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1. Rovalpituzumab Tesirine as a Maintenance Therapy After First-Line Platinum-Based Chemotherapy in Patients With Extensive-Stage–SCLC: Results From the Phase 3 MERU Study

Author

Johnson, Melissa L., Zvirbule, Zanete, Laktionov, Konstantin, Helland, Aslaug, Cho, Byoung Chul, Gutierrez, Vanesa, Colinet, Benoît, Lena, Herve, Wolf, Martin, Gottfried, Maya, Okamoto, Isamu, van der Leest, Cor, Rich, Patricia, Hung, Jen-Yu, Appenzeller, Christina, Sun, Zhaowen, Maag, David, Luo, Yan, Nickner, Caroline, Vajikova, Alena, Komarnitsky, Philip, and Bar, Jair

Published
2021
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2. Systemic Therapy in Advanced Thymic Epithelial Tumors: Insights from the RYTHMIC Prospective Cohort

Author

Merveilleux du Vignaux, Claire, Dansin, Eric, Mhanna, Laurent, Greillier, Laurent, Pichon, Eric, Kerjouan, Mallorie, Clément-Duchêne, Christelle, Mennecier, Bertrand, Westeel, Virginie, Robert, Marie, Quantin, Xavier, Zalcman, Gérard, Thiberville, Luc, Lena, Hervé, Molina, Thierry, Calcagno, Fabien, Fournel, Pierre, Mazières, Julien, Besse, Benjamin, and Girard, Nicolas

Published
2018
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3. 30 Immunotherapy in advanced NSCLC—from the ‘tsunami’ of therapeutic knowledge to a clinical practice algorithm: results from an international expert panel meeting of the Italian Association of Thoracic Oncology (AIOT)

Author

de Marinis, Filippo, Ciardiello, Fortunato, Baas, Paul, Crinò, Lucio, Giaccone, Giuseppe, Grossi, Francesco, Hellmann, Matthew D., Mok, Tony S.K., Lena, Hervè, Paz-Ares, Luis, Rodriguez-Abreu, Delvys, Von Pavel, Joachim, and Gridelli, Cesare

Published
2018
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4. Multidisciplinary Tumor Board Decision Making for Postoperative Radiotherapy in Thymic Epithelial Tumors: Insights from the RYTHMIC Prospective Cohort

Author

Basse, Clémence, Thureau, Sébastien, Bota, Suzanna, Dansin, Eric, Thomas, Pascal-Alexandre, Pichon, Eric, Lena, Hervé, Massabeau, Carole, Clément-Duchene, Christelle, Massard, Gilbert, Westeel, Virginie, Quantin, Xavier, Oulkhouir, Youssef, Danhier, Serge, Lerouge, Delphine, Tanguy, Ronan, Thillays, François, Le Pechoux, Cécile, Dubray, Bernard, Thiberville, Luc, Besse, Benjamin, and Girard, Nicolas

Published
2017
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5. Pooled Systemic Efficacy and Safety Data from the Pivotal Phase II Studies (NP28673 and NP28761) of Alectinib in ALK-positive Non-Small Cell Lung Cancer

Author

Yang, James Chih-Hsin, Ou, Sai-Hong Ignatius, De Petris, Luigi, Gadgeel, Shirish, Gandhi, Leena, Kim, Dong-Wan, Barlesi, Fabrice, Govindan, Ramaswamy, Dingemans, Anne-Marie C., Crino, Lucio, Lena, Herve, Popat, Sanjay, Ahn, Jin Seok, Dansin, Eric, Golding, Sophie, Bordogna, Walter, Balas, Bogdana, Morcos, Peter N., Zeaiter, Ali, and Shaw, Alice T.

Published
2017
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6. Characteristics and Outcomes of Patients with Lung Cancer Harboring Multiple Molecular Alterations: Results from the IFCT Study Biomarkers France

Author

Guibert, Nicolas, Barlesi, Fabrice, Descourt, Renaud, Léna, Hervé, Besse, Benjamin, Beau-Faller, Michèle, Mosser, Jean, Pichon, Eric, Merlio, Jean-Philippe, Ouafik, L'Houcine, Guichard, François, Mastroianni, Bénédicte, Moreau, Lionel, Wdowik, Annie, Sabourin, Jean-Christophe, Lemoine, Antoinette, Missy, Pascale, Langlais, Alexandra, Moro-Sibilot, Denis, and Mazières, Julien

Published
2017
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7. Oral Vinorelbine and Cisplatin with Concurrent Radiotherapy After Induction Chemotherapy with Cisplatin and Docetaxel for Patients with Locally Advanced Non-small Cell Lung Cancer: The GFPC 05-03 Study

Author

Descourt, Renaud, Vergnenegre, Alain, Barlesi, Fabrice, Lena, Herve, Fournel, Pierre, Falchero, Lionel, Berard, Henri, Hureaux, Jose, Le Caer, Herve, Chavaillon, Jean Michel, Geriniere, Laurence, Monnet, Isabelle, Chouabe, Stéphane, and Robinet, Gilles

Published
2011
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8. Endoscopic Management of Idiopathic Tracheal Stenosis

Author

Perotin, Jeanne-Marie, Jeanfaivre, Thierry, Thibout, Yoann, Jouneau, Stéphane, Lena, Hervé, Dutau, Hervé, Ramon, Philippe, Lorut, Christine, Noppen, Marc, Vergnon, Jean-Michel, Vallerand, Hervé, Merol, Jean-Claude, Marquette, Charles-Hugo, Lebargy, François, and Deslee, Gaëtan

Published
2011
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9. Rovalpituzumab Tesirine as a Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients With Extensive-Stage Small Cell Lung Cancer: Results From the Phase 3 MERU Study

Author

Johnson, Melissa L, Zvirbule, Zanete, Laktionov, Konstantin, Helland, Aslaug, Cho, Byoung Chul, Gutierrez, Vanesa, Colinet, Benoît, Lena, Herve, Wolf, Martin, Gottfried, Maya, Okamoto, Isamu, van der Leest, Cor, Rich, Patricia, Hung, Jen-Yu, Appenzeller, Christina, Sun, Zhaowen, Maag, David, Luo, Yan, Nickner, Caroline, Vajikova, Alena, Komarnitsky, Philip, Bar, Jair, Sarah Cannon Research Institute [Nashville, Tennessee], Riga East University Hospital, N.N. Blokhin Russian Cancer Research Center, Oslo University Hospital [Oslo], Yonsei University, Universidad de Málaga [Málaga] = University of Málaga [Málaga], Grand Hôpital de Charleroi [Belgium], Chemistry, Oncogenesis, Stress and Signaling (COSS), Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Universität Kassel [Kassel], Meir Medical Center, Kyushu University, Amphia Ziekenhuis = Amphia Hospital [Breda, The Netherlands] (AZ=AH), Brustzentrum Kantonsspital St. Gallen, Abbvie Inc. [North Chicago], Kfar Saba and Sackler School of Medicine, AbbVie, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Kyushu University [Fukuoka], and Amphia Ziekenhuis

Subjects
Small cell lung cancer, Maintenance, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.CAN]Life Sciences [q-bio]/Cancer, DLL3, Phase 3, Rovalpituzumab tesirine, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Platinum-based chemotherapy
Abstract

International audience; Introduction - Rovalpituzumab tesirine (Rova-T) is an antibody-drug conjugate targeting DLL3, an atypical Notch ligand expressed in SCLC tumors. We evaluated the efficacy of Rova-T versus placebo as maintenance therapy in patients with extensive-stage-SCLC after platinum-based chemotherapy.Methods - MERU was a phase 3 randomized, double-blinded, placebo-controlled study. Patients without disease progression after four cycles of platinum-based, front-line chemotherapy were randomized in a 1:1 ratio to receive 0.3 mg/kg Rova-T or placebo (every 6 wk, omitted every third cycle). Primary efficacy end points were progression-free survival (PFS) evaluated by the Central Radiographic Assessment Committee and overall survival (OS) in patients with DLL3-high tumors.Results - Median age of all randomized patients (N = 748) was 64 years; 78% had TNM stage IV disease. At futility analysis of the subset with DLL3-high tumors, the hazard ratio for OS was 1.07 (95% confidence interval: 0.84-1.36) favoring the placebo arm, with median OS of 8.5 and 9.8 months in the Rova-T and placebo arms, respectively; futility criteria were met. Rova-T significantly improved PFS versus placebo by investigator assessment (4.0 versus 1.4 mo, hazard ratio = 0.48, p

Published
2021
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12. High Prevalence of Somatic Oncogenic Driver Alterations in Patients With NSCLC and Li-Fraumeni Syndrome

Author

Mezquita, Laura, Jové, Maria, Nadal, Ernest, Kfoury, Maria, Morán, Teresa, Ricordel, Charles, Dhooge, Marion, Tlemsani, Camille, Léna, Hervé, Teulé, Alex, Álvarez, Jose-Valero, Raimbourg, Judith, Hiret, Sandrine, Lacroix, Ludovic, Menéndez, Mireia, Saldaña, Juana, Brunet, Joan, Lianes, Pilar, Coupier, Isabelle, Auclin, Edouard, Recondo, Gonzalo, Friboulet, Luc, Adam, Julien, Green, Emma, Planchard, David, Frébourg, Thierry, Capellà, Gabriel, Rouleau, Etienne, Lázaro, Conxi, Caron, Olivier, and Besse, Benjamin

Published
2020
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13. First-line carboplatin plus pemetrexed with pemetrexed maintenance in HIV-positive patients with advanced non-squamous non-small cell lung cancer: the phase II IFCT-1001 CHIVA trial

Author

Jean Philippe Spano, Jacques Cadranel, Alexandra Langlais, H. Janicot, Xavier Quantin, Clarisse Audigier-Valette, Armelle Lavolé, Lena Herve, Franck Morin, Alain Makinson, Philippe Fraisse, Isabelle Monnet, Laurent Greillier, Lize Kiakouama-Maleka, and Julien Mazieres

Subjects
Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Lung Neoplasms, Anemia, medicine.medical_treatment, HIV Infections, Pemetrexed, Neutropenia, Carboplatin, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, medicine, Carcinoma, Humans, 030212 general & internal medicine, Lung cancer, business.industry, Immunotherapy, medicine.disease, Clinical trial, Treatment Outcome, chemistry, 030220 oncology & carcinogenesis, business, medicine.drug
Abstract

PurposeHIV infection is an exclusion criterion in lung cancer trials. This multicenter phase II trial aimed to assess feasibility, efficacy and safety of first-line carboplatin plus pemetrexed (CaP) followed by pemetrexed (P) maintenance in people living with HIV (PLHIV) with advanced non-squamous non-small cell lung cancer (NS-NSCLC).MethodsFour cycles of CaP were followed by P-maintenance therapy in patients with Eastern Cooperative Oncology Group performance status (PS) ≤2. The primary objective was a disease control rate (DCR) ≥30% after 12 weeks.ResultsOf the 61 PLHIV enrolled 49 (80%) had a PS 0–1, 19 (31%) brain metastases. Median CD4 lymphocyte count was 418 cells·µL−1(range: 18–1230), median CD4 lymphocyte nadir 169.5 cells·µL−1(1–822); 48 patients (80%) were virologically controlled. Four-cycle inductions were achieved by 38 patients (62%), and 31 (51%) started P maintenance [median of 4.1 cycles (range: 1–19)]. The 12-week DCR was 50.8% (95%CI: 38.3;63.4) and partial response rate 21.3%. Median PFS and OS were respectively 3.5 (95%CI: 2.7;4.4) and 7.6 months (5.7;12.8). Patients with PS 0–1 had the longest median PFS (4.3 months, 95%CI: 3.1;5.2) and OS (11.9 months, 95%CI: 6.4;14.3). During induction, CaP doublet was well tolerated apart from grade 3–4 hematologic toxicities (neutropenia, 53.8%; thrombocytopenia, 35.0%; anemia, 30.0%). Two fatal treatment-related sepsis were reported. No opportunistic infections were experienced.ConclusionIn PLHIV with advanced NS-NSCLC, first-line 4-cycle CaP induction followed by P maintenance was effective and reasonably well-tolerated. Further studies should evaluate combination strategies of CaP with immunotherapy in PLHIV.

Published
2019

16. Quality of Resection and Outcome in Stage III TETs: The French RYTHMIC Network Experience

Author

Bluthgen, Maria, Dansin, Eric, Ou, Dan, Lena, Herve, Mazieres, Julien, Pichon, Eric, Thillays, Francois, Massard, Gilbert, Quantin, Xavier, Oulkhouir, Youssef, Nguyen, Thierry, Thiberville, Luc, Clement-Duchene, Christelle, Lindsay, Colin, Missy, Pascale, thierry Molina, Girard, Nicolas, Besse, Benjamin, Thomas, Pascal Alexandre, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER, Service de pneumologie [Rennes] = Pneumology [Rennes], CHU Pontchaillou [Rennes], Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Service de la Radio-Oncologie [Saint-Herblain], Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER-UNICANCER, CHU Strasbourg, UNICANCER - Institut régional du Cancer Montpellier Val d'Aurelle (ICM), CRLCC Val d'Aurelle - Paul Lamarque, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU), Service de pneumologie, oncologie thoracique et soins intensifs respiratoires [Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Equipe Quantification en Imagerie Fonctionnelle (QuantIF-LITIS), Laboratoire d'Informatique, de Traitement de l'Information et des Systèmes (LITIS), Université Le Havre Normandie (ULH), Normandie Université (NU)-Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Université Le Havre Normandie (ULH), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA), Interactions Gènes-Risques environnementaux et Effets sur la Santé (INGRES), Université de Lorraine (UL), Service de Pneumologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Epidémiologie et Biostatistique, Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Infections Virales et Pathologie Comparée - UMR 754 (IVPC), Institut National de la Recherche Agronomique (INRA)-École pratique des hautes études (EPHE), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, Oncologie thoracique, Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, INSB-INSB-Centre National de la Recherche Scientifique (CNRS), Center Oscar Lambret, CRLCC Oscar Lambret, Service de pneumologie, Hôpital Pontchaillou-CHU Pontchaillou [Rennes], Institut de Cancérologie de l'Ouest- ICO Gauducheau, UNICANCER - Institut régional du Cancer [Montpellier] (ICM), Normandie Université (NU)-Normandie Université (NU)-Hôpital Charles Nicolle [Rouen]-CHU Rouen, Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Université Le Havre Normandie (ULH), Institut National de la Recherche Agronomique (INRA)-École pratique des hautes études (EPHE)-Université Claude Bernard Lyon 1 (UCBL), Université de Lille-UNICANCER, Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Institut National de la Recherche Agronomique (INRA)-École Pratique des Hautes Études (EPHE), and Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS)

Subjects
[SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2017
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19. Efficacy and safety of long-acting pasireotide or everolimus alone or in combination in patients with advanced carcinoids of the lung and thymus (LUNA) : an open-label, multicentre, randomised, phase 2 trial

Author

Ferolla, Piero, Brizzi, Maria Pia, Meyer, Tim, Mansoor, Wasat, Mazieres, Julien, Do Cao, Christine, Lena, Herve, Berruti, Alfredo, Damiano, Vincenzo, Buikhuisen, Wieneke, Gronbaek, Henning, Lombard-Bohas, Catherine, Grohe, Christian, Minotti, Vincenzo, Tiseo, Marcello, De Castro, Javier, Reed, Nicholas, Gislimberti, Gabriella, Singh, Neha, Stankovic, Miona, Öberg, Kjell, Baudin, Eric, Ferolla, Piero, Brizzi, Maria Pia, Meyer, Tim, Mansoor, Wasat, Mazieres, Julien, Do Cao, Christine, Lena, Herve, Berruti, Alfredo, Damiano, Vincenzo, Buikhuisen, Wieneke, Gronbaek, Henning, Lombard-Bohas, Catherine, Grohe, Christian, Minotti, Vincenzo, Tiseo, Marcello, De Castro, Javier, Reed, Nicholas, Gislimberti, Gabriella, Singh, Neha, Stankovic, Miona, Öberg, Kjell, and Baudin, Eric

Abstract

Background There are no data from prospective studies focused exclusively on patients with advanced lung and thymic carcinoids. We aimed to assess the efficacy and safety of long-acting pasireotide and everolimus, administered alone or in combination, in patients with advanced carcinoids of the lung or thymus. Methods LUNA was a prospective, multicentre, randomised, open-label, phase 2 trial of adult patients (aged >18 years) with advanced (unresectable or metastatic), well differentiated carcinoid tumours of the lung or thymus, with radiological progression within 12 months before randomisation, and a WHO performance status of 0–2. At each centre, the investigator or their designee registered each patient using an interactive voice recognition system into one of the three treatment groups. The randomisation allocation sequence was generated by an external company; patients were randomly assigned (1:1:1) to receive treatment with long-acting pasireotide (60 mg intramuscularly every 28 days), everolimus (10 mg orally once daily), or both in combination, for the core 12-month treatment period. Patients were stratified by carcinoid type (typical vs atypical) and line of study treatment (first line vs others). The primary endpoint was the proportion of patients progression-free at month 9, defined as the proportion of patients with overall lesion assessment at month 9 showing a complete response, partial response, or stable disease according to local Response Evaluation Criteria in Solid Tumors, version 1.1, assessed in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. The trial is registered with ClinicalTrials.gov, number NCT01563354. The extension phase of the study is ongoing. Findings Between Aug 16, 2013, and Sept 30, 2014, 124 patients were enrolled from 36 centres in nine countries: 41 were allocated to the long-acting pasireotide group, 42

Published
2017
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21. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial

Author

Rizvi, Naiyer A., Mazieres, Julien, Planchard, David, Stinchcombe, Thomas E., Dy, Grace K., Antonia, Scott J., Horn, Leora, Lena, Herve, Minenza, Elisa, Mennecier, Bertrand, Otterson, Gregory A., Campos, Luis T., Gandara, David R., Levy, Benjamin P., Nair, Suresh G., Zalcman, Gerard, Wolf, Juergen, Souquet, Pierre-Jean, Baldini, Editta, Cappuzzo, Federico, Chouaid, Christos, Dowlati, Afshin, Sanborn, Rachel, Lopez-Chavez, Ariel, Grohe, Christian, Huber, Rudolf M., Harbison, Christopher T., Baudelet, Christine, Lestini, Brian J., Ramalingam, Suresh S., Rizvi, Naiyer A., Mazieres, Julien, Planchard, David, Stinchcombe, Thomas E., Dy, Grace K., Antonia, Scott J., Horn, Leora, Lena, Herve, Minenza, Elisa, Mennecier, Bertrand, Otterson, Gregory A., Campos, Luis T., Gandara, David R., Levy, Benjamin P., Nair, Suresh G., Zalcman, Gerard, Wolf, Juergen, Souquet, Pierre-Jean, Baldini, Editta, Cappuzzo, Federico, Chouaid, Christos, Dowlati, Afshin, Sanborn, Rachel, Lopez-Chavez, Ariel, Grohe, Christian, Huber, Rudolf M., Harbison, Christopher T., Baudelet, Christine, Lestini, Brian J., and Ramalingam, Suresh S.

Abstract

Background Patients with squamous non-small-cell lung cancer that is refractory to multiple treatments have poor outcomes. We assessed the activity of nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, for patients with advanced, refractory, squamous non-small-cell lung cancer. Methods We did this phase 2, single-arm trial at 27 sites (academic, hospital, and private cancer centres) in France, Germany, Italy, and USA. Patients who had received two or more previous treatments received intravenous nivolumab (3 mg/kg) every 2 weeks until progression or unacceptable toxic effects. The primary endpoint was the proportion of patients with a confirmed objective response as assessed by an independent radiology review committee. We included all treated patients in the analyses. This study is registered with ClinicalTrials. gov, number NCT01721759. Findings Between Nov 16, 2012, and July 22, 2013, we enrolled and treated 117 patients. 17 (14.5%, 95% CI 8.7-22.2) of 117 patients had an objective response as assessed by an independent radiology review committee. Median time to response was 3 . 3 months (IQR 2.2-4.8), and median duration of response was not reached (95% CI 8 . 31-not applicable); 13 (77%) of 17 of responses were ongoing at the time of analysis. 30 (26%) of 117 patients had stable disease (median duration 6 . 0 months, 95% CI 4.7-10.9). 20 (17%) of 117 patients reported grade 3-4 treatmentrelated adverse events, including: fatigue (five [4%] of 117 patients), pneumonitis (four [3%]), and diarrhoea (three [3%]). There were two treatment-associated deaths caused by pneumonia and ischaemic stroke that occurred in patients with multiple comorbidities in the setting of progressive disease. Interpretation Nivolumab has clinically meaningful activity and a manageable safety profile in previously treated patients with advanced, refractory, squamous non-small cell lung cancer. These data support the assessment of nivolumab in randomised, controlled

Published
2015

22. Crizotinib Therapy for Advanced Lung Adenocarcinoma and a ROS1 Rearrangement: Results From the EUROS1 Cohort

Author

Mazieres, Julien, Zalcman, Gerard, Crino, Lucio, Biondani, Pamela, Barlesi, Fabrice, Filleron, Thomas, Dingemans, Anne-Marie C., Lena, Herve, Monnet, Isabelle, Rothschild, Sacha I., Cappuzzo, Federico, Besse, Benjamin, Thiberville, Luc, Rouviere, Damien, Dziadziuszko, Rafal, Smit, Egbert F., Wolf, Jurgen, Spirig, Christian, Pecuchet, Nicolas, Leenders, Frauke, Heuckmann, Johannes M., Diebold, Joachim, Milia, Julie D., Thomas, Roman K., Gautschi, Oliver, Mazieres, Julien, Zalcman, Gerard, Crino, Lucio, Biondani, Pamela, Barlesi, Fabrice, Filleron, Thomas, Dingemans, Anne-Marie C., Lena, Herve, Monnet, Isabelle, Rothschild, Sacha I., Cappuzzo, Federico, Besse, Benjamin, Thiberville, Luc, Rouviere, Damien, Dziadziuszko, Rafal, Smit, Egbert F., Wolf, Jurgen, Spirig, Christian, Pecuchet, Nicolas, Leenders, Frauke, Heuckmann, Johannes M., Diebold, Joachim, Milia, Julie D., Thomas, Roman K., and Gautschi, Oliver

Abstract

Purpose Approximately 1% of lung adenocarcinomas are driven by oncogenic ROS1 rearrangement. Crizotinib is a potent inhibitor of both ROS1 and ALK kinase domains. Patients and Methods In the absence of a prospective clinical trial in Europe, we conducted a retrospective study in centers that tested for ROS1 rearrangement. Eligible patients had stage IV lung adenocarcinoma, had ROS1 rearrangement according to fluorescent in situ hybridization, and had received crizotinib therapy through an individual off-label use. Best response was assessed locally using RECIST (version 1.1). All other data were analyzed centrally. Results We identified 32 eligible patients. One patient was excluded because next-generation sequencing was negative for ROS1 fusion. Median age was 50.5 years, 64.5% of patients were women, and 67.7% were never-smokers. Thirty patients were evaluable for progression-free survival (PFS), and 29 patients were evaluable for best response. We observed four patients with disease progression, two patients with stable disease, and objective response in 24 patients, including five complete responses (overall response rate, 80%; disease control rate, 86.7%). Median PFS was 9.1 months, and the PFS rate at 12 months was 44%. No unexpected adverse effects were observed. Twenty-six patients received pemetrexed (either alone or in combination with platinum and either before or after crizotinib) and had a response rate of 57.7% and a median PFS of 7.2 months. Conclusion Crizotinib was highly active at treating lung cancer in patients with a ROS1 rearrangement, suggesting that patients with lung adenocarcinomas should be tested for ROS1. Prospective clinical trials with crizotinib and other ROS1 inhibitors are ongoing or planned. (C) 2015 by American Society of Clinical Oncology

Published
2015

23. Longer-Term Follow-Up of a Phase 2 Study (CheckMate 063) of Nivolumab in Patients with Advanced, Refractory Squamous Non-Small Cell Lung Cancer

Author

Horn, Leora, Rizvi, Naiyer A., Mazieres, Julien, Planchard, David, Stinchcombe, Thomas E., Dy, Grace K., Antonia, Scott J., Lena, Herve, Minenza, Elisa, Mennecier, Bertrand, Otterson, Gregory A., Campos, Luis T., Gandara, David R., Levy, Benjamin P., Nair, Suresh G., Zalcman, Gerard, Wolf, Juergen, Paik, Paul, Li, Ang, Xu, Dong, Neely, Jaclyn, Qi, Zhenhao, Harbison, Christopher, Lynch, Mark, Ramalingam, Suresh S., Horn, Leora, Rizvi, Naiyer A., Mazieres, Julien, Planchard, David, Stinchcombe, Thomas E., Dy, Grace K., Antonia, Scott J., Lena, Herve, Minenza, Elisa, Mennecier, Bertrand, Otterson, Gregory A., Campos, Luis T., Gandara, David R., Levy, Benjamin P., Nair, Suresh G., Zalcman, Gerard, Wolf, Juergen, Paik, Paul, Li, Ang, Xu, Dong, Neely, Jaclyn, Qi, Zhenhao, Harbison, Christopher, Lynch, Mark, and Ramalingam, Suresh S.

Published
2015

24. LONGER-TERM FOLLOW-UP OF A PHASE 2 STUDY (CHECKMATE 063) OF NIVOLUMAB IN PATIENTS WITH ADVANCED REFRACTORY SQUAMOUS (SQ) NON-SMALL CELL LUNG CANCER (NSCLC)

Author

Horn, Leora, Rizvi, Naiyer, Mazieres, Julien, Planchard, David, Stinchcombe, Thomas E., Dy, Grace K., Antonia, Scott J., Lena, Herve, Minenza, Elisa, Mennecier, Bertrand, Otterson, Gregory A., Campos, Luis T., Gandara, David R., Levy, Benjamin P., Nair, Suresh G., Zalman, Gerard, Wolf, Juergen, Paik, Paul, Zhu, Jin, Xu, Dong, Neely, Jaclyn, Qi, Zenhao, Harbison, Christopher T., Lynch, Mark, Ramalingam, Suresh S., Horn, Leora, Rizvi, Naiyer, Mazieres, Julien, Planchard, David, Stinchcombe, Thomas E., Dy, Grace K., Antonia, Scott J., Lena, Herve, Minenza, Elisa, Mennecier, Bertrand, Otterson, Gregory A., Campos, Luis T., Gandara, David R., Levy, Benjamin P., Nair, Suresh G., Zalman, Gerard, Wolf, Juergen, Paik, Paul, Zhu, Jin, Xu, Dong, Neely, Jaclyn, Qi, Zenhao, Harbison, Christopher T., Lynch, Mark, and Ramalingam, Suresh S.

Published
2015

25. Efficacy of crizotinib in ROSI-rearranged lung cancer: The European experience.

Author

Mazieres, Julien, Zalcman, Gerard, Crino, Lucio, Biondani, Pamela, Besse, Benjamin, Dingemans, Anne-Marie C., Lena, Herve, Monnet, Isabelle, Rothschild, Sacha, Cappuzzo, Federico, Thiberville, Luc, Rouviere, Damien, Dziadziuszko, Rafal, Smit, Egbert F., Wolf, Juergen, Spirig, Christian, Pecuchet, Nicolas, Diebold, Joachim, Milia, Julie, Gautschi, Oliver, Mazieres, Julien, Zalcman, Gerard, Crino, Lucio, Biondani, Pamela, Besse, Benjamin, Dingemans, Anne-Marie C., Lena, Herve, Monnet, Isabelle, Rothschild, Sacha, Cappuzzo, Federico, Thiberville, Luc, Rouviere, Damien, Dziadziuszko, Rafal, Smit, Egbert F., Wolf, Juergen, Spirig, Christian, Pecuchet, Nicolas, Diebold, Joachim, Milia, Julie, and Gautschi, Oliver

Published
2014

26. P3.02a-016 Pooled Efficacy and Safety Data from Two Phase II Studies (NP28673 and NP28761) of Alectinib in ALK+ Non-Small-Cell Lung Cancer (NSCLC): Topic: ALK Clinical

Author

Chih-Hsin Yang, James, Ou, Sai-Hong, De Petris, Luigi, Gadgeel, Shirish, Gandhi, Leena, Kim, Dong-Wan, Barlesi, Fabrice, Govindan, Ramaswamy, Dingemans, Anne-Marie, Crinò, Lucio, Léna, Hervé, Popat, Sanjay, Ahn, Jin Seok, Dansin, Eric, Golding, Sophie, Bordogna, Walter, Balas, Bogdana, Morcos, Peter N., Zeaiter, Ali, and Shaw, Alice

Published
2017
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27. P2.04-003 Chemotherapy in Advanced Thymic Epithelial Tumors: Insights from the RYTHMIC Prospective Cohort: Topic: Thymic Malignancies Clinical and Translational

Author

Du Vignaux, Claire Merveilleux, Bluthgen, Maria, Mhanna, Laurent, Dansin, Eric, Greillier, Laurent, Pichon, Eric, Léna, Hervé, Clément-Duchêne, Christelle, Massard, Gilbert, Westeel, Virginie, Robert, Marie, Quantin, Xavier, Zalcman, Gérard, Thiberville, Luc, Molina, Thierry, Mazieres, Julien, Besse, Benjamin, and Girard, Nicolas

Published
2017
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28. P2.03b-037 Prognostic Impact of 1st-Line Treatment and Molecular Testing in Advanced NSCLC in France - Results of the IFCT-PREDICT.amm Study: Topic: Biomarkers

Author

Cadranel, Jacques, Quoix, Elisabeth, Duruisseaux, Michael, Friard, Sylvie, Wislez, Marie, Daniel, Catherine, Fabre, Elizabeth, Madroszyk, Anne, Westeel, Virginie, Merle, Patrick, Léna, Hervé, Dansin, Eric, Mazieres, Julien, Scherpereel, Arnaud, Hiret, Sandrine, Kaderbhai, Coureche, Souquet, Pierre-Jean, Missy, Pascale, Langlais, Alexandra, Morin, Franck, Zalcman, Gérard, Moro-Sibilot, Denis, and Barlesi, Fabrice

Published
2017
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30. OA18.01 Postoperative Radiotherapy in Thymic Epithelial Tumors: Insights from the RYTHMIC Prospective Cohort

Author

Basse, Clémence, Thureau, Sébastien, Bota, Suzanna, Dansin, Eric, Thomas, Pascal Alexandre, Pichon, Eric, Léna, Hervé, Massabeau, Carole, Clément-Duchêne, Christelle, Massard, Gilbert, Westeel, Virginie, Thillays, François, Quantin, Xavier, Oulkhouir, Youssef, Danhier, Serge, Lerouge, Delphine, Thiberville, Luc, Besse, Benjamin, and Girard, Nicolas

Published
2017
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31. OA10.06 Characteristics and Outcomes of Patients with Lung Cancer Harboring Multiple Molecular Alterations (Biomarker IFCT Study)

Author

Guibert, Nicolas, Barlesi, Fabrice, Descourt, Renaud, Léna, Hervé, Besse, Benjamin, Beau-Faller, Michèle, Mosser, Jean, Pichon, Eric, Merlio, Jean-Philippe, Ouafik, L'Houcine, Guichard, François, Mastroianni, Bénédicte, Moreau, Lionel, Wdowik, Annie, Sabourin, Jean-Christophe, Lemoine, Antoinette, Missy, Pascale, Langlais, Alexandra, Moro-Sibilot, Denis, and Mazieres, Julien

Published
2017
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32. OA03.07 KEYNOTE-010: Durable Clinical Benefit in Patients with Previously Treated, PD-L1-Expressing NSCLC Who Completed Pembrolizumab

Author

Herbst, Roy, Garon, Edward, Kim, Dong-Wan, Cho, Byoung Chul, Gadgeel, Shirish, Léna, Hervé, Gúrpide, Alfonso, Han, Ji-Youn, Arvis, Catherine Dubos, Majem, Margarita, Forster, Martin, Monnet, Isabelle, Novello, Silvia, Saka, Hideo, Szalai, Zsuzsanna, Gubens, Matthew, Su, Wu-Chou, Lubiniecki, Gregory, Shentu, Yue, Ferraro, Geri, and Baas, Paul

Published
2017
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37. First-line carboplatin plus pemetrexed with pemetrexed maintenance in HIV-positive patients with advanced non-squamous non-small cell lung cancer: the phase II IFCT-1001 CHIVA trial.

Author

Lavole A, Greillier L, Mazières J, Monnet I, Kiakouama-Maleka L, Quantin X, Spano JP, Lena H, Fraisse P, Janicot H, Audigier-Valette C, Langlais A, Morin F, Makinson A, and Cadranel J

Subjects
Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carboplatin, Humans, Pemetrexed therapeutic use, Treatment Outcome, Carcinoma, Non-Small-Cell Lung drug therapy, HIV Infections complications, HIV Infections drug therapy, Lung Neoplasms drug therapy
Abstract

HIV infection is an exclusion criterion in lung cancer trials. This multicentre phase II trial aimed to assess feasibility, efficacy and safety of first-line carboplatin plus pemetrexed (CaP) followed by pemetrexed (P) maintenance in people living with HIV (PLHIV) with advanced non-squamous non-small cell lung cancer (NS-NSCLC).Four cycles of CaP were followed by P-maintenance therapy in patients with Eastern Cooperative Oncology Group performance status ≤2. The primary objective was a disease control rate (DCR) ≥30% after 12 weeks.Of the 61 PLHIV enrolled, 49 (80%) had a performance status of 0-1, and 19 (31%) had brain metastases. Median CD4 lymphocyte count was 418 cells·µL -1 (range 18-1230), median CD4 lymphocyte nadir was 169.5 cells·µL -1 (1-822); 48 (80%) patients were virologically controlled. Four-cycle inductions were achieved by 38 (62%) patients, and 31 (51%) started P-maintenance (median of 4.1 cycles (range 1-19)). The 12-week DCR was 50.8% (95% CI 38.3-63.4) and partial response rate 21.3%. Median progression-free survival and overall survival were 3.5 (95% CI 2.7-4.4) and 7.6 months (5.7-12.8), respectively. Patients with a performance status of 0-1 had the longest median progression-free survival (4.3 months, 95% CI 3.1-5.2) and overall survival (11.9 months, 95% CI 6.4-14.3). During induction, CaP doublet was well tolerated apart from grade 3-4 haematological toxicities (neutropenia 53.8%; thrombocytopenia 35.0%; anaemia 30.0%). Two fatal treatment-related sepses were reported. No opportunistic infections were experienced.In PLHIV with advanced NS-NSCLC, first-line four-cycle CaP induction followed by P-maintenance was effective and reasonably well-tolerated. Further studies should evaluate combination strategies of CaP with immunotherapy in PLHIV., Competing Interests: Conflict of interest: A. Lavole has nothing to disclose. Conflict of interest: L. Greillier reports personal fees from AstraZeneca, Boehringer Ingelheim, Roche, Bristol-Myers Squibb, MSD, Takeda, Abbvie and Novartis, outside the submitted work; travel and accommodation expenses from MSD and Pfizer. Conflict of interest: J. Mazières has nothing to disclose. Conflict of interest: I. Monnet has nothing to disclose. Conflict of interest: L. Kiakouama-Maleka has nothing to disclose. Conflict of interest: X. Quantin has nothing to disclose. Conflict of interest: J.P. Spano reports personal fees for consultancy from MSD, Roche and Biogaran, personal fees for advisory board work from Lilly, Mylan and Novartis, personal fees for advisory board work and lectures from Pfizer and Leopharma, personal fees for lectures from Pierre Fabre Oncology, AstraZeneca and Gilead, grants from BMS and MSD Avenir, outside the submitted work. Conflict of interest: H. Lena has nothing to disclose. Conflict of interest: P. Fraisse has nothing to disclose. Conflict of interest: H. Janicot has nothing to disclose. Conflict of interest: C. Audigier-Valette has nothing to disclose. Conflict of interest: A. Langlais has nothing to disclose. Conflict of interest: F. Morin has nothing to disclose. Conflict of interest: A. Makinson has nothing to disclose. Conflict of interest: J. Cadranel reports grants from AstraZeneca, Novartis and Pfizer, outside the submitted work., (Copyright ©ERS 2020.)

Published
2020
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