Background: Oncology research is increasingly adopting new clinical trial models that implement the concept of precision medicine. One of these is the basket clinical trial design. Basket clinical trials allow new treatments to be evaluated across multiple tumor types. Patients recruited to basket clinical trials share certain molecular characteristics of their cancer that are predictive of clinical benefit from the experimental treatment.
Objective: Our aim was to describe the risks and benefits of basket clinical trials in oncology.
Methods: Our study was prospectively registered in PROSPERO (CRD42023406401). We systematically searched PubMed, Embase, and ClinicalTrials.gov for reports of basket clinical trials in oncology published between 1 January, 2001, and 14 June, 2023. We measured the risk by treatment-related adverse events (grades 3, 4, and 5), and the benefit by objective response rate. We also extracted and analyzed data on progression-free survival and overall survival. When possible, data were meta-analyzed.
Results: We included 126 arms of 75 basket clinical trials accounting for 7659 patients. The pooled objective response rate was 18.0% (95% confidence interval [CI] 14.8-21.1). The rate of treatment-related death was 0.7% (95% CI 0.4-1.0), while 30.4% (95% CI 24.2-36.7) of patients experienced grade 3/4 drug-related toxicity. The median progression-free survival was 3.1 months (95% CI 2.6-3.9), and the median overall survival was 8.9 months (95% CI 6.7-10.2).
Conclusions: Our results provide an empirical basis for communicating about the risks and benefits of basket clinical trials and for refining new models of clinical trials applied in precision medicine.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1007/s11523-024-01107-3 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Durvalumab and tremelimumab in patients with advanced rare cancer: a multi-centre, non-blinded, open-label phase II basket trial.
EClinicalMedicine
January 2025
Canadian Cancer Trials Group, Queen's University, Kingston, ON, Canada.
Background: Dual inhibition of cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and programmed death ligand 1 (PD-L1) has been shown to be an effective treatment strategy in many cancers. We sought to determine the objective response rate of combination durvalumab (D) plus tremelimumab (TM) in parallel cohorts of patients with carefully selected rare cancer types in which these agents had not previously been evaluated in phase II trials and for which there was clinical or biological rationale for dual immune checkpoint inhibitor therapy to be active.
Methods: We designed a multi-centre, non-blinded, open-label phase II basket trial with each of the following 8 rare cancers considered a separate phase II trial: salivary carcinoma, carcinoma of unknown primary (CUP) with tumour infiltrating lymphocytes and/or expressing PD-L1, mucosal melanoma, acral melanoma, osteosarcoma, undifferentiated pleomorphic sarcoma, clear cell carcinoma of the ovary (CCCO) or squamous cell carcinoma of the anal canal (SCCA).
Utilizing the Ellik bladder evacuator during cystoscopic retrieval of urocystoliths in 12 dogs.
J Vet Intern Med
December 2024
North Carolina Veterinary Hospital, College of Veterinary Medicine, North Carolina State University, Raleigh, North Carolina, USA.
Background: Urocystolithiasis is a common problem in dogs; many canine uroliths are resistant to medical dissolution. Novel management options would expand, and in some cases improve, current urolith retrieval strategies.
Hypothesis/objectives: To describe a previously unreported technique by the Ellik bladder evacuator (EE) to assist in minimally invasive, cystoscopic retrieval of canine cystoliths.
If it is a solid tumor target, then it may be a hematologic cancer target: Bridging the great divide.
Med
December 2024
Division of Hematology and Oncology, Medical College of Wisconsin, Milwaukee, WI, USA; WIN Consortium, Paris, France; University of Nebraska, Omaha, NE, USA. Electronic address:
Tumor-agnostic US Food and Drug Administration approvals are transforming oncology. They include larotrectinib/entrectinib/repotrectinib (NTRK fusions), selpercatinib (RET fusions), dabrafenib/trametinib (BRAF mutations), pembrolizumab/dostarlimab (microsatellite instability), pembrolizumab (high tumor mutational burden), and trastuzumab deruxtecan (HER2 3+ expression) (all solid cancers). Pemigatinib is approved for FGFR1-rearranged myeloid/lymphoid neoplasms.
View Article and Find Full Text PDFStigma among ebola disease survivors in Mubende and Kassanda districts, Central Uganda, 2022.
PLOS Glob Public Health
December 2024
Division of Global Health Protection, US Centers for Disease Control and Prevention, Kampala, Uganda.
Ebola disease survivors often experience stigma in multiple forms, including felt (perceived) stigma, enacted (action-based) stigma, and institutional stigma. On September 20, 2022, Uganda declared a Sudan Virus Disease (species orthoebolavirus sudanense) outbreak after a patient with confirmed Sudan virus (SUDV) infection was identified in Mubende District. The outbreak led to 142 confirmed and 22 probable cases over the next two months.
View Article and Find Full Text PDFFrom the valve to the basket: facilitated balloon valvuloplasty for palliative treatment of severe calcified mitral valve stenosis.
Can J Cardiol
December 2024
GMV Care & Research, Maria Cecilia Hospital, Cotignola, Italy.
Mitral annular calcification (MAC) is a chronic degenerative process linked to increased cardiovascular disease and mortality. In patients with degenerative mitral stenosis (DMS), management is typically pharmacological until severe symptoms arise, with surgery often deemed too high-risk. Balloon valvuloplasty has never been a viable option due to the extensive mitral calcifications of DMS anatomies; however, lithotripsy-assisted percutaneous mitral commissurotomy recently emerged as a new alternative for surgery-ineligible patients.
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!