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3. Author Correction: Pembrolizumab and cabozantinib in recurrent metastatic head and neck squamous cell carcinoma: a phase 2 trial

Author

Saba, Nabil F., Steuer, Conor E., Ekpenyong, Asari, McCook-Veal, Ashley, Magliocca, Kelly, Patel, Mihir, Schmitt, Nicole C., Stokes, William, Bates, James E., Rudra, Soumon, Remick, Jill, McDonald, Mark, Abousaud, Marin, Tan, Aik Choon, Fadlullah, Muhammad Zaki Hidayatullah, Chaudhary, Ritu, Muzaffar, Jameel, Kirtane, Kedar, Liu, Yuan, Chen, Georgia Z., Shin, Dong M., Teng, Yong, and Chung, Christine H.

Published
2024
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6. Efficacy and Safety of Patritumab Deruxtecan (HER3-DXd) in EGFR Inhibitor–Resistant, EGFR-Mutated Non–Small Cell Lung CancerHER3-DXd in EGFR TKI–Resistant EGFR-Mutated NSCLC

Author

Jänne, Pasi A, Baik, Christina, Su, Wu-Chou, Johnson, Melissa L, Hayashi, Hidetoshi, Nishio, Makoto, Kim, Dong-Wan, Koczywas, Marianna, Gold, Kathryn A, Steuer, Conor E, Murakami, Haruyasu, Yang, James Chih-Hsin, Kim, Sang-We, Vigliotti, Michele, Shi, Rong, Qi, Zhenhao, Qiu, Yang, Zhao, Lihui, Sternberg, David, Yu, Channing, and Yu, Helena A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Lung, Lung Cancer, Clinical Research, Development of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Immunological, Camptothecin, Carcinoma, Non-Small-Cell Lung, Disease-Free Survival, Dose-Response Relationship, Drug, ErbB Receptors, Female, Humans, Infusions, Intravenous, Lung Neoplasms, Male, Middle Aged, Neoplasm Metastasis, Treatment Outcome, Biochemistry and cell biology, Oncology and carcinogenesis
Abstract

Receptor tyrosine-protein kinase ERBB3 (HER3) is expressed in most EGFR-mutated lung cancers but is not a known mechanism of resistance to EGFR inhibitors. HER3-DXd is an antibody-drug conjugate consisting of a HER3 antibody attached to a topoisomerase I inhibitor payload via a tetrapeptide-based cleavable linker. This phase I, dose escalation/expansion study included patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) with prior EGFR tyrosine kinase inhibitor (TKI) therapy. Among 57 patients receiving HER3-DXd 5.6 mg/kg intravenously once every 3 weeks, the confirmed objective response rate by blinded independent central review (Response Evaluation Criteria in Solid Tumors v1.1) was 39% [95% confidence interval (CI), 26.0-52.4], and median progression-free survival was 8.2 (95% CI, 4.4-8.3) months. Responses were observed in patients with known and unknown EGFR TKI resistance mechanisms. Clinical activity was observed across a broad range of HER3 membrane expression. The most common grade ≥3 treatment-emergent adverse events were hematologic toxicities. HER3-DXd has clinical activity in EGFR TKI-resistant cancers independent of resistance mechanisms, providing an approach to treat a broad range of drug-resistant cancers. SIGNIFICANCE: In metastatic EGFR-mutated NSCLC, after disease progression on EGFR TKI therapy, treatment approaches include genotype-directed therapy targeting a known resistance mechanism or chemotherapy. HER3-DXd demonstrated clinical activity spanning known and unknown EGFR TKI resistance mechanisms. HER3-DXd could present a future treatment option agnostic to the EGFR TKI resistance mechanism.See related commentary by Lim et al., p. 16.This article is highlighted in the In This Issue feature, p. 1.

Published
2022

8. Pembrolizumab and cabozantinib in recurrent metastatic head and neck squamous cell carcinoma: a phase 2 trial

Author

Saba, Nabil F., Steuer, Conor E., Ekpenyong, Asari, McCook-Veal, Ashley, Magliocca, Kelly, Patel, Mihir, Schmitt, Nicole C., Stokes, William, Bates, James E., Rudra, Soumon, Remick, Jill, McDonald, Mark, Abousaud, Marin, Tan, Aik Choon, Fadlullah, Muhammad Zaki Hidayatullah, Chaudhary, Ritu, Muzaffar, Jameel, Kirtane, Kedar, Liu, Yuan, Chen, Georgia Z., Shin, Dong M., Teng, Yong, and Chung, Christine H.

Published
2023
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12. Phase 1 safety and pharmacodynamic study of lenalidomide combined with everolimus in patients with advanced solid malignancies with efficacy signal in adenoid cystic carcinoma

Author

Harvey, R. Donald, Carthon, Bradley C., Lewis, Colleen, Hossain, Mohammad S., Zhang, Chao, Chen, Zhengjia, Harris, Wayne B., Alese, Olatunji B., Shaib, Walid, Bilen, Mehmet A., Lawson, David H., Wu, Christina, Steuer, Conor E., El-Rayes, Bassel F., Khuri, Fadlo R., Lonial, Sagar, Waller, Edmund K., Ramalingam, Suresh S., and Owonikoko, Taofeek K.

Published
2020
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15. MAST1 Drives Cisplatin Resistance in Human Cancers by Rewiring cRaf-Independent MEK Activation

Author

Jin, Lingtao, Chun, Jaemoo, Pan, Chaoyun, Li, Dan, Lin, Ruiting, Alesi, Gina N., Wang, Xu, Kang, Hee-Bum, Song, Lina, Wang, Dongsheng, Zhang, Guojing, Fan, Jun, Boggon, Titus J., Zhou, Lu, Kowalski, Jeanne, Qu, Cheng-Kui, Steuer, Conor E., Chen, Georgia Z., Saba, Nabil F., Boise, Lawrence H., Owonikoko, Taofeek K., Khuri, Fadlo R., Magliocca, Kelly R., Shin, Dong M., Lonial, Sagar, and Kang, Sumin

Published
2018
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18. The evolving landscape of salivary gland tumors

Author

Steuer, Conor E., primary, Hanna, Glenn J., additional, Viswanathan, Kartik, additional, Bates, James E., additional, Kaka, Azeem S., additional, Schmitt, Nicole C., additional, Ho, Alan L., additional, and Saba, Nabil F., additional

Published
2023
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21. Chronic 3,4-Methylenedioxymethamphetamine (MDMA) use is related to glutamate and GABA concentrations in the striatum, but not in the anterior cingulate cortex

Author

Zimmermann, Josua, primary, Zölch, Niklaus, additional, Coray, Rebecca, additional, Bavato, Francesco, additional, Friedli, Nicole, additional, Baumgartner, Markus R, additional, Steuer, Andrea E, additional, Opitz, Antje, additional, Werner, Annett, additional, Oeltzschner, Georg, additional, Seifritz, Erich, additional, Stock, Ann Kathrin, additional, Beste, Christian, additional, Cole, David M, additional, and Quednow, Boris B, additional

Published
2023
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25. Do dried blood spots have the potential to support result management processes in routine sports drug testing?—Part 3: LC–MS/MS‐based peptide analysis for dried blood spot sampling time point estimation

Author

Brockbals, Lana; https://orcid.org/0000-0001-7310-2671, Thomas, Andreas; https://orcid.org/0000-0003-1199-0743, Schneider, Tom D; https://orcid.org/0000-0001-6297-2954, Kraemer, Thomas; https://orcid.org/0000-0002-3283-606X, Steuer, Andrea E; https://orcid.org/0000-0001-8983-2353, Thevis, Mario; https://orcid.org/0000-0001-5972-8854, Brockbals, Lana; https://orcid.org/0000-0001-7310-2671, Thomas, Andreas; https://orcid.org/0000-0003-1199-0743, Schneider, Tom D; https://orcid.org/0000-0001-6297-2954, Kraemer, Thomas; https://orcid.org/0000-0002-3283-606X, Steuer, Andrea E; https://orcid.org/0000-0001-8983-2353, and Thevis, Mario; https://orcid.org/0000-0001-5972-8854

Abstract

Along with the recent acknowledgement of the World Anti-Doping Agency to use dried blood spot (DBS) samples for routine doping control purposes, there have been propositions to use DBS as a matrix that allows regular proactive remotely supervised self-sampling, providing potential longitudinal monitoring of an athlete's exposure to doping agents. However, several organizational aspects have to be considered before implementation, such as the verification of the sample collections time point. Based on a previous untargeted proteomics workflow utilizing liquid chromatography–high-resolution mass spectrometry (LC–HRMS) to identify protein/peptide markers to define the time since deposition of a bloodstain, the aim of the current study was to develop a targeted LC–HRMS/MS analytical method for promising peptidic target analytes. A long-term DBS storage experiment was carried out over a 3-month period (sample collection time points: 0, 2, 4, 7, 14, 21, 28, 42, 56, 70, 84 and 91 days) with DBS samples of 10 volunteers for longitudinal investigation of signal abundance changes of targeted peptide sequences at different storage temperatures (room temperature [RT], 4°C and −20°C). Prior to experimental analysis, LC–HRMS/MS method characteristics were successfully assessed, including intraday precision, carryover and sample extract stability. For estimation of DBS sample collection time points, ratios of two peptides that originate from the same protein prior to tryptic digestion were created. Two targeted peptide area ratios were found to significantly increase after being stored at RT for 28 days, representing potential markers for future use in routine doping controls that contribute to advancing complementary avenues in anti-doping.

Published
2023

26. Chronic 3,4-Methylenedioxymethamphetamine (MDMA) Use Is Related to Glutamate and GABA Concentrations in the Striatum But Not the Anterior Cingulate Cortex

Author

Zimmermann, Josua, Zölch, Niklaus, Coray, Rebecca, Bavato, Francesco, Friedli, Nicole, Baumgartner, Markus R., Steuer, Andrea E., Opitz, Antje, Werner, Annett, Oeltzschner, Georg, Seifritz, Erich, Stock, Ann-Kathrin, Beste, Christian, Cole, David M., and Quednow, Boris B.

Subjects
GABA, MRS, PRESS, MDMA, MEGA-PRESS, serotonin, glutamate
Abstract

Background 3,4-Methylenedioxymethamphetamine (MDMA) is a widely used recreational substance inducing acute release of serotonin. Previous studies in chronic MDMA users demonstrated selective adaptations in the serotonin system, which were assumed to be associated with cognitive deficits. However, serotonin functions are strongly entangled with glutamate as well as gamma-aminobutyric acid (GABA) neurotransmission, and studies in MDMA-exposed rats show long-term adaptations in glutamatergic and GABAergic signaling. Methods We used proton magnetic resonance spectroscopy (MRS) to measure the glutamate-glutamine complex (GLX) and GABA concentrations in the left striatum and medial anterior cingulate cortex (ACC) of 44 chronic but recently abstinent MDMA users and 42 MDMA-naive healthy controls. While the Mescher-Garwood point-resolved-spectroscopy sequence (MEGA-PRESS) is best suited to quantify GABA, recent studies reported poor agreement between conventional short-echo-time PRESS and MEGA-PRESS for GLX measures. Here, we applied both sequences to assess their agreement and potential confounders underlying the diverging results. Results Chronic MDMA users showed elevated GLX levels in the striatum but not the ACC. Regarding GABA, we found no group difference in either region, although a negative association with MDMA use frequency was observed in the striatum. Overall, GLX measures from MEGA-PRESS, with its longer echo time, appeared to be less confounded by macromolecule signal than the short-echo-time PRESS and thus provided more robust results. Conclusion Our findings suggest that MDMA use affects not only serotonin but also striatal GLX and GABA concentrations. These insights may offer new mechanistic explanations for cognitive deficits (e.g., impaired impulse control) observed in MDMA users., The International Journal of Neuropsychopharmacology, 26 (6), ISSN:1461-1457, ISSN:1469-5111

Published
2023

27. Sites of metastasis and association with clinical outcome in advanced stage cancer patients treated with immunotherapy

Author

Bilen, Mehmet Asim, Shabto, Julie M., Martini, Dylan J., Liu, Yuan, Lewis, Colleen, Collins, Hannah, Akce, Mehmet, Kissick, Haydn, Carthon, Bradley C., Shaib, Walid L., Alese, Olatunji B., Steuer, Conor E., Wu, Christina, Lawson, David H., Kudchadkar, Ragini, Master, Viraj A., El-Rayes, Bassel, Ramalingam, Suresh S., Owonikoko, Taofeek K., and Harvey, R. Donald

Published
2019
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30. Towards a New Qualitative Screening Assay for Synthetic Cannabinoids Using Metabolomics and Machine Learning

Author

Streun, Gabriel L, Steuer, Andrea E, Poetzsch, Sandra N, Ebert, Lars C, Dobay, Akos, Kraemer, Thomas, and University of Zurich

Subjects
Machine Learning, Forensic Toxicology, Cannabinoids, Biochemistry (medical), Clinical Biochemistry, Humans, Metabolomics, 340 Law, 610 Medicine & health, 1308 Clinical Biochemistry, 2704 Biochemistry (medical), 10218 Institute of Legal Medicine, Chromatography, Liquid
Abstract

Background Synthetic cannabinoids (SCs) are steadily emerging on the drug market. To remain competitive in clinical or forensic toxicology, new screening strategies including high-resolution mass spectrometry (HRMS) are required. Machine learning algorithms can detect and learn chemical signatures in complex datasets and use them as a proxy to predict new samples. We propose a new screening tool based on a SC-specific change of the metabolome and a machine learning algorithm. Methods Authentic human urine samples (n = 474), positive or negative for SCs, were used. These samples were measured with an untargeted metabolomics liquid chromatography (LC)–quadrupole time-of-flight-HRMS method. Progenesis QI software was used to preprocess the raw data. Following feature engineering, a random forest (RF) model was optimized in R using a 10-fold cross-validation method and a training set (n = 369). The performance of the model was assessed with a test (n = 50) and a verification (n = 55) set. Results During RF optimization, 49 features, 200 trees, and 7 variables at each branching node were determined as most predictive. The optimized model accuracy, clinical sensitivity, clinical specificity, positive predictive value, and negative predictive value were 88.1%, 83.0%, 92.7%, 91.3%, and 85.6%, respectively. The test set was predicted with an accuracy of 88.0%, and the verification set provided evidence that the model was able to detect cannabinoid-specific changes in the metabolome. Conclusions An RF approach combined with metabolomics enables a novel screening strategy for responding effectively to the challenge of new SCs. Biomarkers identified by this approach may also be integrated in routine screening methods.

Published
2022
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31. Do dried blood spots have the potential to support result management processes in routine sports drug testing?—Part 3: LC–MS/MS‐based peptide analysis for dried blood spot sampling time point estimation

Author

Brockbals, Lana, Thomas, Andreas, Schneider, Tom D, Kraemer, Thomas, Steuer, Andrea E, Thevis, Mario, University of Zurich, and Thevis, Mario

Subjects
1602 Analytical Chemistry, LC, 3003 Pharmaceutical Science, 340 Law, 1607 Spectroscopy, Pharmaceutical Science, 610 Medicine & health, 10218 Institute of Legal Medicine, Analytical Chemistry DBS, age estimation, Analytical Chemistry, peptide analysis, anti, 2304 Environmental Chemistry, Environmental Chemistry, doping control, Spectroscopy, HRMS/MS
Published
2023
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41. Efficacy and Safety of Patritumab Deruxtecan (HER3-DXd) in EGFR Inhibitor-Resistant, EGFR-Mutated Non-Small Cell Lung Cancer.

Author

Jänne, Pasi A, Jänne, Pasi A, Baik, Christina, Su, Wu-Chou, Johnson, Melissa L, Hayashi, Hidetoshi, Nishio, Makoto, Kim, Dong-Wan, Koczywas, Marianna, Gold, Kathryn A, Steuer, Conor E, Murakami, Haruyasu, Yang, James Chih-Hsin, Kim, Sang-We, Vigliotti, Michele, Shi, Rong, Qi, Zhenhao, Qiu, Yang, Zhao, Lihui, Sternberg, David, Yu, Channing, Yu, Helena A, Jänne, Pasi A, Jänne, Pasi A, Baik, Christina, Su, Wu-Chou, Johnson, Melissa L, Hayashi, Hidetoshi, Nishio, Makoto, Kim, Dong-Wan, Koczywas, Marianna, Gold, Kathryn A, Steuer, Conor E, Murakami, Haruyasu, Yang, James Chih-Hsin, Kim, Sang-We, Vigliotti, Michele, Shi, Rong, Qi, Zhenhao, Qiu, Yang, Zhao, Lihui, Sternberg, David, Yu, Channing, and Yu, Helena A

Abstract

Receptor tyrosine-protein kinase ERBB3 (HER3) is expressed in most EGFR-mutated lung cancers but is not a known mechanism of resistance to EGFR inhibitors. HER3-DXd is an antibody-drug conjugate consisting of a HER3 antibody attached to a topoisomerase I inhibitor payload via a tetrapeptide-based cleavable linker. This phase I, dose escalation/expansion study included patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) with prior EGFR tyrosine kinase inhibitor (TKI) therapy. Among 57 patients receiving HER3-DXd 5.6 mg/kg intravenously once every 3 weeks, the confirmed objective response rate by blinded independent central review (Response Evaluation Criteria in Solid Tumors v1.1) was 39% [95% confidence interval (CI), 26.0-52.4], and median progression-free survival was 8.2 (95% CI, 4.4-8.3) months. Responses were observed in patients with known and unknown EGFR TKI resistance mechanisms. Clinical activity was observed across a broad range of HER3 membrane expression. The most common grade ≥3 treatment-emergent adverse events were hematologic toxicities. HER3-DXd has clinical activity in EGFR TKI-resistant cancers independent of resistance mechanisms, providing an approach to treat a broad range of drug-resistant cancers. SIGNIFICANCE: In metastatic EGFR-mutated NSCLC, after disease progression on EGFR TKI therapy, treatment approaches include genotype-directed therapy targeting a known resistance mechanism or chemotherapy. HER3-DXd demonstrated clinical activity spanning known and unknown EGFR TKI resistance mechanisms. HER3-DXd could present a future treatment option agnostic to the EGFR TKI resistance mechanism.See related commentary by Lim et al., p. 16.This article is highlighted in the In This Issue feature, p. 1.

Published
2022

42. Easy and convenient millimole‐scale synthesis of new, potential biomarkers for gamma‐hydroxybutyric acid (GHB) intake: Feasible for analytical laboratories

Author

Steuer, Christian; https://orcid.org/0000-0002-6102-3367, Quattrini, Dario, Raeber, Justine, Waser, Philipp, Steuer, Andrea E; https://orcid.org/0000-0001-8983-2353, Steuer, Christian; https://orcid.org/0000-0002-6102-3367, Quattrini, Dario, Raeber, Justine, Waser, Philipp, and Steuer, Andrea E; https://orcid.org/0000-0001-8983-2353

Abstract

New biomarkers indicating the abuse of drugs and alcohol are still of major interest for clinical and forensic sciences. The endogenous neurotransmitter and approved drug, gamma-hydroxybutyric acid (GHB), is often illegally used for drug-facilitated crimes by spiking GHB into alcoholic beverages. Analytical detection windows of only 6 h in blood and 12 h in urine are often too short to provide reliable proof of GHB ingestion. Therefore, new biomarkers are needed to prove exogenous GHB administration. Previously, amino acid GHB conjugates were discovered in an untargeted metabolomics screening and fatty acid esters with GHB were recently discussed as promising biomarkers to enlarge the analytical detection time windows. However, the development of analytical methods is still slowed down since reference compounds for targeted screenings are still missing. In this paper, we describe simple procedures for the rapid synthesis and purification of amino acid GHB conjugates as well as fatty acid esters, which can be adopted in analytical and clinical/forensic laboratories. Structural characterization data, together with IR, $^1$H-nuclear magnetic resonance (NMR), $^{13}$C-NMR, high-resolution mass spectra (MS), and MS/MS spectra in positive and negative ionization mode are reported for all obtained GHB conjugates and GHB conjugate precursors.

Published
2022

43. Urinary concentrations of GHB and its novel amino acid and carnitine conjugates following controlled GHB administration to humans.

Author

Steuer, Andrea E., Bavato, Francesco, Schnider, Laura K., Dornbierer, Dario A., Bosch, Oliver G., Quednow, Boris B., Seifritz, Erich, Steuer, Christian, and Kraemer, Thomas

Subjects
*GAMMA-hydroxybutyrate, *AMINO acids, *CARNITINE, *GLYCOLIC acid, *ORGANIC acids, *DRUG toxicity
Abstract

Gamma-hydroxybutyrate (GHB) remains a challenging clinical/forensic toxicology drug. Its rapid elimination to endogenous levels mainly causes this. Especially in drug-facilitated sexual assaults, sample collection often occurs later than the detection window for GHB. We aimed to investigate new GHB conjugates with amino acids (AA), fatty acids, and its organic acid metabolites for their suitability as ingestion/application markers in urine following controlled GHB administration to humans. We used LC–MS/MS for validated quantification of human urine samples collected within two randomized, double-blinded, placebo-controlled crossover studies (GHB 50 mg/kg, 79 participants) at approximately 4.5, 8, 11, and 28 h after intake. We found significant differences (placebo vs. GHB) for all but two analytes at 4.5 h. Eleven hours post GHB administration, GHB, GHB-AAs, 3,4-dihydroxybutyric acid, and glycolic acid still showed significantly higher concentrations; at 28 h only GHB-glycine. Three different discrimination strategies were evaluated: (a) GHB-glycine cut-off concentration (1 µg/mL), (b) metabolite ratios of GHB-glycine/GHB (2.5), and (c) elevation threshold between two urine samples (> 5). Sensitivities were 0.1, 0.3, or 0.5, respectively. Only GHB-glycine showed prolonged detection over GHB, mainly when compared to a second time- and subject-matched urine sample (strategy c). [ABSTRACT FROM AUTHOR]

Published
2023
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45. Abstract CT033: KontRASt-01: A phase Ib/II, dose-escalation study of JDQ443 in patients (pts) with advanced, KRAS G12C-mutated solid tumors

Author

Tan, Daniel S., primary, Shimizu, Toshio, additional, Solomon, Benjamin, additional, Heist, Rebecca S., additional, Schuler, Martin, additional, Luken, Maria J. De Miguel, additional, Gazzah, Anas, additional, Wermke, Martin, additional, Dooms, Christophe, additional, Loong, Herbert H., additional, Steeghs, Neeltje, additional, Felip, Enriqueta, additional, Steuer, Conor E., additional, van Cutsem, Eric, additional, Soo, Ross A., additional, Jaeger, Ashley C., additional, Kim, Jaeyeon, additional, Xu, Kun, additional, Chen, Xueying, additional, Cui, Xiaoming, additional, Burks, Heather, additional, Farago, Anna, additional, and Cassier, Philippe A., additional

Published
2022
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46. T cell repertoire in peripheral blood as a potential biomarker for predicting response to concurrent cetuximab and nivolumab in head and neck squamous cell carcinoma

Author

Wang, Xuefeng, primary, Muzaffar, Jameel, additional, Kirtane, Kedar, additional, Song, Feifei, additional, Johnson, Matthew, additional, Schell, Michael J, additional, Li, Jiannong, additional, Yoder, Sean J, additional, Conejo-Garcia, Jose R, additional, Guevara-Patino, Jose A, additional, Bonomi, Marcelo, additional, Bhateja, Priyanka, additional, Rocco, James W, additional, Steuer, Conor E, additional, Saba, Nabil F, additional, and Chung, Christine H, additional

Published
2022
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47. A Multicenter Randomized Phase II Study of Single Agent Efficacy and Optimal Combination Sequence of Everolimus and Pasireotide LAR in Advanced Thyroid Cancer

Author

Bauman, Julie E., primary, Chen, Zhengjia, additional, Zhang, Chao, additional, Ohr, James P., additional, Ferris, Robert L., additional, McGorisk, Gerald M., additional, Brandt, Stephen, additional, Srivatsa, Sumathi, additional, Chen, Amy Y., additional, Steuer, Conor E., additional, Shin, Dong M., additional, Saba, Nabil F., additional, Khuri, Fadlo R., additional, and Owonikoko, Taofeek K., additional

Published
2022
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