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2. EP11.03-09 Profile of Patients with NSCLC Who Benefit from Immunochemotherapy. Real-World Data from the Multicenter Polish Lung Cancer Group Study

Author

Knetki-Wróblewska, M., primary, Krawczyk, P., additional, Bryl, M., additional, Jankowski, T., additional, Milanowski, J., additional, Wrona, A., additional, Bandura, A., additional, Dziadziuszko, R., additional, Smok-Kalwat, J., additional, Rok-Knapińska, J., additional, Szydziak-Zwierzyńska, K., additional, Rogoziewicz, K., additional, Stencel, K., additional, Czyżewicz, G., additional, Wójtowicz, M., additional, Wojtukiewicz, M., additional, Kalinka, E., additional, Wysocki, P., additional, Lobacz, M., additional, Pawlik, H., additional, Kowalski, D.M., additional, and Krzakowski, M., additional

Published
2023
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4. Cilengitide combined with cetuximab and platinum-based chemotherapy as first-line treatment in advanced non-small-cell lung cancer (NSCLC) patients: results of an open-label, randomized, controlled phase II study (CERTO)

Author

Vansteenkiste, J., Barlesi, F., Waller, C.F., Bennouna, J., Gridelli, C., Goekkurt, E., Verhoeven, D., Szczesna, A., Feurer, M., Milanowski, J., Germonpre, P., Lena, H., Atanackovic, D., Krzakowski, M., Hicking, C., Straub, J., Picard, M., Schuette, W., and O'Byrne, K.

Published
2015
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5. MA13.04 Entrectinib in Patients with ROS1 Fusion-Positive (ROS1-fp) NSCLC: Updated Efficacy and Safety Analysis

Author

Fan, Y., primary, Drilon, A., additional, Chiu, C.-H., additional, Bowles, D.W., additional, Loong, H.H.F., additional, Siena, S., additional, Goto, K., additional, Krzakowski, M., additional, Ahn, M.-J., additional, Murakami, H., additional, Dziadziuszko, R., additional, Zeuner, H., additional, Pitcher, B., additional, Cheick, D., additional, and Krebs, M.G., additional

Published
2022
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6. EP.11A.24 Clinical Prognostic Index for Immunochemiotherapy in Lung Cancer (CLIPI-LC)- A Prognostic Score for Advanced Non-Small-Cell Lung Cancer

Author

Knetki-Wróblewska, M., Krawczyk, P., Bryl, M., Jankowski, T., Milanowski, J., Wrona, A., Bandura, A., Dziadziuszko, R., Smok-Kalwat, J., Rok-Knapińska, J., Szydziak-Zwierzyńska, K., Rogoziewicz, K., Stencel, K., Czyżewicz, G., Wójtowicz, M., Wojtukiewicz, M., Kalinka, E., Wysocki, P.J., Łobacz, M., Pawlik, H., Rosińska, M., Kowalski, D.M., and Krzakowski, M.

Published
2024
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9. 533P Efficacy and safety of entrectinib in patients with locally advanced/metastatic NTRK fusion-positive (NTRK-fp) solid tumours

Author

Bazhenova, L., primary, Liu, S.V., additional, Lin, J.J., additional, Lu, S., additional, Drilon, A., additional, Chawla, S.P., additional, Fakih, M., additional, Krzakowski, M., additional, Paz-Ares, L., additional, Blakely, C., additional, Buchschacher, G.L., additional, Cassier, P., additional, Fan, Y., additional, Folprecht, G., additional, McCallum, S., additional, Pitcher, B., additional, Chen, D., additional, Freund, R., additional, and Springfeld, C., additional

Published
2021
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12. P37.02 Identification of Gene Fusions and Mutations in Patients with NSCLC using two Diagnostic Approaches: Rapid qPCR and NGS

Author

Tysarowski, A., primary, Seliga, K., additional, Nowak, A., additional, Wagrodzki, M., additional, Gos, A., additional, Zub, R., additional, Olszewska, K., additional, Jagielska, B., additional, Knetki-Wróblewska, M., additional, Pluzanski, A., additional, Krzakowski, M., additional, Siedlecki, J., additional, and Prochorec-Sobieszek, M., additional

Published
2021
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14. OA11.06 IMpower133: Exploratory Analysis of Maintenance Therapy in Patients With Extensive-Stage Small-Cell Lung Cancer

Author

Reck, M., primary, Horn, L., additional, Mok, T.S.K., additional, Mansfield, A., additional, De Boer, R., additional, Losonczy, G., additional, Sugawara, S., additional, Dziadziuszko, R., additional, Krzakowski, M., additional, Smolin, A., additional, Hochmair, M., additional, Garassino, M., additional, Castro, G., additional, Bischoff, H., additional, Cardona, A., additional, Morris, S., additional, and Liu, S., additional

Published
2021
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20. 539P Patient-reported outcomes (PROs) from patients (Pts) with NTRK fusion-positive (NTRK-fp) solid tumours receiving entrectinib in the global phase II STARTRK-2 study

Author

Conley, A.P., primary, Demetri, G.D., additional, Doebele, R.C., additional, Drilon, A., additional, Paz-Ares, L., additional, Cassier, P., additional, Siena, S., additional, Ahn, M-J., additional, Buchschacher, G.L., additional, Seto, T., additional, Chee, C.E., additional, Krzakowski, M., additional, Ou, S-H.I., additional, Grohé, C., additional, Zagonel, V., additional, Spira, A., additional, Cheng, A., additional, Kapre, A., additional, Piault, E., additional, and Rolfo, C.D., additional

Published
2020
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21. 1781MO IMpower133: Characterisation of long-term survivors treated first-line with chemotherapy ± atezolizumab in extensive-stage small cell lung cancer

Author

Liu, S.V., primary, Horn, L., additional, Mok, T., additional, Mansfield, A., additional, De Boer, R., additional, Losonczy, G., additional, Sugawara, S., additional, Dziadziuszko, R., additional, Krzakowski, M., additional, Smolin, A., additional, Hochmair, M.J., additional, Garassino, M.C., additional, Lam, S., additional, McCleland, M., additional, Cardona, A., additional, Morris, S., additional, and Reck, M., additional

Published
2020
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28. P2.06-01 STELLAR Trial: Radiological Response Patterns of TTFields Plus Chemotherapy in First-Line Treatment of Malignant Pleural Mesothelioma

Author

Grosso, F., primary, Aerts, J., additional, Ramlau, R., additional, Cedres, S., additional, Mencoboni, M., additional, Van Meerbeeck, J., additional, Dziadziuszko, R., additional, Planchard, D., additional, Chella, A., additional, Crino, L., additional, Krzakowski, M., additional, Ceresoli, G.L., additional, and Weinberg, U., additional

Published
2019
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29. Tumor Treating Fields plus chemotherapy for first-line treatment of malignant pleural mesothelioma: Final Results of the STELLAR Trial

Author

Ceresoli, G., primary, Aerts, J., additional, Madrzak, J., additional, Dziadziuszko, R., additional, Ramlau, R., additional, Cedres, S., additional, Hiddinga, B., additional, Van Meerbeeck, J.P., additional, Mencoboni, M., additional, Planchard, D., additional, Chella, A., additional, Krzakowski, M., additional, Crino, L., additional, and Grosso, F., additional

Published
2019
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30. OA05.05 Avelumab vs Docetaxel for Previously Treated Advanced NSCLC: Primary Analysis of the Phase 3 JAVELIN Lung 200 Trial

Author

Barlesi, F., primary, Vansteenkiste, J., additional, Spigel, D., additional, Ishii, H., additional, Garassino, M., additional, De Marinis, F., additional, Özgüroğlu, M., additional, Szczesna, A., additional, Polychronis, A., additional, Uslu, R., additional, Krzakowski, M., additional, Lee, J., additional, Calabro, L., additional, Frontera, O., additional, Ellers-Lenz, B., additional, Bajars, M., additional, Ruisi, M., additional, and Park, K., additional

Published
2018
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31. P1.11-03 MicroRNA with Ability to Reciprocal Regulation of Dicer and Drosha – Plasma Expression Status and Diagnostic Value in Non-Small Cell Lung Cancer

Author

Grenda, A., primary, Szczyrek, M., additional, Kuźnar-Kamińska, B., additional, Krawczyk, P., additional, Sawicki, M., additional, Głogowski, M., additional, Rolska-Kopińska, A., additional, Balicka, G., additional, Nicoś, M., additional, Jakimiec, M., additional, Batura-Gabryel, H., additional, Kowalski, D., additional, Mlak, R., additional, Krzakowski, M., additional, and Milanowski, J., additional

Published
2018
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32. PL02.07 IMpower 133: Primary PFS, OS and Safety in a PH1/3 Study of 1L Atezolizumab + Carboplatin + Etoposide in Extensive-Stage SCLC

Author

Liu, S., primary, Mansfield, A., additional, Szczesna, A., additional, Havel, L., additional, Krzakowski, M., additional, Hochmair, M., additional, Huemer, F., additional, Losonczy, G., additional, Johnson, M., additional, Nishio, M., additional, Reck, M., additional, Mok, T., additional, Lam, S., additional, Shames, D., additional, Liu, J., additional, Ding, B., additional, Kabbinavar, F., additional, Lin, W., additional, Sandler, A., additional, and Horn, L., additional

Published
2018
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33. MA12.06 STELLAR – Final Results of a Phase 2 Trial of TTFields with Chemotherapy for First-Line Treatment of Malignant Pleural Mesothelioma

Author

Ceresoli, G., primary, Aerts, J., additional, Madrzak, J., additional, Dziadziuszko, R., additional, Ramlau, R., additional, Cedres, S., additional, Hiddinga, B., additional, Van Meerbeeck, J., additional, Mencoboni, M., additional, Planchard, D., additional, Chella, A., additional, Crinò, L., additional, Krzakowski, M., additional, and Grosso, F., additional

Published
2018
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34. Third CECOG consensus on the systemic treatment of non-small-cell lung cancer

Author

Brodowicz, T., Ciuleanu, T., Crawford, J., Filipits, M., Fischer, J. R., Georgoulias, V., Gridelli, C., Hirsch, F. R., Jassem, J., Kosmidis, P., Krzakowski, M., Manegold, Ch, Pujol, J. L., Stahel, R., Thatcher, N., Vansteenkiste, J., Minichsdorfer, C., Zöchbauer-Müller, S., Pirker, R., Zielinski, C. C., Brodowicz, T., Ciuleanu, T., Crawford, J., Filipits, M., Fischer, J. R., Georgoulias, V., Gridelli, C., Hirsch, F. R., Jassem, J., Kosmidis, P., Krzakowski, M., Manegold, Ch, Pujol, J. L., Stahel, R., Thatcher, N., Vansteenkiste, J., Minichsdorfer, C., Zöchbauer-Müller, S., Pirker, R., and Zielinski, C. C.

Abstract

The current third consensus on the systemic treatment of non-small-cell lung cancer (NSCLC) builds upon and updates similar publications on the subject by the Central European Cooperative Oncology Group (CECOG), which has published such consensus statements in the years 2002 and 2005 (Zielinski CC, Beinert T, Crawford J et al. Consensus on medical treatment of non-small-cell lung cancer—update 2004. Lung Cancer 2005; 50: 129-137). The principle of all CECOG consensus is such that evidence-based recommendations for state-of-the-art treatment are given upon which all participants and authors of the manuscript have to agree (Beslija S, Bonneterre J, Burstein HJ et al. Third consensus on medical treatment of metastatic breast cancer. Ann Oncol 2009; 20 (11): 1771-1785). This is of particular importance in diseases in which treatment options depend on very particular clinical and biologic variables (Zielinski CC, Beinert T, Crawford J et al. Consensus on medical treatment of non-small-cell lung cancer—update 2004. Lung Cancer 2005; 50: 129-137; Beslija S, Bonneterre J, Burstein HJ et al. Third consensus on medical treatment of metastatic breast cancer. Ann Oncol 2009; 20 (11): 1771-1785). Since the publication of the last CECOG consensus on the medical treatment of NSCLC, a series of diagnostic tools for the characterization of biomarkers for personalized therapy for NSCLC as well as therapeutic options including adjuvant treatment, targeted therapy, and maintenance treatment have emerged and strongly influenced the field. Thus, the present third consensus was generated that not only readdresses previous disease-related issues but also expands toward recent developments in the management of NSCLC. It is the aim of the present consensus to summarize minimal quality-oriented requirements for individual patients with NSCLC in its various stages based upon levels of evidence in the light of a rapidly expanding array of individual therapeutic options

Published
2017

36. Diagnostic value of plasma expression of microRNAs complementary to Drosha and Dicer in lung cancer patients.

Author

SZCZYREK, M., KUŹNAR-KAMIŃSKA, B., GRENDA, A., KRAWCZYK, P., SAWICKI, M., GŁOGOWSKI, M., BALICKA, G., ROLSKA-KOPIŃSKA, A., NICOŚ, M., JAKIMIEC, M., BATURA-GABRYEL, H., KOWALSKI, D. M., MLAK, R., KRZAKOWSKI, M., and MILANOWSKI, J.

Abstract

OBJECTIVE: Lung cancer (LC) is diagnosed mostly in advanced, non-operable stage, with poor prognosis. The analysis of microRNAs may be a useful tool for early and non-invasive detection of cancer. Dicer and Drosha are enzymes with an essential role for microRNA biogenesis. The aim of our study was to analyze the expression of miRNA-27a-3p, miRNA- 31, miRNA-182, miRNA-195 with the ability to reciprocal regulation of Dicer and Drosha expression in lung cancer patients. PATIENTS AND METHODS: The relative expression of microRNAs was detected by qPCR in plasma of 160 LC patients. The U-Mann Whitney test was used to compare the relative expression between particular groups of lung cancer patients and healthy individuals. The diagnostic value of microRNAs examination was analyzed using a receiver operating curve. RESULTS: We demonstrated that the plasma levels of miRNA-27, miRNA-31 and miRNA-182 were significantly higher and miRNA-195 significantly lower in the whole group of LC patients and in patients with early stages of NSCLC, in comparison with healthy donors. ROC analysis showed that four studied microRNAs have a potential diagnostic value for early stages of NSCLC with AUC=0.95 for miRNA-27a (94% sensitivity and 81% specificity, p=0.0001), 0.71 for miRNA-31 (73% sensitivity and 61% specificity, p=0.001) 0.77 for miRNA-182 (70% sensitivity and 79% specificity, p=0.0001) and 0.82 for miRNA-195 (74% sensitivity and 80% specificity, p=0.0001). CONCLUSIONS: We have proved that the expression of miRNA-27a-3p, miRNA-31, miRNA-182, and miRNA-195 in patients with LC is different from the expression of these molecules in healthy people. The examination of these microRNAs in plasma could be used in non-invasive lung cancer diagnosis. [ABSTRACT FROM AUTHOR]

Published
2019
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37. Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUME-Lung 1): a phase 3, double-blind, randomised controlled trial

Author

Reck, M, Kaiser, R, Mellemgaard, A, Douillard, Jy, Orlov, S, Krzakowski, M, von Pawel, J, Gottfried, M, Bondarenko, I, Liao, M, Gann, Cn, Barrueco, J, Gaschler Markefski, B, Novello, Silvia, and LUME Lung, 1 Study Group

Subjects
Male, medicine.medical_specialty, Asia, Indoles, Lung Neoplasms, Time Factors, Bevacizumab, medicine.medical_treatment, Adenocarcinoma of Lung, Docetaxel, Kaplan-Meier Estimate, Adenocarcinoma, Placebo, Gastroenterology, Disease-Free Survival, chemistry.chemical_compound, South Africa, Double-Blind Method, Risk Factors, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Odds Ratio, Humans, Lung cancer, Protein Kinase Inhibitors, Aged, Neoplasm Staging, Proportional Hazards Models, Chemotherapy, Intention-to-treat analysis, business.industry, Middle Aged, medicine.disease, Surgery, Europe, Treatment Outcome, Oncology, chemistry, Disease Progression, Nintedanib, Female, Taxoids, business, medicine.drug
Abstract

Summary Background The phase 3 LUME-Lung 1 study assessed the efficacy and safety of docetaxel plus nintedanib as second-line therapy for non-small-cell lung cancer (NSCLC). Methods Patients from 211 centres in 27 countries with stage IIIB/IV recurrent NSCLC progressing after first-line chemotherapy, stratified by ECOG performance status, previous bevacizumab treatment, histology, and presence of brain metastases, were allocated (by computer-generated sequence through an interactive third-party system, in 1:1 ratio), to receive docetaxel 75 mg/m 2 by intravenous infusion on day 1 plus either nintedanib 200 mg orally twice daily or matching placebo on days 2–21, every 3 weeks until unacceptable adverse events or disease progression. Investigators and patients were masked to assignment. The primary endpoint was progression-free survival (PFS) by independent central review, analysed by intention to treat after 714 events in all patients. The key secondary endpoint was overall survival, analysed by intention to treat after 1121 events had occurred, in a prespecified stepwise order: first in patients with adenocarcinoma who progressed within 9 months after start of first-line therapy, then in all patients with adenocarcinoma, then in all patients. This trial is registered with ClinicalTrials.gov, number NCT00805194. Findings Between Dec 23, 2008, and Feb 9, 2011, 655 patients were randomly assigned to receive docetaxel plus nintedanib and 659 to receive docetaxel plus placebo. The primary analysis was done after a median follow-up of 7·1 months (IQR 3·8–11·0). PFS was significantly improved in the docetaxel plus nintedanib group compared with the docetaxel plus placebo group (median 3·4 months [95% CI 2·9–3·9] vs 2·7 months [2·6–2·8]; hazard ratio [HR] 0·79 [95% CI 0·68–0·92], p=0·0019). After a median follow-up of 31·7 months (IQR 27·8–36·1), overall survival was significantly improved for patients with adenocarcinoma histology who progressed within 9 months after start of first-line treatment in the docetaxel plus nintedanib group (206 patients) compared with those in the docetaxel plus placebo group (199 patients; median 10·9 months [95% CI 8·5–12·6] vs 7·9 months [6·7–9·1]; HR 0·75 [95% CI 0·60–0·92], p=0·0073). Similar results were noted for all patients with adenocarcinoma histology (322 patients in the docetaxel plus nintedanib group and 336 in the docetaxel plus placebo group; median overall survival 12·6 months [95% CI 10·6–15·1] vs 10·3 months [95% CI 8·6–12·2]; HR 0·83 [95% CI 0·70–0·99], p=0·0359), but not in the total study population (median 10·1 months [95% CI 8·8–11·2] vs 9·1 months [8·4–10·4]; HR 0·94, 95% CI 0·83–1·05, p=0·2720). Grade 3 or worse adverse events that were more common in the docetaxel plus nintedanib group than in the docetaxel plus placebo group were diarrhoea (43 [6·6%] of 652 vs 17 [2·6%] of 655), reversible increases in alanine aminotransferase (51 [7·8%] vs six [0·9%]), and reversible increases in aspartate aminotransferase (22 [3·4%] vs three [0·5%]). 35 patients in the docetaxel plus nintedanib group and 25 in the docetaxel plus placebo group died of adverse events possibly unrelated to disease progression; the most common of these events were sepsis (five with docetaxel plus nintedanib vs one with docetaxel plus placebo), pneumonia (two vs seven), respiratory failure (four vs none), and pulmonary embolism (none vs three). Interpretation Nintedanib in combination with docetaxel is an effective second-line option for patients with advanced NSCLC previously treated with one line of platinum-based therapy, especially for patients with adenocarcinoma. Funding Boehringer Ingelheim.

Published
2014

38. Tecemotide (L-BLP25) versus placebo after chemoradiotherapy for stage III non-small-cell lung cancer (START): a randomised, double-blind, phase 3 trial

Author

Butts C, Ma, Socinski, Pl, Mitchell, Thatcher N, Havel L, Krzakowski M, Nawrocki S, Te, Ciuleanu, Bosquée L, Jm, Trigo, Spira A, Tremblay L, Nyman J, Ramlau R, Wickart-Johansson G, Ellis P, Gladkov O, Jr, Pereira, We, Eberhardt, Helwig C, Andreas Schröder, Fa, Shepherd, and Start, On Behalf Of The Trial Team

Subjects
Adult, Male, medicine.medical_specialty, Lung Neoplasms, Population, Medizin, Placebo, Cancer Vaccines, Gastroenterology, law.invention, Double-Blind Method, Randomized controlled trial, Maintenance therapy, law, Carcinoma, Non-Small-Cell Lung, Internal medicine, medicine, Clinical endpoint, Humans, Lung cancer, education, Aged, Neoplasm Staging, Aged, 80 and over, education.field_of_study, Membrane Glycoproteins, business.industry, Chemoradiotherapy, Middle Aged, medicine.disease, Surgery, Oncology, Tecemotide (L-BLP25), stage III, non-small-cell lung cancer, START, chemoradiotherapy, phase 3 trial, Tecemotide, Female, business
Abstract

Summary Background Effective maintenance therapies after chemoradiotherapy for lung cancer are lacking. Our aim was to investigate whether the MUC1 antigen-specific cancer immunotherapy tecemotide improves survival in patients with stage III unresectable non-small-cell lung cancer when given as maintenance therapy after chemoradiation. Methods The phase 3 START trial was an international, randomised, double-blind trial that recruited patients with unresectable stage III non-small-cell lung cancer who had completed chemoradiotherapy within the 4–12 week window before randomisation and received confirmation of stable disease or objective response. Patients were stratified by stage (IIIA vs IIIB), response to chemoradiotherapy (stable disease vs objective response), delivery of chemoradiotherapy (concurrent vs sequential), and region using block randomisation, and were randomly assigned (2:1, double-blind) by a central interactive voice randomisation system to either tecemotide or placebo. Injections of tecemotide (806 μg lipopeptide) or placebo were given every week for 8 weeks, and then every 6 weeks until disease progression or withdrawal. Cyclophosphamide 300 mg/m 2 (before tecemotide) or saline (before placebo) was given once before the first study drug administration. The primary endpoint was overall survival in a modified intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00409188. Findings From Feb 22, 2007, to Nov 15, 2011, 1513 patients were randomly assigned (1006 to tecemotide and 507 to placebo). 274 patients were excluded from the primary analysis population as a result of a clinical hold, resulting in analysis of 829 patients in the tecemotide group and 410 in the placebo group in the modified intention-to-treat population. Median overall survival was 25·6 months (95% CI 22·5–29·2) with tecemotide versus 22·3 months (19·6–25·5) with placebo (adjusted HR 0·88, 0·75–1·03; p=0·123). In the patients who received previous concurrent chemoradiotherapy, median overall survival for the 538 (65%) of 829 patients assigned to tecemotide was 30·8 months (95% CI 25·6–36·8) compared with 20·6 months (17·4–23·9) for the 268 (65%) of 410 patients assigned to placebo (adjusted HR 0·78, 0·64–0·95; p=0·016). In patients who received previous sequential chemoradiotherapy, overall survival did not differ between the 291 (35%) patients in the tecemotide group and the 142 (35%) patients in the placebo group (19·4 months [95% CI 17·6–23·1] vs 24·6 months [18·8–33·0], respectively; adjusted HR 1·12, 0·87–1·44; p=0·38). Grade 3–4 adverse events seen with a greater than 2% frequency with tecemotide were dyspnoea (49 [5%] of 1024 patients in the tecemotide group vs 21 [4%] of 477 patients in the placebo group), metastases to central nervous system (29 [3%] vs 6 [1%]), and pneumonia (23 [2%] vs 12 [3%]). Serious adverse events with a greater than 2% frequency with tecemotide were pneumonia (30 [3%] in the tecemotide group vs 14 [3%] in the placebo group), dyspnoea (29 [3%] vs 13 [3%]), and metastases to central nervous system (32 [3%] vs 9 [2%]). Serious immune-related adverse events did not differ between groups. Interpretation We found no significant difference in overall survival with the administration of tecemotide after chemoradiotherapy compared with placebo for all patients with unresectable stage III non-small-cell lung cancer. However, tecemotide might have a role for patients who initially receive concurrent chemoradiotherapy, and further study in this population is warranted. Funding Merck KGaA (Darmstadt, Germany).

Published
2014

39. Efficacy and safety of nintedanib (NIN)/docetaxel (DOC) in patients with lung adenocarcinoma: Further analyses from the LUME-Lung 1 study

Author

Heigener, D., primary, Gottfried, M., additional, Bennouna, J., additional, Bondarenko, I., additional, Douillard, J.-Y., additional, Krzakowski, M., additional, Mellemgaard, A., additional, Novello, S., additional, Orlov, S., additional, Summers, Y.J., additional, von Pawel, J., additional, Hocke, J., additional, Kaiser, R., additional, and Reck, M., additional

Published
2016
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40. 477TiP Phase IV study of afatinib as second-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring common epidermal growth factor receptor (EGFR) mutations (Del19 and/or L858R)

Author

Thongprasert, S., primary, Alexandru, A., additional, Schenker, M., additional, Abdelaziz, A., additional, Clement, D., additional, Boldeanu, C., additional, Jovanovic, D., additional, Reyes-Igama, J., additional, Petrović, M., additional, Geater, S., additional, Radosavljevic, D., additional, Perin, B., additional, Krzakowski, M., additional, Serwatowski, P., additional, Parra, J., additional, Sriuranpong, V., additional, Jones, H., additional, Cseh, A., additional, and Gaafar, R., additional

Published
2015
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41. Carpal tunnel syndrome and musculoskeletal symptoms in postmenopausal women with early breast cancer treated with exemestane or tamoxifen after 2-3 years of tamoxifen: a retrospective analysis of the Intergroup Exemestane Study

Author

Mieog, Js, Morden, Jp, Bliss, Jm, Coombes, Rc, van de Velde CJ, IES Steering Committee: Delozier, T, Veronesi, A, Vrdoljak, E, Monnier, A, Coombes, C, Nagykalnai, T, Roumen, Rm, Utracka Hutka, B, Pluzanska, A, Porpiglia, M, Genta, F, Benedetto, Chiara, Sozzani, P, Steiner, M, Rubinov, R, Leviov, M, Semiglazov, V, Fox, J, Mayordomo, Ji, Cervek, J, Sleeboom, Hp, Jassem, J, Hinton, Cp, Paulsen, Th, Guleng, Rj, Fein, L, Gutulescu, N, Florián, J, Rosso, R, Rutgers, Ej, Krzakowski, M, Pienkowski, T, Krajina, Z, Siffnerova, H, Pawlicki, M, Drosik, K, Wagnerowa, M, Brunt, M, Vukelja, S, Mitrowic, L, Cataliotti, L, Karnicka Mlodkowska, H, Bonnefoi, H, Tilch, G, Chollet, P, Patel, A, Kamby, C, Giustini, L, Acito, L, Mouridsen, H, Roche, H, De Lafontan, B, Tomczak, P, Petruzelka, L, Lortholary, A, Pacquola, Mg, Skene, A, Rici, S, Michelotti, A, Ghilezan, N, Stewart, A, Beauduin, M, Andersen, J, Vassilaros, S, Celio, L, Bajetta, E, Bastús, R, Marsland, T, Paridaens, R, Tzekova, V, Lichtenegger, W, Piersma, H, Jones, S, Holmberg, S, Verhoeven, D, Hill, A, Porcile, G, Bruno, Mf, Chernozemski, I, Coleman, R, Jadeja, J, Cohn, A, Merlano, M, Perroni, D, Di Costanzo, F, Van Bochove, A, Gerrits, Ma, Malec, V, Balil, A, Mendiola, C, Dodwell, D, Knox, R, Horgan, K, Joannides, T, Leonard, Rc, Cawthorn, Sj, Ghosh, C, Cantrell, J, Campos, D, Orti, R, Diedrich, K, Aas, H, Barnadas, A, Vila, Mm, Makris, A, Anderson, T, Chittor, S, Michel, J, Philip, P, Redmond, P, Mastboom, Wj, Nordenskjöld, B, Simmonds, P, Grieve, Rj, Tomova, A, Piot, G, Borea, G, Ucci, G, Einarsson, E, Nicholson, S, Gardiol, Ea, Kerger, J, Schlosser, J, Namer, M, Pinotti, G, Rutten, Ht, Iversen, T, Nejim, A, Dudov, A, Grundtvig, P, Lang, I, Massidda, B, Van De Velde CH, Gervasio, Mh, Tengrup, I, Tennvall, L, Goodman, S, Modgill, Vk, Vorobiof, Da, Mickiewicz, E, Chirgwin, J, Focan, C, Albin, N, Contu, Aa, Svensson, Jh, Borghede, G, Källström, Ac, Forbes, Jf, Hurtz, Hj, Tubiana Hulin, M, Viens, P, Scanni, A, Arnoldi, E, Nastasi, G, Bottini, A, Alquati, P, Muscat, V, Brincat, S, Holmen, K, Amaral, N, Moreno, I, Trask, C, Robinson, A, Mcintyre, K, Otsuka, A, Hohaus, B, Hoefig, G, Georgoulias, V, Salvagni, S, Bidin, L, Artioli, F, Engan, T, Benedikstsson, Kp, Campbell, I, Harvey, V, Zimbler, H, Mrsic Krmpotic, Z, Canon, Jl, Tchilingirov, Pv, Buser, K, Bolanca, A, Reztke, U, Rhein, U, Jouve, M, Mullins, G, Vesentini, L, Gallo, L, Merlini, L, Decensi, A, Carreca, I, Van Tienhoven, G, Börjesson, B, Hansen, J, Koza, I, Arcusa, A, Inoriza, A, Pelegri, A, Eremin, O, Modiano, Mr, Anthony, S, Donat, D, Richardet, E, Kochli, O, Zeißig, P, Gauch, G, Aabo, K, Fumoleau, P, Erdkamp, Fl, Lovén, L, Jönsson, Pe, Perren, T, Stuart, N, Galindo, E, Marek, Bj, Salmon, Jp, Dohollou, N, Thompson, R, Folco, U, Rosa, A, Tonato, M, Heijmans, Gj, Koralewski, P, Bång, H, Lescure, Ar, Carrato, A, Martin, M, Neave, F, Howell, T, Savin, M, Loesch, D, Hannois, A, Mohr, A, Laube, T, Omar, S, Bonneterre, J, Servent, V, Danese, S, Sertoli, Mr, Butzelaar, Rm, Steller, Ep, Gomez, H, Skoog, P, Alvarez, I, Aguilar, Ea, Giner, Jl, Yosef, Hm, Barrett Lee, P, Buzdar, Au, George, T, Olivaires, J, Vsianska, M, Köhler, U, Lindeløv, B, Toftdahl, Db, Nielsen, Eb, Veyret, C, Castera, D, Kerbrat, P, Vassilaros, P, Yeo, W, Boni, C, Aitini, E, Luporini, G, Herben, Mg, Espelid, H, Dahl, S, Ingvar, C, Meana, A, Pico, C, Garcia, Am, Agrawal, Rk, Gruenberg, D, Nunez de Pierro, A, Gill, G, Nogaret, Jm, Honhon, B, Wassenaar, H, Nielander, R, Warnier, P, Sessa, C, Padrik, P, Guastalla, Jp, Serin, D, Jaubert, D, Dank, M, Given, Fh, Mascia, V, De Fraia, E, Silingardi, V, Conte, Pf, Labianca, R, Tondini, C, Bagnulo, A, Gardani, G, Wils, J, Liem, G, Nuytinck, Jk, Formoe, E, Ambré, T, Alés, J, Aramburo, P, Mansi, J, Graham, J, Joffe, J, Sainsbury, J, Stone, J, Good, Rh, Cartwright, T, Werner, Id, Murray, E, Beith, J, Tigges, Fj, Bojko, P, Sandberg, E, Jensen, B, Lotz, Jp, Carney, D, Shapira, J, Neumann, A, Goldhirsch, A, Dicato, M, de Graaf, H, Maartense, E, Burghouts, J, Cassinello, J, Jones, A, Gaffney, C, Blum, R, Abdi, E, Becquart, D, Dirix, L, Janssens, J, Nmarschner, N, Blaska Jaulerry, B, Prevot, G, Mirah Lev, L, Shani, A, Baruch, Nb, Peretz, T, Gips, M, Cognetti, F, Carlini, P, Nortier, Jw, Huinink D, ten B., Roussel, Jg, Unneberg, K, Kylberg, F, Hovind, H, Nestvold, T, Fogelkvist, R, Due, J, Muller, S, Gilligan, D, Russel, S, Mcaleer, J, Yiangou, C, Foote, L, Schottstaedt, M, Holmes, Fa, Wainstein, R, Contreras, O, Martinez, J, Della Fiorentina, S, Beslija, S, Vermorken, Jb, Thirion, M, Fraikin, J, Castiglione, M, Jäger, W, Fasching, P, Fabriz, H, Neis, K, Kirschbaum, M, Labat, Jp, Dupuis, O, Bernard, J, Datchary, J, Provencal, J, Allain, P, Clerico, M, Lopez, M, Nalli, G, Aspevik, R, Fràguas, A, Curescu, S, Cuevas, Jm, Oltra, A, Bradley, C, Kapoor, R, Akbain, S, Croghan, Mk, Modiano, M, Taetle, R, Beale, P, Gobert, P, Bondue, H, Böhm, R, Møller, Ka, Brettes, Jp, Netter, G, Grogan, L, Klein, B, Botta, M, Barni, S, Van Meerwijk, I, Kåresen, R, Godes, J, Aramburo, A, Jara, C, Zanger, B, Fleagle, Jt, Greenspan, A, Marschke, R, Medgyesy, Dc, Garbo, L., CCA -Cancer Center Amsterdam, and Radiotherapy

Subjects
medicine.medical_specialty, Population, Breast Neoplasms, Disease-Free Survival, chemistry.chemical_compound, Breast cancer, Exemestane, Internal medicine, Surveys and Questionnaires, medicine, Clinical endpoint, Humans, Carpal tunnel syndrome, education, Aged, Retrospective Studies, Aged, 80 and over, education.field_of_study, business.industry, Aromatase Inhibitors, Hazard ratio, Middle Aged, medicine.disease, Carpal Tunnel Syndrome, Surgery, Musculoskeletal Abnormalities, Androstadienes, Postmenopause, Tamoxifen, Treatment Outcome, Oncology, chemistry, Hormonal therapy, Female, business, medicine.drug
Abstract

BACKGROUND: Aromatase inhibitors are more effective than is tamoxifen in prevention of breast-cancer recurrence, but at the expense of increased musculoskeletal side-effects, such as carpal tunnel syndrome. The aim of this study was to assess risk factors and the prognostic value of musculoskeletal symptoms during treatment with the steroidal aromatase inhibitor exemestane or with tamoxifen after 2-3 years of tamoxifen. METHODS: In the Intergroup Exemestane Study, postmenopausal women treated for early invasive breast cancer who remained disease free and on treatment after 2-3 years of tamoxifen were randomised to switch to exemestane or to continue tamoxifen for the remainder of the 5-year period of endocrine treatment. The primary endpoint for this retrospective analysis was occurrence of carpal tunnel syndrome and any musculoskeletal events, analysed in the safety population, which consisted of all patients who had received any trial treatment. As well as case-report forms, questionnaires were distributed retrospectively to gain more details of cases of carpal tunnel syndrome. The relation between musculoskeletal symptoms reported by 6 months from randomisation and survival from 9 months onwards was assessed by Cox proportional hazards models. The trial is registered, number ISRCTN11883920. It has completed accrual and follow-up is continuing for enrolled participants. FINDINGS: After a median follow-up of 91·0 months (IQR 83·0-99·2), carpal tunnel syndrome had been reported for 66 (2·8%) of 2319 patients in the exemestane group compared with 13 (0·6%) of 2338 in the tamoxifen group (odds ratio [OR] 5·23, 99% CI 2·39-11·49; p

Published
2012

44. Cilengitide (Cil) Combined with Cetuximab and Platinum-Based Chemotherapy As First-Line Treatment in Advanced Non-Small Cell Lung Cancer (Nsclc) Patients (Pts): Phase Ii Randomised Certo Study

Author

Vansteenkiste, J.F., primary, Barlesi, F., additional, Waller, C., additional, Bennouna, J., additional, Gridelli, C., additional, Goekkurt, E., additional, Verhoeven, D., additional, Szczesna, A., additional, Feurer, M., additional, Milanowski, J., additional, Germonpre, P., additional, Lena, H., additional, Atanackovic, D., additional, Krzakowski, M., additional, Hicking, C., additional, Straub, J., additional, Picard, M., additional, Schuette, W., additional, and Byrne, K. O', additional

Published
2014
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45. Effect of Nintedanib (Bibf 1120) Combined with Standard 2Nd-Line Docetaxel in Nsclc Patients Who Received Prior Pemetrexed in Lume-Lung 1: a Randomised, Placebo-Controlled Phase III Trial

Author

Mellemgaard, A., primary, Orlov, S., additional, Krzakowski, M., additional, von Pawel, J., additional, Gottfried, M., additional, Bondarenko, I., additional, Barrueco, J., additional, Buchner, H., additional, Hocke, J., additional, Kaiser, R., additional, Novello, S., additional, Douillard, J., additional, and Reck, M., additional

Published
2014
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46. Prior Taxane Use in the Lume-Lung 1 Phase III Trial and the Effect on Outcome Following 2Nd-Line Treatment with Nintedanib (Bibf 1120) and Docetaxel in Patients with Advanced Nsclc

Author

Krzakowski, M., primary, Mellemgaard, A., additional, Orlov, S., additional, von Pawel, J., additional, Gottfried, M., additional, Bondarenko, I., additional, Liao, M., additional, Barrueco, J., additional, Gaschler-Markefski, B., additional, Kaiser, R., additional, Novello, S., additional, Douillard, J., additional, and Reck, M., additional

Published
2014
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47. 30 Nintedanib (BIBF 1120) + docetaxel as second-line therapy in patients with stage IIIB/IV or recurrent NSCLC: results of the phase III, randomised, double-blind LUME-Lung 1 trial

Author

Reck, M., primary, Mellemgaard, A., additional, Douillard, J.-Y., additional, Orlov, S., additional, Krzakowski, M., additional, von Pawel, J., additional, Gottfried, M., additional, Bondarenko, I., additional, Liao, M., additional, Barrueco, J., additional, Gaschler-Markefski, B., additional, Kaiser, R., additional, and Novello, S., additional

Published
2014
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48. Third CECOG consensus on the systemic treatment of non-small-cell lung cancer

Author

Brodowicz, T, Ciuleanu, T, Crawford, J, Filipits, M, Fischer, J R, Georgoulias, V, Gridelli, C, Hirsch, F R, Jassem, J, Kosmidis, P, Krzakowski, M, Manegold, C, Pujol, J L, Stahel, R, Thatcher, N, Vansteenkiste, J, Minichsdorfer, C, Zöchbauer-Müller, S, Pirker, R, Zielinski, C C, Brodowicz, T, Ciuleanu, T, Crawford, J, Filipits, M, Fischer, J R, Georgoulias, V, Gridelli, C, Hirsch, F R, Jassem, J, Kosmidis, P, Krzakowski, M, Manegold, C, Pujol, J L, Stahel, R, Thatcher, N, Vansteenkiste, J, Minichsdorfer, C, Zöchbauer-Müller, S, Pirker, R, and Zielinski, C C

Abstract

The current third consensus on the systemic treatment of non-small-cell lung cancer (NSCLC) builds upon and updates similar publications on the subject by the Central European Cooperative Oncology Group (CECOG), which has published such consensus statements in the years 2002 and 2005 (Zielinski CC, Beinert T, Crawford J et al. Consensus on medical treatment of non-small-cell lung cancer-update 2004. Lung Cancer 2005; 50: 129-137). The principle of all CECOG consensus is such that evidence-based recommendations for state-of-the-art treatment are given upon which all participants and authors of the manuscript have to agree (Beslija S, Bonneterre J, Burstein HJ et al. Third consensus on medical treatment of metastatic breast cancer. Ann Oncol 2009; 20 (11): 1771-1785). This is of particular importance in diseases in which treatment options depend on very particular clinical and biologic variables (Zielinski CC, Beinert T, Crawford J et al. Consensus on medical treatment of non-small-cell lung cancer-update 2004. Lung Cancer 2005; 50: 129-137; Beslija S, Bonneterre J, Burstein HJ et al. Third consensus on medical treatment of metastatic breast cancer. Ann Oncol 2009; 20 (11): 1771-1785). Since the publication of the last CECOG consensus on the medical treatment of NSCLC, a series of diagnostic tools for the characterization of biomarkers for personalized therapy for NSCLC as well as therapeutic options including adjuvant treatment, targeted therapy, and maintenance treatment have emerged and strongly influenced the field. Thus, the present third consensus was generated that not only readdresses previous disease-related issues but also expands toward recent developments in the management of NSCLC. It is the aim of the present consensus to summarize minimal quality-oriented requirements for individual patients with NSCLC in its various stages based upon levels of evidence in the light of a rapidly expanding array of individual therapeutic options.

Published
2012

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