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152 results on '"Laack, E."'

2. 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., Jonge, M. de, Orlov, S.V., Smit, E.F., Souquet, P.J., Vansteenkiste, J., Hochmair, M., Felip, E., Nishio, M., Thomas, M., Ohashi, K., Toyozawa, R., Overbeck, T.R., Marinis, F. de, Kim, T.M., Laack, E., Robeva, A., Mouhaer, S. le, Waldron-Lynch, M., Sankaran, B., Balbin, O.A., Cui, X.M., Giovannini, M., Akimov, M., Heist, R.S., GEOMETRY Mono-1, Guided Treatment in Optimal Selected Cancer Patients (GUTS), and Damage and Repair in Cancer Development and Cancer Treatment (DARE)

Subjects
MULTICENTER, ERLOTINIB, 030204 cardiovascular system & hematology, medicine.disease_cause, 03 medical and health sciences, Exon, 14 MUTATIONS, 0302 clinical medicine, medicine, Carcinoma, 030212 general & internal medicine, CRIZOTINIB, Lung cancer, DOCETAXEL, Mutation, Crizotinib, business.industry, AMPLIFICATION, ADENOCARCINOMA, General Medicine, CHEMOTHERAPY, medicine.disease, OPEN-LABEL, MET Exon 14 Skipping Mutation, PHASE-III, respiratory tract diseases, Cancer research, Adenocarcinoma, Erlotinib, business, medicine.drug
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.).

Published
2020

3. Capmatinib in patients with METex14-mutated or high-level MET-amplified advanced non-small- cell lung cancer (NSCLC): results from cohort 6 of the phase 2 GEOMETRY mono-1 study

Author

Wolf, J., Groen, H. J. M., Akerley, W., Souquet, P. -J., Laack, E., Han, J. -Y., Smit, E. F., Mansfield, A. S., Garon, E. B., Tan, D. S. W., Heist, R. S., Waldron-Lynch, M., Le Mouhaer, S., Nwana, N., Giovannini, M., Orlov, S., Wolf, J., Groen, H. J. M., Akerley, W., Souquet, P. -J., Laack, E., Han, J. -Y., Smit, E. F., Mansfield, A. S., Garon, E. B., Tan, D. S. W., Heist, R. S., Waldron-Lynch, M., Le Mouhaer, S., Nwana, N., Giovannini, M., and Orlov, S.

Published
2020

8. CheckMate 384 : essai clinique de phase 3b/4 évaluant nivolumab 480 mg toutes les 4 semaines (Q4S) vs nivolumab 240 mg toutes les 2 semaines (Q2S) chez les patients (pts) atteints d’un cancer bronchique non à petites cellules (CBNPC) avancé préalablement traité par nivolumab pendant une durée ≤ 12 mois

Author

Garon, E., primary, Reinmuth, N., additional, Falchero, L., additional, García, Y., additional, Hureaux, J., additional, Gore, I., additional, Harris, R., additional, Bidoli, P., additional, Baldini, E., additional, Ros, S., additional, Laack, E., additional, Mitchell, P., additional, Wolf, M., additional, O’byrne, K., additional, Zibdawi, L., additional, Jao, K., additional, Spigel, D., additional, Li, A., additional, Rabindran, S., additional, and Pichon, E., additional

Published
2020
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23. Efficacy of afatinib in the clinical practice: First results of the GIDEON trial: A prospective non-interventional study (NIS) in EGFR mutated NSCLC in Germany

Author

Brueckl, W.M., primary, Laack, E., additional, Reck, M., additional, Griesinger, F., additional, Schäfer, H., additional, Kortsik, C., additional, Gaska, T., additional, Rawluk, J., additional, Krüger, S., additional, Kokowski, K., additional, Budweiser, S., additional, Schueler, A., additional, and Kiessling, S., additional

Published
2018
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24. An expanded access program of osimertinib (Tagrisso) in patients with advanced non-small cell lung cancer: data report from Germany

Author

Stratmann, J. A., Hornetz, S., Griesinger, F., Wolf, J., Christoph, D. C., Sackmann, S., Spengler, W., Bischoff, H., Schaefer, M., Alt, J., Mlueller, A., Laack, E., Kimmich, M., Sebastian, M., Stratmann, J. A., Hornetz, S., Griesinger, F., Wolf, J., Christoph, D. C., Sackmann, S., Spengler, W., Bischoff, H., Schaefer, M., Alt, J., Mlueller, A., Laack, E., Kimmich, M., and Sebastian, M.

Published
2017

31. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial

Author

Paz-Ares, L, de Marinis, F, Dediu, M, Thomas, M, Pujol, J, Bidoli, P, Molinier, O, Sahoo, T, Laack, E, Reck, M, Corral, J, Melemed, S, John, W, Chouaki, N, Zimmermann, A, Visseren-Grul, C, Gridelli, C, Pujol, JL, Sahoo, TP, Zimmermann, AH, Paz-Ares, L, de Marinis, F, Dediu, M, Thomas, M, Pujol, J, Bidoli, P, Molinier, O, Sahoo, T, Laack, E, Reck, M, Corral, J, Melemed, S, John, W, Chouaki, N, Zimmermann, A, Visseren-Grul, C, Gridelli, C, Pujol, JL, Sahoo, TP, and Zimmermann, AH

Abstract

Background: Patients with advanced non-squamous non-small-cell lung cancer (NSCLC) benefit from pemetrexed maintenance therapy after induction therapy with a platinum-containing, non-pemetrexed doublet. The PARAMOUNT trial investigated whether continuation maintenance with pemetrexed improved progression-free survival after induction therapy with pemetrexed plus cisplatin. Methods: In this double-blind, multicentre, phase 3, randomised placebo-controlled trial, patients with advanced non-squamous NSCLC aged 18 years or older, with no previous systemic chemotherapy for lung cancer, with at least one measurable lesion, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 participated. Before randomisation, patients entered an induction phase which consisted of four cycles of induction pemetrexed (500 mg/m 2) plus cisplatin (75 mg/m 2) on day 1 of a 21-day cycle. Patients who did not progress after completion of four cycles of induction and who had an ECOG performance status of 0 or 1 were stratified according to disease stage (IIIB or IV), ECOG performance status (0 or 1), and induction response (complete or partial response, or stable disease), and randomly assigned (2:1 ratio) to receive maintenance therapy with either pemetrexed (500 mg/m 2 every 21 days) plus best supportive care or placebo plus best supportive care until disease progression. Randomisation was done with the Pocock and Simon minimisation method. Patients and investigators were masked to treatment assignment. The primary endpoint was progression-free survival in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT00789373. Findings: Of the 1022 patients enrolled, 939 participated in the induction phase. Of these, 539 patients were randomly assigned to receive continuation maintenance with pemetrexed plus best supportive care (n=359) or with placebo plus best supportive care (n=180). Among the 359 patients randomised to continuation mainten

Published
2012

32. Elevated Pretreatment Serum Concentration of YKL-40-An Independent Prognostic Biomarker for Poor Survival in Patients With Metastatic Nonsmall Cell Lung Cancer

Author

Thom, I., Andritzky, B., Schuch, G., Burkholder, I., Edler, L., Johansen, J.S., Bokemeyer, C., Schumacher, U., Laack, E., Thom, I., Andritzky, B., Schuch, G., Burkholder, I., Edler, L., Johansen, J.S., Bokemeyer, C., Schumacher, U., and Laack, E.

Abstract

BACKGROUND: The glycoprotein YKL-40 is synthesized both by cancer cells and by tumor-associated macrophages and plays a functional role in tumor progression. Consequently, high serum YKL-40 levels have been associated with a poor prognosis in patients with several cancer types. However, the role of YKL-40 has not been established in non-small cell lung cancer (NSCLC). METHODS: Pretreatment serum levels of YKL-40 were determined in 189 patients with NSCLC (143 men and 46 women; median age, 62 years;, age range, 41-76 years). Twelve percent of patients had stage IIIB disease, and 88% had stage IV disease. Ninety-eight patients received combined gemcitabine and vinorelbine, and 91 received combined gemcitabine, vinorelbine, and cisplatin as first-line chemotherapy. The median overall survival was 37 weeks. RESULTS: Patients had a median serum YKL-40 level of 209 ng/mL (range, 19-2153 ng/mL). No correlation was observed between overall survival and the type of chemotherapy regimen used, tumor stage, sex, or histologic types. Patients with high serum YKL-40 levels (greater than the median level for all patients [209 ng/mL]) had a significantly shorter survival than patients with serum YKL-40 levels below the median (median survival, 32 weeks vs 41 weeks; P = .007). In multivariate analysis, the serum YKL-40 level, the presence of bone lesions, and the serum lactate dehydrogenase level were independent, statistically significant prognostic factors. CONCLUSIONS: The pretreatment serum YKL-40 level was identified as a new, independent prognostic biomarker in patients with metastatic NSCLC and may help to determine the individual prognosis of these patients. Cancer 2010;116:4114-21. (C) 2010 American Cancer Society

Published
2010

33. PARAMOUNT : résultats finaux de survie globale de la phase 3 comparant un traitement de maintenance par Pem + BSC vs placebo (plb) + BSC après un ttt d’induction par Pem-Cisplatine (Cis) dans les CBNPC non épidermoïdes (NE) avancés

Author

Pujol, J.-L., primary, Molinier, O., additional, El-Kouri, C., additional, Favier, L., additional, Godbert, B., additional, Gatineau, M., additional, Hilgers, W., additional, Uwer, L., additional, Paz-Ares, L., additional, Demarinis, F., additional, Dediu, M., additional, Thomas, M., additional, Bidoli, P., additional, Sahoo, T.-., additional, Laack, E., additional, Reck, M., additional, Corral, J., additional, Melemed, S., additional, John, W., additional, Chouaki, N., additional, Zimmermann, A., additional, Visseren-Grul, C.-., additional, and Gridelli, C., additional

Published
2013
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35. Maintenance Pemetrexed (PEM) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC after PEM Plus Cisplatin for Advanced Nonsquamous NSCLC

Author

Obasaju, C.K., primary, Paz-Ares, L.G., additional, De Marinis, F., additional, Dediu, M., additional, Thomas, M., additional, Pujol, J.L., additional, Bidoli, P., additional, Molinier, O., additional, Sahoo, T.P., additional, Laack, E., additional, Reck, M., additional, Corral, J., additional, Melemed, S.A., additional, John, W.J., additional, Chouaki, N., additional, Zimmermann, A., additional, Visseren-Grul, C.M., additional, and Gridelli, C., additional

Published
2012
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36. Paramount: Descriptive Subgroup Analyses of Final Overall Survival (OS) for the Phase III Study of Maintenance Pemetrexed (PEM) Versus Placebo (PLB) Following Induction Treatment with PEM Plus Cisplatin (CIS) for Advanced Nonsquamous (NS) Non-Small Cell Lung Cancer (NSCLC)

Author

Reck, M., primary, Paz-Ares, L., additional, De Marinis, F., additional, Molinier, O., additional, Prasad Sahoo, T., additional, Laack, E., additional, John, W., additional, Zimmermann, A., additional, Visseren-Grul, C.M., additional, and Gridelli, C., additional

Published
2012
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37. PARAMOUNT : phase 3 comparant un traitement (ttt) de maintenance par Pemetrexed (Pem) plus soins de support (BSC) versus placebo plus BSC après un ttt d’induction par Pem-Cisplatine (Cispt) dans les CBNPC non épidermoïdes avancés

Author

Pujol, J.-L., primary, Paz-Ares, L., additional, Demarinis, F., additional, Dediu, M., additional, Thomas, M., additional, Molinier, O., additional, Bidoli, P., additional, Sahoo, T.-P., additional, Laack, E., additional, Reck, M., additional, El Kouri, C., additional, Favier, L., additional, Corral, J., additional, Martinet, Y., additional, Melemed, S., additional, John, W., additional, Zimmermann, A., additional, Chouaki, N., additional, and Gridelli, C., additional

Published
2012
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38. PARAMOUNT: Phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC immediately following induction treatment with pem plus cisplatin for advanced nonsquamous non-small cell lung cancer (NSCLC).

Author

Paz-Ares, L. G., primary, De Marinis, F., additional, Dediu, M., additional, Thomas, M., additional, Pujol, J., additional, Bidoli, P., additional, Molinier, O., additional, Sahoo, T. P., additional, Laack, E., additional, Reck, M., additional, Corral, J., additional, Melemed, S. A., additional, John, W. J., additional, Chouaki, N., additional, Zimmerman, A., additional, Visseren Grul, C. M., additional, and Gridelli, C., additional

Published
2011
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