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107 results on '"Souquet, P. J."'

1. First-line nivolumab plus ipilimumab with two cycles of chemotherapy versus chemotherapy alone (four cycles) in advanced non-small-cell lung cancer: CheckMate 9LA 2-year update

Author

Reck, M., Ciuleanu, T.-E., Cobo, M., Schenker, M., Zurawski, B., Menezes, J., Richardet, E., Bennouna, J., Felip, E., Juan-Vidal, O., Alexandru, A., Sakai, H., Lingua, A., Reyes, F., Souquet, P.-J., De Marchi, P., Martin, C., Pérol, M., Scherpereel, A., Lu, S., Paz-Ares, L., Carbone, D.P., Memaj, A., Marimuthu, S., Zhang, X., Tran, P., and John, T.

Published
2021
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7. Clinical Presentation, Diagnosis, and Bacterial Epidemiology of Peritoneal Tuberculosis in Two University Hospitals in France

Author

Cavalli, Zoé, Ader, Florence, Valour, Florent, Saison, Julien, Boussel, Loïc, Dumitrescu, Oana, Perpoint, Thomas, Chidiac, Christian, May, Thierry, Ferry, Tristan, Adelaïde, L., Ader, F., Biron, F., Boibieux, A., Bouaziz, A., Bouledrak, K., Braun, E., Broussolle, C., Carret, G., Catho, G., Charhon, N., Chidiac, C., Chumbi-Flores, W., Coppere, B., Couraud, S., Demontclos, M., Devouassoux, G., Dumitrescu, O., Ernesto, S., Ferry, T., Floret, D., Fredenucci, I., Freymond, N., Gardes, S., Gerbier-Colomban, S., Gillet, Y., Girard-Madoux, M. H., Goutelle, S., Grando, J., Grima, R., Hees, L., Hodille, E., Hot, A., Karsenty, J., Kiakouama-Maleka, L., Lina, G., Maury, J. M., Miailhes, P., Moreau, L., Nesme, P., Ninet, J., Perard, L., Perpoint, T., Perrot, E., Ranc, A. G., Rasigade, J. P., Reix, R., Renaud-Baron, A. S., Saison, J., Senechal, A., Sève, P., Souquet, P. J., van Thai, H., Tronc, F., Valour, F., Vanhems, P., and Lyon TB Study group

Published
2016
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8. Corrigendum to ‘First-line nivolumab plus ipilimumab with 2 cycles of chemotherapy versus chemotherapy alone (4 cycles) in advanced non-small cell lung cancer: CheckMate 9LA 2-year update’: [ESMO Open Volume 6, Issue 5, October 2021, 100273]

Author

Reck, M., Ciuleanu, T.-E., Cobo, M., Schenker, M., Zurawski, B., Menezes, J., Richardet, E., Bennouna, J., Felip, E., Juan-Vidal, O., Alexandru, A., Sakai, H., Lingua, A., Reyes, F., Souquet, P.-J., De Marchi, P., Martin, C., Pérol, M., Scherpereel, A., Lu, S., Paz-Ares, L., Carbone, D.P., Memaj, A., Marimuthu, S., Zhang, X., Tran, P., and John, T.

Published
2021
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9. Randomized phase II–III study of bevacizumab in combination with chemotherapy in previously untreated extensive small-cell lung cancer: results from the IFCT-0802 trial†

Author

Pujol, J.-L., Lavole, A., Quoix, E., Molinier, O., Souquet, P.-J., Barlesi, F., Le Caer, H., Moro-Sibilot, D., Fournel, P., Oster, J. P., Chatellain, P., Barre, P., Jeannin, G., Mourlanette, P., Derollez, M., Herman, D., Renault, A., Dayen, C., Lamy, P. J., Langlais, A., Morin, F., Zalcman, G., Westeel, V., Poudenx, M., Mazieres, J., Martinet, Y., Gury, J-P., Baize, N., Dumont, P., Vaylet, F., Foucher, P., Dauba, J., Tredaniel, J., Laize, H., Petit, L., Coëtmeur, D., Doubre, H., Pichon, E., Schneider, S., Goutorbe, F., Gervais, R., Zaegel, M., Dehette, S., Coudert, B., Duhamel, J-P., Dixmier, A., Thiberville, L., Deguiral, P., Monnot, H., Romand, P., Berard, H., and Raspaud, C.

Published
2015
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14. From randomized trials to the clinic: is it time to implement individual lung-cancer screening in clinical practice? A multidisciplinary statement from French experts on behalf of the french intergroup (IFCT) and the groupe dʼOncologie de langue française (GOLF)

Author

Couraud, S., Cortot, A. B., Greillier, L., Gounant, V., Mennecier, B., Girard, N., Besse, B., Brouchet, L., Castelnau, O., Frappé, P., Ferretti, G. R., Guittet, L., Khalil, A., Lefebure, P., Laurent, F., Liebart, S., Molinier, O., Quoix, E., Revel, M.-P., Stach, B., Souquet, P.-J., Thomas, P., Trédaniel, J., Lemarié, E., Zalcman, G., Barlési, F., and Milleron, B.

Published
2013
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20. Results of a phase III study of early versus delayed whole brain radiotherapy with concurrent cisplatin and vinorelbine combination in inoperable brain metastasis of non-small-cell lung cancer: Groupe Français de Pneumo-Cancérologie (GFPC) Protocol 95-1*

Author

Robinet, G., Thomas, P., Breton, J. L., Léna, H., Gouva, S., Dabouis, G., Bennouna, J., Souquet, P. J., Balmes, P., Thiberville, L., Fournel, P., Quoix, E., Riou, R., Rebattu, P., Pérol, M., Paillotin, D., and Mornex, F.

Published
2001

25. 1273P Durvalumab (D) compared to maintenance chemotherapy (SoC) in patients (pts) with metastatic non-small cell lung cancer (NSCLC): Results from the randomized SAFIR02 LUNG-IMMUNO trial

Author

Barlesi, F., Karimi, M., Tomasini, P., Daniel, C., Raimbourg, J., Quoix, A-E., Flandin, A-C. Madroszyk, Mazieres, J., Molinier, O., Audigier-Valette, C., Moro-Sibilot, D., Morel, H., Souquet, P-J., Bieche, I., Tran-Dien, A., Jacquet, A., Adam, J., Soria, J-C., and Besse, B.

Published
2020
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27. [Long-term results of lung cancer surgery in octogenarians]

Author

Gardet, E, Tabutin, M, Couraud, S, Maury, J-M, Guibert, B, Nguyen Van, M, Tchalla, Achille Edem, Souquet, P-J, Tronc, F, Institut de Recherche en Gestion et en Economie (IREGE), Université Savoie Mont Blanc (USMB [Université de Savoie] [Université de Chambéry]), Centre International de Recherche contre le Cancer - International Agency for Research on Cancer (CIRC - IARC), Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), Atys Medical, Alcatel Lucent Bell Labs, ALCATEL, Handicap, Activité, Vieillissement, Autonomie, Environnement (HAVAE), Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), and Daviet, Jean-Christophe

Subjects
Aged, 80 and over, Male, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Lung Neoplasms, Survival Analysis, Postoperative Complications, Treatment Outcome, Humans, Female, Pneumonectomy, Geriatric Assessment, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Aged, Retrospective Studies
Abstract

International audience; This retrospective study was undertaken to evaluate late results of lung cancer surgery in octogenerians. All patients 80years old or more who underwent a lung resection for cancer from 2000 to 2010 at Lyon University Hospital were included. No patients were treated with video-assisted surgery. Wedge resections were excluded. Sixty-three patients (42 men, 21 women) were operated. The median age was 82years. Operative mortality was 4.7%. The rate of perioperative complications was 49%. The late survival was 34% at 5years. Five-year survival by nodal involvement was N0, 36%; N1, 29%; N2 20%, P

Published
2016

30. 1591TiP - IFCT-1701 DICIPLE: A randomized phase III trial comparing continuation nivolumab-Ipilimumab doublet immunotherapy until progression versus observation in patients with PDL1-positive stage IV non-small cell lung cancer (NSCLC) after nivolumab-ipilimumab induction treatment

Author

Zalcman, G., Toffart, A.C., Madroszyk Flandin, A.-C., Molinier, O., Dayen, C., Egenod, T., Dixmier, A., Giroux Leprieur, E., Masson, P., Cloarec, N., Thibonnier, L., Favier, L., Debieuvre, D., Mazieres, J., Van Hulst, S., Pichon, E., Amour, E., Morin, F., and Souquet, P.-J.

Published
2019
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31. LBA52 - Results of the GEOMETRY mono-1 phase II study for evaluation of the MET inhibitor capmatinib (INC280) in patients (pts) with METΔex14 mutated advanced non-small cell lung cancer (NSCLC)

Author

Wolf, J., Seto, T., Han, J.-Y., Reguart, N., Garon, E.B., Groen, H.J.M., Tan, D.S., Hida, T., de Jonge, M.J.A., Orlov, S.V., Smit, E.F., Souquet, P.-J., Vansteenkiste, J.F., Giovannini, M., Le Mouhaer, S., Robeva, A., Waldron-Lynch, M., and Heist, R.S.

Published
2018
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32. LBA56 - Maintenance chemotherapy versus follow-up after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non-small cell lung cancer (NSCLC): IFCT-1201 MODEL randomised phase III trial

Author

Quoix, E., Audigier Valette, C., Lavolé, A., Molinier, O., Westeel, V., Barlesi, F., Le Treut, J., Pichon, E., Dauba, J., Otto, J., Dumont, P., Moreau, L., Madelaine, J., Margery, J., Debieuvre, D., Renault, P.A., Langlais, A., Morin, F., Moro-Sibilot, D., and Souquet, P.-J.

Published
2018
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33. 1664O - A randomized non-comparative phase II study of anti–PD-L1 ATEZOLIZUMAB or chemotherapy as second-line therapy in patients with small cell lung cancer: Results from the IFCT-1603 trial

Author

Pujol, J.-L., Greillier, L., Audigier Valette, C., Moro-Sibilot, D., Uwer, L., Hureaux, J., Thiberville, L., Carmier, D., Madelaine, J., Otto, J., Gounant, V., Merle, P., Mourlanette, P., Molinier, O., Renault, P.A., Mazieres, J., Antoine, M., Langlais, A., Morin, F., and Souquet, P.-J.

Published
2018
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35. 125P - Molecular heterogeneity assessment by NGS in non-small cell lung cancer (NSCLC) harboring EGFR mutations: Results of the French Cooperative Thoracic Intergroup (IFCT) Biomarkers France study

Author

Blons, H., Oudart, J.-B., Merlio, J.-P., Hominal, S., de Fraipont, F., Debieuvre, D., Escande, F., Audigier Valette, C., Bringuier, P.-P., Moreau Fraboulet, S., Ouafik, L., Moro-Sibilot, D., Lemoine, A., Langlais, A., Missy, P., Morin, F., Souquet, P.-J., Barlesi, F., Cadranel, J., and Beau-Faller, M.

Published
2018
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40. Mésothéliomes familiaux : une composante génétique associée aux risques environnementaux ?

Author

You, Benoit, Blandin, S., Gérinière, L., Lasset, Christine, Souquet, P.-J., Biostatistiques santé, Département biostatistiques et modélisation pour la santé et l'environnement [LBBE], Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), and Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)

Subjects
[SDV.OT]Life Sciences [q-bio]/Other [q-bio.OT]
Published
2007

41. Expression of class III beta tubulin in non-small cell lung cancer is correlated with resistance to taxane chemotherapy

Author

Charles Dumontet, Isaac, S., Souquet, P. J., Bejui-Thivolet, F., Pacheco, Y., Peloux, N., Frankfurter, A., Luduena, R., Perol, M., Institut National de la Santé et de la Recherche Médicale (INSERM), Hospices Civils de Lyon (HCL), Rétrovirus et Pathologie Comparée (RPC), 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-Ecole Nationale Vétérinaire de Lyon (ENVL), University of Virginia, University of Texas Health Science Center, The University of Texas Health Science Center at Houston (UTHealth), and ProdInra, Migration

Subjects
[SDV] Life Sciences [q-bio], NON-SMALL CELL LUNG, BETA TUBULIN, [SDV]Life Sciences [q-bio], CHEMOTHERAPY, TAXANE, RESISTANCE
Abstract

International audience; This study determined the prevalence and the prognostic value of the expression of microtubule components in tumors of 19 patients with non small cell lung cancer receiving taxane-based regimens. Patient samples were stained with antibodies directed against total β tubulin, classes I, II and III β tubulin isotypes, δ2 alpha tubulin, τ protein, and the P-gp protein involved in the classical multidrug resistance phenotype. All tumors were stained with pan-β tubulin antibody and class I tubulin isotype. A majority of the tumor samples expressed class II and class III, although the percentage of positive cells varied significantly between tumors. δ2 alpha tubulin, τ protein and Pgp protein were found in only one tumor sample each. Progression-free survival was shorter (41 days) in patients whose tumors expressed high levels of class III tubulin isotype in comparison to patients with low levels (288 days, p = 0.02). There were 2 responses to chemotherapy among 9 patients (22%) with high levels of class III tubulin vs. 6 among 10 patients (60%) with low levels of expression (Fisher exact test: p = 0.11). These data suggest that high expression of class III tubulin by tumor cells is associated with poor prognosis in patients with NSCLC receiving a taxane-based regimen.

Published
2005

42. 1285TiP - IFCT-1003 LADIE trial: Randomized phase II trial evaluating treatment with EGFR-TKI versus EGFR-TKI associated with anti-estrogen in women with non-squamous advanced stage NSCLC

Author

Mazieres, J., Barlesi, F., Molinier, O., Monnet, I., Audigier-Valette, C., Besse, B., Toffart, A.-C., Renault, P.A., Hiret, S., Fraboulet-Moreau, S., Mennecier, B., Masson, P., Westeel, V., Souquet, P.-J., Pichon, E., Amour, E., Morin, F., and Moro-Sibilot, D.

Published
2016
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44. EPICC study: evaluation of pharmaceutical intervention in cancer care.

Author

Vantard, N., Ranchon, F., Schwiertz, V., Gourc, C., Gauthier, N., Guedat, M.‐G., He, S., Kiouris, E., Alloux, C., You, B., Souquet, P.‐J., Freyer, G., Salles, G., Trillet‐Lenoir, V., and Rioufol, C.

Subjects
ANTINEOPLASTIC agents, CANCER patient medical care, DRUG interactions, DRUG side effects, MEDICATION errors, PATIENT safety, PHARMACISTS, TUMORS, OCCUPATIONAL roles, DATA analysis software, DESCRIPTIVE statistics
Abstract

What is known and objectives In cancer care, clinical pharmacists contribute to improving prevention and management of drug-related problems ( DRPs). The 3-year EPICC study (Evaluation of Pharmaceutical Intervention in Cancer Care) aimed to collect and analyse pharmaceutical interventions ( PIs) in oncology. Methods The free online version of the French Society of Clinical Pharmacy ( SFPC) coding system, ACT- IP, was used, supplemented by a standardized dedicated cancer-care decision tree. Results A total of 29 589 medication orders (77 004 anticancer drug preparations) were analysed. Eight hundred and ninety-four PIs were recorded. ACT- IP identified 54·1% of DRPs as concerning over- or underdosage. The standardized dedicated cancer-care decision tree identified the three principal causes of dosage problems: 50·2% due to miscalculation, 20% to omission of dose adjustment and 12% to poor choice of antineoplastic regimen. About 13·8% of DRPs were adverse effects and 3·9% were drug-drug interactions. The decision tree showed that 22% of adverse events could be circumvented by a switch within the same drug family and 72% of drug-drug interactions would have led to increased neoplastic toxicity. Discussion Pharmaceutical analysis of prescription forms contributes to medication safety in cancer care, and the present dedicated decision tree highlights additional information about DRPs and PIs. The DRP rate (3% of prescriptions) was consistent with the literature. The pharmacist has a role to play in optimizing the management of patients with cancer in terms of dose adjustment, drug toxicity management, improvement of administration and drug-drug interactions. What is new and conclusion This study, highlighting PIs in cancer care, is the first of this scale in terms of number of prescriptions analysed (nearly 30 000). Results demonstrated the specificity of DRPs and PIs for patients with cancer and the value of a dedicated coding system in cancer care. [ABSTRACT FROM AUTHOR]

Published
2015
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45. Evaluation of RECIST in chemotherapy-treated lung cancer: the Pharmacogenoscan Study.

Author

Toffart, A. C., Moro-Sibilot, D., Couraud, S., Merle, P., Perol, M., Girard, N., Souquet, P. J., Mastroianni, B., Ferretti, G. R., Romand, P., Chatellain, P., Vesin, A., Brambilla, E., Brambilla, C., and Timsit, J. F.

Subjects
LUNG cancer treatment, CANCER patients, CANCER chemotherapy, PHARMACOGENOMICS, CANCER invasiveness, MEDICAL databases, SURVIVAL analysis (Biometry)
Abstract

Background Response Evaluation Criteria in Solid Tumors (RECIST) are widely used to assess the effect of chemotherapy in patients with cancer. We hypothesised that the change in unidimensional tumour size handled as a continuous variable was more reliable than RECIST in predicting overall survival (OS). Methods The prospective Pharmacogenoscan study enrolled consecutive patients with non-small-cell lung cancer (NSCLC) at any stage seen between 2005 and 2010 at six hospitals in France, given chemotherapy. After exclusion of patients without RECIST or continuous-scale tumour size data and of those with early death, 464 patients were left for the survival analyses. Cox models were built to assess relationships between RECIST 1.1 categories or change in continuous-scale tumour size and OS. The best model was defined as the model minimising the Akaike Information Criterion (AIC). Results OS was 14.2 months (IQR, 7.3-28.9 months). According to RECIST 1.1, 146 (31%) patients had a partial or complete response, 245 (53%) stable disease, and 73 (16%) disease progression. RECIST 1.1 predicted better OS than continuous-scale tumour in early (<6 months) predicted survival analyses (p = 0.03) but the accuracy of the two response evaluation methods was similar in late (≤6 months) predicted survival analyses (p = 0.15). Conclusion In this large observational study, change in continuous-scale tumour size did not perform better than RECIST 1.1 in predicting survival of patients given chemotherapy to treat NSCLC. [ABSTRACT FROM AUTHOR]

Published
2014
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48. Lessons from the ‘Iressa’ Expanded Access Programme: gefitinib in special non-small-cell lung cancer patient populations.

Author

Stahel, R., Rossi, A., Petruzelka, L., Kosimidis, P., de Braud, F., Bernardo, M. M., Souquet, P-J, Parra, H. Sotto, and Gridelli, C.

Subjects
SMALL cell lung cancer, CANCER treatment, DRUG therapy, COMORBIDITY
Abstract

Some subgroups of patients with advanced/metastatic non-small-cell lung cancer (NSCLC) are frequently considered ineligible for the aggressive, platinum-based combination chemotherapy that is the recommended treatment. Elderly patients may have a poorer tolerance of chemotherapy due to impaired organ function and frequent comorbidities; patients with poor performance status (PS; ?2 due to NSCLC and/or coexisting illnesses) are often considered unfit for chemotherapy; other patients may be unable or unwilling to endure the toxicity or inconvenience of chemotherapy. These patient groups may benefit from novel, relatively nontoxic treatment modalities. Gefitinib (‘Iressa’, ZD1839) 250?mg?day-1 is well tolerated and has proven antitumour and symptom improvement activity in patients with previously treated NSCLC. Phase II trials (IDEAL 1 and 2) of gefitinib in advanced/metastatic NSCLC included 70 out of 425 (16.5%) patients with PS ?2, and their response rate, clinical benefit rate and rates of adverse events were similar to those of the overall trial population. In addition, many patients with advanced/metastatic NSCLC with poor PS or advanced age have received gefitinib 250?mg?day-1 in an Expanded Access Programme (EAP). Observations from the EAP support those of IDEAL 1 and 2, and indicate that gefitinib 250?mg?day-1 warrants further investigation in these patient groups.British Journal of Cancer (2003) 89 (Suppl 2), S19-S23. doi:10.1038/sj.bjc.6601479 www.bjcancer.com [ABSTRACT FROM AUTHOR]

Published
2003
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49. PTEN, ATM, IDH1 mutations and MAPK pathway activation as modulators of PFS and OS in patients treated by first line EGFR TKI, an ancillary study of the French Cooperative Thoracic Intergroup (IFCT) Biomarkers France project.

Author

Blons, H., Oudart, J.-B., Merlio, J.-P., Debieuvre, D., de Fraipont, F., Audigier-Valette, C., Escande, F., Hominal, S., Bringuier, P.‐P., Fraboulet-Moreau, S., Ouafik, L., Moro-Sibilot, D., Lemoine, A., Langlais, A, Missy, P., Morin, F., Souquet, P.-J., Barlesi, F., Cadranel, J., and Beau‐Faller, M.

Subjects
*MITOGEN-activated protein kinases, *CANCER genes, *BIOMARKERS
Abstract

• Response to EGFR TKI is heterogeneous among patients with EGFR mutated NSCLC. • Routine use of NGS enables co-mutations detection that may impact response to treatment. • Complex EGFR mutations are linked to reduced PFS and OS in patients with NSCLC. • MAPK activation is linked to reduced OS in patients with EGFR mutated NSCLC. • PTEN , ATM and IDH1 mutations are linked to low PFS and OS in patients with EGFR mutated NSCLC. Tumor mutation screening is standard of care for patients with stage IV NSCLC. Since a couple of years, widespread NGS approaches used in routine diagnostics to detect driver mutations such as EGFR , KRAS, BRAF or MET allows the identification of other alterations that could modulated the intensity or duration of response to targeted therapies. The prevalence of co-occurring alterations that could affect response or prognosis as not been largely analyzed in clinical settings and large cohorts of patients. Thanks to the IFCT program "Biomarkers France", a collection of samples and data at a nation-wide level was available to test the impact of co-mutations on first line EGFR TKI in patients with EGFR mutated cancers. Targeted NGS was assessed on available (n = 208) samples using the Ion AmpliSeq™ Cancer Hotspot Panel v2 to screen for mutations in 50 different cancer genes. This study showed that PTEN inactivating mutations, ATM alterations, IDH1 mutations and complex EGFR mutations were predictors of short PFS in patients with a stage 4 lung adenocarcinoma receiving first line EGFR TKI and that PTEN , ATM , IDH1 and KRAS mutations as well as alterations in the MAPK pathway were related to shorter OS. These findings may lead to new treatment options in patients with unfavorable genotypes to optimize first line responses. [ABSTRACT FROM AUTHOR]

Published
2021
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50. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer.

Author

Wolf, J., Seto, T., Han, J.-Y., Reguart, N., Garon, E. B., Groen, H. J. M., Tan, D. S. W., Hida, T., de Jonge, M., Orlov, S. V., Smit, E. F., Souquet, P.-J., Vansteenkiste, J., Hochmair, M., Felip, E., Nishio, M., Thomas, M., Ohashi, K., Toyozawa, R., and Overbeck, T. R.

Subjects
*NON-small-cell lung carcinoma, *MET receptor, *GENE amplification
Abstract

BACKGROUND Among patients with non–small-cell lung cancer (NSCLC), MET exon 14 skipping mutations occur in 3 to 4% and MET amplifications occur in 1 to 6%. Capmatinib, a selective inhibitor of the MET receptor, has shown activity in cancer models with various types of MET activation. METHODS We conducted a multiple-cohort, phase 2 study evaluating capmatinib in patients with MET-dysregulated advanced NSCLC. Patients were assigned to cohorts on the basis of previous lines of therapy and MET status (MET exon 14 skipping mutation or MET amplification according to gene copy number in tumor tissue). Patients received capmatinib (400-mg tablet) twice daily. The primary end point was overall response (complete or partial response), and the key secondary end point was response duration; both end points were assessed by an independent review committee whose members were unaware of the cohort assignments. RESULTS A total of 364 patients were assigned to the cohorts. Among patients with NSCLC with a MET exon 14 skipping mutation, overall response was observed in 41% (95% confidence interval [CI], 29 to 53) of 69 patients who had received one or two lines of therapy previously and in 68% (95% CI, 48 to 84) of 28 patients who had not received treatment previously; the median duration of response was 9.7 months (95% CI, 5.6 to 13.0) and 12.6 months (95% CI, 5.6 to could not be estimated), respectively. Limited efficacy was observed in previously treated patients with MET amplification who had a gene copy number of less than 10 (overall response in 7 to 12% of patients). Among patients with MET amplification and a gene copy number of 10 or higher, overall response was observed in 29% (95% CI, 19 to 41) of previously treated patients and in 40% (95% CI, 16 to 68) of those who had not received treatment previously. The most frequently reported adverse events were peripheral edema (in 51%) and nausea (in 45%); these events were mostly of grade 1 or 2. CONCLUSIONS Capmatinib showed substantial antitumor activity in patients with advanced NSCLC with a MET exon 14 skipping mutation, particularly in those not treated previously. The efficacy in MET-amplified advanced NSCLC was higher in tumors with a high gene copy number than in those with a low gene copy number. Low-grade peripheral edema and nausea were the main toxic effects. (Funded by Novartis Pharmaceuticals; GEOMETRY mono-1 ClinicalTrials.gov number, NCT02414139.) [ABSTRACT FROM AUTHOR]

Published
2020
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