When Wisconsin’s first patient was treated last year with a newly introduced drug therapy for a neuroendocrine tumor (NET), it truly took a village to make the treatment become a reality. UW Hospital clinicians and staff from the Nuclear Medicine and Molecular Imaging Section of the Department of Radiology and the Department of Medicine’s Division of Hematology, Medical Oncology and Palliative Care, plus hospital safety experts and pharmacists, all worked together to be able to make the radioactive, tumor-specific drug treatment available to treat patients in record time.
Steve Cho, MD, Nuclear Medicine and Molecular Imaging Faculty member, Director of the UW Radiopharmaceutical Production Facility and Associate Director of the UW PET Imaging Center, remembers the great effort behind the orchestration. “Our clinicians and techs played a critical role in getting the proper treatment to the patient very quickly,” he said. “At that time, there was a lot of public interest in this new drug treatment available in the United States, as it was previously only available in Europe.”
NETs of the gastrointestinal tract arise from specialized cells called neuroendocrine cells. They represent only about a half of one percent of newly diagnosed cancers. “There is a very low incidence for these types of cancer,” Cho said, “they are also very slow-growing, and people can live with them for a long time so there is actually a high prevalence or number of patients with this cancer. They can be widely metastatic,” he said. After a while, the current treatment used becomes less effective, and the majority of patients do not survive the disease.
The new drug, Lutetium-177 dotatate (marketed as Lutathera®), showed in clinical trials that it stopped the growth of 65 percent of patient’s tumors after treatment, as compared with 11 percent whose tumors stopped growing that instead received a higher dose of common NET therapy. With those who received the revolutionary Lutathera treatment, 18 percent of the patient’s tumors actually shrank. “Lutathera treatment showed markedly longer survival rates for NET patients,” Cho said. “It was a game-changer, and showed much more dramatic results than people anticipated.”
Lutathera was approved by the FDA for use in the US on January 28, 2018, and calls to UW Hospital from NET patients started flowing in right away. Physicians and staff in both Nuclear Medicine and Oncology acted immediately. Dr. Cho and Scott Perlman, MD, MS, Director of the UW PET Imaging Center, and Section Chief of UW Nuclear Medicine and Molecular Imaging, and Scott Knishka, RPh, BCNP, Nuclear Pharmacy Manager, orchestrated the Nuclear Medicine effort. “Collaborating closely with the Carbone Cancer Center, including the patient’s oncologist, Noelle LoConte, and medical oncologists Sam Lubner and Dan Mulkerin, we began the process of developing the treatment protocol,” Cho said. According to Dr. Perlman, one of the first obstacles we faced was where to administer the intravenous treatment. “This led to our team searching around the hospital complex for an adequate space to administer the therapy. This is where we were fortunate to meet Kendra O’Connell, RN, the Carbone Cancer Center clinic manager who was willing to allow us to use a room a few days a week along with nursing support, even though their clinic was already very busy. This was a huge help and really allowed us to move forward rapidly,” said Dr. Perlman.
“We had to immediately focus on the many different elements that needed to be completed,” Dr. Perlman continued. “We had to complete all the paperwork – protocol consent form, written directives, get P & T and Human Radiation Use Committees approvals, engage radiation safety – everything, as it was a brand-new drug,” he said. Much of this was coordinated by Mr. Knishka, who coordinated the development of the protocols, written directives, the consent form, and other paperwork required to get the drug approved within Radiology and UW Hospital.
The Nuclear Medicine team learned that the commercial FDA approved amino acid solutions used as a radioprotectant induced acute nausea. The Nuclear Medicine physician now prescribes a custom compounded amino solution that reduces this side effect. This has lead to a better patient experience. The procurement of the radiopharmaceutical and the radioproctectant is coordinated by Angel Kubly, RPh, in the nuclear pharmacy.
As a result of the UW Department of Radiology’s Nuclear Medicine and Molecular Imaging excellent work, the UW Hospital became the first facility in the state and the 20th in the nation to administer this specific cancer therapy. “During the treatment, nuclear medicine physicians and techs were there the whole time, and oversaw everything,” Dr. Perlman said. “We have successfully managed the side effects and are now treating one or two patients per week with Lutathera. People are still calling to schedule treatment, and those we are treating rave about being able to receive the Lutathera right here in Wisconsin,” he said. According to Dr. Perlman, the demand has been so high there is currently about a five month wait for patients to be treated.
“Treating and imaging using the same target therapy is known as ‘theranostics,’ combining molecular imaging and targeted radionuclide therapy (TRT),” Dr. Cho said. “We expect this treatment to be the first of many new theranostic therapies to become available. It is the ideal example of personalized and precision medicine,” Cho said. “Theranostics is the future of nuclear medicine.”
The Nuclear Medicine Section would like to also recognize the expert assistance of the Nuclear Medicine Manager Derek Fuerbringer, CNMT, nuclear medicine technologists Rosalie Hovey-Andersen and Dani Brunk, and the radiation safety team headed by Jason Timm, Radiation Safety Officer, to make this feat become a reality. Lutathera is manufactured by Advanced Accelerator Applications.