A multi-center Phase III clinical trial demonstrates that Abraxane (nab-paclitaxel) plus gemcitabine is the first combination of cancer drugs to extend survival of late-stage pancreatic cancer patients compared to standard treatment.
The MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study was led by physicians from Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials, a partnership between Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).
Their findings show that Abraxane plus gemcitabine was well tolerated and resulted in clinically meaningful outcomes compared to gemcitabine alone, the current standard of care. The study abstract was released today and the data will be presented at the American Society of Clinical Oncology (ASCO) 2013 Gastrointestinal Cancers annual meeting Jan. 25 in San Francisco.
“We are ecstatic that this clinical trial of Abraxane plus gemcitabine improves survival for patients with advanced stage IV pancreatic cancer,” said Dr. Daniel Von Hoff, international lead investigator for MPACT, chief scientific officer for Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, and TGen’s Physician-In-Chief. “It once again demonstrates that laboratory science based medicine can make a difference for patients.”
MPACT is the largest phase III clinical trial completed in advanced pancreatic cancer with more than 800 patients. Findings from the study showed a 59 percent increase in one-year median survival rates from less than a quarter of the patients (22 percent) to more than a third (35 percent). The two-year survival rate for this cancer is negligible, less than 4 percent, but that more than doubles (9 percent) with the nab-paclitaxel/gemcitabine combination.
One of those patients was Lynne Jacoby, 48, of Phoenix, who works as a director of compliance for a healthcare company. Jacoby was given only weeks to live when her Stage 4 pancreatic adenocarcinoma, a tumor the size of a golf ball, was first diagnosed in April 2012 - nine months ago.
The pancreas is an organ in the upper abdomen located beneath the stomach and adjacent to the first portion of the small intestine, called the duodenum. The pancreas is composed of glands that are responsible for a wide variety of tasks. The glandular functions of the pancreas can be divided into the following 2 categories:
Exocrine: The exocrine glands secrete enzymes into ducts that eventually empty into the duodenum. These enzymes then help in the digestion of food as it moves through the intestines.
Endocrine: The endocrine glands secrete hormones, including insulin, into the bloodstream. Insulin is carried by the blood throughout the rest of the body to assist in the process of using sugar as an energy source. Insulin also controls the levels of sugar in the blood.
The pancreas can be divided into the following 4 anatomical sections:
Head - The rightmost portion that lies adjacent to the duodenum
Uncinate process - An extension of the head of the pancreas
Body - The middle portion of the pancreas
Tail - The leftmost portion of the pancreas that lies adjacent to the spleen
Intraductal papillary mucinous neoplasia (IPMN) is a type of pancreatic cancer that is beginning to be recognized more frequently. This pancreatic cancer has a better prognosis than other types of pancreatic cancer. Intraductal papillary mucinous neoplasia is usually diagnosed endoscopically (see Exams and Tests).
The most common type of pancreatic cancer arises from the exocrine glands and is called adenocarcinoma of the pancreas. The endocrine glands of the pancreas can give rise to a completely different type of cancer, referred to as pancreatic neuroendocrine carcinoma or islet cell tumor. This article only discusses issues related to the more common type of pancreatic adenocarcinoma.
Pancreatic adenocarcinoma is among the most aggressive of all cancers. By the time that pancreatic cancer is diagnosed, most people already have disease that has spread to distant sites in the body. Pancreatic cancer is also relatively resistant to medical treatment, and the only potentially curative treatment is surgery. In 2004, approximately 31,800 people in the United States were diagnosed with pancreatic cancer, and approximately 31,200 people died of this disease. These numbers reflect the challenge in treating pancreatic cancer and the relative lack of curative options.
“If you had to live your life in a year, and that is all the time you have, wouldn’t you do everything you could to experience this time,” said Jacoby, who for nearly a year before her diagnosis had experienced night sweats, indigestion, stomach pains, neck and back pain, and an elevated white-blood count.
She began the treatment of Abraxane plus gemcitabine in May 2012 and continues on the medications, saying now that she “feels awesome, wonderful.” She is scheduled to remain on the drug combination through May 2013.
“Life is priceless. No amount of money can be placed on life. I know I would be gone already if it was not for Dr. Von Hoff,” said Jacoby, who also refers to him as “Dr. Von Hope.”
The study showed significant improvement among some of the sickest patients including those with increased metastases. Significantly there was no increase in life-threatening toxicity. Other drug combinations that have demonstrated benefit have been limited by increased toxicities.
“This is a major improvement in a cancer with the lowest survival rates among all cancer types,” said Dr. Ramesh Ramanathan, medical director of Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare and principal investigator for the clinical trial in the United States. “Advanced pancreatic cancer is fourth most common cause of cancer death in the United States and throughout the world. It is difficult to diagnose with a majority of the cases diagnosed at a late stage after the disease has already advanced.”
Abraxane wraps traditional chemotherapy, paclitaxel, in near-nano sized shells of albumin, a protein that the tumor sees as food. The tumor uses various mechanisms to preferentially attract the albumin, which then acts like a “Trojan Horse” to release its package of chemotherapy inside the tumor. It is approved in the U.S. for metastatic breast cancer and non-small cell lung cancer.
The pancreas is a gland behind the stomach that secretes enzymes into the upper part of the small intestine to help digestion. It also produces hormones, including insulin, which helps regulate the metabolism of sugars.
The incidence of pancreatic cancer is increasing worldwide with an estimated 279,000 cases per year, including nearly 44,000 in the U.S. in 2012, and resulting in more than 37,000 American deaths last year.
The Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. Research at TGen is focused on helping patients with diseases such as cancer, neurological disorders and diabetes. TGen is on the cutting edge of translational research where investigators are able to unravel the genetic components of common and complex diseases. Working with collaborators in the scientific and medical communities, TGen believes it can make a substantial contribution to the efficiency and effectiveness of the translational process.
The Translational Genomics Research Institute