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510 results on '"Krämer, N"'

8. Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer

Author

Cohen, EEW, Licitra, LF, Burtness, B, Fayette, J, Gauler, T, Clement, PM, Grau, JJ, del Campo, JM, Mailliez, A, Haddad, RI, Vermorken, JB, Tahara, M, Guigay, J, Geoffrois, L, Merlano, MC, Dupuis, N, Krämer, N, Cong, XJ, Gibson, N, Solca, F, Ehrnrooth, E, and Machiels, J-PH

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Dental/Oral and Craniofacial Disease, Rare Diseases, Cancer, Clinical Research, 4.2 Evaluation of markers and technologies, Detection, screening and diagnosis, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Administration, Intravenous, Administration, Oral, Afatinib, Antimetabolites, Antineoplastic, Biomarkers, Tumor, Biopsy, Carcinoma, Squamous Cell, Disease-Free Survival, Head and Neck Neoplasms, Humans, Methotrexate, Neoplasm Metastasis, Neoplasm Recurrence, Local, Predictive Value of Tests, Quinazolines, Squamous Cell Carcinoma of Head and Neck, afatinib, methotrexate, HNSCC, biomarker, phase III, EGFR, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundIn the phase III LUX-Head & Neck 1 (LUX-H&N1) trial, second-line afatinib significantly improved progression-free survival (PFS) versus methotrexate in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Here, we evaluated association of prespecified biomarkers with efficacy outcomes in LUX-H&N1.Patients and methodsRandomized patients with R/M HNSCC and progression following ≥2 cycles of platinum therapy received afatinib (40 mg/day) or methotrexate (40 mg/m2/week). Tumor/serum samples were collected at study entry for patients who volunteered for inclusion in biomarker analyses. Tumor biomarkers, including p16 (prespecified subgroup; all tumor subsites), EGFR, HER2, HER3, c-MET and PTEN, were assessed using tissue microarray cores and slides; serum protein was evaluated using the VeriStrat® test. Biomarkers were correlated with efficacy outcomes.ResultsOf 483 randomized patients, 326 (67%) were included in the biomarker analyses; baseline characteristics were consistent with the overall study population. Median PFS favored afatinib over methotrexate in patients with p16-negative [2.7 versus 1.6 months; HR 0.70 (95% CI 0.50-0.97)], EGFR-amplified [2.8 versus 1.5 months; HR 0.53 (0.33-0.85)], HER3-low [2.8 versus 1.8 months; HR 0.57 (0.37-0.88)], and PTEN-high [1.6 versus 1.4 months; HR 0.55 (0.29-1.05)] tumors. Afatinib also improved PFS in combined subsets of patients with p16-negative and EGFR-amplified tumors [2.7 versus 1.5 months; HR 0.47 (0.28-0.80)], and patients with p16-negative tumors who were EGFR therapy-naïve [4.0 versus 2.4 months; HR 0.55 (0.31-0.98)]. PFS was improved in afatinib-treated patients who were VeriStrat 'Good' versus 'Poor' [2.7 versus 1.5 months; HR 0.71 (0.49-0.94)], but no treatment interaction was observed. Afatinib improved tumor response versus methotrexate in all subsets analyzed except for those with p16-positive disease (n = 35).ConclusionsSubgroups of HNSCC patients who may achieve increased benefit from afatinib were identified based on prespecified tumor biomarkers (p16-negative, EGFR-amplified, HER3-low, PTEN-high). Future studies are warranted to validate these findings.Clinical trial registrationNCT01345682.

Published
2017

20. Best clinical practice guidance for treating deep carious lesions in primary teeth:an EAPD policy document

Author

Duggal, M. (M.), Gizani, S. (S.), Albadri, S. (S.), Krämer, N. (N.), Stratigaki, E. (E.), Tong, H. J. (H. J.), Seremidi, K. (K.), Kloukos, D. (D.), BaniHani, A. (A.), Santamaría, R. M. (R. M.), Hu, S. (S.), Maden, M. (M.), Amend, S. (S.), Boutsiouki, C. (C.), Bekes, K. (K.), Lygidakis, N. (N.), Frankenberger, R. (R.), Monteiro, J. (J.), Anttonnen, V. (V.), Leith, R. (R.), Sobczak, M. (M.), Rajasekharan, S. (S.), Parekh, S. (S.), Duggal, M. (M.), Gizani, S. (S.), Albadri, S. (S.), Krämer, N. (N.), Stratigaki, E. (E.), Tong, H. J. (H. J.), Seremidi, K. (K.), Kloukos, D. (D.), BaniHani, A. (A.), Santamaría, R. M. (R. M.), Hu, S. (S.), Maden, M. (M.), Amend, S. (S.), Boutsiouki, C. (C.), Bekes, K. (K.), Lygidakis, N. (N.), Frankenberger, R. (R.), Monteiro, J. (J.), Anttonnen, V. (V.), Leith, R. (R.), Sobczak, M. (M.), Rajasekharan, S. (S.), and Parekh, S. (S.)

Abstract

Purpose: The European Academy of Paediatric Dentistry (EAPD) has developed this best clinical practice guidance to help clinicians manage deep carious lesions in primary teeth. Methods: Three expert groups conducted systematic reviews of the relevant literature. The topics were: (1) conventional techniques (2) Minimal Intervention Dentistry (MID) and (3) materials. Workshops were held during the corresponding EAPD interim seminar in Oslo in April 2021. Several clinical based recommendations and statements were agreed upon, and gaps in our knowledge were identified. Results: There is strong evidence that indirect pulp capping and pulpotomy techniques, and 38% Silver Diamine Fluoride are shown to be effective for the management of caries in the primary dentition. Due to the strict criteria, it is not possible to give clear recommendations on which materials are most appropriate for restoring primary teeth with deep carious lesions. Atraumatic Restorative Technique (ART) is not suitable for multi-surface caries, and Pre-formed Metal Crowns (PMCs) using the Hall technique reduce patient discomfort. GIC and RMGIC seem to be more favourable given the lower annual failure rate compared to HVGIC and MRGIC. Glass carbomer cannot be recommended due to inferior marginal adaptation and fractures. Compomers, hybrid composite resins and bulk-fill composite resins demonstrated similar values for annual failure rates. Conclusion: The management of deep carious lesions in primary teeth can be challenging and must consider the patient’s compliance, operator skills, materials and costs. There is a clear need to increase the use of MID techniques in managing carious primary teeth as a mainstream rather than a compromise option.

Published
2022

41. P13 Impact of ErbB Mutations on Clinical Outcomes in Afatinib- or Erlotinib-Treated Patients with SCC of the Lung

Author

Goss, G., primary, Cobo, M., additional, Lu, S., additional, Syrigos, K., additional, Lee, K.H., additional, Göker, E., additional, Georgoulias, V., additional, Li, W., additional, Isla, D., additional, Young, J.M., additional, Morabito, A., additional, Gadgeel, S., additional, Gibson, N., additional, Krämer, N., additional, Solca, F., additional, Cseh, A., additional, and Felip, E., additional

Published
2018
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45. Self-transcendent media experiences: Taking meaningful media to a higher level

Author

Raney, A.A., Slater, M.D., Appel, M., Hartmann, T., Bartsch, A., Schneider, F.M., Janicke-Bowles, S.H., Krämer, N., Mares, M.L., Vorderer, P., Rieger, D., Dale, K.R., Das, E., Raney, A.A., Slater, M.D., Appel, M., Hartmann, T., Bartsch, A., Schneider, F.M., Janicke-Bowles, S.H., Krämer, N., Mares, M.L., Vorderer, P., Rieger, D., Dale, K.R., and Das, E.

Abstract

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Published
2018

46. Self-transcendent media experiences: Taking meaningful media to a higher level

Author

Oliver, M.B., Raney, A.A., Slater, M.D., Appel, M., Hartmann, T., Bartsch, A., Schneider, F.M., Janicke-Bowles, S.H., Krämer, N., Mares, M.L., Vorderer, P., Rieger, D., Dale, K.R., Das, E., Oliver, M.B., Raney, A.A., Slater, M.D., Appel, M., Hartmann, T., Bartsch, A., Schneider, F.M., Janicke-Bowles, S.H., Krämer, N., Mares, M.L., Vorderer, P., Rieger, D., Dale, K.R., and Das, E.

Abstract

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Published
2018

50. Evaluation of the VeriStrat® serum protein test in patients with advanced squamous cell carcinoma of the lung treated with second-line afatinib or erlotinib in the phase III LUX-Lung 8 study

Author

Gadgeel, S. Goss, G. Soria, J.-C. Felip, E. Georgoulias, V. Lu, S. Cobo, M. Syrigos, K. Lee, K.H. Göker, E. Guclu, S.Z. Isla, D. Morabito, A. Dupuis, N. Bühnemann, C. Krämer, N. Solca, F. Ehrnrooth, E. Ardizzoni, A.

Abstract

Objectives Identification of biomarkers associated with clinical benefit may be crucial in establishing optimal treatment choice for patients with squamous cell carcinoma (SCC) of the lung after first-line chemotherapy. In this study, the ability of the VeriStrat serum protein test to predict differential clinical benefit with afatinib versus erlotinib, and the association of VeriStrat status with clinical outcomes irrespective of EGFR-TKI used, was assessed in a retrospective analysis of the phase III LUX-Lung 8 trial. Materials and methods Pretreatment plasma samples were analyzed using matrix-assisted laser desorption ionization time-of-flight mass spectrometry. Spectra were evaluated to assign a VeriStrat ‘Good’ (VS-G) or VeriStrat ‘Poor’ (VS-P) classification. Overall survival (OS), progression-free survival, and other endpoints were assessed with respect to pretreatment VeriStrat status; OS was the primary efficacy variable. Outcomes with other efficacy endpoints were similar. Results Of 795 patients randomized in LUX-Lung 8, 675 were classified (VS-G: 412; VS-P: 263). In the VS-G group, OS was significantly longer with afatinib versus erlotinib (HR 0.79 [95% CI: 0.63–0.98]). In the VS-P group, there was no significant difference in OS between afatinib and erlotinib (HR 0.90 [0.70–1.16]). However, there was no interaction between VeriStrat classification and treatment group for OS (pinteraction = 0.5303). OS was significantly longer in VS-G versus VS-P patients, both in the overall VeriStrat-classified population (HR 0.41 [0.35–0.49]) and afatinib-treated patients (HR 0.40 [0.31–0.51]). Multivariate analysis showed that VeriStrat was an independent predictor of OS in afatinib-treated patients, regardless of ECOG PS or best response to first-line chemotherapy. Conclusion VS-G classification is strongly associated with favorable survival outcomes with either afatinib or erlotinib compared with VS-P classification. In VS-G patients, survival outcomes with afatinib are superior to those with erlotinib. VeriStrat classification may guide treatment decisions in patients with SCC of the lung. ClinicalTrials.gov registration number: NCT01523587. © 2017

Published
2017

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