Pitfalls in Clinical Trials and Future Directions
Out of every 100 patients with newly diagnosed pancreatic cancer, only a handful is considered to be cured of the disease. The median survival of patients with advanced pancreatic cancer remains at <6 months. This highlights the significance of overt and micrometastases in this disease. Improvements in the survival of patients with pancreatic cancer depends on future advances in systemic therapies. Unfortunately, therapy of pancreatic cancer has not made the major headway seen with the treatment of other nonhematologic cancers, such as breast and colon. This is not to dismiss the relentless research efforts over the past decade or so that involved a large number of phase II trials and over a dozen well-conducted phase III trials. Clinical trials during the 1990s and early 2000s focused on the addition of newer agents to gemcitabine. Drugs tested included different classes of cytotoxics and more recently biological agents. Despite some interesting results in phase II settings, the translation of benefit to phase III testing was absent with one or two exceptions.
There is growing pressure from within and without pancreas research groups to improve the efficacy of clinical drug development in pancreatic cancer. This chapter discusses some of the issues related to existing experimental designs and challenges to clinical and translational research in this disease. The discussion points are partly generic in that they also pertain to research in other nonhematologic cancers.
KeywordsVascular Endothelial Growth Factor Pancreatic Cancer Clin Oncol Advanced Pancreatic Cancer Single Agent Activity
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