Targeted therapies in neuroendocrine tumors (NET): Clinical trial challenges and lessons learned Journal Article
| Authors: | Yao, J. C.; Lagunes, D. R.; Kulke, M. H. |
| Article Title: | Targeted therapies in neuroendocrine tumors (NET): Clinical trial challenges and lessons learned |
| Abstract: | In the past 3 years, we have witnessed the completion of four randomized phase III studies in neuroendocrine tumors and the approval of two new drugs, everolimus and sunitinib, for the treatment of patients with well-differentiated pancreatic neuroendocrine tumors. These studies demonstrate a shift from case series and single-arm studies toward prospective, randomized controlled clinical trials and evidence-based therapy in the neuroendocrine tumor field. However, the clinical development of these agents also highlights the potential challenges awaiting other new drugs in this area. Herein, we discuss the strengths and weaknesses of the most recent phase II and phase III neuroendocrine tumor studies and discuss how limitations inherent in current trial design can lead to potential pitfalls. We also discuss how trial design can be improved, with the hope of increasing the number of drugs successfully developed to treat patients with neuroendocrine tumors. © AlphaMed Press 2013. |
| Keywords: | overall survival; placebo; sunitinib; diarrhea; drug efficacy; drug safety; unspecified side effect; sensitivity analysis; progression free survival; neuroendocrine tumor; liver metastasis; carcinoid; octreotide; tumor growth; everolimus; angiopeptin; neuroendocrine tumors; randomized controlled trial (topic); molecularly targeted therapy; chromogranin a; phase 2 clinical trial (topic); gastrin; phase 3 clinical trial (topic); multicenter study (topic); pancreatic neuroendocrine tumor; pasireotide; glucagon; trial design |
| Journal Title: | The Oncologist |
| Volume: | 18 |
| Issue: | 5 |
| ISSN: | 1083-7159 |
| Publisher: | Oxford University Press |
| Date Published: | 2013-01-01 |
| Start Page: | 525 |
| End Page: | 532 |
| Language: | English |
| DOI: | 10.1634/theoncologist.2012-0434 |
| PROVIDER: | scopus |
| PMCID: | PMC3662843 |
| PUBMED: | 23615698 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 1 July 2013" - "CODEN: OCOLF" - "Source: Scopus" |
