Abimbola Farinde, Pharm.D., is a clinical pharmacist specialist with specializations in psychopharmacology and geriatrics.
The Food and Drug Administration’s (FDA) approval of Abraxane, a solvent-free chemotherapy agent used for the treatment of late-stage pancreatic cancer was largely based on the findings from a randomized clinical trial that included 861 participants that were assigned either to receive Abraxane plus gemcitabine or gemcitabine as monotherapy. The purpose of the trial was to assess the safety and efficacy related to the treatment of pancreatic cancer.
The outcome of the trial demonstrated that individuals who were treated with the combination of Abraxane and gemcitabine lived and average of 1.8 months longer in comparison to those treated with gemicitabine alone. An underlying issue that can be identified with the diagnosis of pancreatic cancer is progressive tumor growth, and this is typically the case when a diagnosis of pancreatic cancer is received because it has advanced to the stage where surgical intervention may not be feasible. Pancreatic cancer is especially difficult to treat because many patients are diagnosed after the disease has progressed.
According to the National Cancer Institute, it is estimated that 45,220 people will be diagnosed and from that 38,460 will die from the disease in 2013, and recent research findings indicate that the dense stroma around the pancreatic tumors can contribute to associated difficulty of treatment. Abraxane was designed with the primary intent of slowing the growth of tumors or to be used in combination with gemcitabine in those individuals with cancerous cells that have spread to other part of their bodies. The clinical trial demonstrated that participants that received gemcitabine experienced slower tumor growth leading to the observed, on average, 1.8 month length of life in comparison to the gemcitabine group.
The most commonly observed serious side effects of the Abraxane and gemcitabine treated was vomiting, dehydration, fever, neutropenia, and thrombocytopenia. The combined use of Abraxane and gemcitabine can be observed as a viable treatment option for the reduction or prevention of tumor growth for those who are diagnosed with late-stage pancreatic cancer.
The results of this clinical trial project a degree of promise for both providers and patients given the high mortality rate that can be associated with pancreatic cancer as a result of the time of diagnosis. In most cases, an aggressive approach must be taken to treat this form of caner cancer in order to potentially slow the growth of the tumor and prolong life. The approval of Abraxane can open to gate for other types of cancer treatments to follow.