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Focused High-Dose Chemoradiation Protocol Offers More Time for Pancreatic Cancer Patients

Using IMRT, Dr. Ben-Josef's innovative approach combines full-dose gemcitabine (the most common chemotherapy used for pancreatic cancer) with very high-focused doses of radiation.

When Andy Reddick felt pain in his abdomen, he was sure his gastrointestinal troubles had returned. With a history of Crohn's disease and intestinal surgery in 1985, Andy's GI doctors initially agreed. But after an office evaluation and a colonoscopy the following week found nothing unusual, they ordered a CT scan.

"Around 8:00 p.m. in the evening after the CT scan, my local GI doctor called to say that he wanted me to come in the next day for a MRI. We could tell by the tone of his voice that he thought it was something serious," recalled Andy.

The CT scan and MRI revealed an enlarged pancreatic duct and a suspicious-looking mass, which a biopsy at Jefferson University Hospital in Philadelphia (in January 2008) confirmed was cancer. That year, Andy was one of the nearly 40,000 Americans diagnosed with pancreatic cancer. Compared to other types of cancer, pancreatic cancer is especially deadly, with a five-year survival rate of just 4%. The symptoms of pancreatic cancer are often vague, so the disease is frequently discovered at an advanced stage.

The Reddicks met with renowned pancreatic surgeon, Dr. Charles Yeo, at Jefferson to find out if surgery, the treatment that offers the greatest potential for survival, was an option. Unfortunately, 80 percent of the time surgery is not an option because the cancer has invaded other tissue and there is no way to remove the tumor without causing fatal damage.

"We looked at a 3D image of the mass and even we could tell it was bad -- the blood vessels around the mass were bulging and it was a mess of intertwined tissue," said Andy. "Dr. Yeo told me that there wasn't a surgeon in America that would touch it." With no chance for surgery, Andy was referred to Dr. Alex Lin, a radiation oncologist at the same hospital.

"After reviewing the CT scan, Dr. Lin let me know there really wasn't anything he could do for me there -- he believed the standard radiation doses authorized for use at Jefferson weren't high enough to help," adds Andy. But, as luck would have it, Dr. Lin had completed his residency at the University of Michigan and knew about a pancreatic cancer prospective trial being led by radiation oncologist Dr. Edgar Ben-Josef. The trial was investigating the effectiveness of high-dose radiation in combination with full doses of systemic chemotherapy for inoperable patients with advanced pancreatic cancer.

Dr. Lin made a call and a week later the Reddicks, along with their youngest daughter, Julien, were headed to Ann Arbor.

The University of Michigan is one of only a few cancer centers in the nation with a dedicated Multidisciplinary Pancreatic Cancer Clinic. Patients have access to experts from every applicable specialty for their entire spectrum of pancreatic cancer care. Eligible patients such as Andy may participate in one of U-M's groundbreaking clinical trials.

Regarded as one of the best radiation oncology departments in the world, U-M's team is well-known for their work on an innovative radiation technique called intensity-modulated radiation therapy (IMRT). IMRT allows oncologists to deliver a higher dose of radiation to a pancreatic tumor while minimizing side effects and sparing surrounding sensitive organs such as the stomach, liver, and kidneys, as well as the spinal cord.

Using IMRT, Dr. Ben-Josef's innovative approach combines full-dose gemcitabine (the most common chemotherapy used for pancreatic cancer) with very high-focused doses of radiation. U-M laboratory researchers established that gemcitabine makes pancreatic cancer more sensitive to radiation. In addition, by studying the motion of the pancreas and identifying the changes in the shape of the pancreas associated with breathing during radiation, Dr. Ben-Josef devised a technique to freeze motion and target the radiation, allowing treatment with approximately 150 percent of the standard radiation dose used with pancreatic cancer. The radiation treatment lasts five weeks (25 total radiation treatments) and is followed by four months of additional chemotherapy.

Andy first received two pre-radiation doses of gemcitabine, treatment overseen by U-M medical oncologist and co-investigator of the high-dose radiation trial, Dr. Mark Zalupski. He then began the radiation treatments with Dr. Ben-Josef.

"After about the first 15 radiation treatments, I still felt pretty good, but was losing a lot of weight and my energy level was starting to fade. For the remaining 10 treatments my appetite was nearly non-existent and all I wanted to do was sleep," recalled Andy. "It really helped that Jenny and I completely trusted Dr. Ben-Josef. He believed in what he was doing, so we did too."

"The teamwork among everyone involved was better than we've ever seen it-and we've been to a lot of hospitals over the years," added Jenny. "Everyone at Michigan understood that it wasn't just the patient who needed support, but the whole family."

In the midst of Andy's treatment, the Reddicks' daughter Julien, who was suffering from undiagnosed gastrointestinal symptoms, became very ill. "You can imagine, the stress was almost unbearable," recalled Jenny. "We asked Dr. Ben-Josef for a referral and within an hour we had an appointment scheduled with pediatrician Dr. James Baker. He was painstakingly attentive to Julien and really helped ease her symptoms. It was such a blessing to have doctors who went above and beyond to support us."

In May of 2008, after seven weeks in Ann Arbor, the treatment was completed and Andy and his family returned to Pennsylvania. He slept 16 to 20 hours a day for the first few weeks, but in a little over a month Andy began feeling better. "For the first couple of weeks after the treatment, I was completely wiped out. But then one day I sat up, put my feet on the floor, and felt energetic for the first time in months."

Andy completed the follow-up chemotherapy regimen near his hometown in Pennsylvania with Drs. Zalupski and Ben-Josef providing telephone consultation with his local medical oncologists. In October, Andy had another CT scan at Jefferson in Philadelphia to assess what, if any, progress the treatment had made on his tumor.

"We requested that the CT scan be sent to Dr. Yeo, and he called us within 24 hours. We knew one of the world's most accomplished pancreatic cancer surgeons wouldn't have personally called if he didn't think something was possible."

Andy's instincts were right. Dr. Yeo agreed to the surgery. "The scans looked promising, but before the surgery no one knew for sure if the cancer was gone. Dr. Yeo offered no guarantees that the surgery would be successful. He made sure we understood that there was a strong chance things wouldn't look as good on the inside. That being said, he was willing to try, which meant a lot given that this same surgeon had turned me away six months earlier," said Andy.

The surgery lasted nearly 12 hours, and was, by all measures, a great success. To everyone's amazement, the radiation therapy had reduced the tumor almost entirely to noncancerous scar tissue, which could be completely removed.

"We just couldn't believe it-Dr. Ben-Josef's protocol actually worked," recalled Andy, who became the first patient in the trial to have a pancreatic cancer tumor become operable-an extremely rare outcome. To date, a remarkable 12 other patients in Dr. Ben-Josef's radiation trial have had surgery.

Because the protocol is used with very late stage cancers, ultimately it does not yet offer a cure because the cancer spreads to other organs. But it does offer patients more time. For Andy, it gave him nearly three additional years with his family. On April 28, 2011, Andy passed away. While the high-dose radiation protocol prevented a recurrence in the pancreas, the cancer spread.

"Three years ago Andy was being advised to take Percocet for the pain and arrange hospice," says Jenny. "And while the treatment wasn't a cure, participating in the clinical trial extended his life and gave us three additional years together. I know it meant everything to Andy, and to all of us."

"Andy was one of the very first known patients with a clearly unresectable tumor to have surgery. In other studies, most patients reported as unresectable (who later went on to have surgery) turn out to be 'borderline-resectable,' which is an intermediate category, not truly unresectable," says. Dr. Ben-Josef. "We selected only clearly unresectable patients for this trial. So far, 25 percent of patients on the protocol have had surgery, which is very encouraging."

"What we've learned is that (1) radiation, in high enough doses, can sterilize unresectable pancreatic cancer and (2) a highly skilled surgeon can safely remove the tumor after such high-dose therapy. Andy was instrumental in the discovery of both these groundbreaking findings," adds Dr. Ben-Josef.

Based on his findings so far, Dr. Ben-Josef is planning another trial that will combine the high-dose radiation and chemotherapy protocol with additional drugs designed to weaken cancer cells.

U-M's Pancreatic Cancer Program

The University of Michigan is an internationally recognized leader in pancreatic cancer research and treatment. Because our clinical faculty members actively participate in research studies initiated both within the University and nationally, patients have access to both standard therapies and investigational treatments unavailable at other institutions.

The Multidisciplinary Pancreatic Cancer Clinic is one of just a few programs within the U-M Health System to be designated a "destination program" in recognition of both the advanced treatment options offered and the many steps taken to streamline care for patients and families coming from far away. For more information about Dr. Ben-Josef's high-dose radiation trials, please visit the clinical trial webpage; or call the Cancer AnswerLine™ at 1-800-865-1125.

 

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