Adenocarcinoma of the pancreas affects approximately 337,000 people worldwide annually including nearly 45,000 in the United States, 104,000 in western Europe, 3,030 in Australia and 28,000 in Japan. It is the 4th leading cause of death from cancer in the US, and the 7th leading cause of cancer death in Europe. Pancreatic ductal adenocarcinoma (PDA) represents approximately 95% of all pancreatic cancers, with a 5-year survival rate of approximately 6%. Considering that the median overall survival for previously untreated patients with good performance status is between 8.5 months and 11.1 months with the best available treatment regimens, effective treatment for PDA remains a major unmet medical need.
The diagnosis of pancreatic cancer is usually delayed because the initial clinical signs and symptoms are vague and non-specific. By the time the diagnosis is made, the cancer often is locally advanced or metastatic (usually to regional lymph nodes, liver, lung and peritoneum), and is seldom amenable to surgical resection with curative intent. The most common presenting symptoms include weight loss, epigastric and/or back pain, and jaundice. The back pain is typically dull, constant, and of visceral origin radiating to the back, in contrast to the epigastric pain which is vague and intermittent. Less common symptoms include nausea, vomiting, diarrhea, anorexia, and glucose intolerance.
Currently, surgical resection offers the only potentially curative therapy, but since most patients have disease that is unresectable at the time of diagnosis, cure is unlikely. The prognosis for these patients is poor and most die from complications related to progression. The mainstay of treatment for metastatic disease is chemotherapy. Current chemotherapy treatment regimens vary from single agent gemcitabine and various gemcitabine combinations to the multi-drug FOLFIRINOX (leucovorin [folinic acid], fluorouracil, irinotecan and oxaliplatin) regimen, which is frequently supplemented with white blood cell (WBC) growth factors. These treatments deliver to selected patients with good performance status median survival benefits ranging from 7 weeks to 4 months versus controls of gemcitabine alone. Clearly, more effective treatments for unresectable pancreatic ductal adenocarcinoma are needed. SBP-101 is being proposed as a novel chemotherapeutic agent for the treatment of patients with pancreatic ductal adenocarcinoma.