No clinical studies (i.e., clinical trials, case series, or case reports) have been reported in peer-reviewed scientific journals to support the safety or the efficacy of 714-X. A number of anecdotal reports and testimonials have been published in newspapers and other nonmedical literature. The producers of 714-X state that they have tried to document the long-term experience of patients treated with this compound, but they have encountered difficulty in obtaining information from patients and their...
Carcinoma of the pancreas has had a markedly increased incidence during the past several decades and ranks as the fourth leading cause of cancer death in the United States. Despite the high mortality rate associated with pancreatic cancer, its etiology is poorly understood. Cancer of the exocrine pancreas is rarely curable and has an overall survival (OS) rate of less than 4%. The highest cure rate occurs if the tumor is truly localized to the pancreas; however, this stage of the disease accounts for fewer than 20% of cases. For those patients with localized disease and small cancers (<2 cm) with no lymph node metastases and no extension beyond the capsule of the pancreas, complete surgical resection can yield actuarial 5-year survival rates of 18% to 24%.[Level of evidence: 3iA] Improvements in imaging technology, including spiral computed tomographic scans, magnetic resonance imaging scans, positron emission tomographic scans, endoscopic ultrasound examination, and laparoscopic staging can aid in the diagnosis and the identification of patients with disease that is not amenable to resection. In a case series of 228 patients, positive peritoneal cytology had a positive predictive value of 94%, specificity of 98%, and sensitivity of 25% for determining unresectability. For patients with advanced cancers, the OS rate of all stages is less than 1% at 5 years with most patients dying within 1 year.[7,8,9,10]
No tumor-specific markers exist for pancreatic cancer; markers such as serum CA 19-9 have low specificity. Most patients with pancreatic cancer will have an elevated CA 19-9 at diagnosis. Following or during definitive therapy, the increase of CA 19-9 levels may identify patients with progressive tumor growth.[Level of evidence: 3iDiii] The presence of a normal CA 19-9, however, does not preclude recurrence.
Patients with any stage of pancreatic cancer can appropriately be considered candidates for clinical trials because of the poor response to chemotherapy, radiation therapy, and surgery as conventionally used. Palliation of symptoms, however, may be achieved with conventional treatment. Symptoms caused by pancreatic cancer may depend on the site of the tumor within the pancreas and the degree of involvement. Palliative surgical or radiologic biliary decompression, relief of gastric outlet obstruction, and pain control may improve the quality of life while not affecting OS.[12,13] Palliative efforts may also be directed to the potentially disabling psychological events associated with the diagnosis and treatment of pancreatic cancer. (Refer to the PDQ summary on Pain for more information.)
Information about ongoing clinical trials is available from the NCI Web site.