Background: We report final results with extended follow-up from a global, expanded-access trial that pre-regulatory approval provided sunitinib to metastatic renal cell carcinoma (mRCC) patients, ineligible for registration-directed trials.
Methods: Patients ⩾18 years received oral sunitinib 50 mg per day on a 4-weeks-on-2-weeks-off schedule. Safety was assessed regularly. Tumour measurements were scheduled per local practice.
Results: A total of 4543 patients received sunitinib. Median treatment duration and follow-up were 7.5 and 13.6 months. Objective response rate was 16% (95% confidence interval (CI): 15-17). Median progression-free survival (PFS) and overall survival (OS) were 9.4 months (95% CI: 8.8-10.0) and 18.7 months (95% CI: 17.5-19.5). Median PFS in subgroups of interest: aged ⩾65 years (33%), 10.1 months; Eastern Cooperative Oncology Group performance status ⩾2 (14%), 3.5 months; non-clear cell histology (12%), 6.0 months; and brain metastases (7%), 5.3 months. OS was strongly associated with the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model (n=4065). The most common grade 3/4 treatment-related adverse events were thrombocytopenia (10%), fatigue (9%), and asthenia, neutropenia, and hand-foot syndrome (each 7%).
Conclusion: Final analysis of the sunitinib expanded-access trial provided a good opportunity to evaluate the long-term side effects of a tyrosine kinase inhibitor used worldwide in mRCC. Efficacy and safety findings were consistent with previous results.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4647545 | PMC |
| http://dx.doi.org/10.1038/bjc.2015.196 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Longer survival with precision medicine in late-stage cancer patients.
ESMO Open
January 2025
Department of Oncology and Clinical Cancer Research Center, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address:
Background: In a per-protocol analysis of molecularly profiled patients with treatment-refractory, end-stage cancer discussed at the National Molecular Tumor Board (NMTB), we aimed to assess the overall survival (OS) outcome of targeted treatment compared with no targeted treatment.
Materials And Methods: Patients were prospectively included at a single oncological center. Whole exome and RNA sequencing (tumor-normal) were carried out, and cases were presented at the NMTB for discussion of targeted treatment.
The impact of psoriatic arthritis on quality of life: a systematic review.
Ther Adv Musculoskelet Dis
December 2024
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, Windmill Road, Oxford OX3 7HE, UK.
Background: Psoriatic arthritis (PsA) is a chronic inflammatory condition that can affect individuals of all ages. Patients may experience a range of physical and psychological issues.
Objective: To examine the impact of PsA on an individual's quality of life (QoL) and physical function.
Background: Neurostatus-Expanded Disability Status Scale (EDSS) is the standard measure used to assess impairment and disability in multiple sclerosis (MS) trials but requires trained expert neurologists.
Objectives: This study aims to evaluate the concordance of Neurostatus-EDSS assessments from specially trained health care professionals (HCPs) and standardized trained neurologists.
Methods: A Swiss multicenter, randomized, cross-over study with 100 people with MS.
Real life data of ONC201 (dordaviprone) in pediatric and adult H3K27-altered recurrent diffuse midline glioma: Results of an international academia-driven compassionate use program.
Eur J Cancer
December 2024
Department of Pediatric and Adolescent Oncology, Gustave Roussy, Villejuif, France; Team Genomics and Oncogenesis of Brain Tumors, INSERM U981, Paris Saclay University, Villejuif, France.
Introduction: H3K27-altered diffuse midline gliomas (DMG) have limited therapeutic options and a very poor prognosis. Encouraging responses were observed in early clinical trials with ONC201. As ONC201 was unavailable in Europe, a compassionate use program supported by the French Authorities was launched for patients at progression after standard of care radiotherapy.
View Article and Find Full Text PDFGlobalization of clinical trials in oncology: a worldwide quantitative analysis.
ESMO Open
December 2024
Department of Radiation Oncology, Centre Léon Bérard, Lyon, France; Univ Lyon, INSA-Lyon, Université Claude Bernard Lyon 1, CNRS, Inserm, CREATIS UMR 5220, U1294, Lyon, France. Electronic address:
Background: Over the past two decades, the globalization of oncology clinical trials has expanded, yet significant disparities persist across countries. This study aimed to evaluate these geographical inequalities, the evolution of trial phases, and the adherence to ethical standards according to the World Bank's income group.
Materials And Methods: The ClinicalTrials.
Want 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!