Background: Nintedanib is a small molecule tyrosine kinase inhibitor (TKI) targeting vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), and fibroblast growth factor receptor (FGFR). The purpose of the study was to evaluate the response rate for patients with advanced non-small cell lung cancer (NSCLC) with mutations in , , , , and treated with nintedanib as part of an open-label, single-arm pilot study.
Methods: Patients with advanced NSCLC previously treated with platinum-doublet chemotherapy with the above mutations were enrolled. Exclusion criteria included necrotic tumors with invasion of blood vessels, history of recent thromboembolic events, increased risk of bleeding or thrombosis, myocardial infarction, and weight loss >10% within past 6 months. Nintedanib was administered at a dose of 200 mg orally twice daily until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Secondary endpoints included progression-free survival (PFS) and correlating outcomes with specific mutations. This study was registered with ClinicalTrials.gov, number NCT02299141.
Results: Between 2015 and 2019, 20 patients were enrolled with a median age was 66 years, 15 (75%) were females, 15 (75%) had adenocarcinoma, and 17 patients had a mutation (85%). Seventeen (85%) had received prior immunotherapy and 11 (55%) had received at least three prior lines of systemic therapy. The ORR was 15% with three partial responses (PR), while 12 patients had stable disease (SD), with disease control rate (DCR) consisting of a PR and SD greater than or equal to 16 weeks of 65% (n=13). Median PFS was 4.3 months [95% confidence interval (CI): 1.8-7.9] and median overall survival (OS) was 11.3 months (95% CI: 3.5-44.2). Three patients experienced prolonged clinical benefit from nintedanib, remaining on treatment for over 1 year and all three had a mutation and received prior immunotherapy. The most common adverse events of any grade included nausea (80%), fatigue (70%), diarrhea (60%), and anorexia (60%).
Conclusions: In this pilot study in heavily pretreated and molecularly selected patients with metastatic NSCLC, nintedanib showed modest activity.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11228753 | PMC |
| http://dx.doi.org/10.21037/jtd-23-1717 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Augmented prediction of vertebral collapse after osteoporotic vertebral compression fractures through parameter-efficient fine-tuning of biomedical foundation models.
Sci Rep
December 2024
Department of Medical Device Development, Seoul National University College of Medicine, Seoul, Republic of Korea.
Vertebral collapse (VC) following osteoporotic vertebral compression fracture (OVCF) often requires aggressive treatment, necessitating an accurate prediction for early intervention. This study aimed to develop a predictive model leveraging deep neural networks to predict VC progression after OVCF using magnetic resonance imaging (MRI) and clinical data. Among 245 enrolled patients with acute OVCF, data from 200 patients were used for the development dataset, and data from 45 patients were used for the test dataset.
View Article and Find Full Text PDFAttention-guided convolutional network for bias-mitigated and interpretable oral lesion classification.
Sci Rep
December 2024
Faculty of Dental Medicine and Oral Health Sciences, McGill University, Montreal, Canada.
Accurate diagnosis of oral lesions, early indicators of oral cancer, is a complex clinical challenge. Recent advances in deep learning have demonstrated potential in supporting clinical decisions. This paper introduces a deep learning model for classifying oral lesions, focusing on accuracy, interpretability, and reducing dataset bias.
View Article and Find Full Text PDFDeep learning on CT scans to predict checkpoint inhibitor treatment outcomes in advanced melanoma.
Sci Rep
December 2024
Medical Image Analysis, Department of Biomedical Engineering, Eindhoven University of Technology, Eindhoven, The Netherlands.
Immune checkpoint inhibitor (ICI) treatment has proven successful for advanced melanoma, but is associated with potentially severe toxicity and high costs. Accurate biomarkers for response are lacking. The present work is the first to investigate the value of deep learning on CT imaging of metastatic lesions for predicting ICI treatment outcomes in advanced melanoma.
View Article and Find Full Text PDFNon-operative treatment in advanced atraumatic osteonecrosis of the humeral head in patients under 50 years old: an observational study.
Sci Rep
December 2024
Department of Orthopedic Surgery, Arthroscopy and Joint Research Institute, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
The humeral head is the second most common anatomical site of osteonecrosis after the femoral head. Studies have reported satisfactory clinical outcomes after shoulder arthroplasty to treat osteonecrosis of the humeral head (ONHH). However, there are concerns regarding implant longevity in relatively young patients.
View Article and Find Full Text PDFAI allows pre-screening of FGFR3 mutational status using routine histology slides of muscle-invasive bladder cancer.
Nat Commun
December 2024
Institute of Pathology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Pathogenic activating mutations in the fibroblast growth factor receptor 3 (FGFR3) drive disease maintenance and progression in urothelial cancer. 10-15% of muscle-invasive and metastatic urothelial cancer (MIBC/mUC) are FGFR3-mutant. Selective targeting of FGFR3 hotspot mutations with tyrosine kinase inhibitors (e.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!