Pancreas cancer remains one of the deadliest cancers worldwide. In the United States, it accounts for only three percent of all diagnosed cancers but it causes almost seven percent of all cancer deaths. A pancreas cancer diagnosis often comes after age 50 and after the cancer has spread, making it difficult to remove surgically. A new clinical trial that recently opened at the University of New Mexico Comprehensive Cancer Center may help more people to undergo surgery to remove their pancreas tumors. And that may help more of them to live longer.
According to Itzhak Nir, MD, at the UNM Comprehensive Cancer Center, surgically removing the tumors is the only way to cure pancreas cancer. Nir specializes in cancers of the liver, pancreas and other digestive system organs. He says, “Only 20 percent of patients ever make it to surgery, which is the only way to cure someone of this cancer.” And, he says that fewer than five percent of people whose tumors cannot be removed surgically survive for five years or more.
The new clinical trial uses an aggressive treatment approach. “This clinical trial utilizes some of the best aspects of what we’ve learned so far with chemotherapy and radiation,” says Gregory Gan, MD, PhD. “It combines these with a new and exciting therapy called immunotherapy — a treatment which harnesses the body's immune system to help with fighting cancer.” Gan specializes in radiation oncology and serves as the trial’s principal investigator at UNM Cancer Center.
“This clinical trial uses innovative therapies and a unique approach,” says Olivier Rixe, MD, PhD. Rixe oversees all clinical trials at UNM Cancer Center. He says, “We are one of the few centers to offer this clinical trial and one of very few centers that can combine the technologies that this trial requires.”
Currently, UNM is the only site in the Southwest and Rocky Mountain area to offer this trial. In New Mexico, the trial is conducted in partnership with the New Mexico Cancer Care Alliance. Only a few other academic medical centers offer the trial nationwide.
The trial combines the potent chemotherapy regimen FOLFIRINOX and pinpoint-accurate stereotactic body radiation treatment with an immunotherapy drug called algenpantucel-L from NewLink Genetics. FOLFIRINOX and stereotactic body radiation have been studied separately and the studies showed that each helped people with pancreas cancer become candidates for surgery. The clinical trial’s strategy uses all three treatments to shrink pancreas tumors enough to make surgery possible for more people.
Previous studies have shown FOLFIRINOX to shrink pancreas tumors prior to surgery. It’s used routinely for metastatic pancreas cancer. Stereotactic body radiation is a newer type of radiation therapy which delivers higher doses of radiation to the tumor but spares the surrounding tissue. "This technology [stereotactic body radiation] has been used successfully in both primary and metastatic lung and liver cancers, notably for patients who could not otherwise undergo surgery, with local control rates in excess of 90 percent” says Gan.
The experimental drug algenpantucel-L trains the immune system to recognize pancreas cancer cells. It consists of dead, genetically modified pancreas cancer cells. “The genetic changes in these cells lead to protein changes on the cells’ surface which make them an excellent target for a person's immune system to react to," says Gan. And because the immune system learns to recognize pancreas cancer cells, the drug may control tumors for a very long time.
“The hope is that the combination of the most potent chemotherapy, radiation therapy, and immunotherapy will help make patients who were previously considered non-surgical able to undergo curative surgery," says Gan. “This trial combines the best of what we know.”
Gregory Gan, MD, PhD, is an Assistant Professor in the Department of Internal Medicine, Division of Hematology/Oncology, Section of Radiation Oncology, at the University of New Mexico School of Medicine. Trained as a radiation oncologist, his research focuses on the tumor microenvironment and Hedgehog pathway, which is involved in the epithelial-to-mesenchymal transition. This pathway appears to enhance tumor radioresistance, invasiveness, and metastasis and inhibiting this pathway could lead to improvement in cancer control in head and neck cancers in addition to several other cancers. Dr. Gan is a member of the American Society of Therapeutic Radiation Oncology, the American Board of Radiology and the American Medical Association. He has written multiple peer-reviewed research publications, book chapters, and abstracts, on various topics in cancer biology and radiation oncology.
Itzhak Nir, MD, is a University of New Mexico Assistant Professor of Surgical Oncology in the Division of Surgical Oncology, Department of Surgery at the UNM School of Medicine. Since his recruitment to UNM in 2010, Dr. Nir has performed more than 600 major cancer operations. He is one of only a handful of surgical oncologists in the United States to have completed fellowships in two of the most complex and demanding surgical specialties: multi-organ transplantation surgery and surgical oncology. Dr. Nir treats diseases of the liver, pancreas, gallbladder, and bile ducts. He belongs to a small and exclusive group of surgeons in the United States trained to perform very complex cancer procedure known as Cytoreduction surgery with HIPEC (Hyperthermic Intraperitoneal Chemotherapy), designed to target advanced cancers, and only done in a selected number of cancer centers across the United States.
Olivier Rixe, MD, PhD, is a Professor in the Department of Internal Medicine, Division of Hematology/Oncology, at the University of New Mexico School of Medicine. He serves as the Associate Director for Clinical Research at the UNM Cancer Center. Trained as a medical oncologist, Dr. Rixe is internationally renowned for his work in Phase I clinical trials and as Principal Investigator for several neuro-oncology clinical trials. He was involved in the early development phases of many U.S. Food and Drug Administration approved agents, including oxaliplatin, camptothecins, and taxanes; and many targeted therapies including antiangiogenic compounds sunitinib, axitinib and VEGF-trap.
NewLink Genetics (http://newlinkgenetics.com/) makes Algenpantucel-L and sponsors the clinical trial “Immunotherapy Study in Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer (PILLAR),” NCT01836432. Learn more about the research at http://newlinkgenetics.com/pillar-study. To learn more about the clinical trial, visit https://clinicaltrials.gov/ct2/show/NCT02405585?term=pancreas+newlink&rank=2.
New Mexico Cancer Care Alliance, NMCCA, supports New Mexico cancer patients, their families, and their loved ones by helping patients get access to local investigational treatments and providing the latest information from cancer research studies. A small group of dedicated cancer physicians in Albuquerque formed the Alliance because they were concerned that the newest investigational cancer treatments were only available through research studies and clinical trials conducted outside the state. They saw firsthand that the economic and emotional costs of travel too often kept New Mexico cancer patients from participating in these programs.
NMCCA helps New Mexicans get access to new, investigational oncology research treatments by: maintaining a registry of information about oncology clinical trials; working with government agencies and pharmaceutical companies to bring clinical research trials to New Mexico; handling the administrative work that is required to open and manage local research studies; and, sponsoring training sessions for patients and physicians about the latest oncology research findings.
The University of New Mexico Comprehensive Cancer Center is the Official Cancer Center of New Mexico and the only National Cancer Institute-designated Cancer Center in a 400-mile radius. One of the premier cancer centers nationwide, the UNM CCC has 128 board-certified oncology physicians, forming New Mexico’s largest cancer care team. It treats about 60 percent of adults and virtually all the children in New Mexico diagnosed with cancer — more than 10,000 people— from every county in the state in more than 135,000 clinic visits each year. Through its partnership with the New Mexico Cancer Care Alliance, an “exemplary national model for cancer health care delivery,” the UNM CCC offers access to more than 160 clinical trials to New Mexicans in every part of the state. Annual research funding of more than $72 million supports the UNM CCC’s 132 cancer scientists. Working with partners at Los Alamos and Sandia National Laboratories, Lovelace Respiratory Research Institute, and New Mexico State University, they have developed new diagnostics and drugs for leukemia, breast cancer, ovarian cancer, prostate cancer, liver and pancreatic cancer, brain cancer, and melanoma; garnered 33 new patents and 117 patents pending; and launched 13 new biotechnology companies since 2010. Learn more at cancer.unm.edu.
Dorothy Hornbeck, JKPR, 505-340-5929, email@example.com
Michele Sequeira, UNM Cancer Center, 505-925-0486, firstname.lastname@example.org