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5. Activity of afatinib in patients with NSCLC harboring novel uncommon EGFR mutations with or without co-mutations: a case report.

Author

Christopoulos, Petros, Herster, Franziska, Hoffknecht, Petra, Falk, Markus, Tiemann, Markus, Kopp, Hans-Georg, Althoff, Andre, Stammberger, Anja, and Laack, Eckart

Subjects
EPIDERMAL growth factor receptors, AFATINIB, NON-small-cell lung carcinoma, PROTEIN-tyrosine kinase inhibitors, DELETION mutation
Abstract

Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) represent first-line standard of care in unresectable EGFR mutation-positive (EGFRm+) non-small cell lung cancer (NSCLC). However, 10-20% of patients with EGFRm+ NSCLC have uncommon EGFR variants, defined as mutations other than L858R substitutions or exon 19 deletions. NSCLC harboring uncommon EGFR mutations may demonstrate lower sensitivity to targeted agents than NSCLC with L858R or exon 19 deletion mutations. Prospective clinical trial data in patients with NSCLC uncommon EGFR mutations are lacking. Afatinib is a second-generation TKI and the only Food and Drug Administration-approved drug for some of the more prevalent uncommon EGFR mutations. We present a series of seven case reports describing clinical outcomes in afatinib-treated patients with NSCLC harboring a diverse range of extremely rare mutations with or without co-mutations affecting other genes. EGFR alterations included compound mutations, P-loop αC-helix compressing mutations, and novel substitution mutations. We also present a case with NSCLC harboring a novel EGFR::CCDC6 gene fusion. Overall, the patients responded well to afatinib, including radiologic partial responses in six patients during treatment. Responses were durable for three patients. The cases presented are in line with a growing body of clinical and preclinical evidence that indicating that NSCLC with various uncommon EGFR mutations, with or without co-mutations, may be sensitive to afatinib. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Simulated Acute Hypobaric Hypoxia Effects on Cognition in Helicopter Emergency Medical Service Personnel – A Randomized, Controlled, Single-Blind, Crossover Trial.

Author

Falla, Marika, Hüfner, Katharina, Falk, Markus, Weiss, Elisabeth M., Vögele, Anna, Jan van Veelen, Michiel, Weber, Bernhard, Brandner, Jonas, Palma, Martin, Dejaco, Alexander, Brugger, Hermann, and Strapazzon, Giacomo

Subjects
EMERGENCY medical personnel, EMERGENCY medical services, CROSSOVER trials, COGNITION, COGNITIVE testing
Abstract

Objective: To evaluate, under replicable, blinded and standardised conditions, the effect of acute exposure to hypobaric hypoxia (HH) (equivalent to 200 or 3000 or 5000 m above sea level (asl)) on selected cognitive domains and physiological parameters in personnel of helicopter emergency medical service (HEMS). Methods: We conducted a randomized clinical trial using a single-blind crossover design in an environmental chamber (terraXcube) to induce HH in 48 HEMS personnel. Participants performed cognitive tests (CT) before the ascent, after 5 min at altitude, and after simulated cardiopulmonary resuscitation (SCR). CT evaluated: sustained attention using the psychomotor vigilance test (PVT) that included measurement of reaction time (RT); risky decision making using the balloon analogue risk task (BART), and attention and speed of processing using the digit symbol substitution test (DSST). CT performance was subjectively rated with a visual analogue scale (VAS). Physiological data were recorded with a physiological monitoring system. Data were analysed using a linear mixed model and correlation analysis. Results: Mean reaction time was significantly slower (p = 0.002) at HH (5000 m asl), but there were no independent effects of HH on the other parameters of the PVT, BART or DSST. Participants did not detect subjectively the slower RT at altitude since VAS performance results showed a positive correlation with mean RT (p = 0.009). DSST results significantly improved (p = 0.001) after SCR. Conclusion: Acute exposure of HEMS personnel to HH induced a slower RT but no changes in any other investigated measures of cognition. The reduced RT was not detected subjectively by the participants. Trial number 3489044136, ClinicalTrials.gov trial registration. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Development of the NOGGO GIS v1 Assay, a Comprehensive Hybrid-Capture-Based NGS Assay for Therapeutic Stratification of Homologous Repair Deficiency Driven Tumors and Clinical Validation

Author

Willing, Eva-Maria, primary, Vollbrecht, Claudia, additional, Vössing, Christine, additional, Weist, Peggy, additional, Schallenberg, Simon, additional, Herbst, Johanna M., additional, Schatz, Stefanie, additional, Jóri, Balázs, additional, Bataillon, Guillaume, additional, Harter, Philipp, additional, Salutari, Vanda, additional, Martin, Antonio Gonzáles, additional, Vergote, Ignace, additional, Colombo, Nicoletta, additional, Roeper, Julia, additional, Berg, Tobias, additional, Berger, Regina, additional, Kah, Bettina, additional, Noettrup, Trine Jakobi, additional, Falk, Markus, additional, Arndt, Kathrin, additional, Polten, Andreas, additional, Ray-Coquard, Isabelle, additional, Selzam, Franziska, additional, Pirngruber, Judith, additional, Schmidt, Stefanie, additional, Hummel, Michael, additional, Tiemann, Markus, additional, Horst, David, additional, Sehouli, Jalid, additional, Pujade-Lauraine, Eric, additional, Tiemann, Katharina, additional, Braicu, Elena Ioana, additional, and Heukamp, Lukas C., additional

Published
2023
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19. Development of the NOGGO GIS v1 Assay, a Comprehensive Hybrid-Capture-Based NGS Assay for Therapeutic Stratification of Homologous Repair Deficiency Driven Tumors and Clinical Validation

Author

Willing, Eva Maria, Vollbrecht, Claudia, Vössing, Christine, Weist, Peggy, Schallenberg, Simon, Herbst, Johanna M., Schatz, Stefanie, Jóri, Balázs, Bataillon, Guillaume, Harter, Philipp, Salutari, Vanda, Martin, Antonio Gonzáles, Vergote, Ignace, Colombo, Nicoletta, Roeper, Julia, Berg, Tobias, Berger, Regina, Kah, Bettina, Noettrup, Trine Jakobi, Falk, Markus, Arndt, Kathrin, Polten, Andreas, Ray-Coquard, Isabelle, Selzam, Franziska, Pirngruber, Judith, Schmidt, Stefanie, Hummel, Michael, Tiemann, Markus, Horst, David, Sehouli, Jalid, Pujade-Lauraine, Eric, Tiemann, Katharina, Braicu, Elena Ioana, Heukamp, Lukas C., Willing, Eva Maria, Vollbrecht, Claudia, Vössing, Christine, Weist, Peggy, Schallenberg, Simon, Herbst, Johanna M., Schatz, Stefanie, Jóri, Balázs, Bataillon, Guillaume, Harter, Philipp, Salutari, Vanda, Martin, Antonio Gonzáles, Vergote, Ignace, Colombo, Nicoletta, Roeper, Julia, Berg, Tobias, Berger, Regina, Kah, Bettina, Noettrup, Trine Jakobi, Falk, Markus, Arndt, Kathrin, Polten, Andreas, Ray-Coquard, Isabelle, Selzam, Franziska, Pirngruber, Judith, Schmidt, Stefanie, Hummel, Michael, Tiemann, Markus, Horst, David, Sehouli, Jalid, Pujade-Lauraine, Eric, Tiemann, Katharina, Braicu, Elena Ioana, and Heukamp, Lukas C.

Abstract

The worldwide approval of the combination maintenance therapy of olaparib and bevacizumab in advanced high-grade serous ovarian cancer requires complex molecular diagnostic assays that are sufficiently robust for the routine detection of driver mutations in homologous recombination repair (HRR) genes and genomic instability (GI), employing formalin-fixed (FFPE) paraffin-embedded tumor samples without matched normal tissue. We therefore established a DNA-based hybrid capture NGS assay and an associated bioinformatic pipeline that fulfils our institution’s specific needs. The assay´s target regions cover the full exonic territory of relevant cancer-related genes and HRR genes and more than 20,000 evenly distributed single nucleotide polymorphism (SNP) loci to allow for the detection of genome-wide allele specific copy number alterations (CNA). To determine GI status, we implemented an %CNA score that is robust across a broad range of tumor cell content (25–85%) often found in routine FFPE samples. The assay was established using high-grade serous ovarian cancer samples for which BRCA1 and BRCA2 mutation status as well as Myriad MyChoice homologous repair deficiency (HRD) status was known. The NOGGO (Northeastern German Society for Gynecologic Oncology) GIS (GI-Score) v1 assay was clinically validated on more than 400 samples of the ENGOT PAOLA-1 clinical trial as part of the European Network for Gynaecological Oncological Trial groups (ENGOT) HRD European Initiative. The “NOGGO GIS v1 assay” performed using highly robust hazard ratios for progression-free survival (PFS) and overall survival (OS), as well a significantly lower dropout rate than the Myriad MyChoice clinical trial assay supporting the clinical utility of the assay. We also provide proof of a modular and scalable routine diagnostic method, that can be flexibly adapted and adjusted to meet future clinical needs, emerging biomarkers, and further tumor entities.

Published
2023

25. 2022-RA-873-ESGO Validation study of the ‘NOGGO-GIS ASSAY’ based on ovarian cancer samples from the first-line PAOLA-1/ENGOT-ov25 phase-III trial

Author

Willing, Eva-Maria, primary, Vollbrecht, Claudia, additional, Voessing, Christine, additional, Weist, Peggy, additional, Schallenberg, Simon, additional, Jori, Balazs, additional, Tiemann, Markus, additional, Bataillon, Guillaume, additional, Harter, Philipp, additional, Pignata, Sandro, additional, Martin, Antonio Gonzales, additional, Vergote, Ignace, additional, Colombo, Nicoletta, additional, Marth, Christian, additional, Berg, Tobias, additional, Kah, Bettina, additional, Herbst, Johanna, additional, Noettrup, Trine Jakobi, additional, Falk, Markus, additional, Arndt, Kathrin, additional, Ray-Coquard, Isabelle, additional, Polten, Andreas, additional, Bernstein, Robert, additional, Selzam, Franziska, additional, Pirngruber, Judith, additional, Schmidt, Stefanie, additional, Hummel, Michael, additional, Sehouli, Jalid, additional, Horst, David, additional, Braicu, Elena Ioana, additional, Lauraine, Eric Pujade, additional, Tiemann, Katharina, additional, and Heukamp, Lukas C, additional

Published
2022
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32. Nasal CPAP support of newborn infants : measurements of interface leakage and performance of selected systems

Author

Falk, Markus and Falk, Markus

Abstract

Objective: The most common treatment for newborns in respiratory distress is nasal continuous positive airway pressure (nCPAP). Comparing clinical studies have shown a better outcome and a lower risk of chronic lung disease compared to invasive mechanical ventilation (MV) when used as primary treatment. Still, when CPAP fails, mechanical ventilation is the available rescue treatment. Since the clinical use of non-invasive CPAP caught on in the 1970’s, a range of devices and interfaces have been developed, of which some are no longer used. Still today, there is a lack of knowledge to guide clinicians around the world as to what device, interface and settings will maximize the clinical CPAP benefit. The overall aim of my dissertation is to evaluate CPAP equipment´s mechanical properties and factors that can affect CPAP performance in patients to identify possible improvements that can reduce the need for harmful mechanical ventilation. Methods: 1. Selected flow meters were tested with mechanical lung simulations to determine their performance in the in-line and flow-through position. 2. Resistance, CPAP performance and mechanism of action were determined for the MediJet pressure generators using mechanical lung simulations. 3. The unconventionally designed Pumani bubble-CPAP system, aimed for developing countries, was tested with regard to resistance and CPAP performance using mechanical lung simulations. A traditional bubble-CPAP system was added for comparison. 4. A scoping review was performed to determine common alterations to the original bubbleCPAP design in clinical use. The effects of these modifications on CPAP performance were tested in-vitro using mechanical lung simulations. 5. A randomized, clinical cross-over study was performed, comparing absolute interface leakage with prongs and nasal mask. The effects of common leakage-reducing care maneuvers were evaluated. Results: 1. In the in-line position, the flow meter volume added dead space. An increased flo

Published
2022

33. Simulated Acute Hypobaric Hypoxia Effects on Cognition in Helicopter Emergency Medical Service Personnel – A Randomized, Controlled, Single-Blind, Crossover Trial

Author

Falla, Marika, primary, Hüfner, Katharina, additional, Falk, Markus, additional, Weiss, Elisabeth M., additional, Vögele, Anna, additional, Jan van Veelen, Michiel, additional, Weber, Bernhard, additional, Brandner, Jonas, additional, Palma, Martin, additional, Dejaco, Alexander, additional, Brugger, Hermann, additional, and Strapazzon, Giacomo, additional

Published
2022
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36. Outcome of Ordinary Polymorphous Adenocarcinomas of the Salivary Glands in Comparison With Papillary and Cribriform Subtypes

Author

CLAUSEN, STELLA, primary, FALK, MARKUS, additional, OESTERLING, FLORIAN, additional, FEHR, ANDRÉ, additional, STANG, ANDREAS, additional, BOECKER, WERNER, additional, GESK, STEFAN, additional, SCHATZ, STEFANIE, additional, STENMAN, GÖRAN, additional, TIEMANN, KATHARINA, additional, LOENING, THOMAS, additional, and FRIEDRICH, REINHARD E., additional

Published
2022
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39. Neonatal Resuscitation With T-Piece Systems : Risk of Inadvertent PEEP Related to Mechanical Properties

Author

Drevhammar, Thomas, Falk, Markus, Donaldsson, Snorri, Tracy, Mark, Hinder, Murray, Drevhammar, Thomas, Falk, Markus, Donaldsson, Snorri, Tracy, Mark, and Hinder, Murray

Abstract

Background: Resuscitation of infants using T-piece resuscitators (TPR) allow positive pressure ventilation with positive end-expiratory pressure (PEEP). The adjustable PEEP valve adds resistance to expiration and could contribute to inadvertent PEEP. The study indirectly investigated risk of inadvertent peep by determining expiratory time constants. The aim was to measure system expiratory time constants for a TPR device in a passive mechanical model with infant lung properties. Methods: We used adiabatic bottles to generate four levels of compliance (0.5–3.4 mL/cm H2O). Expiratory time constants were recorded for combinations of fresh gas flow (8, 10, 15 L/min), PEEP (5, 8, 10 cm H2O), airway resistance (50, 200 cm H2O/L/sec and none), endotracheal tube (none, size 2.5, 3.0, 3.5) with a peak inflation pressure of 15 cm H2O above PEEP. Results: Low compliances resulted in time constants below 0.17 s contrasting to higher compliances where the expiratory time constants were 0.25–0.81 s. Time constants increased with increased resistance, lower fresh gas flows, higher set PEEP levels and with an added airway resistance or endotracheal tube. Conclusions: The risk of inadvertent PEEP increases with a shorter time for expiration in combination with a higher compliance or resistance. The TPR resistance can be reduced by increasing the fresh gas flow or reducing PEEP. The expiratory time constants indicate that this may be clinically important. The risk of inadvertent PEEP would be highest in intubated term infants with highly compliant lungs. These results are useful for interpreting clinical events and recordings.

Published
2021
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40. Comparison of Resistance Spectra after First and Second Line Osimertinib Treatment Detected by Liquid Biopsy

Author

Jóri, Balázs, primary, Schatz, Stefanie, additional, Kaller, Len, additional, Kah, Bettina, additional, Roeper, Julia, additional, Ramdani, Hayat O., additional, Diehl, Linda, additional, Hoffknecht, Petra, additional, Grohé, Christian, additional, Griesinger, Frank, additional, Tiemann, Markus, additional, Heukamp, Lukas C., additional, and Falk, Markus, additional

Published
2021
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43. BRAF mutations and BRAF mutation functional class have no negative impact on the clinical outcome of advanced NSCLC and associate with susceptibility to immunotherapy

Author

Wiesweg, Marcel, primary, Preuß, Cedric, additional, Roeper, Julia, additional, Metzenmacher, Martin, additional, Eberhardt, Wilfried, additional, Stropiep, Ursula, additional, Wedeken, Katrin, additional, Reis, Henning, additional, Herold, Thomas, additional, Darwiche, Kaid, additional, Aigner, Clemens, additional, Stuschke, Martin, additional, Schildhaus, Hans-Ulrich, additional, Schmid, Kurt W., additional, Falk, Markus, additional, Heukamp, Lukas, additional, Tiemann, Markus, additional, Griesinger, Frank, additional, and Schuler, Martin, additional

Published
2021
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