Psychedelic Therapy Can Advance the Scope of Oncology Care

Although mental health challenges are often thought of as being outside the scope of oncology practice, more and more oncologists are beginning to explore how psychedelic treatment may be shifting the potential for the field. Oncologists have been less focused on issues outside the scope of anticancer treatments because, until recently, evidence-based treatments have been rather limited, according to oncologist Anthony L. Back, MD, a physician in colorectal services at the University of Washington (UW) Medical Center, codirector of UW Center for Excellence in Palliative Care, and a professor of oncology and medicine and adjunct professor of bioethics and humanities at UW in Seattle.

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“It wasn’t until Jennifer Temel’s study [NCT01038271] showing that early palliative care really improved outcomes for patients with metastatic lung cancer,” Back said in an interview with Pharmacy Times. “[That] led a lot of oncologists to say, ‘Wow, I need to be more involved in getting palliative care to my patients early.’”

Back noted that he thinks the same will be true of psychedelic medicine for the treatment of mental health issues related to cancer.

“Once oncologists feel like they have something to offer that is really valuable, I think they will be a lot more interested in figuring out when to refer [patients],” he said.

Additionally, having an option available for patients with cancer that would effectively address mental health issues could help alleviate the burden of managing that issue themselves during the cancer care process, Back said.

“I, of course, think oncologists have been taking care of mental health issues for a long time for [patients] with cancer, and I think they’re not that crazy about the options. I’ve treated lots of patients with [selective serotonin reuptake inhibitors] in this situation of advanced cancer and symptoms of depression. Honestly, the results are not that great, and there’s not much evidence,” he said.

The same issue presents itself when looking to treat anxiety for patients with cancer, as the evidence base for available treatments is limited.

“We end up giving [patients] benzodiazepines, but those are kind of a temporary fix at best, and a lot of high benzodiazepine use often leads to other complications in the future that I think many oncologists are quite aware of,” Back said. “So these are not treatments that oncologists are super excited about. That’s one of the reasons oncologists have, in the past, spent less time and energy on mental health issues.”

Treating the Whole Person

For oncologist Manish Agrawal, MD, addressing the mental health challenges of his patients with cancer became too important to ignore during the trajectory of his career in oncology. Agrawal is faculty at the Center for Psychedelic Therapy and Research at California Institute of Integral Studies, codirector of clinical research at Aquilino Cancer Center, and cofounder and CEO of Sunstone Therapies.“

I’ve been an oncologist for 20 years, and after practicing for 18 to 19 years, what became very clear is I was very good at helping patients get cancer treatment, and [treating the] cancer, and many times [curing it], but really not doing a good job affecting the quality of their life, which was determined by their emotional health. I really didn’t have enough tools for it,” Agrawal said in an interview with Pharmacy Times.

Agrawal explained that, the reason he went into medicine, and even oncology, was to help the whole person have not only a longer life, but also a good quality of life.

“They really go hand in hand,” Agrawal said. “I show an iceberg when I give a talk [on this subject]. Above the iceberg, I have chemotherapy, radiation, and surgery. Underneath the iceberg, I put psychospiritual care. The emotional aspect is part of cancer care. You have to take care of the whole iceberg, not just what’s above the water, and total cancer care involves treating the whole person and not just the physical symptoms. That’s what our patients want. They want to feel better, not just have the cancer treated.”

Agrawal said his perspective on the value of psychedelic medicine in cancer care changed when he met with investigators working at Johns Hopkins Center for Psychedelic and Consciousness Research.

“I met with Roland Griffiths, PhD, at Johns Hopkins, along with Mary Cosimano, LMSW. They showed me their data and shared their stories as well as what they’ve seen, and that really piqued my interest based on the research that had been done previously, as well as with Stanislav Grof, MD. Then I met with William A. Richards, PhD, and all of that really drew me to psilocybin-assisted therapy, given the data that [were] already present for treatment of patients [with cancer] with psilocybin,” Agrawal said.

Agrawal also came to understand that for oncology professionals, adapting oncology treatment practices to include psychedelic therapies for patients with cancer may be a smoother transition than one might expect. Agrawal explained that the complex delivery of psychedelic therapies in the palliative care setting for patients with cancer is far more analogous to oncology care than to traditional mental health care.

“Psychedelic care requires a screening, preparation, [and] then the dosing and integration. So I think in many ways, oncologists will be more familiar with this type of delivery than even mental health practitioners, because that is how cancer care is delivered,” he said. “That being said, [oncologists will] also appreciate the complexity of the delivery—that you’ll need a team of [individuals who] are trained [and] know how to administer the medicine, how to be safe, how to support the person, and how to manage anything that comes up.”

In this way, Agrawal explained that oncology professionals will be familiar with such a complex delivery system and understand that the process will not be accomplished overnight.

“You have to have training and facilities and the right personnel for it,” he said, adding that both oncology treatment and psychedelic treatment require a multidisciplinary team that includes nurses, pharmacists, and other coordinators playing integral roles.

Oncology Pharmacists' Role in Psychedelic Therapy

The role of pharmacy professionals in psychedelic therapy may be quite similar to their current role in the treatment process for patients with cancer on chemotherapy and oral oncolytic therapies, according to Agrawal. “The [drugs are] highly specialized, they’ll be expensive, and they’ll have to be handled with some safety and installed properly,” Agrawal said. “So far, they’re not intravenous. Most of them are oral, but the pharmacists will have to store and manage medications like they do other oral pharmaceuticals for oncology patients.”

Agrawal noted that the other piece that will be familiar to pharmacists will be adhering to the requirements of the Risk Evaluation and Mitigation Strategy (REMS) program.

“There’s a safety component, too, that [pharmacists will] have to be familiar with. And the medication won’t be able to be given by just anyone, [so] they’ll have to have special licenses,” he said. “In that way, pharmacists will be involved in the storage, correct administration, [and] the REMS program and making sure the correct licensed professional is able to administer the medication.”

Additionally, pharmacists are likely going to have an increasingly important role helping to screen patients and evaluate them for suitability as psychedelic medicine comes further into cancer care, according to Back. He explained that pharmacists will be uniquely adept at assessing suitability for psychedelic medicine with their knowledge of potential drug interactions.

“For example, the use of antipsychotics might point to a prior personal or first-degree family history of a psychosis disorder that might be an exclusion,” Back said. “There’s [also] a lot of concern that high benzodiazepine use may affect the efficacy of psychedelic therapy. I think that is going to be something else that pharmacists will be very in touch with.”

Back noted that pharmacists will also play an important role in the interdisciplinary team for psychedelic therapy delivery, both in evaluating patients for appropriate fit with psychedelic medicine and as a part of the psychedelic therapy treatment team for patients with cancer receiving psychedelic therapy in the palliative care setting.

Obstacles to Psychedelic Therapy

There are, however, some challenges ahead in the process of bringing more oncology professionals into the fold on assessing psychedelic therapy for patients with cancer.

“I think the first challenge is [that] there’s not going to be a lot of research trials for all the patients who are interested,” Back said. “I think there’s going to be limited access there. Then I think the first indication—the first FDA-approved indication—for psilocybin is likely to be for major depressive disorder, not cancer. So I think that’s going to create another challenge.”

Back noted that the current shortage of therapists facing the country may also pose a challenge, especially due to the need for qualified therapists with training and experience with psychedelic therapy. “I think that’s going to be the third challenge,” Back said.

Generally, the FDA has also been inquisitive about the efficacy and safety of treating patients with cancer and symptoms of depression with therapies that have been FDA approved for treating only major depressive disorder. Back explained that the best way to address these concerns will be to conduct more research and gather more evidence.

“In the short term, I am not sure what will happen when psilocybin is approved for major depressive disorder and how that will be interpreted by payers and other networks in terms of availability for [patients] with cancer. That’s an open question that I don’thave a prediction about,” Back said. “That’s why I think the evidence base developing is really important.”

Novel Approach, Meaningful Improvements

Agrawal and his team have been looking to address this need for more research and evidence by investigating the safety and efficacy of psychedelic therapy in patients with cancer and major depressive disorder. Published in JAMA Oncology in April 2023, the study findings were promising, with 50% of patients showing full remission of depressive symptoms, as measured primarily by the Montgomery-Åsberg Depression Rating Scale (MADRS).¹

“Eighty percent of the participants had more than 50% reduction in their depression symptoms based on the MADRS [score], and 50% had a complete remission—that is, their MADRS score came down to the same level as someone [who] did not have depression,” Agrawal said.

The study used a group approach and was conducted in a community cancer center. To date, all prior studies using psychedelic-assisted therapy in patients with cancer were done in specialized academic hospitals or in large psychiatric facilities.

“Our study was done in a community cancer center,” Agrawal said. “So that’s a novel approach, and patients in the community are coming [to thecommunity cancer center] rather than going to a specialized place.”

Agrawal noted that even more novel was the group approach of the study; his research team treated patients with cancer and major depressive disorder in groups of 3 to 4 patients at a time.

“They would come in and have a group preparation, and then all 4 get psilocybin at the same time in 4 rooms that were adjacent to each other—we call that simultaneous administration,” Agrawal said. “The next day, [they] come back and talk about their experience, and then...a week later [they again] talk about their experience—[that’s] called integration. That has not yet been done in patients [with cancer] or really any population, where there was a simultaneous administration, group prep, and group integration all at the same time. So we were really excited about that.”

Additionally, the study also had a 1:1 therapist-to-patient ratio instead of the more common 2:1 therapist-to-patient ratio, with 1 therapist lead. This change in staffing requirements allowed the process to be less resource intensive, potentially indicating this model could be more scalable, according to Agrawal.

“[What was] even more exciting was [that individuals] really found a connection in the group and found a benefit in speaking about their experience and their story together,” Agrawal said. “Even though the trials completed and people followed up for 8 weeks, [they] continue to meet once a month [even] now—2 years later—because of the benefits they found.”

Reference

Agrawal M, Emanuel E, Richards B, Richards W, Roddy K, Thambi P. Assessment of psilocybin therapy for patients with cancer and major depression disorder. JAMA Oncol. Published online April 13, 2023. doi:10.1001/jamaoncol.2023.0351