Community Oncology and CAR T-Cell Therapy: A Q&A With Lucio Gordan, MD

AJMC: How do the dosing schedules of chimeric antigen receptor (CAR) T-cell therapy differ from bispecific antibodies, and why is this relevant to clinical practice?

Lucio Gordan, MD: CAR T-cell therapy is usually a onetime treatment, whereas bispecific antibodies represent a chronic therapy, and that distinction has several important clinical implications. CAR T-cell therapy, when given before a bispecific antibody, may offer a better chance of prolonged disease-free survival and overall survival. That’s an important point to keep in mind.

Bispecific T-cell–engaging therapies, or bispecifics, are a phenomenal development and great therapy. We do quite a lot of it in community oncology, specifically at Florida Cancer Specialists. But bispecifics are typically administered until disease progression or the development of intolerable adverse effects.

As for specific dosing schedules, certain CAR T-cell products may carry fewer toxicities than others, potentially allowing for less aggressive sites of service and fewer grade 2, 3, and 4 toxicity events. The selection of a CAR T-cell product depends heavily on the local expertise of the clinician, what the clinic can operationally support, hospital infrastructure, and how the patient presents, including diagnosis, staging, lines of prior therapy, performance status, and organ function. It’s not a straightforward decision.

For bispecifics, product selection is also highly dependent on local knowledge of a given drug for a specific indication, ramp-up dosing schedules, and management protocols for potential adverse effects such as [cytokine release syndrome] and [immune effector cell–associated neurotoxicity syndrome]. All of this adds complexity, which remains a barrier to broader expansion of cell therapy in medical oncology.

AJMC: From your experience, which aspects of the CAR T-cell therapy patient journey are most challenging to coordinate?

Lucio Gordan, MD: The CAR T-cell therapy journey is a very complex one. From a patient standpoint, they need to be treated at a center with the right expertise, track record, and institutional support to deliver these therapies. We are actively working to expand this in community oncology, knowing that cell therapy will move earlier in lines of therapy for many disease processes, and potentially into solid tumors and autoimmune disorders as well.

Going back to the patient journey itself, the patient first needs to have the right indication for a given product, meaning the diagnosis, number of prior lines of therapy, and adequate organ function. That said, CAR T-cell therapy and bispecifics are generally easier to administer than other salvage therapies like autologous stem cell transplant or allogeneic bone marrow transplant, which is an advantage.

Patient education is critical, understanding potential adverse effects, what it means to receive CAR T-cell therapy, the timeline for cell collection (apheresis), and the several weeks required for product engineering before infusion. One barrier we frequently encounter is that patients arrive expecting treatment to begin the following Monday, not realizing the process takes several weeks to set up. When patients are referred to a tertiary center, the bottleneck in scheduling can extend that timeline to months.

The ecosystem required to deliver CAR T-cell therapy is complex. It’s not easily established, especially in community oncology. But it must be fixed, because 75% or more of patients are treated in community settings. There simply isn’t the capacity to send them all elsewhere.

The journey is also challenging for providers and clinics building these programs, training physicians, coordinating with pharmacy, social work, nutrition, remote patient monitoring, and subspecialty consultants in neurology and infectious disease who understand the nuances of cell therapy toxicity.

AJMC: Who are the key team members involved in cellular therapy workflows, and what are their roles?

Lucio Gordan, MD: Cell therapy requires a true multidisciplinary team. At Florida Cancer Specialists, when I get on a call with our cell therapy team, there are at least 10 to 15 people from different areas of the organization represented.

We have cell therapy physicians, dedicated nurse practitioners and physician assistants who work closely with those physicians, and cell therapy–trained pharmacists. We have 3 pharmacists who serve an educational function, helping train physicians, practitioners, and nursing staff, and coordinating the development of standard operating procedures for each drug and each disease-specific indication.

We have an informatics and data department that tracks everything pertaining to the patient: diagnosis, organ function, performance status, prior lines of therapy, treatment outcomes, complications, and even travel distance from the patient’s home to our center.

We have coordinators who ensure all the moving parts are working in sync, because any gap creates potential delays. Our revenue cycle team and contract specialists have received targeted training on the cell therapy space, including how to navigate the group purchasing organizations and pharmaceutical company relationships. Our pharmacy and therapeutics committee evaluates each product by indication and, following [National Comprehensive Cancer Network] guidelines, helps develop decision support tools for product selection.

Infusion nurses trained for specific products round out the team, whether in the clinic for bispecifics or in the hospital for CAR T-cell infusion. It truly takes a village. And we must also measure outcomes rigorously, to ensure patients are receiving the safest and most effective care possible.

AJMC: Have there been any operational adjustments necessary to manage the financial and administrative aspects of CAR T-cell therapy delivery?

Lucio Gordan, MD: This is a great question, and it reflects a very difficult reality. Larger practices like ours may have more financial buffer to invest in developing a cell therapy program, but the investment required is significant; we’re talking hundreds of thousands of dollars, potentially a few million, to build the infrastructure necessary for prime-time delivery.

We are doing it because it’s the right thing for our patients, and because we believe strongly that access to cell therapy in the United States cannot be concentrated solely in academic centers, given their capacity limitations. But it is an extremely difficult equation to solve. There are practices that have struggled financially despite delivering excellent care.

As a physician in an executive role and president of a large practice, building the vision, securing the resources, and managing the delayed return on investment is genuinely challenging. We have worked hard to put the right guardrails in place, not just for safety, but for financial sustainability. Losing hundreds of thousands or millions of dollars per year is simply not viable for any organization, regardless of mission.

I’m confident we’ve built the program correctly, but I want to be honest: This is not an easy road, and better mechanisms to offset the setup costs for community oncology practices would make a meaningful difference in expanding patient access.

AJMC: How commonly do you encounter payer confusion between CAR T-cell therapy and hematopoietic stem cell transplant, and what is your approach?

Lucio Gordan, MD: There has been significant effort invested in educating payers about the differences between CAR T-cell therapy and autologous or allogeneic transplant. I think we’ve seen meaningful improvement lately.

One of the persistent barriers has been related to accreditation pathways: the question of which accreditation standards should apply and whether certain designations should function as gatekeepers to coverage. I strongly believe clinics and hospital systems must meet the highest safety standards, but we need a framework that is more rational and conducive to getting patients into treatment efficiently, not one that can be weaponized by payers to deny coverage simply because a practice lacks a particular seal of approval from a specific organization when the quality of care is clearly there.

Payers are beginning to understand that CAR T-cell therapy and bispecifics are here to stay. I also believe they’re starting to recognize the potential value argument, that giving these therapies earlier in the disease course may improve disease-free survival, overall survival, and tolerability, which ultimately reduces downstream costs. We saw the same dynamic play out with monoclonal antibodies years ago: initial pushback, then gradual recognition that better treatment is often also the safer and cheaper option in the long run.

We’re not quite there yet, but I’m more optimistic than I was. The direction of travel is right.

AJMC: What was your reaction to the removal of Risk Evaluation and Mitigation Strategy (REMS) requirements for CAR T-cell therapy, and what do you believe it signified about the maturity of these therapies?

Lucio Gordan, MD: My position is straightforward: Anything that does not truly correlate with improved patient outcomes, whether that’s paperwork, REMS, FACT (Foundation for the Accreditation of Cellular Therapy) accreditation requirements, or other administrative burdens, should be eliminated thoughtfully. Not overnight, but with clear, evidence-based rationale.

The presence of REMS requirements did not, in my view, correlate with survival benefit, improved safety, or reduced grade 3 or 4 toxicities. What it did was add administrative complexity and cost for every practice trying to deliver care, and in some cases gave payers a mechanism to restrict access. When we eliminate barriers that don’t add value, we help patients get to the right treatment more quickly, at more accessible and cost-effective care settings.

There’s also a broader principle here. We treat patients with acute myelogenous leukemia, ovarian cancer, stage 4 non–small cell lung cancer, and many other devastating conditions without REMS or FACT requirements. Why should cell therapy be held to a different standard that looks more like market protectionism than patient protection? That framing has never made sense to me.

I applaud any thoughtful initiative that streamlines treatment access. The removal of REMS requirements is a step toward a more rational framework, one centered on quality and access, not administrative gatekeeping.

AJMC: Which staff roles are most critical for the success of CAR T-cell therapy programs?

Lucio Gordan, MD: Honestly, there is no single most critical role; success in cell therapy is entirely a team outcome. Cell therapy epitomizes the need for the highest level of multidisciplinary coordination we have ever seen in hematology and medical oncology.

Every role matters: pharmacy, insurance authorization and revenue cycle, apheresis coordinators, subspecialty consultants in neurology and infectious disease, trained physicians and advanced practice providers, infusion nurses, data and informatics staff, social workers, and remote patient monitoring teams. Each piece of the ecosystem must perform at a high level and in synchrony. A breakdown in any 1 area creates delays or safety risks.

What I can say is that when you see a cell therapy team operating in true sync, each staff member in each role delivering at their best, the patient outcomes reflect it. That coordination is visible, and it matters enormously.

We are always happy to share what we’ve learned as we’ve built this program at Florida Cancer Specialists & Research Institute, and I look forward to the continued evolution of these workflows as cell therapy expands its reach in community oncology.