keyword
https://read.qxmd.com/read/38545845/inconsistency-in-steroid-use-as-antiemetics-in-clinical-trial-protocols-involving-immune-checkpoint-inhibitors-combined-with-chemotherapy
#1
JOURNAL ARTICLE
Soh Mee Park, Yu Jung Kim, Ju-Yeun Lee
OBJECTIVES: This study aims to investigate the use of steroids as antiemetics in clinical trials involving immune checkpoint inhibitors with chemotherapy. METHODS: Focusing on phase III trials registered before August 2023, it evaluated the consistency of steroid use guidelines. RESULTS: Out of 3452 trials screened, 44 were selected for in-depth review. The findings indicate a considerable variation: 13 trials did not specify the use of antiemetics, while 31 provided criteria for antiemetics, with 13 conforming to local standards, six to international guidelines, and five allowing either...
April 2024: Cancer Medicine
https://read.qxmd.com/read/38543932/nucleic-acid-vaccines-encoding-proteins-and-virus-like-particles-for-hiv-prevention
#2
REVIEW
Ferran Tarrés-Freixas, Bonaventura Clotet, Jorge Carrillo, Julià Blanco
The development of HIV prophylactic vaccines is facing an impasse, since all phase IIb/III clinical trials were halted in 2023 without demonstrating efficacy. Thus, the field is in need of developing novel immunogens and vaccination strategies that induce broadly neutralising antibodies together with potent Fc-dependent effector functions, as well as protective cross-reactive CD4+ and CD8+ T cell responses. Nucleic acid vaccines, particularly mRNA vaccines, have been one of the major groundbreaking advances in the current decade...
March 12, 2024: Vaccines
https://read.qxmd.com/read/38542278/targeting-kras-g12c-mutation-in-colorectal-cancer-a-review-new-arrows-in-the-quiver
#3
REVIEW
Javier Ros, Caterina Vaghi, Iosune Baraibar, Nadia Saoudi González, Marta Rodríguez-Castells, Ariadna García, Adriana Alcaraz, Francesc Salva, Josep Tabernero, Elena Elez
Kirsten rat sarcoma virus oncogene homolog ( KRAS ) is the most frequently mutated oncogene in human cancer. In colorectal cancer (CRC), KRAS mutations are present in more than 50% of cases, and the KRAS glycine-to-cysteine mutation at codon 12 ( KRAS G12C) occurs in up to 4% of patients. This mutation is associated with short responses to standard chemotherapy and worse overall survival compared to non-G12C mutations. In recent years, several KRAS G12C inhibitors have demonstrated clinical activity, although all patients eventually progressed...
March 14, 2024: International Journal of Molecular Sciences
https://read.qxmd.com/read/38541968/renal-al-amyloidosis-updates-on-diagnosis-staging-and-management
#4
REVIEW
Areez Shafqat, Hassan Elmaleh, Ali Mushtaq, Zaina Firdous, Omer Ashruf, Debduti Mukhopadhyay, Maheen Ahmad, Mahnoor Ahmad, Shahzad Raza, Faiz Anwer
AL amyloidosis is caused by the excessive production of nonfunctional immunoglobulins, leading to the formation of amyloid fibrils that damage vital organs, especially the heart and kidneys. AL amyloidosis presents with non-specific symptoms such as fatigue, weight loss, numbness, pain, and nephrotic syndrome. Consequently, diagnosis is often delayed, and patients typically present with advanced disease at diagnosis. The Pavia renal staging model stratifies patients based on their likelihood of progressing to dialysis...
March 18, 2024: Journal of Clinical Medicine
https://read.qxmd.com/read/38541928/fatigue-item-response-among-hemoglobin-normalized-patients-with-paroxysmal-nocturnal-hemoglobinuria-pegasus-trial-results-at-16-and-48-weeks
#5
JOURNAL ARTICLE
Carolyn E Schwartz, Katrina Borowiec, Jinny Min, Jesse Fishman
Background. A common symptom of paroxysmal nocturnal hemoglobinuria (PNH) is fatigue, which in some patients can be severe. Eculizumab (Ecu) has proven efficacy in controlling intravascular hemolysis, but commonly results in persistent anemia and fatigue. Pegcetacoplan's (Peg) efficacy was documented in the PEGASUS phase III clinical trial, showing improved hemoglobin (Hb) and patient-reported fatigue. This post-hoc analysis sought to describe this fatigue improvement related to Hb normalization using the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F)'s individual questions to speak more directly to patients' experience and clinicians' day-to-day practice...
March 15, 2024: Journal of Clinical Medicine
https://read.qxmd.com/read/38539426/venetoclax-resistance-in-acute-myeloid-leukemia
#6
REVIEW
Sylvain Garciaz, Marie-Anne Hospital, Yves Collette, Norbert Vey
Venetoclax is a BH3-mimetics agent interacting with the anti-apoptotic protein BCL2, facilitating cytochrome c release from mitochondria, subsequent caspases activation, and cell death. Venetoclax combined with azacitidine (VEN-AZA) has become a new standard treatment for AML patients unfit for intensive chemotherapy. In the phase III VIALE-A study, VEN-AZA showed a 65% overall response rate and 14.7 months overall survival in comparison with 22% and 8 months in the azacitidine monotherapy control arm. Despite these promising results, relapses and primary resistance to venetoclax are frequent and remain an unmet clinical need...
March 8, 2024: Cancers
https://read.qxmd.com/read/38538587/bayesian-interim-analysis-for-prospective-randomized-studies-reanalysis-of-the-acute-myeloid-leukemia-hovon-132-clinical-trial
#7
JOURNAL ARTICLE
Niek G van der Maas, Jurjen Versluis, Kazem Nasserinejad, Joost van Rosmalen, Thomas Pabst, Johan Maertens, Dimitri Breems, Markus Manz, Jacqueline Cloos, Gert J Ossenkoppele, Yngvar Floisand, Patrycja Gradowska, Bob Löwenberg, Gerwin Huls, Douwe Postmus, Francesco Pignatti, Jan J Cornelissen
Randomized controlled trials (RCTs) are the gold standard to establish the benefit-risk ratio of novel drugs. However, the evaluation of mature results often takes many years. We hypothesized that the addition of Bayesian inference methods at interim analysis time points might accelerate and enforce the knowledge that such trials may generate. In order to test that hypothesis, we retrospectively applied a Bayesian approach to the HOVON 132 trial, in which 800 newly diagnosed AML patients aged 18 to 65 years were randomly assigned to a "7 + 3" induction with or without lenalidomide...
March 27, 2024: Blood Cancer Journal
https://read.qxmd.com/read/38537158/impact-of-broadening-trial-eligibility-criteria-on-the-inclusion-of-patients-with-brain-metastases-in-cancer-clinical-trials-time-series-analyses-for-2012-2022
#8
JOURNAL ARTICLE
Hong Xiao, Riha Vaidya, Dawn L Hershman, Joseph M Unger
PURPOSE: In October 2017, an ASCO, Friends of Cancer Research (FoCR), and US Food and Drug Administration (ASCO/FoCR/FDA) task force recommended that common eligibility criteria be modified to make trials more inclusive. We examined whether patterns of exclusions regarding patients with brain metastases changed over time in relation to these recommendations. METHODS: Trial eligibility criteria were abstracted from ClinicalTrials.gov for phase I-III US-based interventional clinical trials for patients with advanced breast, colorectal, lung, or melanoma cancers from January 2012 to December 2022...
March 27, 2024: Journal of Clinical Oncology
https://read.qxmd.com/read/38533739/rozanolixizumab-a-new-therapy-in-the-treatment-of-myasthenia-gravis
#9
REVIEW
Emily M Hitt
OBJECTIVE: The aims of this article are to review the clinical aspects of rozanolixizumab, to describe clinical trial results that led to the drug's approval, and to examine the impact on patient care to aid clinical decision making. DATA SOURCES: A PubMed search was conducted using the terms Rystiggo ™, rozanolixizumab , rozanolixizumab therapy , and myasthenia gravis . The most recent prescribing information was also used for information relating to the drug and for identification of pertinent studies...
March 27, 2024: Annals of Pharmacotherapy
https://read.qxmd.com/read/38533633/clinical-trial-randomized-controlled-trial-of-linaclotide-in-children-aged-6-17-years-with-functional-constipation
#10
JOURNAL ARTICLE
Carlo Di Lorenzo, Samuel Nurko, Jeffrey S Hyams, Gerardo Rodriguez-Araujo, Cristina Almansa, Valentina Shakhnovich, Miguel Saps, Michael Simon
OBJECTIVES: Linaclotide, a guanylate cyclase-C agonist, was recently approved in the United States for treatment of children 6-17 years old with functional constipation (FC). This study evaluated the safety and efficacy of several linaclotide doses in children 6-17 years old with FC. METHODS: In this multicenter, randomized, double-blind, placebo-controlled phase 2 study, 173 children with FC (based on Rome III criteria) were randomized to once-daily linaclotide (A: 9 or 18 μg, B: 18 or 36 μg, or C: 36 or 72 μg) or placebo in a 1:1:1:1 ratio for 6- to 11-year-olds (dosage determined by weight: 18 to <35 or ≥35 kg) and linaclotide (18, 36, 72, or 145 μg) or placebo in a 1:1:1:1:1 ratio for 12- to 17-year-olds...
March 27, 2024: Journal of Pediatric Gastroenterology and Nutrition
https://read.qxmd.com/read/38533530/are-measures-and-related-symptoms-of-cachexia-recorded-as-outcomes-in-gastrointestinal-cancer-chemotherapy-clinical-trials
#11
JOURNAL ARTICLE
Ross Valaire, Frances Garden, Valentina Razmovski-Naumovski
BACKGROUND: Cachexia is prevalent in gastrointestinal cancers and worsens patient outcomes and chemotherapy compliance. We examined to what extent registered gastrointestinal cancer chemotherapy clinical trials record measures and related symptoms of cachexia as outcomes, and whether these were associated with trial characteristics. METHODS: Four public trial registries (2012-2022) were accessed for Phase II and/or III randomized controlled pancreatic, gastric, and colorectal cancer chemotherapy trial protocols...
March 27, 2024: Journal of Cachexia, Sarcopenia and Muscle
https://read.qxmd.com/read/38533502/5-6-dimethylxanthenone-4-acetic-acid-dmxaa-a-partial-sting-agonist-competes-for-human-sting-activation
#12
JOURNAL ARTICLE
Burcu Temizoz, Takayuki Shibahara, Kou Hioki, Tomoya Hayashi, Kouji Kobiyama, Michelle Sue Jann Lee, Naz Surucu, Erdal Sag, Atsushi Kumanogoh, Masahiro Yamamoto, Mayda Gursel, Seza Ozen, Etsushi Kuroda, Cevayir Coban, Ken J Ishii
5,6-dimethylxanthenone-4-acetic acid (DMXAA) is a mouse-selective stimulator of interferon gene (STING) agonist exerting STING-dependent anti-tumor activity. Although DMXAA cannot fully activate human STING, DMXAA reached phase III in lung cancer clinical trials. How DMXAA is effective against human lung cancer is completely unknown. Here, we show that DMXAA is a partial STING agonist interfering with agonistic STING activation, which may explain its partial anti-tumor effect observed in humans, as STING was reported to be pro-tumorigenic for lung cancer cells with low antigenicity...
2024: Frontiers in Immunology
https://read.qxmd.com/read/38530074/certolizumab-pegol-in-the-treatment-of-axial-spondyloarthritis
#13
REVIEW
Elizabeth Anderson, Secia Beier, Julianna Desmarais
Axial spondyloarthritis is a chronic, immune-mediated systemic inflammatory disease encompassing ankylosing spondylitis and nonradiographic axial spondyloarthritis. TNF inhibitors are the preferred second line therapy for patients with active axial spondyloarthritis. Certolizumab pegol is a TNF inhibitor approved for treatment of both. Three large phase III trials (RAPID-axSpA, C-axSpAnd and C-OPTIMISE) and one large phase IV trial (CIMAX) establish its clinical efficacy in treatment of active disease and maintenance of remission for both diseases...
March 26, 2024: Immunotherapy
https://read.qxmd.com/read/38529687/the-feasibility-and-acceptability-of-an-app-based-intervention-with-brief-behavioural-support-approach-to-promote-brisk-walking-in-people-diagnosed-with-breast-prostate-and-colorectal-cancer-in-the-uk
#14
JOURNAL ARTICLE
Phillippa Lally, Fiona Kennedy, Susan Smith, Rebecca J Beeken, Caroline Buck, Chloe Thomas, Nicholas Counsell, Lynda Wyld, Charlene Martin, Sarah Williams, Anna Roberts, Diana M Greenfield, Jacqui Gath, Henry W W Potts, Nicholas Latimer, Lee Smith, Abi Fisher
INTRODUCTION: Increased moderate to vigorous physical activity (MVPA) can improve clinical and psychosocial outcomes for people living with and beyond cancer (LWBC). This study aimed to assess the feasibility and acceptability of trial procedures in a pilot randomised controlled trial (RCT) of a theory-driven app-based intervention with behavioural support focused on promoting brisk walking (a form of MVPA) in people LWBC (APPROACH). METHODS: Participants diagnosed with breast, prostate or colorectal cancer were recruited from a single UK hospital site...
March 2024: Cancer Medicine
https://read.qxmd.com/read/38528257/early-and-sustained-improvements-in-symptoms-and-quality-of-life-with-upadacitinib-in-adults-and-adolescents-with-moderate-to-severe-atopic-dermatitis-52-week-results-from-two-phase-iii-randomized-clinical-trials-measure-up-1-and-measure%C3%A2-up%C3%A2-2
#15
JOURNAL ARTICLE
Jonathan I Silverberg, Melinda J Gooderham, Amy S Paller, Mette Deleuran, Christopher G Bunick, Linda F Stein Gold, DirkJan Hijnen, Brian M Calimlim, Wan-Ju Lee, Henrique D Teixeira, Xiaofei Hu, Shiyu Zhang, Yang Yang, Ayman Grada, Andrew M Platt, Diamant Thaçi
BACKGROUND: Atopic dermatitis is a chronic inflammatory disease characterized by increased itch, skin pain, poor sleep quality, and other symptoms that negatively affect patient quality of life. Upadacitinib, an oral selective Janus kinase (JAK) inhibitor with greater inhibitory potency for JAK1 than JAK2, JAK3, or tyrosine kinase 2, is approved to treat moderate-to-severe atopic dermatitis. OBJECTIVE: We aimed to evaluate the effect of upadacitinib on patient-reported outcomes over 52 weeks in adults and adolescents with moderate-to-severe atopic dermatitis...
March 25, 2024: American Journal of Clinical Dermatology
https://read.qxmd.com/read/38527258/treatment-of-stage-iii-resectable-melanoma-adjuvant-and-neoadjuvant-approaches
#16
JOURNAL ARTICLE
Ahmad A Tarhini, Ella Castellano, Islam Eljilany
Patients with stage III resectable melanoma carry a high risk of melanoma recurrence that ranges from approximately 40% to 90% at 5 years following surgical management alone. Postoperative systemic adjuvant therapy targets residual micrometastatic disease that could be the source of future recurrence and death from melanoma. Randomized phase III adjuvant trials reported significant improvements in overall survival with high-dose interferon α in 2 of 3 studies (compared with observation and GMK ganglioside vaccine) and with anti-cytotoxic T-lymphocyte antigen 4 ipilimumab at 10 mg/kg compared with placebo and ipilimumab 3 mg/kg compared with high-dose interferon α...
March 2024: Cancer Journal
https://read.qxmd.com/read/38524632/effectiveness-and-safety-of-glucagon-like-peptide-1-receptor-agonists-in-patients-with-type-2-diabetes-evidence-from-a-retrospective-real-world-study
#17
JOURNAL ARTICLE
Yan Jiang, Han-Sheng Bai, Guo-Xin Liu, Shi-Yi Wang, Li Yin, Zhao-Ting Hou, Chen-Yang Zhao, Guang-Jun Fan
INTRODUCTION: Global phase III clinical trials have shown superior hypoglycemic efficacy to insulin and other oral hypoglycemic agents. However, there is a scarcity of real-world data comparing different glucagon-like peptide 1 receptor agonist (GLP-1RA) directly. This study aimed to assess the safety and effectiveness of various GLP-1RA in treating type 2 diabetes mellitus (T2DM) in a real-world clinical setting and identify predictive factors for favorable treatment outcomes. METHODS: This was a retrospective, single-center, real-world study...
2024: Frontiers in Endocrinology
https://read.qxmd.com/read/38523553/nomogram-for-predicting-pathological-response-to-neoadjuvant-treatment-in-patients-with-locally-advanced-gastric-cancer-data-from-a-phase-iii-clinical-trial
#18
JOURNAL ARTICLE
Han Shao, Nai Li, Yi-Hong Ling, Ji-Jin Wang, Yi Fang, Ming Jing, Zhi-Wei Zhou, Yu-Jing Zhang
PURPOSE: This study aimed to establish a nomogram using routinely available clinicopathological parameters to predict the pathological response in patients with locally advanced gastric cancer (LAGC) undergoing neoadjuvant treatment. MATERIALS AND METHODS: We conducted this study based on the ongoing Neo-CRAG trial, a prospective study focused on preoperative treatment in patients with LAGC. A total of 221 patients who underwent surgery following neoadjuvant chemotherapy (nCT) or neoadjuvant chemoradiotherapy (nCRT) at Sun Yat-sen University Cancer Center between June 2013 and July 2022 were included in the analysis...
March 2024: Cancer Medicine
https://read.qxmd.com/read/38521641/toward-a-comprehensive-supportive-care-intervention-for-older-men-with-metastatic-prostate-cancer-topcop3-a-pilot-randomized-controlled-trial-and-process-evaluation
#19
JOURNAL ARTICLE
Shabbir M H Alibhai, Martine Puts, Rana Jin, Kian Godhwani, Maryjo Antonio, Soha Abdallah, Gregory Feng, Monika K Krzyzanowska, Enrique Soto-Perez-de-Celis, Efthymios Papadopoulos, Calvin Mach, Ferozah Nasiri, Srikala S Sridhar, Rachel Glicksman, Lesley Moody, Jacqueline Bender, Hance Clarke, Andrew Matthew, Dennis McIntosh, Winston Klass, Urban Emmenegger
INTRODUCTION: Current management of metastatic prostate cancer (mPC) includes androgen receptor axis-targeted therapy (ARATs), which is associated with substantial toxicity in older adults. Geriatric assessment and management and remote symptom monitoring have been shown to reduce toxicity and improve quality of life in patients undergoing chemotherapy, but their efficacy in patients being treated with ARATs has not been explored. The purpose of this study is to examine whether these interventions, alone or in combination, can improve treatment tolerability and quality of life (QOL) for older adults with metastatic prostate cancer on ARATs...
March 22, 2024: Journal of Geriatric Oncology
https://read.qxmd.com/read/38521086/pembrolizumab-or-placebo-with-chemoradiotherapy-followed-by-pembrolizumab-or-placebo-for-newly-diagnosed-high-risk-locally-advanced-cervical-cancer-engot-cx11-gog-3047-keynote-a18-a-randomised-double-blind-phase-3-clinical-trial
#20
JOURNAL ARTICLE
Domenica Lorusso, Yang Xiang, Kosei Hasegawa, Giovanni Scambia, Manuel Leiva, Pier Ramos-Elias, Alejandro Acevedo, Vladyslav Sukhin, Noelle Cloven, Andrea J Pereira de Santana Gomes, Fernando Contreras Mejía, Ari Reiss, Ali Ayhan, Jung-Yun Lee, Valeriya Saevets, Flora Zagouri, Lucy Gilbert, Jalid Sehouli, Ekkasit Tharavichitkul, Kristina Lindemann, Roberta Lazzari, Chih-Long Chang, Rudolf Lampé, Hong Zhu, Ana Oaknin, Melissa Christiaens, Stephan Polterauer, Tomoka Usami, Kan Li, Karin Yamada, Sarper Toker, Stephen M Keefe, Sandro Pignata, Linda R Duska
BACKGROUND: Pembrolizumab has shown efficacy in persistent, recurrent, or metastatic cervical cancer. The effect of chemoradiotherapy might be enhanced by immunotherapy. In this phase 3 trial, we assessed the efficacy and safety of adding pembrolizumab to chemoradiotherapy in locally advanced cervical cancer. METHODS: In this randomised, double-blind, placebo-controlled, phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 clinical trial, adults (age ≥18 years) at 176 medical centres in 30 countries with newly diagnosed, high-risk, locally advanced cervical cancer were randomly assigned (1:1) using an interactive voice-response system with integrated web response to receive 5 cycles of pembrolizumab (200 mg) or placebo every 3 weeks plus chemoradiotherapy, followed by 15 cycles of pembrolizumab (400 mg) or placebo every 6 weeks...
March 20, 2024: Lancet
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