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

Author

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

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

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

Published
2017

6. 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

7. 6 months versus 12 months of adjuvant trastuzumab in early breast cancer (PHARE): final analysis of a multicentre, open-label, phase 3 randomised trial

Author

Piprot, C, Cals, L, Chaigneau, L, Demarchi, F, N'Guyen, T, Stein, U, Villanueva, C, Bréau, JL, Chouahnia, AK, Saintigny, P, Boué, F, deSaint-Hilaire, P, Guimont, I, Grossat, N, Valenza, B, Lévy, E, Médioni, J, Delbaldo, C, Grenier, J, Pouessel, D, Lavau-Denès, S, Falandry, C, Fournel-Fédérico, C, Freyer, G, Tartas, S, Trillet-Lenoir, V, Bons, F, Auclerc, G, Chièze, S, Raban, N, Tournigand, C, Trager-Maury, S, Bousquet, G, Cuvier, C, Giacchetti, S, Hocini, A, LeMaignan, C, Misset, JL, Avenin, D, Beerblock, C, Gligorov, J, Rivera, P, Roché, H, Bougnoux, P, Hajjaji, N, Capitain, O, Delva, R, Maillart, P, Soulié, P, Bonnefoi, H, Durand, M, Madranges, N, Mauriac, L, Chollet, P, Dillies, AF, Durando, X, Ferrière, JP, Mouret-Reynier, C, Nabholtz, JM, Van Praagh, I, Cottu, P, Diéras, V, Durieux, A, Galotte, M, Girre, V, Henry, S, Iurisci, I, Jouve, M, Laurence, V, Mignot, L, Piperno-Neumann, S, Tresca, P, Coudert, B, Ferrant, E, Mayer, F, Vanneuville, AC, Bonneterre, J, Servent, V, Vanlemmens, L, Vennin, P, Guastalla, JP, Biron, P, Dupuy-Brousseau, L, Lancry, L, Ray-Coquard, I, Rebattu, P, Trédan, O, Extra, JM, Rousseau, F, Tarpin, C, Fabbro, M, Luporsi, E, Uwer, L, Weber, B, Berton-Rigaud, D, Bourbouloux, E, Campone, M, Ferrero, JM, Follana, P, Largillier, R, Mari, V, Costa, B, Curé, H, Eymard, JC, Jovenin, N, Lebrun, D, Meunier, J, Yazbek, G, Gedoin, D, Laguerre, B, Lefeuvre, C, Vauléon, E, Chevrier, A, Guillemet, C, Leheurteur, M, Rigal, O, Tennevet, I, Veyret, C, Brain, E, Guiterrez, M, Mefti-Lacheraf, F, Petit, T, Dalenc, F, Gladieff, L, André, F, Delaloge, S, Domont, J, Ezenfis, J, Spielmann, M, Guillet, P, Boulanger, V, Provençal, J, Stefani, L, Alliot, C, Ré, D, Bellaiche-Miccio, C, Boutan-Laroze, G, Vanica, R, Dion, P, Sadki-Benaoudia, G, Marti, A, Villing, AL, Slama, B, Dutel, JL, Nguyen, S, Saad, R, Arsène, O, Merad-Boudia, Z, Orfeuvre, H, Egreteau, J, Goudier, MJ, Lamy, R, Leduc, B, Sarda, C, Salles, B, Agostini, C, Cauvin, I, Dufresne, A, Mangold, M, Lebouvier-Sadot, S, Audhuy, B, Barats, JC, Cluet-Dennetière, S, Zylberait, D, Netter, G, Gautier-Felizot, L, Cojean-Zelek, I, Plantade, A, Vignot, S, Guardiola, E, Marti, P, deHartingh, I, Diab, R, Dietmann, A, Ruck, S, Portois, C, Oddou-Lagranière, S, Campos-Gazeau, F, Bourcier, A, Priou, F, Geay, JF, Mayeur, D, Gabez, P, ElAmarti, R, Combe, M, Raichon-Patru, P, Amsalhem, P, Dauba, J, Paraiso, D, Guinet, F, Duvert, B, Litor, M, Kara-Slimane, F, Bichoffe, A, Denizon, N, Soyer, P, Morvan, F, Van-Hulst, S, Vincent, L, Alleaume, C, Ibanez-Martin, P, Youssef, A, Tadrist, Z, Carola, E, Pourny, C, Toccanier, JF, Al-Aukla, N, Mahour-Bacha, K, Salvat, J, Nouyrigat, P, Clippe, S, Gouttebel, MC, Vedrine, L, Clavreul, G, Collard, O, Mille, D, Goubely, Y, Hervé, R, Kirscher, S, Plat, F, Delecroix, V, Ligeza-Poisson, V, Coeffic, D, Fric, D, Garnier, C, Leyronnas, C, Kreitman, T, Teissier, E, Martin, P, Rohart deCordoue, S, ElKouri, C, Ramée, JF, Laporte, C, Bernard, O, Altwegg, T, Darut-Jouve, A, Dujols, JP, Darloy, F, Giraud, C, Pottier-Kyndt, V, Achour, N, Drony, S, Moriceau, M, Sarrazin, C, Legueul, JC, Mandet, J, Besson, D, Hardy-Bessard, AC, Cretin, J, Houyau, P, Achille, E, Genêt, D, Thévenot, H, Moran-Ribon, A, Pavlovitch, JM, Ardisson, P, Moullet, I, Couderc, B, Fichet, V, Burki, F, Auliard, A, Levaché, CB, Cailleux, P, Schaeffer, F, Albin, N, Sévin-Robiche, D, Domas, J, Ellis, S, Montcuquet, P, Baumont, GA, Bégue, M, Gréget, S, Ratoanina, JL, Vanoli, A, Bielsa, C, Bonichon-Lamichhane, M, Jaubert, D, Laharie-Mineur, H, Alcaraz, L, Legouffe, E, Bourgeois, H, Cartron, G, Denis, F, Dupuis, O, Ganem, G, Roche-Forestier, S, Delzenne, L, Chirat, E, Baticle, JL, Béguier, E, Jacquot, S, Janssen, E, Lauché, H, LeRol, A, Chantelard, JP, L'Helgoualc'h, GA, Antoine, EC, Kanoui, A, Llory, JF, Vannetzel, JM, Vignoud, J, Bruna, C, Facchini, T, Moutel-Corviole, K, Voloch, A, Ghoul, A, Loiseau, D, Barbet, N, Dohollou, N, Yakendji, K, Pivot, Xavier, Romieu, Gilles, Debled, Marc, Pierga, Jean-Yves, Kerbrat, Pierre, Bachelot, Thomas, Lortholary, Alain, Espié, Marc, Fumoleau, Pierre, Serin, Daniel, Jacquin, Jean-Philippe, Jouannaud, Christelle, Rios, Maria, Abadie-Lacourtoisie, Sophie, Venat-Bouvet, Laurence, Cany, Laurent, Catala, Stéphanie, Khayat, David, Gambotti, Laetitia, Pauporté, Iris, Faure-Mercier, Celine, Paget-Bailly, Sophie, Henriques, Julie, and Grouin, Jean Marie

Published
2019
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8. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

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

Published
2017
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9. Preexisting autoantibodies as predictor of immune related adverse events (irAEs) for advanced solid tumors treated with immune checkpoint inhibitors (ICIs)

Author

Daban, A, primary, Gonnin, C, additional, Phan, L, additional, Saldmann, A, additional, Granier, C, additional, Lillo-Lelouet, A, additional, Le Beller, C, additional, Pouchot, J, additional, Weiss, l, additional, Tartour, E, additional, Fabre, E, additional, Medioni, J, additional, Oudard, S, additional, Vano, YA, additional, Dragon-Durey, MA, additional, and Simonaggio, A., additional

Published
2023
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11. 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-Martin, A, Marth, C, Nagao, S, Vergote, I, Colombo, N, Mäenpää, J, Selle, F, Sehouli, J, Lorusso, D, Alia, E, Bogner, G, Yoshida, H, Lefeuvre-Plesse, C, Buderath, P, Mosconi, A, Lortholary, A, Burges, A, Medioni, J, El-Balat, A, Rodrigues, M, Park-Simon, T, Dubot, C, Denschlag, D, You, B, Pujade-Lauraine, E, Harter, P, Alia, E M Guerra, Mosconi, A M, Park-Simon, T-W, Ray-Coquard, I, Leary, A, Pignata, S, Cropet, C, González-Martin, A, Marth, C, Nagao, S, Vergote, I, Colombo, N, Mäenpää, J, Selle, F, Sehouli, J, Lorusso, D, Alia, E, Bogner, G, Yoshida, H, Lefeuvre-Plesse, C, Buderath, P, Mosconi, A, Lortholary, A, Burges, A, Medioni, J, El-Balat, A, Rodrigues, M, Park-Simon, T, Dubot, C, Denschlag, D, You, B, Pujade-Lauraine, E, Harter, P, Alia, E M Guerra, Mosconi, A M, and Park-Simon, T-W

Abstract

Background: In the PAOLA-1/ENGOT-ov25 primary analysis, maintenance olaparib plus bevacizumab demonstrated a significant progression-free survival (PFS) benefit in newly diagnosed advanced ovarian cancer patients in clinical response after first-line platinum-based chemotherapy plus bevacizumab, irrespective of surgical status. Prespecified, exploratory analyses by molecular biomarker status showed substantial benefit in patients with a BRCA1/BRCA2 mutation (BRCAm) or homologous recombination deficiency (HRD; BRCAm and/or genomic instability). We report the prespecified final overall survival (OS) analysis, including analyses by HRD status. Patients and methods: Patients were randomized 2 : 1 to olaparib (300 mg twice daily; up to 24 months) plus bevacizumab (15 mg/kg every 3 weeks; 15 months total) or placebo plus bevacizumab. Analysis of OS, a key secondary endpoint in hierarchical testing, was planned for ∼60% maturity or 3 years after the primary analysis. Results: After median follow-up of 61.7 and 61.9 months in the olaparib and placebo arms, respectively, median OS was 56.5 versus 51.6 months in the intention-to-treat population [hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.76-1.12; P = 0.4118]. Subsequent poly(ADP-ribose) polymerase inhibitor therapy was received by 105 (19.6%) olaparib patients versus 123 (45.7%) placebo patients. In the HRD-positive population, OS was longer with olaparib plus bevacizumab (HR 0.62, 95% CI 0.45-0.85; 5-year OS rate, 65.5% versus 48.4%); at 5 years, updated PFS also showed a higher proportion of olaparib plus bevacizumab patients without relapse (HR 0.41, 95% CI 0.32-0.54; 5-year PFS rate, 46.1% versus 19.2%). Myelodysplastic syndrome, acute myeloid leukemia, aplastic anemia, and new primary malignancy incidence remained low and balanced between arms. Conclusions: Olaparib plus bevacizumab provided clinically meaningful OS improvement for first-line patients with HRD-positive ovarian cancer. These prespecified expl

Published
2023

12. 36MO Maintenance olaparib plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced ovarian cancer (OC): 5-year (y) progression-free survival (PFS) by molecular subgroup in the PAOLA-1/ENGOT-ov25 trial

Author

Gonzalez Martin, A.J., primary, Medioni, J., additional, Harter, P., additional, Cropet, C., additional, Cinieri, S., additional, Denison, U., additional, Fujiwara, H., additional, Vergote, I.B., additional, Bologna, A., additional, Hietanen, S., additional, Rodrigues, M.J., additional, Hanker, L.C., additional, Zamagni, C., additional, Hernando Polo, S., additional, Bello Roufai, D., additional, Bauerschlag, D., additional, You, B., additional, Hillemanns, P., additional, Pujade-Lauraine, E., additional, and Ray-Coquard, I.L., additional

Published
2023
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15. Olaparib tablets as maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a final analysis of a double-blind, randomised, placebo-controlled, phase 3 trial

Author

Poveda, A, Floquet, A, Ledermann, J, Asher, R, Penson, R, Oza, A, Korach, J, Huzarski, T, Pignata, S, Friedlander, M, Baldoni, A, Park-Simon, T, Tamura, K, Sonke, G, Lisyanskaya, A, Kim, J, Filho, E, Milenkova, T, Lowe, E, Rowe, P, Vergote, I, Pujade-Lauraine, E, Byrski, T, Pautier, P, Harter, P, Colombo, N, Scambia, G, Nicoletto, M, Nussey, F, Clamp, A, Poveda Velasco, A, Rodrigues, M, Lotz, J, Selle, F, Ray-Coquard, I, Provencher, D, Prat Aparicio, A, Vidal Boixader, L, Scott, C, Yunokawa, M, Medioni, J, Pecuchet, N, Dubot, C, De La Motte Rouge, T, Kaminsky, M, Weber, B, Lortholary, A, Parkinson, C, Williams, S, Banerjee, S, Cosin, J, Hoffman, J, Plante, M, Covens, A, Joly, F, Hirte, H, Amit, A, Matsumoto, K, Tjulandin, S, Hoon Kim, J, Gladieff, L, Sabbatini, R, O'Malley, D, Timmins, P, Kredentser, D, Lainez Milagro, N, Barretina Ginesta, M, Tibau Martorell, A, Gomez De Liano Lista, A, Ojeda Gonzalez, B, Mileshkin, L, Mandai, M, Boere, I, Ottevanger, P, Nam, J, Hamizi, S, Cognetti, F, Warshal, D, Dickson-Michelson, E, Kamelle, S, Mckenzie, N, Rodriguez, G, Armstrong, D, Chalas, E, Celano, P, Behbakht, K, Davidson, S, Welch, S, Helpman, L, Fishman, A, Bruchim, I, Sikorska, M, Slowinska, A, Rogowski, W, Bidzinski, M, Spiewankiewicz, B, Casado Herraez, A, Mendiola Fernandez, C, Gropp-Meier, M, Saito, T, Takehara, K, Enomoto, T, Watari, H, Choi, C, Kim, B, Weon Kim, J, Hegg, R, Poveda A., Floquet A., Ledermann J. A., Asher R., Penson R. T., Oza A. M., Korach J., Huzarski T., Pignata S., Friedlander M., Baldoni A., Park-Simon T. -W., Tamura K., Sonke G. S., Lisyanskaya A., Kim J. -H., Filho E. A., Milenkova T., Lowe E. S., Rowe P., Vergote I., Pujade-Lauraine E., Byrski T., Pautier P., Harter P., Colombo N., Scambia G., Nicoletto M., Nussey F., Clamp A., Penson R., Poveda Velasco A., Rodrigues M., Lotz J. -P., Selle F., Ray-Coquard I., Provencher D., Prat Aparicio A., Vidal Boixader L., Scott C., Yunokawa M., Medioni J., Pecuchet N., Dubot C., De La Motte Rouge T., Kaminsky M. -C., Weber B., Lortholary A., Parkinson C., Ledermann J., Williams S., Banerjee S., Cosin J., Hoffman J., Plante M., Covens A., Sonke G., Joly F., Hirte H., Amit A., Matsumoto K., Tjulandin S., Hoon Kim J., Gladieff L., Sabbatini R., O'Malley D., Timmins P., Kredentser D., Lainez Milagro N., Barretina Ginesta M. P., Tibau Martorell A., Gomez De Liano Lista A., Ojeda Gonzalez B., Mileshkin L., Mandai M., Boere I., Ottevanger P., Nam J. -H., Filho E., Hamizi S., Cognetti F., Warshal D., Dickson-Michelson E., Kamelle S., McKenzie N., Rodriguez G., Armstrong D., Chalas E., Celano P., Behbakht K., Davidson S., Welch S., Helpman L., Fishman A., Bruchim I., Sikorska M., Slowinska A., Rogowski W., Bidzinski M., Spiewankiewicz B., Casado Herraez A., Mendiola Fernandez C., Gropp-Meier M., Saito T., Takehara K., Enomoto T., Watari H., Choi C. H., Kim B. -G., Weon Kim J., Hegg R., Poveda, A, Floquet, A, Ledermann, J, Asher, R, Penson, R, Oza, A, Korach, J, Huzarski, T, Pignata, S, Friedlander, M, Baldoni, A, Park-Simon, T, Tamura, K, Sonke, G, Lisyanskaya, A, Kim, J, Filho, E, Milenkova, T, Lowe, E, Rowe, P, Vergote, I, Pujade-Lauraine, E, Byrski, T, Pautier, P, Harter, P, Colombo, N, Scambia, G, Nicoletto, M, Nussey, F, Clamp, A, Poveda Velasco, A, Rodrigues, M, Lotz, J, Selle, F, Ray-Coquard, I, Provencher, D, Prat Aparicio, A, Vidal Boixader, L, Scott, C, Yunokawa, M, Medioni, J, Pecuchet, N, Dubot, C, De La Motte Rouge, T, Kaminsky, M, Weber, B, Lortholary, A, Parkinson, C, Williams, S, Banerjee, S, Cosin, J, Hoffman, J, Plante, M, Covens, A, Joly, F, Hirte, H, Amit, A, Matsumoto, K, Tjulandin, S, Hoon Kim, J, Gladieff, L, Sabbatini, R, O'Malley, D, Timmins, P, Kredentser, D, Lainez Milagro, N, Barretina Ginesta, M, Tibau Martorell, A, Gomez De Liano Lista, A, Ojeda Gonzalez, B, Mileshkin, L, Mandai, M, Boere, I, Ottevanger, P, Nam, J, Hamizi, S, Cognetti, F, Warshal, D, Dickson-Michelson, E, Kamelle, S, Mckenzie, N, Rodriguez, G, Armstrong, D, Chalas, E, Celano, P, Behbakht, K, Davidson, S, Welch, S, Helpman, L, Fishman, A, Bruchim, I, Sikorska, M, Slowinska, A, Rogowski, W, Bidzinski, M, Spiewankiewicz, B, Casado Herraez, A, Mendiola Fernandez, C, Gropp-Meier, M, Saito, T, Takehara, K, Enomoto, T, Watari, H, Choi, C, Kim, B, Weon Kim, J, Hegg, R, Poveda A., Floquet A., Ledermann J. A., Asher R., Penson R. T., Oza A. M., Korach J., Huzarski T., Pignata S., Friedlander M., Baldoni A., Park-Simon T. -W., Tamura K., Sonke G. S., Lisyanskaya A., Kim J. -H., Filho E. A., Milenkova T., Lowe E. S., Rowe P., Vergote I., Pujade-Lauraine E., Byrski T., Pautier P., Harter P., Colombo N., Scambia G., Nicoletto M., Nussey F., Clamp A., Penson R., Poveda Velasco A., Rodrigues M., Lotz J. -P., Selle F., Ray-Coquard I., Provencher D., Prat Aparicio A., Vidal Boixader L., Scott C., Yunokawa M., Medioni J., Pecuchet N., Dubot C., De La Motte Rouge T., Kaminsky M. -C., Weber B., Lortholary A., Parkinson C., Ledermann J., Williams S., Banerjee S., Cosin J., Hoffman J., Plante M., Covens A., Sonke G., Joly F., Hirte H., Amit A., Matsumoto K., Tjulandin S., Hoon Kim J., Gladieff L., Sabbatini R., O'Malley D., Timmins P., Kredentser D., Lainez Milagro N., Barretina Ginesta M. P., Tibau Martorell A., Gomez De Liano Lista A., Ojeda Gonzalez B., Mileshkin L., Mandai M., Boere I., Ottevanger P., Nam J. -H., Filho E., Hamizi S., Cognetti F., Warshal D., Dickson-Michelson E., Kamelle S., McKenzie N., Rodriguez G., Armstrong D., Chalas E., Celano P., Behbakht K., Davidson S., Welch S., Helpman L., Fishman A., Bruchim I., Sikorska M., Slowinska A., Rogowski W., Bidzinski M., Spiewankiewicz B., Casado Herraez A., Mendiola Fernandez C., Gropp-Meier M., Saito T., Takehara K., Enomoto T., Watari H., Choi C. H., Kim B. -G., Weon Kim J., and Hegg R.

Abstract

Background: Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, has previously been shown to extend progression-free survival versus placebo when given to patients with relapsed high-grade serous or endometrioid ovarian cancer who were platinum sensitive and who had a BRCA1 or BRCA2 (BRCA1/2) mutation, as part of the SOLO2/ENGOT-Ov21 trial. The aim of this final analysis is to investigate the effect of olaparib on overall survival. Methods: This double-blind, randomised, placebo-controlled, phase 3 trial was done across 123 medical centres in 16 countries. Eligible patients were aged 18 years or older, had an Eastern Cooperative Oncology Group performance status at baseline of 0–1, had histologically confirmed, relapsed, high-grade serous or high-grade endometrioid ovarian cancer, including primary peritoneal or fallopian tube cancer, and had received two or more previous platinum regimens. Patients were randomly assigned (2:1) to receive olaparib tablets (300 mg in two 150 mg tablets twice daily) or matching placebo tablets using an interactive web or voice-response system. Stratification was by response to previous chemotherapy and length of platinum-free interval. Treatment assignment was masked to patients, treatment providers, and data assessors. The primary endpoint of progression-free survival has been reported previously. Overall survival was a key secondary endpoint and was analysed in all patients as randomly allocated. Safety was assessed in all patients who received at least one treatment dose. This trial is registered with ClinicalTrials.gov, NCT01874353, and is no longer recruiting patients. Findings: Between Sept 3, 2013 and Nov 21, 2014, 295 patients were enrolled. Patients were randomly assigned to receive either olaparib (n=196 [66%]) or placebo (n=99 [34%]). One patient, randomised in error, did not receive olaparib. Median follow-up was 65·7 months (IQR 63·6–69·3) with olaparib and 64·5 months (63·4–68·7) with placebo. Median overall survi

Published
2021

16. 544P Feasibility of two different first-line carboplatin plus paclitaxel regimens in elderly women with ovarian cancer: A retrospective study

Author

Delanoy, N., primary, Ashton, E., additional, Mebarki, S., additional, Gisselbrecht, M., additional, Nicaise, B., additional, Azais, H., additional, Koual, M., additional, Mongardon, A-S. Bats, additional, Fournier, L., additional, Le Frère-Belda, M-A., additional, Medioni, J., additional, Paillaud, E., additional, and Oudard, S., additional

Published
2022
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24. Feasibility of an adapted schedule of carboplatin + paclitaxel in elderly women with Ovarian Cancer: a retrospective cohort

Author

Nicaise, B., primary, Mebarki, S., additional, Gisselbrecht, M., additional, Elisabeth, A., additional, Azais, H., additional, Koual, M., additional, Bats, A.S., additional, Fournier, L., additional, Marie-Aude, L.F.B., additional, Medioni, J., additional, Oudard, S., additional, Paillaud, E., additional, and Delanoy, N., additional

Published
2021
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32. Vinflunine in the treatment of relapsed metastatic urothelial cancer: A systematic review and meta-analysis of real-world series

Author

Bamias, A. Hegele, A. Medioni, J. Castellano, D. Doni, L. Passalacqua, R. Zagouri, F. Tzannis, K. Hussain, S. Ullen, A.

Abstract

Background: Vinflunine (VFL) is approved in Europe as second-line treatment of metastatic urothelial cancer after failure of platinum-containing therapy. We performed a systematic review and meta-analysis of real-world data (RWD) to assess utilization, efficacy and safety of VFL. Methods: We performed a MEDLINE search for the period of 1/1/2000-31/8/2017. Full-length articles providing post-marketing RWD on VFL in patients failing previous chemotherapy were eligible. Interventional clinical trials were excluded. Results: Ten studies with 797 patients were identified. According to pooled REs analysis, overall response rate was 19%, most frequent, all-grade toxicities were fatigue (41%), constipation (39%), nausea/vomiting (25%), and most prevalent Grade 3–4 toxicities were neutropenia (13%), anaemia (9%), fatigue (8%). Median OS was comparable to results reported in recent randomized studies. Conclusion: Our findings confirm the efficacy and safety of VFL in an unselected population and support the use of VFL in the changing treatment paradigm of relapsed mUC. © 2019 Elsevier B.V.

Published
2019

33. Palbociclib rechallenge in hormone receptor (HR)[+]/HER2[-] advanced breast cancer (ABC). PALMIRA trial

Author

Llombart Cussac, A., primary, Medioni, J., additional, Colleoni, M.A., additional, Ettl, J., additional, Schmid, P., additional, Macpherson, I., additional, Gligorov, J., additional, Albanell, J., additional, Bellet Ezquerra, M., additional, Fernández, A., additional, Ruiz Borrego, M., additional, Gavilá-Gregori, J., additional, Wheatley, D., additional, Zamora, P., additional, Martínez, E., additional, Sampayo, M., additional, Riva, F., additional, Malfettone, A., additional, Pérez-García, J.M., additional, and Cortés, J., additional

Published
2019
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34. Phase II randomised discontinuation trial of brivanib in patients with advanced solid tumours

Author

Jones, R.L. (Robin L.), Ratain, M.J. (Mark), O'Dwyer, P.J. (Peter J.), Siu, R.K. (Ronald), Jassem, J., Medioni, J. (Jacques), DeJonge, M.J.A. (Maja J.), Rudin, C.M. (Charles), Sawyer, M. (Michael), Khayat, D. (David), Awada, A. (Ahmad), de Vos-Geelen, J. (Judith), Evans, T.R.J. (Jeffry), Obel, J. (Jennifer), Brockstein, B. (Bruce), DeGreve, J. (Jacques), Baurain, J.F., Maki, R.G. (Robert G.), D'Adamo, D. (David), Dickson, M.A. (Mark A.), Undevia, S. (Samir), Geary, D. (David), Janisch, L. (Linda), Bedard, P.L. (Philippe L.), Abdul Razak, A.R. (Albiruni R.), Kristeleit, R.S. (R.), Vitfell-Rasmussen, J. (Joanna), Walters, I. (Ian), Kaye, S.B. (Stan B.), Schwartz, G. (Gary), Jones, R.L. (Robin L.), Ratain, M.J. (Mark), O'Dwyer, P.J. (Peter J.), Siu, R.K. (Ronald), Jassem, J., Medioni, J. (Jacques), DeJonge, M.J.A. (Maja J.), Rudin, C.M. (Charles), Sawyer, M. (Michael), Khayat, D. (David), Awada, A. (Ahmad), de Vos-Geelen, J. (Judith), Evans, T.R.J. (Jeffry), Obel, J. (Jennifer), Brockstein, B. (Bruce), DeGreve, J. (Jacques), Baurain, J.F., Maki, R.G. (Robert G.), D'Adamo, D. (David), Dickson, M.A. (Mark A.), Undevia, S. (Samir), Geary, D. (David), Janisch, L. (Linda), Bedard, P.L. (Philippe L.), Abdul Razak, A.R. (Albiruni R.), Kristeleit, R.S. (R.), Vitfell-Rasmussen, J. (Joanna), Walters, I. (Ian), Kaye, S.B. (Stan B.), and Schwartz, G. (Gary)

Abstract

Background: Brivanib is a selective inhibitor of vascular endothelial growth factor and fibroblast growth factor (FGF) signalling. We performed a phase II randomised discontinuation trial of brivanib in 7 tumour types (soft-tissue sarcomas [STS], ovarian cancer, breast cancer, pancreatic cancer, non-small-cell lung cancer [NSCLC], gastric/esophageal cancer and transitional cell carcinoma [TCC]). Patients and methods: During a 12-week open-label lead-in period, patients received brivanib 800 mg daily and were evaluated for FGF2 status by immunohistochemistry. Patients with stable disease at week 12 were randomised to brivanib or placebo. A study steering committee evaluated week 12 response to determine if enrolment in a tumour type would continue. The primary objective was progression-free survival (PFS) for brivanib versus placebo in patients with FGF2-positive tumours. Results: A total of 595 patients were treated, and stable disease was observed at the week 12 randomisation point in all tumour types. Closure decisions were made for breast cancer, pancreatic cancer, NSCLC, gastric cancer and TCC. Criteria for expansion were met for STS and ovarian cancer. In 53 randomised patients with STS and FGF2-positive tumours, the median PFS was 2.8 months for brivanib and 1.4 months for placebo (hazard ratio [HR]: 0.58, p = 0.08). For all randomised patients with sarcomas, the median PFS was 2.8 months (95% confidence interval [CI]: 1.4–4.0) for those treated with brivanib compared with 1.4 months (95% CI: 1.3–1.6) for placebo (HR = 0.64, 95% CI: 0.38–1.07; p = 0.09). In the 36 randomised patients with ovarian cancer and FGF2-positive tumours, the median PFS was 4.0 (95% CI: 2.6–4.2) months for brivanib and 2.0 months (95% CI: 1.2–2.7) for placebo (HR: 0.56, 95% CI: 0.26–1.22). For all randomised patients with ovarian cancer, the median PFS in those randomised to brivanib was 4.0 months (95% CI: 2.6–4.2) and was 2.0 months (95% CI: 1.2–2.7) in those randomised to placebo (H

Published
2019
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35. Phase II randomised discontinuation trial of brivanib in patients with advanced solid tumours

Author

Jones, RL, Ratain, MJ, O'Dwyer, PJ, Siu, LL, Jassem, J, Medioni, J, de Jonge, Maja, Rudin, C, Sawyer, M, Khayat, D, Awada, A, de Vos-Geelen, J, Evans, TRJ, Obel, J, Brockstein, B, DeGreve, J, Baurain, JF, Maki, R, D'Adamo, D, Dickson, M, Undevia, S, Geary, D, Janisch, L, Bedard, PL, Razak, ARA, Kristeleit, R, Vitfell-Rasmussen, J, Walters, I, Kaye, SB, Schwartz, G, Jones, RL, Ratain, MJ, O'Dwyer, PJ, Siu, LL, Jassem, J, Medioni, J, de Jonge, Maja, Rudin, C, Sawyer, M, Khayat, D, Awada, A, de Vos-Geelen, J, Evans, TRJ, Obel, J, Brockstein, B, DeGreve, J, Baurain, JF, Maki, R, D'Adamo, D, Dickson, M, Undevia, S, Geary, D, Janisch, L, Bedard, PL, Razak, ARA, Kristeleit, R, Vitfell-Rasmussen, J, Walters, I, Kaye, SB, and Schwartz, G

Published
2019

37. Clinical response and pharmacodynamic assessment of INVAC-1, a DNA plasmid encoding an inactive form of human telomerase reverse transcriptase (hTERT), on immune responses, immune tolerability, tumor burden and circulating tumor DNA (ctDNA) in patients with advanced solid tumors

Author

Medioni, J., primary, Brizard, M., additional, Teixeira, L.O., additional, Doucet, L., additional, Ghrieb, Z., additional, Angelergues, A., additional, Oudard, S., additional, Culine, S., additional, Adotevi, O., additional, Laheurte, C., additional, Dragon-Durey, M.-A., additional, Laurent-Puig, P., additional, Kiladjian, J.-J., additional, Doppler, V., additional, Souttou, B., additional, Wain-Hobson, S., additional, Defrance, R., additional, Huet, T., additional, and Langlade-Demoyen, P., additional

Published
2018
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38. Bcl-2 proteins expression and response to navitoclax in platinum resistant/refractory recurrent ovarian cancer (PROC)

Author

Brachet, P.E., primary, Joly Lobbedez, F., additional, Fabbro, M., additional, Leary, A., additional, Medioni, J., additional, Follana, P., additional, Lesoin, A.F., additional, Frenel, J.-S., additional, Abadie Lacourtoisie, S., additional, Floquet, A., additional, Gladieff, L., additional, You, B., additional, Gavoille, C., additional, Kalbacher, E., additional, Briand, M., additional, Just, P.A., additional, Blanc-Fournier, C., additional, Giffard, F., additional, Clarisse, B., additional, and Poulain, L., additional

Published
2018
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41. A GINECO phase II study of Navitoclax (ABT 263) in women with platinum resistant/refractory recurrent ovarian cancer (ROC)

Author

Brachet, P.E., primary, Fabbro, M., additional, Leary, A., additional, Medioni, J., additional, Follana, P., additional, Lesoin, A., additional, Frenel, J-S., additional, Abadie Lacourtoisie, S., additional, Floquet, A., additional, Gladieff, L., additional, You, B., additional, Gavoille, C., additional, Kalbacher, E., additional, Briand, M., additional, Just, P-A., additional, Blanc-Fournier, C., additional, Leconte, A., additional, Lequesne, J., additional, Poulain, L., additional, and Joly Lobbedez, F., additional

Published
2017
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42. Circulating tumor cells as prognostic marker in ovarian carcinoma: Results from the ANTHALYA study

Author

de La Motte Rouge, T., primary, Cottu, P., additional, Pautier, P., additional, Provansal, M., additional, Floquet, A., additional, Selle, F., additional, Fabbro, M., additional, Kalbacher, E., additional, Follana, P., additional, Lesoin, A.F., additional, Medioni, J., additional, Dupin, J., additional, Ferri, R-M., additional, Bidard, F-C., additional, Dubot, C., additional, Rouzier, R., additional, and Joly Lobbedez, F., additional

Published
2017
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43. PL02.08 Registrational Results of LIBRETTO-001: A Phase 1/2 Trial of LOXO-292 in Patients with RET Fusion-Positive Lung Cancers

Author

Drilon, A., Oxnard, G., Wirth, L., Besse, B., Gautschi, O., Tan, S.W.D., Loong, H., Bauer, T., Kim, Y.J., Horiike, A., Park, K., Shah, M., McCoach, C., Bazhenova, L., Seto, T., Brose, M., Pennell, N., Weiss, J., Matos, I., Peled, N., Cho, B.C., Ohe, Y., Reckamp, K., Boni, V., Satouchi, M., Falchook, G., Akerley, W., Daga, H., Sakamoto, T., Patel, J., Lakhani, N., Barlesi, F., Burkard, M., Zhu, V., Moreno Garcia, V., Medioni, J., Matrana, M., Rolfo, C., Lee, D.H., Nechushtan, H., Johnson, M., Velcheti, V., Nishio, M., Toyozawa, R., Ohashi, K., Song, L., Han, J., Spira, A., De Braud, F., Staal Rohrberg, K., Takeuchi, S., Sakakibara, J., Waqar, S., Kenmotsu, H., Wilson, F., B.Nair, Olek, E., Kherani, J., Ebata, K., Zhu, E., Nguyen, M., Yang, L., Huang, X., Cruickshank, S., Rothenberg, S., Solomon, B., Goto, K., and Subbiah, V.

Published
2019
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46. Phase I/II dose-finding, safety and efficacy study of radium-223 dichloride in renal cell carcinoma patients with bone metastases

Author

Elaidi, R., primary, Vano, Y.A., additional, Aide, N., additional, Fournier, L., additional, Deandreis, D., additional, Tenenbaum, F., additional, Lebtahi, R., additional, De Clermont-Galleran, H., additional, Albiges, L., additional, Escudier, B., additional, Joly, F., additional, Alexandre, J., additional, Bernardini, M., additional, Baron, S., additional, Arfi-Rouche, J., additional, Noel, C., additional, Braychenko, E., additional, O'Quigley, J., additional, Medioni, J., additional, and Oudard, S., additional

Published
2016
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49. 415PD - Clinical response and pharmacodynamic assessment of INVAC-1, a DNA plasmid encoding an inactive form of human telomerase reverse transcriptase (hTERT), on immune responses, immune tolerability, tumor burden and circulating tumor DNA (ctDNA) in patients with advanced solid tumors

Author

Medioni, J., Brizard, M., Teixeira, L.O., Doucet, L., Ghrieb, Z., Angelergues, A., Oudard, S., Culine, S., Adotevi, O., Laheurte, C., Dragon-Durey, M.-A., Laurent-Puig, P., Kiladjian, J.-J., Doppler, V., Souttou, B., Wain-Hobson, S., Defrance, R., Huet, T., and Langlade-Demoyen, P.

Published
2018
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