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1. Prospective Multicenter Validation of the Detection of ALK Rearrangements of Circulating Tumor Cells for Noninvasive Longitudinal Management of Patients With Advanced NSCLC

Author

Israel-Biet, Dominique, Pison, Christophe, Moro-Sibilot, Denis, Lantuejoul, Sylvie, Stephanov, Olivier, Juliette, Meyzenc, Mendozat, Christophe, Zaidi, Manel, Coulouvrat, Sandra, Col, Edwige, Chanez, Pascal, Greillier, Laurent, Tomasini, Pascale, Barlesi, Fabrice, Mascaux, Céline, Jourdan, Sandrine, Roger, Aurélie, Biemar, Julie, Randriamampionona, Rondro, Chabot, François, Tiotiu, Angélica, Clement-Duchene, Christelle, Vignaud, Jean-Michel, Lacomme, Stéphanie, Lomazzi, Sandra, Laurent, Carine, Bulsei, Xavier, Bischoff, Laura, Rakotonirina, Raymond, Layouni, Mehdi, Deslee, Gaëtan, Mal, Hervé, Kessler, Romain, Vergnon, Jean-Michel, Pelissier, Isabelle, Cuvelier, Antoine, Bourdin, Arnaud, Jounieaux, Vincent, Roche, Nicolas, Jouneau, Stéphane, Bonniaud, Philippe, Scherpereel, Arnaud, Mornex, Jean François, Steenhouwer, François, Leroy, Sylvie, Marquette, Charles Hugo, Benzaquen, Jonathan, Mazzette, Andrea, Padovani, Bernard, Hofman, Paul, Ilié, Marius, Hofman, Véronique, Fayada, Julien, Long-Mira, Elodie, Lassalle, Sandra, Pradelli, Johanna, Martinez, Estelle, Habault, Marine, Bonnard, Mélanie, Moutarde, Julie, Yatimi, Rachida, Labsi, Hakima, Gazoppi, Loïc, Lpce, Tumorothèque, Griffonnet, Jennifer, Fontaine, Maureen, Guillemart, Ariane, Butori, Catherine, Selva, Eric, Poudenx, Michel, Otto, Josiane, Hebert, Christophe, Botchiellini, Delphine, Boudouf, Soukaina, Menier, Margaux, Occeli, Estelle, Bellentani, Sophie, Pion, Carine, Fournier, Elodie, Thariat, Juliette, Gervais, Radj, Hamond, Karim, Marchand-Adam, Sylvain, Plantier, Laurent, Fajolle, Gaelle, Rayez, Mélanie, Cadranel, Jacques, Fallet, Vincent, Wislez, Marie, Antoine, Martine, Cote, Jean-François, Chaabane, Nouha, Ruppert, Anne Marie, Bertrand, Eliane, Rodenas, Anita, Pontdeme, Gwenaëlle, Mathiot, Nathalie, Ribert, Tamazouzt, Mazières, Julien, Guibert, Nicolas, Rouviere, Damien, Bousquet, Emilie, Bigay-Game, Laurence, Hermant, Christophe, Plat, Gavin, Rouquette, Isabelle, Evrard, Solène, Gouin, Sandrine, Clermont, Estelle Taranchon, Dormoy, Inge, Coulomb, Christelle, Pradine, Anne, Lambert, Véronique, Laborde, Lilian, Castelnau, Olivier, Chamorey, Emmanuel, Heeke, Simon, Thamphya, Brice, Boutros, Jacques, Clément-Duchêne, Christelle, and Marquette, Charles-Hugo

Published
2021
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2. Efficacy and Safety of Rovalpituzumab Tesirine Compared With Topotecan as Second-Line Therapy in DLL3-High SCLC: Results From the Phase 3 TAHOE Study

Author

Ilié, Marius, Mazières, Julien, Chamorey, Emmanuel, Heeke, Simon, Benzaquen, Jonathan, Thamphya, Brice, Boutros, Jacques, Tiotiu, Angélica, Fayada, Julien, Cadranel, Jacques, Poudenx, Michel, Moro-Sibilot, Denis, Barlesi, Fabrice, Thariat, Juliette, Clément-Duchêne, Christelle, Tomasini, Pascale, Hofman, Véronique, Marquette, Charles-Hugo, Hofman, Paul, Israel-Biet, Dominique, Pison, Christophe, Lantuejoul, Sylvie, Stephanov, Olivier, Juliette, Meyzenc, Mendozat, Christophe, Zaidi, Manel, Coulouvrat, Sandra, Col, Edwige, Chanez, Pascal, Greillier, Laurent, Mascaux, Céline, Jourdan, Sandrine, Roger, Aurélie, Biemar, Julie, Randriamampionona, Rondro, Chabot, François, Vignaud, Jean-Michel, Lacomme, Stéphanie, Lomazzi, Sandra, Laurent, Carine, Bulsei, Xavier, Bischoff, Laura, Rakotonirina, Raymond, Layouni, Mehdi, Deslee, Gaëtan, Mal, Hervé, Kessler, Romain, Vergnon, Jean-Michel, Pelissier, Isabelle, Cuvelier, Antoine, Bourdin, Arnaud, Jounieaux, Vincent, Roche, Nicolas, Jouneau, Stéphane, Bonniaud, Philippe, Scherpereel, Arnaud, Mornex, Jean François, Steenhouwer, François, Leroy, Sylvie, Marquette, Charles Hugo, Mazzette, Andrea, Padovani, Bernard, Long-Mira, Elodie, Lassalle, Sandra, Pradelli, Johanna, Martinez, Estelle, Habault, Marine, Bonnard, Mélanie, Moutarde, Julie, Yatimi, Rachida, Labsi, Hakima, Gazoppi, Loïc, Lpce, Tumorothèque, Griffonnet, Jennifer, Fontaine, Maureen, Guillemart, Ariane, Butori, Catherine, Selva, Eric, Otto, Josiane, Hebert, Christophe, Botchiellini, Delphine, Boudouf, Soukaina, Menier, Margaux, Occeli, Estelle, Bellentani, Sophie, Pion, Carine, Fournier, Elodie, Gervais, Radj, Hamond, Karim, Marchand-Adam, Sylvain, Plantier, Laurent, Fajolle, Gaelle, Rayez, Mélanie, Fallet, Vincent, Wislez, Marie, Antoine, Martine, Cote, Jean-François, Chaabane, Nouha, Ruppert, Anne Marie, Bertrand, Eliane, Rodenas, Anita, Pontdeme, Gwenaëlle, Mathiot, Nathalie, Ribert, Tamazouzt, Guibert, Nicolas, Rouviere, Damien, Bousquet, Emilie, Bigay-Game, Laurence, Hermant, Christophe, Plat, Gavin, Rouquette, Isabelle, Evrard, Solène, Gouin, Sandrine, Clermont, Estelle Taranchon, Dormoy, Inge, Coulomb, Christelle, Pradine, Anne, Lambert, Véronique, Laborde, Lilian, Castelnau, Olivier, University of Manchester [Manchester], Hôpital du Sacré-Coeur de Montréal, Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Assistance Publique - Hôpitaux de Marseille (APHM), Yonsei University College of Medicine [Séoul, Corée du Sud], August Pi i Sunyer Biomedical Research Institute - IDIBAPS [Barcelona, Spain], Hospital de la Santa Creu i Sant Pau, University Hospitals Leuven [Leuven], National and Kapodistrian University of Athens (NKUA), Odense University Hospital (OUH), Oregon Health and Science University [Portland] (OHSU), Kyushu University, Hacettepe University = Hacettepe Üniversitesi, University of Copenhagen = Københavns Universitet (UCPH), University of Groningen [Groningen], Abbvie Inc. [North Chicago], Asklepios Klinikum Uckermark GmbH, Méthodes computationnelles pour la prise en charge thérapeutique en oncologie : Optimisation des stratégies par modélisation mécaniste et statistique (COMPO), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Centre de Recherche en Cancérologie de Marseille (CRCM), and Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Institut Paoli-Calmettes

Subjects
0301 basic medicine, Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, medicine.medical_treatment, CELL LUNG-CANCER, Population, Peripheral edema, Phases of clinical research, [SDV.CAN]Life Sciences [q-bio]/Cancer, Delta-like protein 3, Rovalpituzumab tesirine, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, DRUG, education, ComputingMilieux_MISCELLANEOUS, Chemotherapy, education.field_of_study, Small cell lung cancer, business.industry, Hazard ratio, Confidence interval, 030104 developmental biology, 030220 oncology & carcinogenesis, Topotecan, medicine.symptom, business, medicine.drug
Abstract

INTRODUCTION: DLL3, an atypical Notch ligand, is expressed in SCLC tumors but is not detectable in normal adult tissues. Rovalpituzumab tesirine (Rova-T) is an antibody-drug conjugate containing a DLL3-targeting antibody tethered to a cytotoxic agent pyrrolobenzodiazepine by means of a protease-cleavable linker. The efficacy and safety of Rova-T compared with topotecan as second-line therapy in patients with SCLC expressing high levels of DLL3 (DLL3-high) was evaluated. METHODS: The TAHOE study was an open-label, two-to-one randomized, phase 3 study comparing Rova-T with topotecan as second-line therapy in DLL3-high advanced or metastatic SCLC. Rova-T (0.3 mg/kg) was administered intravenously on day 1 of a 42-day cycle for two cycles, with two additional cycles available to patients who met protocol-defined criteria for continued dosing. Topotecan (1.5 mg/m2) was administered intravenously on days 1 to 5 of a 21-day cycle. The primary end point was overall survival (OS). RESULTS: Patients randomized to Rova-T (n = 296) and topotecan (n = 148) were included in the efficacy analyses. The median age was 64 years, and 77% had the extensive disease at initial diagnosis. The median OS (95% confidence interval) was 6.3 months (5.6-7.3) in the Rova-T arm and 8.6 months (7.7-10.1) in the topotecan arm (hazard ratio, 1.46 [95% confidence interval: 1.17-1.82]). An independent data monitoring committee recommended that enrollment be discontinued because of the shorter OS observed with Rova-T compared with topotecan. Safety profiles for both drugs were consistent with previous reports. CONCLUSIONS: Compared with topotecan, which is the current standard second-line chemotherapy, Rova-T exhibited an inferior OS and higher rates of serosal effusions, photosensitivity reaction, and peripheral edema in patients with SCLC. A considerable unmet therapeutic need remains in this population. ispartof: JOURNAL OF THORACIC ONCOLOGY vol:16 issue:9 pages:1547-1558 ispartof: location:United States status: published

Published
2021

3. Prospective Multicenter Validation of the Detection of ALK Rearrangements of Circulating Tumor Cells for Noninvasive Longitudinal Management of Patients With Advanced NSCLC

Author

Ilié, Marius, primary, Mazières, Julien, additional, Chamorey, Emmanuel, additional, Heeke, Simon, additional, Benzaquen, Jonathan, additional, Thamphya, Brice, additional, Boutros, Jacques, additional, Tiotiu, Angélica, additional, Fayada, Julien, additional, Cadranel, Jacques, additional, Poudenx, Michel, additional, Moro-Sibilot, Denis, additional, Barlesi, Fabrice, additional, Thariat, Juliette, additional, Clément-Duchêne, Christelle, additional, Tomasini, Pascale, additional, Hofman, Véronique, additional, Marquette, Charles-Hugo, additional, Hofman, Paul, additional, Israel-Biet, Dominique, additional, Pison, Christophe, additional, Lantuejoul, Sylvie, additional, Stephanov, Olivier, additional, Juliette, Meyzenc, additional, Mendozat, Christophe, additional, Zaidi, Manel, additional, Coulouvrat, Sandra, additional, Col, Edwige, additional, Chanez, Pascal, additional, Greillier, Laurent, additional, Mascaux, Céline, additional, Jourdan, Sandrine, additional, Roger, Aurélie, additional, Biemar, Julie, additional, Randriamampionona, Rondro, additional, Chabot, François, additional, Clement-Duchene, Christelle, additional, Vignaud, Jean-Michel, additional, Lacomme, Stéphanie, additional, Lomazzi, Sandra, additional, Laurent, Carine, additional, Bulsei, Xavier, additional, Bischoff, Laura, additional, Rakotonirina, Raymond, additional, Layouni, Mehdi, additional, Deslee, Gaëtan, additional, Mal, Hervé, additional, Kessler, Romain, additional, Vergnon, Jean-Michel, additional, Pelissier, Isabelle, additional, Cuvelier, Antoine, additional, Bourdin, Arnaud, additional, Jounieaux, Vincent, additional, Roche, Nicolas, additional, Jouneau, Stéphane, additional, Bonniaud, Philippe, additional, Scherpereel, Arnaud, additional, Mornex, Jean François, additional, Steenhouwer, François, additional, Leroy, Sylvie, additional, Marquette, Charles Hugo, additional, Mazzette, Andrea, additional, Padovani, Bernard, additional, Ilié, Marius, additional, Long-Mira, Elodie, additional, Lassalle, Sandra, additional, Pradelli, Johanna, additional, Martinez, Estelle, additional, Habault, Marine, additional, Bonnard, Mélanie, additional, Moutarde, Julie, additional, Yatimi, Rachida, additional, Labsi, Hakima, additional, Gazoppi, Loïc, additional, Lpce, Tumorothèque, additional, Griffonnet, Jennifer, additional, Fontaine, Maureen, additional, Guillemart, Ariane, additional, Butori, Catherine, additional, Selva, Eric, additional, Otto, Josiane, additional, Hebert, Christophe, additional, Botchiellini, Delphine, additional, Boudouf, Soukaina, additional, Menier, Margaux, additional, Occeli, Estelle, additional, Bellentani, Sophie, additional, Pion, Carine, additional, Fournier, Elodie, additional, Gervais, Radj, additional, Hamond, Karim, additional, Marchand-Adam, Sylvain, additional, Plantier, Laurent, additional, Fajolle, Gaelle, additional, Rayez, Mélanie, additional, Fallet, Vincent, additional, Wislez, Marie, additional, Antoine, Martine, additional, Cote, Jean-François, additional, Chaabane, Nouha, additional, Ruppert, Anne Marie, additional, Bertrand, Eliane, additional, Rodenas, Anita, additional, Pontdeme, Gwenaëlle, additional, Mathiot, Nathalie, additional, Ribert, Tamazouzt, additional, Guibert, Nicolas, additional, Rouviere, Damien, additional, Bousquet, Emilie, additional, Bigay-Game, Laurence, additional, Hermant, Christophe, additional, Plat, Gavin, additional, Rouquette, Isabelle, additional, Evrard, Solène, additional, Gouin, Sandrine, additional, Clermont, Estelle Taranchon, additional, Dormoy, Inge, additional, Coulomb, Christelle, additional, Pradine, Anne, additional, Lambert, Véronique, additional, Laborde, Lilian, additional, and Castelnau, Olivier, additional

Published
2021
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4. Prospective multi-center validation of the detection of ALKrearrangements of circulating tumor cells for non-invasive longitudinal management of patients with advanced non-small cell lung cancer

Author

ILIE, Marius, MAZIÈRES, Julien, CHAMOREY, Emmanuel, HEEKE, Simon, BENZAQUEN, Jonathan, THAMPHYA, Brice, BOUTROS, Jacques, TIOTIU, Angelica, FAYADA, Julien, CADRANE, Jacques, POUDENX, Michel, MORO-SIBILOT, Denis, BARLESI, Fabrice, THARIAT, Juliette, CLEMENT-DUCHENE, Christelle, TOMASINI, Pascale, HOFMAN, Véronique, MARQUETTE, Charles-Hugo, HOFMAN, Paul, ISRAEL-BIET, Dominique, PISON, Christophe, MORO-SIBILOT, Denis, LANTUEJOUL, Sylvie, STEPHANOV, Olivier, Juliette, M.E.Y.Z.E.N.C., MENDOZAT, Christophe, ZAIDI, Manel, COULOUVRAT, Sandra, COL, Edwige, CHANEZ, Pascal, GREILLIER, Laurent, TOMASINI, Pascale, BARLESI, Fabrice, MASCAUX, Céline, JOURDAN, Sandrine, ROGER, Aurélie, BIEMAR, Julie, RANDRIAMAMPIONONA, Rondro, CHABOT, François, TIOTIU, Angélica, CLEMENT-DUCHENE, Christelle, Jean-Michel, V.I.G.N.A.U.D., LACOMME, Stéphanie, LOMAZZI, Sandra, LAURENT, Carine, BULSEI, Xavier, BISCHOFF, Laura, RAKOTONIRINA, Raymond, LAYOUNI, Mehdi, DESLEE, Gaëtan, MAL, Hervé, KESSLER, Romain, VERGNON, Jean-Michel, PELISSIER, Isabelle, CUVELIER, Antoine, BOURDIN, Arnaud, JOUNIEAUX, Vincent, ROCHE, Nicolas, JOUNEAU, Stéphane, BONNIAUD, SCHERPEREEL, Arnaud, MORNEX, Jean François, STEENHOUWER, François, LEROY, Sylvie, MARQUETTE, Charles Hugo, BENZAQUEN, Jonathan, MAZZETTE, Andrea, PADOVANI, Bernard, HOFMAN, Paul, ILIE, Marius, HOFMAN, Véronique, FAYADA, Julien, LONG-MIRA, Elodie, LASSALLE, Sandra, PRADELLI, Johanna, MARTINEZ, Estelle, HABAULT, Marine, BONNARD, Mélanie, MOUTARDE, Julie, YATIMI, Rachida, LABSI, Hakima, GAZOPPI, Loïc, LPCE, Tumorothèque, GRIFFONNET, Jennifer, FONTAINE, Maureen, GUILLEMART, Ariane, BUTORI, Catherine, SELVA, Eric, POUDENX, Michel, OTTO, Josiane, HEBERT, Christophe, BOTCHIELLINI, Delphine, BOUDOUF, Soukaina, MENIER, Margaux, OCCELI, Estelle, BELLENTANI, Sophie, PION, Carine, FOURNIER, Elodie, THARIAT, Juliette, GERVAIS, Radj, HAMOND, Karim, MARCHAND-ADAM, Sylvain, PLANTIER, Laurent, FAJOLLE, Gaelle, RAYEZ, Mélanie, CADRANEL, Jacques, FALLET, Vincent, WISLEZ, Marie, ANTOINE, Martine, COTE, Jean-François, CHAABANE, Nouha, RUPPERT, Anne Marsie, BERTRAND, Eliane, RODENAS, Anita, PONTDEME, Gwenaëlle, MATHIOT, Nathalie, RIBERT, Tamazouzt, MAZIÈRES, Julien, GUIBERT, Nicolas, ROUVIERE, Damien, BOUSQUET, Emilie, BIGAY-GAME, Laurence, HERMANT, Christophe, PLAT, Gavin, ROUQUETTE, Isabelle, EVRARD, Solène, GOUIN, Sandrine, TARANCHON CLERMONT, Estelle, DORMOY, Inge, COULOMB, Christelle, PRADINE, Anne, LAMBERT, Véronique, LABORDE, Lilian, and CASTELNAU, Olivier

Abstract

Patients with advanced-stage non-small cell lung cancer (NSCLC) whose tumors harbor an anaplastic lymphoma kinase (ALK) gene rearrangement benefit from treatment with multiple ALK inhibitors (ALKi). Approximately 30% of tumor biopsies contain insufficient tissue for successful ALKmolecular characterization. This study evaluated the added value of analyzing circulating tumor cells (CTCs) as a surrogate to ALKtissue analysis and as a function of the response to ALKi.

Published
2021
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