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JOURNAL ARTICLE
Mo Yang, Helene Vioix, Emma S Hook, Anthony J Hatswell, Rachael L Batteson, Bruce R Gaumond, Aurora O'Brate, Sanjay Popat, Paul K Paik
OBJECTIVES: The VISION trial showed durable activity of tepotinib in MET exon 14 (METex14) skipping non-small cell lung cancer. We analyzed health state utilities using patient-reported outcomes from VISION. METHODS: 5-level version of EQ-5D (EQ-5D-5L) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 responses were collected at baseline, every 6 to 12 weeks during treatment, and at the end of treatment and safety follow-up...
February 18, 2023: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
#22
Fei Li, Yizhe Wang, Inah Hwang, Ja-Young Jang, Libo Xu, Zhong Deng, Eun Young Yu, Yiming Cai, Caizhi Wu, Zhenbo Han, Yu-Han Huang, Xiangao Huang, Ling Zhang, Jun Yao, Neal F Lue, Paul M Lieberman, Haoqiang Ying, Jihye Paik, Hongwu Zheng
Telomere length maintenance is essential for cellular immortalization and tumorigenesis. 5% - 10% of human cancers rely on a recombination-based mechanism termed alternative lengthening of telomeres (ALT) to sustain their replicative immortality, yet there are currently no targeted therapies. Through CRISPR/Cas9-based genetic screens in an ALT-immortalized isogenic cellular model, here we identify histone lysine demethylase KDM2A as a molecular vulnerability selectively for cells contingent on ALT-dependent telomere maintenance...
February 11, 2023: bioRxiv
#23
Shuchen Liu, Alberto Benito-Martin, Fanny A Pelissier Vatter, Sarah Z Hanif, Catherine Liu, Priya Bhardwaj, Praveen Sethupathy, Alaa R Farghli, Phoebe Piloco, Paul Paik, Malik Mushannen, David M Otterburn, Leslie Cohen, Rohan Bareja, Jan Krumsiek, Leona Cohen-Gould, Samuel Calto, Jason A Spector, Olivier Elemento, David Lyden, Kristy A Brown
Breast adipose tissue is an important contributor to the obesity-breast cancer link. Dysregulated cell metabolism is now an accepted hallmark of cancer. Extracellular vesicles (EVs) are nanosized particles containing selective cargo, such as miRNAs, that act locally or circulate to distant sites to modulate target cell functions. Here, we found that long-term education of breast cancer cells (MCF7, T47D) with EVs from breast adipose tissue of women who are overweight or obese (O-EVs) leads to sustained increased proliferative potential...
February 9, 2023: bioRxiv
#24
JOURNAL ARTICLE
Paul K Paik, Ravi K Goyal, Beilei Cai, Mark A Price, Keith L Davis, Valerie Derrien Ansquer, Nydia Caro, Teddy R Saliba
Aim: To assess real-world clinical outcomes in patients with non-small-cell lung cancer with MET exon 14 skipping mutation and brain metastases (BM) who received capmatinib, a recently approved MET inhibitor, in routine US clinical practice. Materials & methods: Patient data were collected using a retrospective medical record review, led by participating oncologists. Eligible patients initiated treatment with capmatinib in any line, after BM diagnosis, between May 2020 and June 2021. Data on real-world overall response rate (rwORR) and real-world progression-free survival (rwPFS) were descriptively analyzed...
January 2023: Future Oncology
#25
JOURNAL ARTICLE
Arielle Elkrief, Alex Makhnin, Khadeja A Moses, Linda S Ahn, Isabel R Preeshagul, Afsheen N Iqbal, Sara A Hayes, Andrew J Plodkowski, Paul K Paik, Marc Ladanyi, Mark G Kris, Gregory J Riely, Franziska Michor, Helena A Yu
PURPOSE: Primary and acquired resistance to osimertinib remain significant challenges for patients with EGFR-mutant lung cancers. Acquired EGFR alterations such as EGFR T790M or C797S mediate resistance to EGFR tyrosine kinase inhibitors (TKI) and combination therapy with dual EGFR TKIs may prevent or reverse on-target resistance. PATIENTS AND METHODS: We conducted two prospective, phase I/II trials assessing combination osimertinib and dacomitinib to address on-target resistance in the primary and acquired resistance settings...
April 14, 2023: Clinical Cancer Research
#26
JOURNAL ARTICLE
Adam Buckholz, Lindsay Clarke, Paul Paik, Arun Jesudian, Robert Schwartz, Ana Krieger, Russell Rosenblatt, Robert S Brown
BACKGROUND AND AIMS: Covert HE (CHE) is a common early stage of HE associated with poor outcomes. Available neuropsychiatric diagnostic testing is underutilized and has significant clinical limitations. Sleep deterioration is consistently associated with CHE and HE; however, objective data is sparse and it has not been studied longitudinally. We longitudinally study and describe an association of sleep metrics with CHE as detected by a commercial wearable technology. METHODS: We monitored sleep for 6 months using a commercial fitness tracker in 25 participants with cirrhosis, hypothesizing that CHE as diagnosed by psychometric testing would be associated with significant reductions in sleep quality, especially restorative sleep (deep sleep + rapid eye movement)...
February 1, 2023: Hepatology Communications
#27
JOURNAL ARTICLE
Mo Yang, Helene Vioix, Rameet Sachdev, Matthew Stargardter, Jon Tosh, Boris M Pfeiffer, Paul K Paik
OBJECTIVES: From the US Medicare perspective, this study compared the cost-effectiveness of tepotinib and capmatinib for treating metastatic NSCLC with tumors harboring mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping. METHODS: A three-state partitioned survival model assessed outcomes over a lifetime horizon. Parametric survival analysis of the Phase 2 VISION trial informed clinical inputs for tepotinib. Capmatinib inputs were captured using hazard ratios derived from an unanchored matching-adjusted indirect comparison study and published literature...
December 8, 2022: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
#28
JOURNAL ARTICLE
Calesta Hui Yi Teo, Molly Tzu-Yu Lin, Isabelle Xin Yu Lee, Siew-Kwan Koh, Lei Zhou, Dylan Shaoying Goh, Hyungwon Choi, Hiromi Wai Ling Koh, Amanda Yun Rui Lam, Paik Shia Lim, Jodhbir S Mehta, Jean-Paul Kovalik, Thomas M Coffman, Hong Chang Tan, Yu-Chi Liu
Diabetic corneal neuropathy (DCN) is a common complication of diabetes mellitus (DM). However, there are very limited therapeutic options. We investigated the effects of a peroxisome proliferator-activated receptor-alpha (PPAR)-α agonist, fenofibrate, on thirty patients (60 eyes) with type II DM. On in-vivo confocal microscopy evaluation, there was significant stimulation of corneal nerve regeneration and a reduction in nerve edema after 30 days of oral fenofibrate treatment, evidenced by the significant improvement in corneal nerve fiber density (CNFD) and corneal nerve fiber width, respectively...
November 29, 2022: Diabetes
#29
JOURNAL ARTICLE
Justin Jee, Emily S Lebow, Randy Yeh, Jeeban P Das, Azadeh Namakydoust, Paul K Paik, Jamie E Chaft, Gowtham Jayakumaran, A Rose Brannon, Ryma Benayed, Ahmet Zehir, Mark Donoghue, Nikolaus Schultz, Debyani Chakravarty, Ritika Kundra, Ramyasree Madupuri, Yonina R Murciano-Goroff, Hai-Yan Tu, Chong-Rui Xu, Andrés Martinez, Clare Wilhelm, Jesse Galle, Bobby Daly, Helena A Yu, Michael Offin, Matthew D Hellmann, Piro Lito, Kathryn C Arbour, Marjorie G Zauderer, Mark G Kris, Kenneth K Ng, Juliana Eng, Isabel Preeshagul, W Victoria Lai, John J Fiore, Afsheen Iqbal, Daniela Molena, Gaetano Rocco, Bernard J Park, Lee P Lim, Mark Li, Candace Tong-Li, Madhawa De Silva, David L Chan, Connie I Diakos, Malinda Itchins, Stephen Clarke, Nick Pavlakis, Adrian Lee, Natasha Rekhtman, Jason Chang, William D Travis, Gregory J Riely, David B Solit, Mithat Gonen, Valerie W Rusch, Andreas Rimner, Daniel Gomez, Alexander Drilon, Howard I Scher, Sohrab P Shah, Michael F Berger, Maria E Arcila, Marc Ladanyi, Ross L Levine, Ronglai Shen, Pedram Razavi, Jorge S Reis-Filho, David R Jones, Charles M Rudin, James M Isbell, Bob T Li
Circulating tumor DNA (ctDNA) sequencing guides therapy decisions but has been studied mostly in small cohorts without sufficient follow-up to determine its influence on overall survival. We prospectively followed an international cohort of 1,127 patients with non-small-cell lung cancer and ctDNA-guided therapy. ctDNA detection was associated with shorter survival (hazard ratio (HR), 2.05; 95% confidence interval (CI), 1.74-2.42; P < 0.001) independently of clinicopathologic features and metabolic tumor volume...
November 2022: Nature Medicine
#30
JOURNAL ARTICLE
Paul K Paik, Jia Luo, Ni Ai, Rachel Kim, Linda Ahn, Anup Biswas, Courtney Coker, Wanchao Ma, Phillip Wong, Darren J Buonocore, W Victoria Lai, Jamie E Chaft, Swarnali Acharyya, Joan Massagué, Mark G Kris
We previously identified a chemotherapy-induced paracrine inflammatory loop that paradoxically mitigates the anti-tumor effect of chemotherapy and triggers metastatic propagation in breast and lung cancer models. Therefore, we sought to further validate and translate these findings into patient care by coupling the anti-TNF-α drug certolizumab pegol with standard cisplatin doublet chemotherapy. Here we first validate the anti-metastatic effect of certolizumab in a liver-metastatic Lewis Lung Carcinoma model...
October 15, 2022: Nature Communications
#31
JOURNAL ARTICLE
Paul K Paik, Pang-Dian Fan, Besnik Qeriqi, Azadeh Namakydoust, Bobby Daly, Linda Ahn, Rachel Kim, Andrew Plodkowski, Ai Ni, Jason Chang, Rachel Fanaroff, Marc Ladanyi, Elisa de Stanchina, Charles M Rudin
INTRODUCTION: Increased insight into the mutational landscape of squamous cell lung cancers (LUSCs) in the past decade has not translated into effective targeted therapies for patients with this disease. NRF2, encoded by NFE2L2, and its upstream regulator, KEAP1, control key aspects of redox balance and are frequently mutated in NSCLCs. METHODS: Here, we describe the specific potent activity of TAK-228, a TORC1/2 inhibitor, in NSCLC models harboring NRF2-activating alterations and results of a phase 2 clinical trial of TAK-228 in patients with advanced NSCLC harboring NRF2-activating alterations including three cohorts (NFE2L2-mutated LUSC, KEAP1-mutated LUSC, KRAS/NFE2L2- or KEAP1-mutated NSCLC)...
October 12, 2022: Journal of Thoracic Oncology
#32
JOURNAL ARTICLE
Omid Savari, Christopher Febres-Aldana, Jason C Chang, Rachel E Fanaroff, Katia Ventura, Francis Bodd, Paul Paik, Murty Vundavalli, Anjali Saqi, Frederic B Askin, William D Travis, Natasha Rekhtman
Thyroid transcription factor 1 (TTF1) and p40 are widely-utilized diagnostic markers of lung adenocarcinoma (LUAD) and squamous cell carcinoma (LUSC), respectively. Diffuse coexpression of TTF1 and p40 has been described in only rare case reports. In a multi-institutional study, we collected the largest cohort of these unusual tumours to-date (n = 14), with the goal of elucidating their clinicopathological and genomic characteristics. Lung tumours with diffuse coexpression (labelling 50-100% tumour cells) of TTF1 clone 8G7G3/1 and p40 clone BC28 were identified...
January 2023: Histopathology
#33
JOURNAL ARTICLE
Hiroki Sato, Daisuke Kubota, Huan Qiao, Achim Jungbluth, Natasha Rekhtman, Adam J Schoenfeld, Helena A Yu, Gregory J Riely, Shinichi Toyooka, Christine M Lovly, Paul Paik, Marc Ladanyi, Pang-Dian Fan
PURPOSE: The identification of novel oncogenic driver alterations and novel mechanisms of acquired resistance (AR) is the key for further development of personalized therapy. The current study investigates the potential role of YES1 amplification as a primary driver of tumorigenesis and of YES1/YAP1 amplifications as mediators of AR to ALK and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). METHODS: Models of ectopic expression were established and characterized for YES1 and YAP1 in human bronchial epithelial cells and ALK fusion-positive (ALK+) and EGFR -mutant lung adenocarcinoma cell lines...
August 2022: JCO Precision Oncology
#34
REVIEW
Julie J Paik, Greg Lubin, Austin Gromatzky, Paul N Mudd, Manish P Ponda, Lisa Christopher-Stine
Dermatomyositis (DM) is an idiopathic inflammatory myopathy that commonly manifests with proximal muscle weakness and is associated with extramuscular pathology, including characteristic skin lesions such as Gottron's papules and heliotrope rash, as well as lung, gastrointestinal, joint, and cardiac involvement. Systemic corticosteroids are a cornerstone of therapy, and more recently intravenous immunoglobulin (IVIG; OCTAGAM®) has been approved by the US Food and Drug Administration for the treatment of adults with DM...
March 2023: Clinical and Experimental Rheumatology
#35
JOURNAL ARTICLE
Yanyu Wu, Yu Yin, Victoria Crossland, Sylvie Vincent, Paul K Paik, Neil Lineberry, Douglas V Faller
BACKGROUND: NFE2L2 and/or KEAP1 mutations are associated with worse prognosis in all non-small cell lung cancer (NSCLC). We determined real-world survival outcomes and treatment patterns among patients with advanced squamous cell NSCLC by NFE2L2 and KEAP1 mutation status. PATIENTS AND METHODS: A retrospective study (January 2011-December 2018) was conducted using a de-identified US-based clinico-genomic database. Adult patients with advanced squamous cell NSCLC with ≥ 2 in-network visits and comprehensive genomic profiling during the study period were included...
September 2022: Clinical Lung Cancer
#36
JOURNAL ARTICLE
Paul K Paik, Boris M Pfeiffer, Helene Vioix, Andrea Garcia, Maarten J Postma
INTRODUCTION: MET exon 14 skipping in patients with advanced non-small cell lung cancer (aNSCLC), can be targeted with MET inhibitors including tepotinib, capmatinib, savolitinib, and crizotinib. Matching-adjusted indirect comparison (MAIC) methodology was used to compare outcomes data between agents and to address bias from differences in baseline characteristics. METHODS: Patient-level data from the VISION study (tepotinib) were weighted for comparison with aggregate data from the GEOMETRY mono-1 (capmatinib), NCT02897479 (savolitinib) and PROFILE 1001 (crizotinib) studies in patients with aNSCLC, using baseline characteristics prognostic for overall survival (OS) in VISION...
July 2022: Advances in Therapy
#37
JOURNAL ARTICLE
Remi Veillon, Hiroshi Sakai, Xiuning Le, Enriqueta Felip, Alexis B Cortot, Egbert F Smit, Keunchil Park, Frank Griesinger, Christian Britschgi, Yi-Long Wu, Barbara Melosky, Shobhit Baijal, Gilberto de Castro Jr, Michaela Sedova, Karin Berghoff, Gordon Otto, Paul K Paik
INTRODUCTION: The MET inhibitor tepotinib demonstrated durable clinical activity in patients with advanced MET exon 14 (METex14) skipping NSCLC. We report detailed analyses of adverse events of clinical interest (AECIs) in VISION, including edema, a class effect of MET inhibitors. PATIENTS AND METHODS: Incidence, management, and time to first onset/resolution were analyzed for all-cause AECIs, according to composite categories (edema, hypoalbuminemia, creatinine increase, and ALT/AST increase) or individual preferred terms (pleural effusion, nausea, diarrhea, and vomiting), for patients with METex14 skipping NSCLC in the phase II VISION trial...
June 2022: Clinical Lung Cancer
#38
JOURNAL ARTICLE
Anup Kumar Biswas, Seoyoung Han, Yifan Tai, Wanchao Ma, Courtney Coker, S Aidan Quinn, Ahmad Rushdi Shakri, Timothy James Zhong, Hanna Scholze, Galina G Lagos, Angeliki Mela, Katia Manova-Todorova, Elisa de Stanchina, Adolfo A Ferrando, Cathy Mendelsohn, Peter Canoll, Helena A Yu, Paul K Paik, Anjali Saqi, Catherine A Shu, Mark G Kris, Joan Massague, Swarnali Acharyya
UNLABELLED: The epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) osimertinib has significantly prolonged progression-free survival (PFS) in patients with EGFR-mutant lung cancer, including those with brain metastases. However, despite striking initial responses, osimertinib-treated patients eventually develop lethal metastatic relapse, often to the brain. Although osimertinib-refractory brain relapse is a major clinical challenge, its underlying mechanisms remain poorly understood...
April 1, 2022: Cancer Discovery
#39
JOURNAL ARTICLE
Yonina R Murciano-Goroff, Terry Pak, Sebastian Mondaca, Jessica R Flynn, Joseph Montecalvo, Natasha Rekhtman, Darragh Halpenny, Andrew J Plodkowski, Stephanie L Wu, Mark G Kris, Paul K Paik, Gregory J Riely, Helena A Yu, Charles M Rudin, Matthew D Hellmann, Josiah D Land, Larry W Buie, Glenn Heller, Piro Lito, Rona Yaeger, Alexander Drilon, Dazhi Liu, Bob T Li, Michael Offin
BACKGROUND: While 2-4% of lung cancers possess alterations in BRAF, little is known about the immune responsiveness of these tumours. METHODS: Clinical and genomic data were collected from 5945 patients with lung cancers whose tumours underwent next-generation sequencing between 2015 and 2018. Patients were followed through 2020. RESULTS: In total, 127 patients with metastatic BRAF-altered lung cancers were identified: 29 tumours had Class I mutations, 59 had Class II/III alterations, and 39 had variants of unknown significance (VUS)...
December 28, 2021: British Journal of Cancer
#40
COMMENT
Xiuning Le, Lingzhi Hong, Chuck Hensel, Rongrong Chen, Haley Kemp, Niamh Coleman, Christine A Ciunci, Stephen V Liu, Marcelo V Negrao, Jennifer Yen, Xuefeng Xia, Juergen Scheuenpflug, Christopher Stroh, Dilafruz Juraeva, Anne Tsao, David Hong, Victoria Raymond, Paul Paik, Jianjun Zhang, John V Heymach
UNLABELLED: MET exon 14 skipping alterations ( MET ex14) comprise a diverse set of actionable oncogene drivers in non-small-cell lung cancer (NSCLC). Recent studies have established the efficacy of tyrosine kinase inhibitors for this patient population. The landscape of co-occurring genetic alterations in MET ex14 NSCLC and their potential impact to therapeutic sensitivities has not yet been fully described. MATERIALS AND METHODS: MET ex14 NSCLC cases were collected from three cohorts: the VISION trial, and data sets from Guardant360 and GenePlus...
2021: JCO Precision Oncology
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