In 2014, Doug Meijer feared he had run out of options. A few years earlier, the retail executive from Grand Rapids, Michigan, had been diagnosed with prostate cancer. Unfortunately, his situation took a turn for the worse when a biopsy revealed that the cancer had spread beyond the pelvic area, significantly dimming his prognosis. Doug, who was now facing months of grueling chemotherapy, found a sign of hope.
Doug heard from his expert prostate cancer team at BAMF Health about a clinic based in Germany, that specialized in cutting-edge cancer treatment called theranostics. Nuclear medicine physicians used a novel radioactive drug, to pinpoint the location of cancer cells, and then another one to “burn” them out. Figuring he had nothing to lose, Doug flew to Europe and checked into the clinic to receive treatment. When doctors examined their patient a few weeks after treatment, they could hardly believe their eyes. Doug’s escaped cancer cells had been zapped, and he was making a full recovery. The Michiganite, who is still healthy today, became one of the first ever super-responders.
Doug’s experience is just the first chapter of this story. Expert clinicians believe that the practice of theranostics is set to grow rapidly in coming years, creating tens of thousands more super-responders across the spectrum of cancer care, and embedding itself as a standalone discipline in oncology. “We could imagine a world where there are 10 approved theranostic agents just for prostate cancer, or nuclear medicine specialists that might only specialize in breast cancer theranostics, for example,” said Neil Taunk, an Assistant Professor of Radiation Oncology and Radiology at University of Pennsylvania Perelman School of Medicine.
But theranostics could struggle to establish itself in cancer care’s crowded space of sophisticated treatments, warned the experts, who attended a leadership conference organized by GE HealthCare. To unlock its full potential, clinicians will have to creatively harness the approach in combination with other treatments, proactively share their research and best practices, and ensure they’re ready to support patients every step of the way. “As an oncologist, I want my patient to have every life-prolonging therapy in existence available to them,” said Sandy Srinivas, a medical oncologist at the Stanford Cancer Center.
Ravi Patel, an assistant professor at the UPMC Hillman Cancer Center and radiation oncologist, was excited by the fast-developing field. “They [ongoing trials] provide us with evidence that theranostics could be superior, and that would ultimately drive the best treatment for patients,” he said. “If I were a patient, I would love that kind of competition.”
Advantage, theranostics
During a recent discussion led by Ilya Gipp, GE HealthCare’s Global Clinical Leader for Oncology, clinicians listed various advantages of theranostics over traditional treatments for prostate cancer. “It certainly might have an edge [over chemo], both in terms of the ease of delivering it over a prolonged period, the finite number of treatments, and maybe even the toxicity profile,” said Srinivas.
Theranostics offers clinicians the ability to personalize cancer treatment in a way that wasn’t possible before, says Scott Tagawa, a Professor of Medicine and Urology at Weill Cornell Medicine. “It could even have the edge on some molecular selection tools, since it harnesses imaging as a tool to assess in vivo target expression. Rather than examining a single part of a tumor from a biopsy or a sum of tumors from blood, imaging allows clinicians to assess heterogeneity, which is the bane of oncology,” he adds. That ability allows clinicians to select optimal agents, then target and eliminate cancer cells effectively, accurately and efficiently.
Theranostics is expanding into other disease sites. Patel says that his clinic has plans to run a minimum of two theranostics studies for breast cancer, while Tagawa predicts that the approach would be effective for lung cancer. “It [lung cancer] is one of the biggest killers out there, and it's a radio sensitive disease, so it should work,” he explains. “I would love to see theranostics grow in treating these high-incidence diseases,” he adds.
Stiff competition
Despite the growth projections, some clinicians warn that theranostics would face stiff competition. “It will go up against other treatments, and ultimately we’ll see a crowded space, especially in earlier line indications,” says Patel. He explained that his clinic is running at least 10 other clinical trials for breast cancer. “It’s a very competitive space.”
Srinivas says that oncologists can remain patient-focused amid rapid innovation and healthy competition in their field. “This isn’t a new phenomenon in medical oncology,” she says. “Whenever you get multiple drugs in the same space, we start thinking about what’s the best fit for them.” However, Tagawa sees the emergence of theranostics as an extra option for clinicians, rather than a zero-sum competition between treatments.
Patel urges flexibility in clinical approaches, citing the isolated cases of recurrences in ‘some lesions following radioligand therapy for prostate cancer. This will require clinicians to supplement theranostics with external beam radiation therapy or drugs as a “boost dose” to target micrometastatic diseases. “We need to be creative and think outside the box as we start moving these up in earlier lines,” he said.
Despite the crowded space, clinicians agree that theranostics could start to find its niche. Rainer Hamacher, a medical oncologist at the West German Cancer Center, points out that oncologists now have well-established criteria for the sequencing of hormone therapy and chemotherapy for patients with prostate cancer, and theranostics have become a new important pillar in this prevalent disease. “We still need some patient stratification that will allow us to find a threshold for the treatment,” he added.
Open, transparent dialogue
Clinicians can expedite this process through open, transparent conversations over patient referrals in the field. “It’s vital to feel comfortable about having an open discussion within clinics,” said Patel. “It's OK to not know everything, and it's OK to lean on colleagues to ask for information, opinions, and assessments. It's also OK to have a patient referred, realize that they are not optimal candidates, and send them back.”
Srinivas agrees that communication and teamwork between different specialists are essential to improved outcomes. “Medical oncology and nuclear medicine teams need to work out who's going to select the patient, how is the consenting going to happen, who's going to do the prior authorization, who's scheduling,” she said. “Just ironing out these details really helps from a workflow point of view.”
Patel is optimistic about the further embedding of theranostics within community practices. “This is a team sport, and you're adding members to a patient's care team, and relying heavily on crosstalk to make sure that the patient is adequately supported.” This kind of teamwork should come naturally to oncologists, said Hamacher: “We’ve learned to work in a very interdisciplinary way, because we might need a radiologist, some nuclear medicine, or a surgeon, depending on the situation.”
But the experts concede that there might be some resistance among community oncologists. “They might just follow the guidelines that they’re used to,” said Hamacher. This inertia might have adverse consequences for some patients. “Some patients get referred later, when they have a higher tumor burden, and might have had more cycles of chemotherapy because they haven’t had access to theranostics,” said Patel. “Then there’s the risk of the approach being a little bit less effective.”
The patients with cancer themselves will have a range of responses to theranostics, predicts the experts. “One of the nice things of traditional theranostics, is [allowing] the patient to see their cancer light up too,” says Tagawa. “But we also have a large population of patients that decline to accept additional information about the treatment, or don’t trust any radioactive modality,” warns Taunk. “However, others will say, give me the best treatment, and I trust you to take me there.”
The future for theranostics
The experts shared their views on the regulatory landscape for theranostics, agreeing that clinicians on opposite sides of the Atlantic Ocean may have different experiences as they work up clinical guidelines and pathways. Srinivas, who is part of the team that draws up guidelines for the National Comprehensive Cancer Network, an alliance of 33 cancer centers in the United States, explains the process by which the organization determines the placing of a drug after approval. “It’s based on Level One evidence, right where the clinical trial was done,” she said. “Once it’s peer reviewed, it can then be part of NCCN guidelines, even if it’s still technically ‘off-label.’” By contrast, drawing up guidelines for theranostics is “slower” in Germany and the rest of Europe, said Hamacher.
But the German expert is still optimistic about the growth of the field in Europe. “If we have more indications and we begin treating other types of cancers, he said, “I believe it becomes its own discipline, bridging nuclear medicine and oncology, rather than remaining a niche within one field.”
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