosconi, A.M., Lortholary, A., Burges, A., Medioni, J., El-Balat, A., Rodrigues, M., Park-Simon, T.-W., Dubot, C., Denschlag, D., You, B., Pujade-Lauraine, E., and Harter, P.

Published
2023
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17. European experts consensus: BRCA/homologous recombination deficiency testing in first-line ovarian cancer

Author

Vergote, I., Ausems, M., Brasiuniene, B., Brenton, J., Büttner, R., Colombo, N., González-Martín, A., Harter, P., Lambrechts, D., Lorusso, D., Madry, R., Mirza, M.R., Pujol, P., Ray-Coquard, I., Abreu, M., Balboni, S., Banerjee, S., Barberis, M., Barretina Ginesta, M.P., Baurain, J.-F., Bignami, M., Bjorge, L., Blecharz, P., Bruchim, I., Capilna, M., Cerana, N., Cicchetti, A., Collins, D., Concin, N., D’Incalci, M., Davidson, B., de la Motte Rouge, T., De Iaco, P., Demirkiran, F., Denys, H., Doerk, T., Dorum, A., Ferrero, A., Fidalgo, A.P., Genuardi, M., Gladieff, L., Glasspool, R., Grimm, C., Gultekin, M., Hahnen, E., Hasenburg, A., Hegmane, A., Heinzelmann, V., Hogdall, E., Janavicius, R., Jarmalaite, S., Kalachand, R., Kaneva, R., Kilickap, S., Kocian, R., Kolencik, D., Kristeleit, R., Kryzhanivska, A., Leary, A., Lemley, B., Ligtenberg, M., López-Guerrero, J.A., Lord, C.J., Avall-Lundqvist, E., Maenpaa, J., Mahner, S., Marmé, F., Marth, C., McNeish, I., Merkelbach-Bruse, S., Mourits, M., Normanno, N., Oaknin, A., Ojamaa, K., Papdimitriou, C., Penault-Llorca, F., Perrone, A.M., Pignata, S., Pikarsky, E., Rouleau, E., Rubio, M., Sapino, A., Schmalfeldt, B., Sehouli, J., Shapira, R., Steffensen, K.D., Sukhin, V., Syrios, J., Szallasi, Z., Taskiran, C., Terzic, M., Tischkowitz, M., Toth, I., Van de Vijver, K., Vardar, M.A., Wasag, B., Wimberger, P., Witteveen, E., Brenton, J.D., and Ausems, M.G.E.M.

Published
2022
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18. VP3-2024: A randomized study of 6 vs 3 years of adjuvant imatinib in patients with localized GIST at high risk of relapse

Author

Le Cesne, A., primary, Schiffler, C., additional, Bouche, O., additional, Brahmi, M., additional, Duffaud, F., additional, Toulmonde, M., additional, Landi, B., additional, Lahlou, W., additional, Pannier, D., additional, Bompas, E., additional, Bertucci, F., additional, Chaigneau, L., additional, Collard, O., additional, Pracht, M., additional, Adenis, A., additional, Ray-Coquard, I., additional, Metzger, S., additional, Chabaud, S., additional, Perol, D., additional, and Blay, J-Y., additional

Published
2024
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19. A randomized phase III trial comparing trabectedin to best supportive care in patients with pre-treated soft tissue sarcoma: T-SAR, a French Sarcoma Group trial

Author

Le Cesne, A., Blay, J.-Y., Cupissol, D., Italiano, A., Delcambre, C., Penel, N., Isambert, N., Chevreau, C., Bompas, E., Bertucci, F., Chaigneau, L., Piperno-Neumann, S., Salas, S., Rios, M., Guillemet, C., Bay, J.-O., Ray-Coquard, I., Haddag, L., Bonastre, J., Kapso, R., Fraslin, A., Bouvet, N., Mir, O., and Foulon, S.

Published
2021
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20. 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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21. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial

Author

Pignata, S, Lorusso, D, Joly, F, Gallo, C, Colombo, N, Sessa, C, Bamias, A, Salutari, V, Selle, F, Frezzini, S, De Giorgi, U, Pautier, P, Bologna, A, Orditura, M, Dubot, C, Gadducci, A, Mammoliti, S, Ray-Coquard, I, Zafarana, E, Breda, E, Favier, L, Ardizzoia, A, Cinieri, S, Largillier, R, Sambataro, D, Guardiola, E, Lauria, R, Pisano, C, Raspagliesi, F, Scambia, G, Daniele, G, Perrone, F, Pignata, Sandro, Lorusso, Domenica, Joly, Florence, Gallo, Ciro, Colombo, Nicoletta, Sessa, Cristiana, Bamias, Aristotelis, Salutari, Vanda, Selle, Frédèric, Frezzini, Simona, De Giorgi, Ugo, Pautier, Patricia, Bologna, Alessandra, Orditura, Michele, Dubot, Coraline, Gadducci, Angiolo, Mammoliti, Serafina, Ray-Coquard, Isabelle, Zafarana, Elena, Breda, Enrico, Favier, Laure, Ardizzoia, Antonio, Cinieri, Saverio, Largillier, Rémy, Sambataro, Daniela, Guardiola, Emmanuel, Lauria, Rossella, Pisano, Carmela, Raspagliesi, Francesco, Scambia, Giovanni, Daniele, Gennaro, and Perrone, Francesco

Published
2021
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22. 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, R, Leary, A, Oaknin, A, Redondo, A, George, A, Chui, S, Seiller, A, Liste-Hermoso, M, Willis, J, Shemesh, CS, Xiao, J, Lin, KK, Molinero, L, Guan, Y, Ray-Coquard, I, Mileshkin, L, Kristeleit, R, Leary, A, Oaknin, A, Redondo, A, George, A, Chui, S, Seiller, A, Liste-Hermoso, M, Willis, J, Shemesh, CS, Xiao, J, Lin, KK, Molinero, L, Guan, Y, Ray-Coquard, I, and Mileshkin, L

Abstract

BACKGROUND: Combining PARP inhibitors (PARPis) with immune checkpoint inhibitors may improve clinical outcomes in selected cancers. We evaluated rucaparib and atezolizumab in advanced gynaecological or triple-negative breast cancer (TNBC). METHODS: After identifying the recommended dose, patients with PARPi-naive BRCA-mutated or homologous recombination-deficient/loss-of-heterozygosity-high platinum-sensitive ovarian cancer or TNBC received rucaparib plus atezolizumab. Tumour biopsies were collected pre-treatment, during single-agent rucaparib run-in, and after starting combination therapy. RESULTS: The most common adverse events with rucaparib 600 mg twice daily and atezolizumab 1200 mg on Day 1 every 3 weeks were gastrointestinal effects, fatigue, liver enzyme elevations, and anaemia. Responding patients typically had BRCA-mutated tumours and higher pre-treatment tumour levels of PD-L1 and CD8 + T cells. Markers of DNA damage repair decreased during rucaparib run-in and combination treatment in responders, but typically increased in non-responders. Apoptosis signature expression showed the reverse. CD8 + T-cell activity and STING pathway activation increased during rucaparib run-in, increasing further with atezolizumab. CONCLUSIONS: In this small study, rucaparib plus atezolizumab demonstrated acceptable safety and activity in BRCA-mutated tumours. Increasing anti-tumour immunity and inflammation might be a key mechanism of action for clinical benefit from the combination, potentially guiding more targeted development of such regimens. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT03101280).

Published
2024

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

Author

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

Abstract

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

Published
2024

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

Author

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

Abstract

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

Published
2024

25. ESGO–ESMO–ESP consensus conference recommendations on ovarian cancer: pathology and molecular biology and early, advanced and recurrent disease

Author

Ledermann, J. A., Matias-Guiu, X., Amant, F., Concin, N., Davidson, B., Fotopoulou, C., González-Martin, A., Gourley, C., Leary, A., Lorusso, Domenica, Banerjee, S., Chiva, L., Cibula, D., Colombo, N., Croce, S., Eriksson, A. G., Falandry, C., Fischerova, D., Harter, P., Joly, F., Lazaro, C., Lok, C., Mahner, S., Marmé, F., Marth, C., Mccluggage, W. G., Mcneish, I. A., Morice, P., Nicum, S., Oaknin, A., Pérez-Fidalgo, J. A., Pignata, S., Ramirez, P. T., Ray-Coquard, I., Romero, I., Scambia, Giovanni, Sehouli, J., Shapira-Frommer, R., Sundar, S., Tan, D. S. P., Taskiran, C., van Driel, W. J., Vergote, I., Planchamp, F., Sessa, C., Fagotti, Anna, Lorusso, D., Scambia, G. (ORCID:0000-0003-2758-1063), Fagotti, A. (ORCID:0000-0001-5579-335X), Ledermann, J. A., Matias-Guiu, X., Amant, F., Concin, N., Davidson, B., Fotopoulou, C., González-Martin, A., Gourley, C., Leary, A., Lorusso, Domenica, Banerjee, S., Chiva, L., Cibula, D., Colombo, N., Croce, S., Eriksson, A. G., Falandry, C., Fischerova, D., Harter, P., Joly, F., Lazaro, C., Lok, C., Mahner, S., Marmé, F., Marth, C., Mccluggage, W. G., Mcneish, I. A., Morice, P., Nicum, S., Oaknin, A., Pérez-Fidalgo, J. A., Pignata, S., Ramirez, P. T., Ray-Coquard, I., Romero, I., Scambia, Giovanni, Sehouli, J., Shapira-Frommer, R., Sundar, S., Tan, D. S. P., Taskiran, C., van Driel, W. J., Vergote, I., Planchamp, F., Sessa, C., Fagotti, Anna, Lorusso, D., Scambia, G. (ORCID:0000-0003-2758-1063), and Fagotti, A. (ORCID:0000-0001-5579-335X)

Abstract

The European Society of Gynaecological Oncology, the European Society for Medical Oncology (ESMO) and the European Society of Pathology held a consensus conference (CC) on ovarian cancer on 15-16 June 2022 in Valencia, Spain. The CC panel included 44 experts in the management of ovarian cancer and pathology, an ESMO scientific advisor and a methodologist. The aim was to discuss new or contentious topics and develop recommendations to improve and harmonise the management of patients with ovarian cancer. Eighteen questions were identified for discussion under four main topics: (i) pathology and molecular biology, (ii) early-stage disease and pelvic mass in pregnancy, (iii) advanced stage (including older/frail patients) and (iv) recurrent disease. The panel was divided into four working groups (WGs) to each address questions relating to one of the four topics outlined above, based on their expertise. Relevant scientific literature was reviewed in advance. Recommendations were developed by the WGs and then presented to the entire panel for further discussion and amendment before voting. This manuscript focuses on the recommendation statements that reached a consensus, their voting results and a summary of evidence supporting each recommendation.

Published
2024

26. PARP inhibitor predictive value of the Leuven HRD test compared with Myriad MyChoice CDx PLUS HRD on 468 ovarian cancer patients from the PAOLA-1/ENGOT-ov25 trial

Author

Loverix L., Vergote I., Busschaert P., Vanderstichele A., Venken T., Boeckx B., Harter P., Brems H., Van Nieuwenhuysen E., Pignata S., Baert T., Gonzalez-Martin A., Han S., Marth C., Neven P., Colombo N., Berteloot P., Mäenpää J., Olbrecht S., Laga T., Sablon E., Ray-Coquard I., Pujade-Lauraine E., Lambrechts D., Van Gorp T., Loverix, L, Vergote, I, Busschaert, P, Vanderstichele, A, Venken, T, Boeckx, B, Harter, P, Brems, H, Van Nieuwenhuysen, E, Pignata, S, Baert, T, Gonzalez-Martin, A, Han, S, Marth, C, Neven, P, Colombo, N, Berteloot, P, Mäenpää, J, Olbrecht, S, Laga, T, Sablon, E, Ray-Coquard, I, Pujade-Lauraine, E, Lambrechts, D, and Van Gorp, T

Subjects
Targeted therapy, Cancer Research, PARP inhibitor, Oncology, Ovarian cancer, HRD testing, Leuven HRD test
Abstract

Background: The PAOLA-1/ENGOT-ov25 trial showed improved progression-free (PFS) and overall survival (OS) in homologous recombination deficient (HRD) positive patients treated with olaparib, but not when HRD negative (HRD tested with MyChoice CDx PLUS [Myriad test]). Patients and methods: The academic Leuven HRD test consists of capture-based targeted sequencing of genome-wide single-nucleotide polymorphisms and coding exons of eight HR genes including BRCA1, BRCA2, and TP53. We compared the predictive value of the Leuven HRD versus Myriad HRD test for PFS and OS in the randomised PAOLA-1 trial. Results: 468 patients had left-over DNA after Myriad testing for Leuven HRD testing. Positive/negative/overall percent agreement for the Leuven versus Myriad HRD status was 95%/86%/91%, respectively. Tumours were HRD+ in 55% and 52%, respectively. In Leuven HRD+ patients, 5 years PFS (5yPFS) was 48.6% versus 20.3% (HR 0.431; 95% confidence intervals (CI) 0.312–0.595) for olaparib versus placebo, respectively (Myriad test 0.409; 95% CI 0.292–0.572). In Leuven HRD+/BRCAwt patients 5yPFS was 41.3% versus 12.6% (HR 0.497; 95% CI 0.316–0.783), and 43.6% versus 13.3% (HR 0.435; 95% CI 0.261–0.727) for the Myriad test. 5yOS was prolonged in the HRD+ subgroup with both tests 67.2% versus 54.4% (HR 0.663; 95% CI 0.442–0.995) for the Leuven test, and 68.0% versus 51.8% (HR 0.596 95% CI 0.393–0.904) for the Myriad test. HRD status was undetermined in 10.7% and 9.4% of the samples, respectively. Conclusions: A robust correlation between the Leuven HRD and Myriad test was observed. For HRD+ tumours, the academic Leuven HRD showed a similar difference in PFS and OS as the Myriad test.

Published
2023

28. Prognostic gene expression signature for high-grade serous ovarian cancer

Author

Bowtell, D., Chenevix-Trench, G., Green, A., Webb, P., DeFazio, A., Gertig, D., Traficante, N., Fereday, S., Moore, S., Hung, J., Harrap, K., Sadkowsky, T., Pandeya, N., Malt, M., Mellon, A., Robertson, R., Vanden Bergh, T., Jones, M., Mackenzie, P., Maidens, J., Nattress, K., Chiew, Y.E., Stenlake, A., Sullivan, H., Alexander, B., Ashover, P., Brown, S., Corrish, T., Green, L., Jackman, L., Ferguson, K., Martin, K., Martyn, A., Ranieri, B., White, J., Jayde, V., Mamers, P., Bowes, L., Galletta, L., Giles, D., Hendley, J., Alsop, K., Schmidt, T., Shirley, H., Ball, C., Young, C., Viduka, S., Tran, Hoa, Bilic, Sanela, Glavinas, Lydia, Brooks, Julia, Stuart-Harris, R., Kirsten, F., Rutovitz, J., Clingan, P., Glasgow, A., Proietto, A., Braye, S., Otton, G., Shannon, J., Bonaventura, T., Stewart, J., Begbie, S., Friedlander, M., Bell, D., Baron-Hay, S., Ferrier,a, A., Gard, G., Nevell, D., Pavlakis, N., Valmadre, S., Young, B., Camaris, C., Crouch, R., Edwards, L., Hacker, N., Marsden, D., Robertson, G., Beale, P., Beith, J., Carter, J., Dalrymple, C., Houghton, R., Russell, P., Links, M., Grygiel, J., Hill, J., Brand, A., Byth, K., Jaworski, R., Harnett, P., Sharma, R., Wain, G., Ward, B., Papadimos, D., Crandon, A., Cummings, M., Horwood, K., Obermair, A., Perrin, L., Wyld, D., Nicklin, J., Davy, M., Oehler, M.K., Hall, C., Dodd, T., Healy, T., Pittman, K., Henderson, D., Miller, J., Pierdes, J., Blomfield, P., Challis, D., McIntosh, R., Parker, A., Brown, B., Rome, R., Allen, D., Grant, P., Hyde, S., Laurie, R., Robbie, M., Healy, D., Jobling, T., Manolitsas, T., McNealage, J., Rogers, P., Susil, B., Sumithran, E., Simpson, I., Phillips, K., Rischin, D., Fox, S., Johnson, D., Lade, S., Loughrey, M., O’Callaghan, N., Murray, W., Waring, P., Billson, V., Pyman, J., Neesham, D., Quinn, M., Underhill, C., Bell, R., Ng, L.F., Blum, R., Ganju, V., Hammond, I., Leung, Y., McCartney, A., Buck, M., Haviv, I., Purdie, D., Whiteman, D., Zeps, N., Millstein, J., Budden, T., Goode, E.L., Anglesio, M.S., Talhouk, A., Intermaggio, M.P., Leong, H.S., Chen, S., Elatre, W., Gilks, B., Nazeran, T., Volchek, M., Bentley, R.C., Wang, C., Chiu, D.S., Kommoss, S., Leung, S.C.Y., Senz, J., Lum, A., Chow, V., Sudderuddin, H., Mackenzie, R., George, J., Steed, H., Koziak, J.M., Köbel, M., McNeish, I.A., Goranova, T., Ennis, D., Macintyre, G., Silva De Silva, D., Ramón y Cajal, T., García-Donas, J., Hernando Polo, S., Rodriguez, G.C., Cushing-Haugen, K.L., Harris, H.R., Greene, C.S., Zelaya, R.A., Behrens, S., Fortner, R.T., Sinn, P., Herpel, E., Lester, J., Lubiński, J., Oszurek, O., Tołoczko, A., Cybulski, C., Menkiszak, J., Pearce, C.L., Pike, M.C., Tseng, C., Alsop, J., Rhenius, V., Song, H., Jimenez-Linan, M., Piskorz, A.M., Gentry-Maharaj, A., Karpinskyj, C., Widschwendter, M., Singh, N., Kennedy, C.J., Harnett, P.R., Gao, B., Johnatty, S.E., Sayer, R., Boros, J., Winham, S.J., Keeney, G.L., Kaufmann, S.H., Larson, M.C., Luk, H., Hernandez, B.Y., Thompson, P.J., Wilkens, L.R., Carney, M.E., Trabert, B., Lissowska, J., Brinton, L., Sherman, M.E., Bodelon, C., Hinsley, S., Lewsley, L.A., Glasspool, R., Banerjee, S.N., Stronach, E.A., Haluska, P., Ray-Coquard, I., Mahner, S., Winterhoff, B., Slamon, D., Levine, D.A., Kelemen, L.E., Benitez, J., Chang-Claude, J., Gronwald, J., Wu, A.H., Menon, U., Goodman, M.T., Schildkraut, J.M., Wentzensen, N., Brown, R., Berchuck, A., deFazio, A., Gayther, S.A., García, M.J., Henderson, M.J., Rossing, M.A., Beeghly-Fadiel, A., Fasching, P.A., Orsulic, S., Karlan, B.Y., Konecny, G.E., Huntsman, D.G., Bowtell, D.D., Brenton, J.D., Doherty, J.A., Pharoah, P.D.P., and Ramus, S.J.

Published
2020
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31. The French national network dedicated to rare gynecological cancers diagnosis and management could improve the quality of surgery in daily practice of granulosa cell tumors. A TMRG and GINECO group Study

Author

Lenck, C., Chopin, N., Gouy, S., Bonsang-Kitzis, H., Martinez-Gomez, C., Radosevic-Robin, N., Martin, S., Lefeuvre-plesse, C., Lambaudie, E., Leblanc, E., Guyon, F., Classe, J.-M., Ramanah, R., Beurrier, F., Angeles, M.A., Pomel, C., Joly, F., de la Motte Rouge, T., Provansal, M., Lesoin, A., Floquet, A., Berton, D., Kalbacher, E., Chakiba, C., Meeus, P., Selle, F., Treilleux, I., Lecuru, F., Pautier, P., and Ray-Coquard, I.

Published
2020
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33. EE63 Cost-Effectiveness of Olaparib Plus Bevacizumab First-Line Maintenance in Ovarian Cancer Alongside the PAOLA-1 Trial

Author

Perrier, L., primary, Zarca, K., additional, Cadet, T., additional, Morelle, M., additional, Cropet, C., additional, Burges, A., additional, Cecere, S.C., additional, Palacio, I., additional, Polterauer, S., additional, Yoshida, H., additional, Vuylsteke, P., additional, Colombo, N., additional, Nøttrup, T.J., additional, Abdeddaim, C., additional, El-Balat, A., additional, Cinieri, S., additional, Herrero, A., additional, Kaminski, M.C., additional, Pujade-Lauraine, E., additional, Durand-Zaleski, I., additional, and Ray-Coquard, I., additional

Published
2023
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35. PT33 Cost-Effectiveness of Pembrolizumab Plus Chemotherapy, With or Without Bevacizumab for the First-Line Treatment of PD-L1-Positive Patients With Persistent, Recurrent, or Metastatic Cervical Cancer in France

Author

Ray-Coquard, I., primary, Pautier, P., additional, Muston, D., additional, Monberg, M.J., additional, Swami, S., additional, Chaker, O., additional, Bensimon, L., additional, Lange, S., additional, Kulakova, M., additional, Durand Zaleski, I., additional, and Marié, L., additional

Published
2023
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36. Health-Related Quality of Life in Patients With Advanced Endometrial Cancer Treated With Lenvatinib Plus Pembrolizumab or Treatment of Physician's Choice

Author

Lorusso, D, Colombo, N, Herraez, A, Santin, A, Colomba, E, Miller, D, Fujiwara, K, Pignata, S, Baron-Hay, S, Ray-Coquard, I, Shapira-Frommer, R, Kim, Y, Mccormack, M, Massaad, R, Nguyen, A, Zhao, Q, Mckenzie, J, Prabhu, V, Makker, V, Lorusso D., Colombo N., Herraez A. C., Santin A. D., Colomba E., Miller D. S., Fujiwara K., Pignata S., Baron-Hay S. E., Ray-Coquard I. L., Shapira-Frommer R., Kim Y. M., McCormack M., Massaad R., Nguyen A. M., Zhao Q., McKenzie J., Prabhu V. S., Makker V., Lorusso, D, Colombo, N, Herraez, A, Santin, A, Colomba, E, Miller, D, Fujiwara, K, Pignata, S, Baron-Hay, S, Ray-Coquard, I, Shapira-Frommer, R, Kim, Y, Mccormack, M, Massaad, R, Nguyen, A, Zhao, Q, Mckenzie, J, Prabhu, V, Makker, V, Lorusso D., Colombo N., Herraez A. C., Santin A. D., Colomba E., Miller D. S., Fujiwara K., Pignata S., Baron-Hay S. E., Ray-Coquard I. L., Shapira-Frommer R., Kim Y. M., McCormack M., Massaad R., Nguyen A. M., Zhao Q., McKenzie J., Prabhu V. S., and Makker V.

Abstract

Purpose: Lenvatinib and pembrolizumab (LEN+PEMBRO) demonstrated clinically meaningful and statistically significant improvements in efficacy versus treatment of physician's choice (TPC) in patients with advanced endometrial cancer (aEC) in the phase 3 Study 309/KEYNOTE-775. Health-related quality-of-life (HRQoL) is reported. Patients and Methods: Patients were randomly assigned to receive LEN+PEMBRO (n = 411; LEN 20 mg/day; PEMBRO 200 mg Q3W) or TPC (n = 416; doxorubicin 60 mg/m2 Q3W or paclitaxel 80 mg/m2 [weekly, 3 weeks on/1 week off]). Impact of treatment on HRQoL assessed by the global health status/quality of life (GHS/QoL) score of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) was a secondary objective; other scales of the Quality-of-Life Questionnaire (QLQ-C30), EORTC QLQ-Endometrial, 24 questions (EORTC QLQ-EN24), and EuroQoL 5 dimensions, 5 levels (EQ-5D-5L) were exploratory objectives. HRQoL was assessed on day 1 of each cycle. Completion/compliance, change from baseline, time to first and definitive deterioration were assessed. No multiplicity adjustments were applied for HRQoL endpoints. Results: The latest timepoint at which the predefined rates of completion (≥60%) and compliance (≥80%) were met was week 12. HRQoL at week 12 between treatment groups was generally similar. Time to first deterioration symptom scales favoured LEN+PEMBRO for QLQ-C30 dyspnoea, and QLQ-EN24 for poor body image, tingling/numbness, and hair loss; and TPC was favoured for QLQ-C30 pain, appetite loss, and diarrhoea, and QLQ-EN24 muscular pain. While the QLQ-C30 physical functional scale favoured TPC, other functional scales were generally similar between arms. Time to definitive deterioration favoured LEN+PEMBRO on most scales. Conclusion: HRQoL data from Study 309/KEYNOTE-775, with previously published efficacy and safety results, indicate that LEN+PEMBRO has an overall favourable benefit/risk profile versus TPC fo

Published
2023

37. PARP inhibitor predictive value of the Leuven HRD test compared with Myriad MyChoice CDx PLUS HRD on 468 ovarian cancer patients from the PAOLA-1/ENGOT-ov25 trial

Author

Loverix, L, Vergote, I, Busschaert, P, Vanderstichele, A, Venken, T, Boeckx, B, Harter, P, Brems, H, Van Nieuwenhuysen, E, Pignata, S, Baert, T, Gonzalez-Martin, A, Han, S, Marth, C, Neven, P, Colombo, N, Berteloot, P, Mäenpää, J, Olbrecht, S, Laga, T, Sablon, E, Ray-Coquard, I, Pujade-Lauraine, E, Lambrechts, D, Van Gorp, T, Loverix L., Vergote I., Busschaert P., Vanderstichele A., Venken T., Boeckx B., Harter P., Brems H., Van Nieuwenhuysen E., Pignata S., Baert T., Gonzalez-Martin A., Han S., Marth C., Neven P., Colombo N., Berteloot P., Mäenpää J., Olbrecht S., Laga T., Sablon E., Ray-Coquard I., Pujade-Lauraine E., Lambrechts D., Van Gorp T., Loverix, L, Vergote, I, Busschaert, P, Vanderstichele, A, Venken, T, Boeckx, B, Harter, P, Brems, H, Van Nieuwenhuysen, E, Pignata, S, Baert, T, Gonzalez-Martin, A, Han, S, Marth, C, Neven, P, Colombo, N, Berteloot, P, Mäenpää, J, Olbrecht, S, Laga, T, Sablon, E, Ray-Coquard, I, Pujade-Lauraine, E, Lambrechts, D, Van Gorp, T, Loverix L., Vergote I., Busschaert P., Vanderstichele A., Venken T., Boeckx B., Harter P., Brems H., Van Nieuwenhuysen E., Pignata S., Baert T., Gonzalez-Martin A., Han S., Marth C., Neven P., Colombo N., Berteloot P., Mäenpää J., Olbrecht S., Laga T., Sablon E., Ray-Coquard I., Pujade-Lauraine E., Lambrechts D., and Van Gorp T.

Abstract

Background: The PAOLA-1/ENGOT-ov25 trial showed improved progression-free (PFS) and overall survival (OS) in homologous recombination deficient (HRD) positive patients treated with olaparib, but not when HRD negative (HRD tested with MyChoice CDx PLUS [Myriad test]). Patients and methods: The academic Leuven HRD test consists of capture-based targeted sequencing of genome-wide single-nucleotide polymorphisms and coding exons of eight HR genes including BRCA1, BRCA2, and TP53. We compared the predictive value of the Leuven HRD versus Myriad HRD test for PFS and OS in the randomised PAOLA-1 trial. Results: 468 patients had left-over DNA after Myriad testing for Leuven HRD testing. Positive/negative/overall percent agreement for the Leuven versus Myriad HRD status was 95%/86%/91%, respectively. Tumours were HRD+ in 55% and 52%, respectively. In Leuven HRD+ patients, 5 years PFS (5yPFS) was 48.6% versus 20.3% (HR 0.431; 95% confidence intervals (CI) 0.312–0.595) for olaparib versus placebo, respectively (Myriad test 0.409; 95% CI 0.292–0.572). In Leuven HRD+/BRCAwt patients 5yPFS was 41.3% versus 12.6% (HR 0.497; 95% CI 0.316–0.783), and 43.6% versus 13.3% (HR 0.435; 95% CI 0.261–0.727) for the Myriad test. 5yOS was prolonged in the HRD+ subgroup with both tests 67.2% versus 54.4% (HR 0.663; 95% CI 0.442–0.995) for the Leuven test, and 68.0% versus 51.8% (HR 0.596 95% CI 0.393–0.904) for the Myriad test. HRD status was undetermined in 10.7% and 9.4% of the samples, respectively. Conclusions: A robust correlation between the Leuven HRD and Myriad test was observed. For HRD+ tumours, the academic Leuven HRD showed a similar difference in PFS and OS as the Myriad test.

Published
2023

38. Efficacy and safety of maintenance olaparib and bevacizumab in ovarian cancer patients aged ≥65 years from the PAOLA-1/ENGOT-ov25 trial

Author

Sabatier, R, Rousseau, F, Joly, F, Cropet, C, Montegut, C, Frindte, J, Cinieri, S, Guerra Alia, E, Polterauer, S, Yoshida, H, Vergote, I, Colombo, N, Hietanen, S, Largillier, R, Canzler, U, Gratet, A, Marme, F, Favier, L, Pujade-Lauraine, E, Ray-Coquard, I, Sabatier R., Rousseau F., Joly F., Cropet C., Montegut C., Frindte J., Cinieri S., Guerra Alia E. M., Polterauer S., Yoshida H., Vergote I., Colombo N., Hietanen S., Largillier R., Canzler U., Gratet A., Marme F., Favier L., Pujade-Lauraine E., Ray-Coquard I., Sabatier, R, Rousseau, F, Joly, F, Cropet, C, Montegut, C, Frindte, J, Cinieri, S, Guerra Alia, E, Polterauer, S, Yoshida, H, Vergote, I, Colombo, N, Hietanen, S, Largillier, R, Canzler, U, Gratet, A, Marme, F, Favier, L, Pujade-Lauraine, E, Ray-Coquard, I, Sabatier R., Rousseau F., Joly F., Cropet C., Montegut C., Frindte J., Cinieri S., Guerra Alia E. M., Polterauer S., Yoshida H., Vergote I., Colombo N., Hietanen S., Largillier R., Canzler U., Gratet A., Marme F., Favier L., Pujade-Lauraine E., and Ray-Coquard I.

Abstract

Background: The phase III PAOLA-1/ENGOT-ov25 study (NCT02477644) showed that addition of olaparib to bevacizumab maintenance improved progression-free survival (PFS) in patients with newly diagnosed advanced ovarian cancer. We evaluated maintenance olaparib plus bevacizumab in older patients in PAOLA-1. Methods: Baseline clinical and molecular data, and PFS, were compared between older (aged ≥65 years) and younger patients (<65 years). Factors associated with olaparib efficacy, and safety in age subgroups, were also assessed. Results: Of 806 randomised patients, 292 (36.2%) were ≥65 years. A lower proportion of older versus younger patients had an Eastern Cooperative Oncology Group performance status of 0 (61.0% versus 76.2%) and upfront surgery (42.0% versus 55.7%). Older patients were less likely to have a BRCA1/2 mutation (17.1% versus 36.7%) or homologous recombination deficiency-positive status (34.1% versus 55.7%). After median follow-up of 22.1 months, median PFS was 21.6 months with olaparib versus 16.6 months with placebo in the older population (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.41–0.75), comparable with the younger population (median 22.9 versus 16.9 months; HR 0.61, 95% CI 0.49–0.77). PFS benefits were observed in patients with a BRCA mutation or homologous recombination deficiency-positive tumours. Incidence of olaparib-related grade ≥3 adverse events in older patients was comparable with that of younger patients (36.8% versus 31.7%) although hypertension and anaemia were more common in older patients. No treatment-related deaths occurred in older patients receiving olaparib. Conclusion: Older patients enrolled in PAOLA-1 achieved similar PFS benefits compared with younger patients, with a similar safety profile.

Published
2023

39. Surgery in reference centers improves survival of sarcoma patients: a nationwide study

Author

Blay, J.-Y., Honoré, C., Stoeckle, E., Meeus, P., Jafari, M., Gouin, F., Anract, P., Ferron, G., Rochwerger, A., Ropars, M., Carrere, S., Marchal, F., Sirveaux, F., Di Marco, A., Le Nail, L.R., Guiramand, J., Vaz, G., Machiavello, J.-C., Marco, O., Causeret, S., Gimbergues, P., Fiorenza, F., Chaigneau, L., Guillemin, F., Guilloit, J.-M., Dujardin, F., Spano, J.-P., Ruzic, J.-C., Michot, A., Soibinet, P., Bompas, E., Chevreau, C., Duffaud, F., Rios, M., Perrin, C., Firmin, N., Bertucci, F., Le Pechoux, C., Le Loarer, F., Collard, O., Karanian-Philippe, M., Brahmi, M., Dufresne, A., Dupré, A., Ducimetière, F., Giraud, A., Pérol, D., Toulmonde, M., Ray-Coquard, I., Italiano, A., Le Cesne, A., Penel, N., and Bonvalot, S.

Published
2019
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40. Management of epithelial cancer of the ovary, fallopian tube, primary peritoneum. Long text of the joint French clinical practice guidelines issued by FRANCOGYN, CNGOF, SFOG, GINECO-ARCAGY, endorsed by INCa. (Part 2: systemic, intraperitoneal treatment, elderly patients, fertility preservation, follow-up)

Author

Lavoue, V., Huchon, C., Akladios, C., Alfonsi, P., Bakrin, N., Ballester, M., Bendifallah, S., Bolze, P.A., Bonnet, F., Bourgin, C., Chabbert-Buffet, N., Collinet, P., Courbiere, B., De la motte rouge, T., Devouassoux-Shisheboran, M., Falandry, C., Ferron, G., Fournier, L., Gladieff, L., Golfier, F, Gouy, S., Guyon, F., Lambaudie, E, Leary, A., Lecuru, F., Lefrere-Belda, M.A., Leblanc, E., Lemoine, A, Narducci, F., Ouldamer, L., Pautier, P., Planchamp, F., Pouget, N., Ray-Coquard, I., Rousset-Jablonski, C., Senechal-Davin, C., Touboul, C., Thomassin-Naggara, I., Uzan, C., You, B., and Daraï, E.

Published
2019
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41. Management of epithelial cancer of the ovary, fallopian tube, and primary peritoneum. Long text of the Joint French Clinical Practice Guidelines issued by FRANCOGYN, CNGOF, SFOG, and GINECO-ARCAGY, and endorsed by INCa. Part 1: Diagnostic exploration and staging, surgery, perioperative care, and pathology

Author

Lavoue, V., Huchon, C., Akladios, C., Alfonsi, P., Bakrin, N., Ballester, M., Bendifallah, S., Bolze, P.A., Bonnet, F., Bourgin, C., Chabbert-Buffet, N., Collinet, P., Courbiere, B., De la motte rouge, T., Devouassoux-Shisheboran, M., Falandry, C., Ferron, G., Fournier, L., Gladieff, L., Golfier, F., Gouy, S., Guyon, F., Lambaudie, E., Leary, A., Lecuru, F., Lefrere-Belda, M.A., Leblanc, E., Lemoine, A., Narducci, F., Ouldamer, L., Pautier, P., Planchamp, F., Pouget, N., Ray-Coquard, I., Rousset-Jablonski, C., Senechal-Davin, C., Touboul, C., Thomassin-Naggara, I., Uzan, C., You, B., and Daraï, E.

Published
2019
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42. ESMO–ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease

Author

Baert, T., Banerjee, S., Belaroussi, I., Blecharz, P., Bruchim, I., Cibula, D., Colombo, N., Concin, N., Davidson, B., Dashora, A., Devouassoux-Shisheboran, M., du Bois, A., Ferrero, A., Glasspool, R., González-Martin, A., Heinzelmann-Schwarz, V., Joly, F., Kim, J.W., Kridelka, F., Ledermann, J., Lorusso, D., Mahner, S., McCluggage, W.G., McNeish, I., Mikami, M., Mirza, M.R., Morice, P., Nicum, S., Olbrecht, S., O’Donnell, D.M., Pautier, P., Planchamp, F., Pignata, S., Querleu, D., Ray-Coquard, I., Rodolakis, A., Sehouli, J., Selcukbiricik, F., Sessa, C., Singh, N., Tan, D.S.P., Timmerman, D., Tognon, G., van der Velden, J., Vergote, I., Witteveen, P.O., and Zeimet, A.G.

Published
2019
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43. Molecular screening program to select molecular-based recommended therapies for metastatic cancer patients: analysis from the ProfiLER trial

Author

Trédan, O., Wang, Q., Pissaloux, D., Cassier, P., de la Fouchardière, A., Fayette, J., Desseigne, F., Ray-Coquard, I., de la Fouchardière, C., Frappaz, D., Heudel, P.-E., Bonneville-Levard, A., Fléchon, A., Sarabi, M., Guibert, P., Bachelot, T., Pérol, M., You, B., Bonnin, N., Collard, O., Leyronnas, C., Attignon, V., Baudet, C., Sohier, E., Villemin, J.-P., Viari, A., Boyault, S., Lantuejoul, S., Paindavoine, S., Treillleux, I., Rodriguez, C., Agrapart, V., Corset, V., Garin, G., Chabaud, S., Pérol, D., and Blay, J.-Y.

Published
2019
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44. Management of epithelial cancer of the ovary, fallopian tube, and primary peritoneum. Short text of the French Clinical Practice Guidelines issued by FRANCOGYN, CNGOF, SFOG, and GINECO-ARCAGY, and endorsed by INCa

Author

Lavoue, V., Huchon, C., Akladios, C., Alfonsi, P., Bakrin, N., Ballester, M., Bendifallah, S., Bolze, P.A., Bonnet, F., Bourgin, C., Chabbert-Buffet, N., Collinet, P., Courbiere, B., De la motte rouge, T., Devouassoux-Shisheboran, M., Falandry, C., Ferron, G., Fournier, L., Gladieff, L., Golfier, F., Gouy, S., Guyon, F., Lambaudie, E., Leary, A., Lecuru, F., Lefrere-Belda, M.A., Leblanc, E., Lemoine, A., Narducci, F., Ouldamer, L., Pautier, P., Planchamp, F., Pouget, N., Ray-Coquard, I., Rousset-Jablonski, C., Senechal-Davin, C., Touboul, C., Thomassin-Naggara, I., Uzan, C., You, B., and Daraï, E.

Published
2019
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45. Rare ovarian tumours: Epidemiology, treatment challenges in and outside a network setting

Author

Hackl, Monika, Van Eycken, Elizabeth, Henau, Kris, Dimitrova, Nadya, Sekerija, Mario, Dušek, Ladislav, Mägi, Margit, Malila, Nea, Leinonen, Maarit, Velten, Michel, Troussard, Xavier, Bouvier, Veronique, Guizard, Anne-Valérie, Bouvier, Anne-Marie, Arveux, Patrick, Maynadié, Marc, Woronoff, Anne-Sophie, Robaszkiewicz, Michel, Baldi, Isabelle, Monnereau, Alain, Tretarre, Brigitte, Colonna, Marc, Molinié, Florence, Bara, Simona, Schvartz, Claire, Lapôtre-Ledoux, Bénédicte, Grosclaude, Pascale, Stabenow, Roland, Luttmann, Sabine, Nennecke, Alice, Engel, Jutta, Schubert-Fritschle, Gabriele, Heidrich, Jan, Holleczek, Bernd, Jónasson, Jón Gunnlaugur, Clough-Gorr, Kerri, Comber, Harry, Mazzoleni, Guido, Giacomin, Adriano, Sardo, Antonella Sutera, Barchielli, Alessandro, Serraino, Diego, De Angelis, Roberta, Mallone, Sandra, Tavilla, Andrea, Pierannunzio, Daniela, Rossi, Silvia, Santaquilani, Mariano, Knijn, Arnold, Pannozzo, Fabio, Gennaro, Valerio, Benfatto, Lucia, Ricci, Paolo, Autelitano, Mariangela, Spagnoli, Gianbattista, Fusco, Mario, Usala, Mario, Vitale, Francesco, Michiara, Maria, Tumino, Rosario, Mangone, Lucia, Falcini, Fabio, Ferretti, Stefano, Filiberti, Rosa Angela, Marani, Enza, Iannelli, Arturo, Sensi, Flavio, Piffer, Silvano, Gentilini, Maria, Madeddu, Anselmo, Ziino, Antonio, Maspero, Sergio, Candela, Pina, Stracci, Fabrizio, Tagliabue, Giovanna, Rugge, Massimo, Trama, Annalisa, Gatta, Gemma, Botta, Laura, Capocaccia, Riccardo, Pildava, Santa, Smailyte, Giedre, Calleja, Neville, Johannesen, Tom Børge, Rachtan, Jadwiga, Góźdź, Stanisław, Błaszczyk, Jerzy, Kępska, Kamila, de Lacerda, Gonçalo Forjaz, José Bento, Maria, Miranda, Ana, Safaei Diba, Chakameh, Almar, Enrique, Larrañaga, Nerea, de Munain, Arantza Lopez, Torrella-Ramos, Ana, Díaz García, José María, Marcos-Gragera, Rafael, Josè Sanchez, Maria, Navarro, Carmen, Salmeron, Diego, Moreno-Iribas, Conchi, Galceran, Jaume, Carulla, Marià, Mousavi, Mohsen, Bouchardy, Christine, Ess, Silvia M., Bordoni, Andrea, Konzelmann, Isabelle, Rashbass, Jem, Gavin, Anna, Brewster, David H., Huws, Dyfed Wyn, Visser, Otto, Bielska-Lasota, Magdalena, Primic-Zakelj, Maja, Kunkler, Ian, Benhamou, Ellen, Ray-Coquard, I., Trama, AnnaLisa, Seckl, M.J., Fotopoulou, C., Pautier, P., Pignata, S., Kristensen, G., Mangili, G., Falconer, H., Massuger, L., Sehouli, J., Pujade-Lauraine, E., Lorusso, D., Amant, F., Rokkones, E., Vergote, I., and Ledermann, J.A.

Published
2019
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46. Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): A randomised, multicentre, double-blind, placebo-controlled phase 3 trial

Author

Monk, BJ, Poveda, A, Vergote, I, Raspagliesi, F, Fujiwara, K, Bae, DS, Oaknin, A, Ray-Coquard, I, Provencher, DM, Karlan, BY, Lhommé, C, Richardson, G, Rincón, DG, Coleman, RL, Herzog, TJ, Marth, C, Brize, A, Fabbro, M, Redondo, A, Bamias, A, Tassoudji, M, Navale, L, Warner, DJ, and Oza, AM

Subjects
Oncology & Carcinogenesis, Oncology and Carcinogenesis
Abstract

Background: Angiogenesis is a valid target in the treatment of epithelial ovarian cancer. Trebananib inhibits the binding of angiopoietins 1 and 2 to the Tie2 receptor, and thereby inhibits angiogenesis. We aimed to assess whether the addition of trebananib to single-agent weekly paclitaxel in patients with recurrent epithelial ovarian cancer improved progression-free survival. Methods: For this randomised, double-blind phase 3 study undertaken between Nov 10, 2010, and Nov 19, 2012, we enrolled women with recurrent epithelial ovarian cancer from 32 countries. Patient eligibility criteria included having been treated with three or fewer previous regimens, and a platinum-free interval of less than 12 months. We enrolled patients with a computerised interactive voice response system, and patients were randomly assigned using a permuted block method (block size of four) in a 1:1 ratio to receive weekly intravenous paclitaxel (80 mg/m2) plus either weekly masked intravenous placebo or trebananib (15 mg/kg). Patients were stratified on the basis of platinum-free interval (≥0 and ≤6 months vs >6 and ≤12 months), presence or absence of measurable disease, and region (North America, western Europe and Australia, or rest of world). The sponsor, investigators, site staff, and patients were masked to the treatment assignment. The primary endpoint was progression-free survival assessed in the intention-to-treat population. The trial is registered with ClinicalTrials.gov, NCT01204749, and is no longer accruing patients. Findings: 919 patients were enrolled, of whom 461 were randomly assigned to the trebananib group and 458 to the placebo group. Median progression-free survival was significantly longer in the trebananib group than in the placebo group (7·2 months [5·8-7·4] vs 5·4 months [95% CI 4·3-5·5], respectively, hazard ratio 0·66, 95% CI 0·57-0·77, p

Published
2014

47. Gynecological Carcinosarcomas

Author

Berton-Rigaud, D., Frenel, J. S., Devouassoux-Shisheboran, M., Ray-Coquard, I., Pujade-Lauraine, Eric, editor, Ray-Coquard, Isabelle, editor, and Lécuru, Fabrice, editor

Published
2017
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49. Anti-NaPi2b antibody–drug conjugate lifastuzumab vedotin (DNIB0600A) compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer in a randomized, open-label, phase II study

Author

Banerjee, S., Oza, A.M., Birrer, M.J., Hamilton, E.P., Hasan, J., Leary, A., Moore, K.N., Mackowiak-Matejczyk, B., Pikiel, J., Ray-Coquard, I., Trask, P., Lin, K., Schuth, E., Vaze, A., Choi, Y., Marsters, J.C., Maslyar, D.J., Lemahieu, V., Wang, Y., Humke, E.W., and Liu, J.F.

Published
2018
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50. Improved survival using specialized multidisciplinary board in sarcoma patients

Author

Blay, J.-Y., Soibinet, P., Penel, N., Bompas, E., Duffaud, F., Stoeckle, E., Mir, O., Adam, J., Chevreau, C., Bonvalot, S., Rios, M., Kerbrat, P., Cupissol, D., Anract, P., Gouin, F., Kurtz, J. -E., Lebbe, C., Isambert, N., Bertucci, F., Toumonde, M., Thyss, A., Piperno-Neumann, S., Dubray-Longeras, P., Meeus, P., Ducimetière, F., Giraud, A., Coindre, J. -M., Ray-Coquard, I., Italiano, A., and Le Cesne, A.

Published
2017
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