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JOURNAL ARTICLE
Niklas Klümper, Ngoc Khanh Tran, Stefanie Zschäbitz, Oliver Hahn, Thomas Büttner, Florian Roghmann, Christian Bolenz, Friedemann Zengerling, Constantin Schwab, Dora Nagy, Marieta Toma, Glen Kristiansen, Hendrik Heers, Philipp Ivanyi, Günter Niegisch, Camilla Marisa Grunewald, Christopher Darr, Arian Farid, Katrin Schlack, Mahmoud Abbas, Can Aydogdu, Jozefina Casuscelli, Theresa Mokry, Michael Mayr, Dora Niedersüß-Beke, Steffen Rausch, Dimo Dietrich, Jonas Saal, Jörg Ellinger, Manuel Ritter, Abdullah Alajati, Christoph Kuppe, Joshua Meeks, Francisco E Vera Badillo, J Alberto Nakauma-González, Joost Boormans, Kerstin Junker, Arndt Hartmann, Viktor Grünwald, Michael Hölzel, Markus Eckstein
PURPOSE: The anti-NECTIN4 antibody-drug conjugate enfortumab vedotin (EV) is approved for patients with metastatic urothelial cancer (mUC). However, durable benefit is only achieved in a small, yet uncharacterized patient subset. NECTIN4 is located on chromosome 1q23.3, and 1q23.3 gains represent frequent copy number variations (CNVs) in urothelial cancer. Here, we aimed to evaluate NECTIN4 amplifications as a genomic biomarker to predict EV response in patients with mUC. MATERIALS AND METHODS: We established a NECTIN4 -specific fluorescence in situ hybridization (FISH) assay to assess the predictive value of NECTIN4 CNVs in a multicenter EV-treated mUC patient cohort (mUC-EV, n = 108)...
April 24, 2024: Journal of Clinical Oncology
#2
REVIEW
Soomin Ahn, Yoonjin Kwak, Gui Young Kwon, Kyoung-Mee Kim, Moonsik Kim, Hyunki Kim, Young Soo Park, Hyeon Jeong Oh, Kyoungyul Lee, Sung Hak Lee, Hye Seung Lee
Nivolumab plus chemotherapy in the first-line setting has demonstrated clinical efficacy in patients with human epidermal growth factor receptor 2-negative advanced or metastatic gastric cancer, and is currently indicated as a standard treatment. Programmed death-ligand 1 (PD-L1) expression is an important biomarker for predicting response to anti-programmed death 1/PD-L1 agents in several solid tumors, including gastric cancer. In the CheckMate-649 trial, significant clinical improvements were observed in patients with PD-L1 combined positive score (CPS) ≥ 5, determined using the 28-8 pharmDx assay...
April 25, 2024: Journal of Pathology and Translational Medicine
#3
JOURNAL ARTICLE
J Remon, E Auclin, L Zubiri, S Schneider, D Rodriguez-Abreu, N Minatta, O Gautschi, F Aboubakar, E Muñoz-Couselo, T Pierret, S I Rothschild, F Cortiula, K L Reynolds, C Thibault, A Gavralidis, N Blais, F Barlesi, D Planchard, B M D Besse
BACKGROUND: Patients with solid organ transplant (SOT) and solid tumors are usually excluded from clinical trials testing immune checkpoint blockers (ICB). As transplant rates are increasing, we aimed to evaluate ICB outcomes in this population, with a special focus on lung cancer. METHODS: We conducted a multicenter retrospective cohort study collecting real data of ICB use in patients with SOT and solid tumors. Clinical data and treatment outcomes were assessed by using retrospective medical chart reviews in every participating center...
April 22, 2024: ESMO Open
#4
JOURNAL ARTICLE
Aditya Bardia, Ian E Krop, Takahiro Kogawa, Dejan Juric, Anthony W Tolcher, Erika P Hamilton, Toru Mukohara, Aaron Lisberg, Toshio Shimizu, Alexander I Spira, Junji Tsurutani, Senthil Damodaran, Kyriakos P Papadopoulos, Jonathan Greenberg, Fumiaki Kobayashi, Hong Zebger-Gong, Rie Wong, Yui Kawasaki, Tadakatsu Nakamura, Funda Meric-Bernstam
PURPOSE: Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate consisting of a humanized antitrophoblast cell-surface antigen 2 (TROP2) monoclonal antibody linked to a potent, exatecan-derived topoisomerase I inhibitor payload via a plasma-stable, selectively cleavable linker. PATIENTS AND METHODS: TROPION-PanTumor01 (ClinicalTrials.gov identifier: NCT03401385) is a phase I, dose-escalation, and dose-expansion study evaluating Dato-DXd in patients with previously treated solid tumors...
April 23, 2024: Journal of Clinical Oncology
#5
JOURNAL ARTICLE
Li Xu, Jinzhang Chen, Chang Liu, Xiaoling Song, Yanqiao Zhang, Haitao Zhao, Sheng Yan, Weidong Jia, Zheng Wu, Yabing Guo, Jiayin Yang, Wei Gong, Yue Ma, Xiaobo Yang, Zhenzhen Gao, Nu Zhang, Xin Zheng, Mengyu Li, Dan Su, Minshan Chen
BACKGROUND: Lenvatinib is widely used in treatment of unresectable hepatocellular carcinoma (uHCC), but the benefit of its combination with immunotherapy needs to be verified. This study evaluated the efficacy and safety of tislelizumab plus lenvatinib in systemic treatment-naïve patients with uHCC. METHODS: In this multicenter, single-arm, phase 2 study, systemic treatment-naïve patients with uHCC received tislelizumab 200 mg every three weeks plus lenvatinib (bodyweight ≥ 60 kg: 12 mg; < 60 kg: 8 mg; once daily)...
April 23, 2024: BMC Medicine
#6
JOURNAL ARTICLE
Pierre Tricarico, David Chardin, Nicolas Martin, Sara Contu, Florent Hugonnet, Josiane Otto, Olivier Humbert
PURPOSE: Because of atypical response imaging patterns in patients with metastatic non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors (ICPIs), new biomarkers are needed for a better monitoring of treatment efficacy. The aim of this prospective study was to evaluate the prognostic value of volume-derived positron-emission tomography (PET) parameters on baseline and follow-up 18 F-fluoro-deoxy-glucose PET (18 F-FDG-PET) scans and compare it with the conventional PET Response Criteria in Solid Tumors (PERCIST)...
April 22, 2024: Journal for Immunotherapy of Cancer
#7
JOURNAL ARTICLE
Mayuri Charnalia, Supriya Chopra, Jaahid Mulani, Palak Popat, Sushmita Rath, Maarten Thomeer, Prachi Mittal, Ankita Gupta, Ingrid Boere, Sudeep Gupta, Remi A Nout
OBJECTIVE: To investigate differences in standard clinico-radiological evaluation versus Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for reporting survival outcomes in patients with locally advanced cervical cancer treated with chemoradiation and brachytherapy. METHODS: Between November 2017 and March 2020, patients recruited in cervical cancer trials were identified. MRI at diagnosis and at least one follow-up imaging was mandatory. Disease-free survival and progression-free survival were determined using standard evaluation (clinical examination and symptom-directed imaging) and RECIST 1...
April 22, 2024: International Journal of Gynecological Cancer
#8
Andras Heczey, David Steffin, Nisha Ghatwai, Antonino Montalbano, Purva Rathi, Amy Courtney, Azlann Arnett, Julien Fleurence, Ramy Sweidan, Tao Wang, Huimin Zhang, Prakash Masand, John Maris, Dan Martinez, Jennier Pogoriler, Navin Varadarajan, Sachin Thakkar, Deborah Lyon, Natasha Lapteva, Mei Zhuyong, Kalyani Patel, Dolores Lopez-Terrada, Carlos Ramos, Premal Lulla, Tannaz Armaghany, Bambi Grilley, Gianpietro Dotti, Leonid Metelitsa, Helen Heslop, Malcolm Brenner, Pavel Sumazin
Interleukin-15 (IL15) promotes the survival of T lymphocytes and enhances the antitumor properties of CAR T cells in preclinical models of solid neoplasms in which CAR T cells have limited efficacy1-4. Glypican-3 (GPC3) is expressed in a group of solid cancers5-10, and here we report the first evaluation in humans of the effects of IL15 co-expression on GPC3-CAR T cells. Cohort 1 patients (NCT02905188/NCT02932956) received GPC3-CAR T cells, which were safe but produced no objective antitumor responses and reached peak expansion at two weeks...
April 3, 2024: Research Square
#9
JOURNAL ARTICLE
Claire Miller, Roberto Sommavilla, Cindy L O'Bryant, Minal Barve, Afshin Dowlati, Jason J Luke, Mahmuda Khatun, Thomas Morris, Marie Cullberg
PURPOSE: Capivasertib, a potent, selective inhibitor of all three AKT serine/threonine kinase (AKT) isoforms, is being evaluated in phase 3 trials in advanced breast and prostate cancer. This study evaluated the drug-drug interaction risk of capivasertib with the cytochrome P450 3A substrate midazolam in previously treated adults with advanced solid tumors. METHODS: Patients received oral capivasertib 400 mg twice daily (BID) on an intermittent schedule (4 days on/3 days off) starting on day 2 of cycle 1 (29 days) and on day 1 of each 28-day cycle thereafter...
April 20, 2024: Cancer Chemotherapy and Pharmacology
#10
JOURNAL ARTICLE
Sophia Frentzas, Anna Rachelle Austria Mislang, Charlotte Lemech, Adnan Nagrial, Craig Underhill, Wenjing Wang, Zhongmin Maxwell Wang, Baiyong Li, Yu Xia, Jermaine I G Coward
BACKGROUND: Studies showed that vascular endothelial growth factor (VEGF) inhibitors could improve therapeutic efficacy of PD-1/PD-L1 antibodies by transforming the immunosuppressive tumor microenvironment (TME) into an immunoresponsive TME. Ivonescimab is a first-in-class, humanized tetravalent bispecific antibody targeting PD-1 and VEGF-A simultaneously. Here, we report the first-in-human, phase 1a study of ivonescimab in patients with advanced solid tumors. METHODS: Patients with advanced solid tumors were treated with ivonescimab 0...
April 19, 2024: Journal for Immunotherapy of Cancer
#11
JOURNAL ARTICLE
Yuankui Zhu, Ke Wang, Linghe Yue, Dianbao Zuo, Junfeng Sheng, Sina Lan, Zilong Zhao, Shuang Dong, Sheng Hu, Chen Xin, Mingqian Feng
Chimeric antigen receptor (CAR)-modified T cell therapy has achieved remarkable efficacy in treating hematological malignancies, but it confronts many challenges in treating solid tumors, such as the immunosuppressive microenvironment of the solid tumors. These factors reduce the antitumor activity of CAR-T cells in clinical trials. Therefore, we used the immunocytokine interleukin-12(IL-12) to enhance the efficacy of CAR-T cell therapy. In this study, we engineered CAR-IL12R54 T cells that targeted mesothelin (MSLN) and secreted a single-chain IL-12 fused to a scFv fragment R54 that recognized a different epitope on mesothelin...
April 17, 2024: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
#12
JOURNAL ARTICLE
J Rodon, E Rodriguez, M L Maitland, F Y-C Tsai, M A Socinski, J D Berlin, J S Thomas, T Al Baghdadi, I-M Wang, C Guo, M Golmakani, L N Clark, M Gazdoiu, M Li, A W Tolcher
BACKGROUND: Protein arginine methyltransferase 5 (PRMT5) methylates multiple substrates dysregulated in cancer, including spliceosome machinery components. PF-06939999 is a selective small-molecule PRMT5 inhibitor. PATIENTS AND METHODS: This phase I dose-escalation and -expansion trial (NCT03854227) enrolled patients with selected solid tumors. PF-06939999 was administered orally once or twice a day (q.d./b.i.d.) in 28-day cycles. The objectives were to evaluate PF-06939999 safety and tolerability to identify maximum tolerated dose (MTD) and recommended part 2 dose (RP2D), and assess pharmacokinetics (PK), pharmacodynamics [changes in plasma symmetric dimethylarginine (SDMA) levels], and antitumor activities...
April 18, 2024: ESMO Open
#13
REVIEW
Biqing Chen, Jiaqi Liu
Ovarian cancer ranks as the seventh most prevalent cancer among women and is considered the most lethal gynecological malignancy on a global scale. The absence of reliable screening techniques, coupled with the insidious onset of nonspecific symptoms, often results in a delayed diagnosis, typically at an advanced stage characterized by peritoneal involvement. Management of advanced tumors typically involves a combination of chemotherapy and cytoreductive surgery. However, the therapeutic arsenal for ovarian cancer patients remains limited, highlighting the unmet need for precise, targeted, and sustained-release pharmacological agents...
April 18, 2024: International Immunopharmacology
#14
JOURNAL ARTICLE
Guangshu Zhang, Guizhen Su
OBJECTIVE: Cervical cancer remains a major health concern globally, and combined modality treatment often includes radiotherapy or concurrent chemoradiotherapy. Recently, recombinant human adenovirus-p53 (rAd-p53) has been introduced as a promising agent in treatment of cervical cancer. METHODS: We conducted a systematic review and meta-analysis following the PRISMA guidelines. RCTs were identified through electronic databases without limitations on time or language...
April 18, 2024: Alternative Therapies in Health and Medicine
#15
JOURNAL ARTICLE
Toshihiro Nakao, Mitsuo Shimada, Kozo Yoshikawa, Takuya Tokunaga, Masaaki Nishi, Hideya Kashihara, Chie Takasu, Yuma Wada, Toshiaki Yoshimoto
BACKGROUND: It has been reported that the oral and gut microbiomes are associated with the prognosis in patients who undergo surgery, chemotherapy, and radiation for colorectal cancer. This study is the first to identify a correlation between the number of healthy teeth, which is an oral health indicator, and the efficacy of preoperative chemotherapy for rectal cancer. METHODS: This retrospective single-center study included 30 patients who underwent radical surgery after preoperative chemoradiotherapy (CRT) between December 2013 and June 2021...
April 18, 2024: American Surgeon
#16
JOURNAL ARTICLE
Erica C Nakajima, Amber Simpson, Jan Bogaerts, Elisabeth G E de Vries, Richard Do, Elena Garalda, Greg Goldmacher, Paul E Kinahan, Philippe Lambin, Barbara LeStage, Qin Li, Frank Lin, Saskia Litière, Raquel Perez-Lopez, Nicholas Petrick, Lawrence Schwartz, Lesley Seymour, Lalitha Shankar, Scott A Laurie
Radiomics, the science of extracting quantifiable data from routine medical images, is a powerful tool that has many potential applications in oncology. The Response Evaluation Criteria in Solid Tumors Working Group (RWG) held a workshop in May 2022, which brought together various stakeholders to discuss the potential role of radiomics in oncology drug development and clinical trials, particularly with respect to response assessment. This article summarizes the results of that workshop, reviewing radiomics for the practicing oncologist and highlighting the work that needs to be done to move forward the incorporation of radiomics into clinical trials...
April 2024: JCO Precision Oncology
#17
JOURNAL ARTICLE
Shreya Shalimar Datta Gupta, Shamim A Shamim, Shivanand Gamanagatti, Priyanka Gupta, Maroof A Khan, Madhav B Mallia, Viju Chirayil, Ashutosh Dash, Chandrasekhar Bal
OBJECTIVE: Hepatocellular carcinoma (HCC) with portal vein thrombosis (PVT) have limited therapeutic options, Re-188 lipiodol transarterial therapy being one of them. We aimed to assess the safety and efficacy of Re-188 lipiodol exclusively in HCC with PVT as well as to compare two chelating agents for the synthesis of Re-188 lipiodol: novel bis-(diethyldithiocarbamato) nitrido (N-DEDC) with existing acetylated 4-hexadecyl 1-2,9,9-tetramethyl-4,7-diaza-1,10-decanethiol [(A)HDD]. METHODS: Patients with radiological diagnosis of HCC with PVT having Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and Child Pugh score (PS) A or B were recruited...
April 5, 2024: Nuclear Medicine Communications
#18
JOURNAL ARTICLE
Jon Zugazagoitia, Handerson Osma, Javier Baena, Álvaro C Ucero, Luis Paz-Ares
Platinum-based chemotherapy plus PD-1 axis blockade is the standard of care in the front-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Despite the robust and consistent increase of long-term survival with PD-1 axis inhibition, the magnitude of the benefit from immunotherapy appears lower as compared to other solid tumors. Several immune evasive mechanisms have been shown to be prominently altered in human SCLC, including, among others, T cell exclusion, downregulation of components of the MHC-class I antigen processing and presentation machinery, or upregulation of macrophage inhibitory checkpoints...
April 17, 2024: Clinical Cancer Research
#19
JOURNAL ARTICLE
Neeltje Steeghs, Carlos Gomez-Roca, Kristoffer S Rohrberg, Morten Mau-Sørensen, Debbie Robbrecht, Josep Tabernero, Samreen Ahmed, Maria E Rodriguez-Ruiz, Caroline Ardeshir, Daniela Schmid, Nassim Sleiman, Carl Watson, Hanna Piper-Lepoutre, David Dejardin, Stefan Evers, Christophe Boetsch, Jehad Charo, Volker Teichgräber, Ignacio Melero
PURPOSE: Simlukafusp alfa (FAP-IL2v), a tumor-targeted immunocytokine, comprising an interleukin-2 variant moiety with abolished CD25 binding fused to human immunoglobulin G1, is directed against fibroblast activation protein-α. This phase I, open-label, multicenter, dose-escalation and extension study (NCT02627274) evaluated the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of FAP-IL2v in patients with advanced/metastatic solid tumors. METHODS: Participants received FAP-IL2v intravenously once weekly...
April 17, 2024: Clinical Cancer Research
#20
JOURNAL ARTICLE
Birgit S Geurts, Laurien J Zeverijn, Lindsay V M Leek, Jade M van Berge Henegouwen, Louisa R Hoes, Hanneke van der Wijngaart, Vincent van der Noort, Joris van de Haar, Annemiek van Ommen-Nijhof, Marleen Kok, Paul Roepman, Anne M L Jansen, Wendy W J de Leng, Maja J A de Jonge, Ann Hoeben, Carla M L van Herpen, Hans M Westgeest, Lodewyk F A Wessels, Henk M W Verheul, Hans Gelderblom, Emile E Voest
PURPOSE: To evaluate efficacy of pembrolizumab across multiple cancer types harboring different levels of Whole-Genome Sequencing (WGS)-based tumor mutational load (TML; total of non-synonymous mutations across the genome) in patients included in the Drug Rediscovery Protocol (NCT02925234). PATIENTS AND METHODS: Patients with solid, treatment-refractory, microsatellite-stable tumors were enrolled in cohort A: breast cancer TML 140-290, cohort B: tumor-agnostic cohort TML 140-290, and cohort C: tumor-agnostic cohort TML >290...
April 17, 2024: Clinical Cancer Research
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