RCCA 

Community oncologist Sameer Desai, MD, has been treating patients with hematologic malignancies for over a decade, and sees CAR T-cell therapy as the most exciting treatment right now.

He is hopeful that refinements in this class of agents will allow for them to be safely and effectively administered in the community setting.

“[At the community center] we are waiting for data on the safety from the newer trials on CAR T-cells,” explained Desai. “[Once that data is released] we will feel more comfortable using these agents. Cost is going to be important because it is a very expensive treatment and we need to make sure that it is affordable for patients. Nonetheless, this is an exciting field and there are a lot of advances coming.”

, Desai, medical oncologist/hematologist, Regional Cancer Care Associates, discussed his experience in the hematology field and how CAR T-cell therapy has evolved and its potential integration into community centers.

: What is your experience in the hematologic space?

: I started in 2007 and over the past decade there have been many advances in everything from chemotherapy treatments to targeted therapies and now there are CAR T-cell therapies and immunotherapies. In multiple myeloma, when I was training in 2004 to 2007, all we had were chemotherapy treatments and they were very aggressive. Over the last 2 decades, there has been a big change with oral treatments, immunomodulatory drugs, and proteasome inhibitors. Now, we are starting to get a lot of combination therapies, even triplet and quadruplet regimens. Patients were living for 3 years and are now living for decades.

Please expand on the safety and efficacy advances you are observing.

In my overall experience with patients, they are experiencing fewer adverse events from treatments and they are living longer. For example, lymphomas are a broad category of disease and the most aggressive ones, such as large cell lymphomas, have started seeing the use of molecular tests. This is to separate these different types of lymphomas out and define the level [of aggressiveness]. Some patients are being treated with the standard treatment we have been using for years, R-CHOP. Other patients are now being treated with more aggressive treatments because we discover that their tumor is more aggressive than the standard one so they might get infusion treatments that are longer. Right now, we are still trying to figure out what the right treatments are for those patients.

There is more testing being conducted. Newer treatments are being developed in the second-line and third-line settings. The most exciting therapy right now is CAR T-cell therapy. The first [form of this treatment] was approved 2 or 3 years ago and there are several companies trying to further this treatment to get less toxicity. The adverse events tend to be significant where about 15% to 30% of patients experience some sort of neurological toxicity. The newer [forms of CAR T-cell therapy] are possibly going to have fewer adverse events.

What patients can receive CAR T-cell therapy?

I am in a community practice, so we are just starting to use them as far as clinical trials. In practice, they are mostly sent out to medical centers and cancer centers that have more experience using them.

What are some challenges in the community setting?

The adverse events are the biggest challenge. Patients who experience adverse events [with CAR T-cell therapy] need a medical center that is used to treating those types of adverse events. Our group is gaining experience in using these agents in a clinical trial. Hopefully, these agents [will not only be used] in the clinical trial setting, but in the community setting, as well.

What other work are you involved with in the field of chronic leukemia?

We treat a lot of patients with chronic leukemias but acute leukemias we tend to send to a cancer center. However, if there is a patient who is older and not able to take the intensive treatments, we will offer less intensive treatments [at our center].

Are there any data being presented that you are particularly excited about?

CAR T-cells are the most exciting therapy that everyone is looking at now. There are a few more [forms of CAR T-cell therapy] that are going to come out over the next 1 to 2 years that we are all waiting for. In myeloma, there are many agents that are being studied and there seem to be many exciting novel agents in that class. Then there are BTK inhibitors which are being utilized in both chronic lymphocytic leukemia and some of the lymphomas.

Articles

Sameer Desai, MD, discusses his experience in the hematology field and how CAR T-cell therapy has evolved and its potential integration into community centers.

Community Oncologist Discusses CAR T-Cell Therapy and Other Hematology Advances

Sameer Desai, MD, medical oncologist/hematologist, Regional Cancer Care Associates, discusses current and emerging treatment options under evaluation in lymphomas.

Lymphoma is a very broad category of disease, but among the most aggressive are large cell lymphomas, says Desai. To differentiate between the types of lymphomas and how aggressive they are, the use of molecular testing has become more pronounced in this space.

Although some patients receive standard R-CHOP, a regimen that has been used for years, others are receiving more aggressive approaches, depending on the type of tumor they have, says Desai. For example, those with more aggressive tumors might receive treatments via infusion for a lengthier duration of time. Currently, however, efforts are being focused on determining what the optimal treatment approach is for each patient.

Regarding second- and third-line treatment, newer options are emerging, such as CAR T-cell therapy. In October 2017, the FDA approved axicabtagene ciloleucel (axi-cel; Yescarta) as treatment for adults with relapsed or refractory non-Hodgkin lymphoma. The following year, in May 2018, the FDA approved tisagenlecleucel (Kymriah) for use in patients with large B-cell lymphoma.

Several companies that are now working on developing CAR T-cell therapeutic options with less associated toxicities, says Desai, as existing products result in 15% to 30% of patients experiencing neurotoxicity.

Videos

Sameer Desai, MD, discusses current and emerging treatment options under evaluation in lymphomas.

Dr. Desai on Evolving Treatment Approaches in Lymphomas

Refaat Hegazi, MD, PhD, MPH, medical director, Adult Nutrition, Abbott, discusses nutrition-related toxicities in oncology.

Patients with cancer may experience protein/calorie malnutrition, micronutrient deficiency, electrolyte imbalance, dehydration, and loss of muscle mass or function as a result of their cancer or cancer treatments, says Hegazi.

Early intervention for select patients at risk of detrimental weight loss or muscle loss is necessary to ensure that optimal nutritional care is implemented as soon as possible, Hegazi adds. Moreover, giving specialized nutrients to certain patients may prevent muscle degradation by increasing protein.

Patients who undergo surgery have an increased risk of losing muscle, as the procedure imposes metabolic changes on the patient, Hegazi explains.

Close monitoring of a patient’s nutritional status is important, as loss of muscle mass and function has been associated with a worse prognosis. Moreover, patients experiencing malnutrition appear to have an increased risk of infection, pressure injury, and resistance to therapy, concludes Hegazi.

Refaat Hegazi, MD, PhD, MPH, discusses nutrition-related toxicities in oncology.

Dr. Hegazi on Nutrition-Related Toxicities in Oncology

Terrill Jordan, LLM, JD, president and chief executive officer, Regional Cancer Care Associates, discusses challenges regarding the utility of precision medicine in oncology.

There is a robust pipeline of drugs in development in oncology, explains Jordan. The number of agents that are poised to enter the market may complicate current treatment strategies.

Notably, precision medicine has helped individualize treatment for patients. Among the flood of new agents, physicians should consider patient-specific factors when choosing a treatment.

Precision medicine can be costly; however, it appears to be cost-effective in the long-term, concludes Jordan.

Terrill Jordan, LLM, JD, MAcc, discusses challenges regarding the utility of precision medicine in oncology.

Incorporating Precision Medicine into Oncology

Luke Nordquist, MD, FACP, urologic medical oncologist, founder, CEO, and medical director of the Urology Cancer Center and GU Research Network, founder/CEO, Precision Cancer Research, and founder/CEO, Cancer Specialty Pharmacy, discusses matching specific patients with clinical trials in oncology.

Rather than trying to match a patient to a trial based on disease stage alone, Nordquist recommends looking at the specific inclusion and exclusion criteria. Often, clinical trials will specify which drugs patients should or should not have been exposed to.

In practice, Nordquist may stratify patients with metastatic castration-resistant prostate cancer according to whether they have received abiraterone acetate (Zytiga). An additional stratification criterion may be whether patients have also received enzalutamide (Xtandi), says Nordquist.

If there are several patients that fall into these categories, Norquist looks for a clinical trial that matches the patient population. This may improve accrual and incentivize companies to conduct further research in the future, Nordquist concludes.

Luke Nordquist, MD, FACP, discusses matching patients with clinical trials in oncology.

Dr. Nordquist on Matching Patients to Clinical Trials

Jim M. Koeller, MS FHOPA, professor of pharmacotherapy and Eli Lilly/CRSublett Fellow in the College of Pharmacy, The University of Texas at Austin, and clinical professor of medicine and oncology, University of Texas Health Science Center, discusses the heterogeneity of biologics. 

Biosimilars are subject to an elaborate approval process. Drug developers have to show that the biosimilar is highly similar to the originator biologic. However, some people remain skeptical of biosimilars because they’re not identical to the originator drug. 

It’s important to recognize that even biologics are heterogenous, explains Koeller. Biologics have been on the market for over 35 years. Yet, there lacks a general knowledge about the manufacturing process of these agents. Ultimately, a deeper understanding of the development of biologics and biosimilars is needed, concludes Koeller.

Jim M. Koeller, MS FHOPA, discusses the heterogeneity of biologics. 
 

The Heterogeneity of Biologics

Regional Cancer Care Associates LLC (RCCA), one of the nation’s largest networks of oncology specialists, has appointed Iuliana Shapira, MD, its Chief Medical Officer.

Dr. Shapira joins RCCA from SUNY Downstate Medical Center in Brooklyn, where she served as division chief for Hematology and Oncology.

Terrill Jordan, President and Chief Executive Officer of RCCA, said Dr. Shapira will make crucial contributions to the organization and its mission.

“We are fortunate to have a clinical leader who fully understands the challenges and opportunities our physicians and other health care professionals face in providing cutting-edge, compassionate, and conveniently located care to patients in this rapidly evolving environment. Dr. Shapira brings not only the clinical expertise and health-system acumen needed to lead us forward, but also the spirit and passion that will help us execute our strategy in a very effective fashion,” Mr. Jordan said.

RCCA, which is headquartered in Hackensack, has care sites throughout New Jersey, Connecticut, and the Maryland/Washington, DC area.

Dr. Shapira, a board-certified hematologist oncologist, long has been on the front lines of cancer research. She has conducted basic-science research into the role that ribonucleic acid (RNA) plays in the development of malignancies, and has conducted extensive clinical research in breast cancer, ovarian and gastrointestinal malignancies and drug development. She served for several years as associate professor of Medicine at the Hofstra North Shore-LIJ School of Medicine, and was director of its Center for Cancer Genetics and Cancer Control from 2008 to 2014.

The cancer specialist said she was drawn to RCCA because of its track record of bringing the latest therapies and clinical trials to community-based practices, where most cancer care in the United States is delivered. Among her goals as chief medical officer are to guarantee patient access in various community settings; chart an optimal roadmap of care; foster an understanding of the whole cancer journey and its distinct components; and promote the best quality cancer care and patient experiences while lowering the cost of care.

“The message I have for people dealing with cancer, and for their families, is one of hope,” Dr. Shapira said. “We are learning very fast how cancer starts, works, and travels. New therapies are invented every day. RCCA is working to speed such advances so patients can realize the benefits of an expanding understanding of cancer, of innovative therapies, and of the way cancer care is delivered.” RCCA includes more than 120 physicians supported by 800 employees at 30 care delivery sites, providing care to more than 24,500 new patients annually and more than 245,000 existing patients. For more information, visit 

Regional Cancer Care Associates LLC, one of the nation’s largest networks of oncology specialists, has appointed Iuliana Shapira, MD, its chief medical officer.

RCCA Oncology-Specialist Network Appoints Iuliana Shapira Chief Medical Officer

Terrill Jordan, president and CEO of Regional Cancer Care Associates (RCCA), discusses RCCA’s efforts to further the fee-for-value model in oncology and make drugs more readily available to patients with cancer.

RCCA is working with payers to make sure patients get access to vital medicines and is working with new technologies to make better drug selections for patients, says Jordan. Efforts are being made to ensure that a drug is not being used if a patient is not responding to that therapy. Much work needs to be done in terms of working with technology. RCCA has an affiliation with COTA, which is aggregating real-world data on patient outcomes.

That technology is being used to identify the patients who can benefit from individualized therapy. When RCCA aligns its goals with the right technology for that purpose, prior authorization for a drug may be unnecessary because the payers will already know that the drug will be effective. That way, drugs can be priced appropriately, says Jordan.

Terrill Jordan, president and CEO of Regional Cancer Care Associates, discusses RCCA’s efforts to further the fee-for-value model in oncology and make drugs more readily available to patients with cancer.

Plans to Implement Fee-for-Value Models in Oncology

Ralph Boccia, MD, an oncologist at the Center for Cancer and Blood Disorders, associate clinical professor at Georgetown University, discusses managing adverse events (AEs) associated with chimeric antigen receptor (CAR) T-cell therapy.

CAR T-cell therapy has been a game changer in terms of treating various types of leukemia, but it does have some AEs, such as cytokine release syndrome (CRS). Oncologists are developing strategies to mitigate those effects. Oncologists learned early about CRS with CAR T-therapy that could result in toxicity and neurologic problems. There are keys or clues to the development of CRS, namely, fever, says Boccia. One way oncologists have been able to mitigate this is to recognize CRS early and get the patient started on tocilizumab (Actemra), which would block some of the effects.

Oncologists also have a strategy of grading the degree of CRS and knowing exactly when to implement that drug that would block AEs.

Ralph Boccia, MD, an oncologist at the Center for Cancer and Blood Disorders, associate clinical professor at Georgetown University, discusses managing adverse events associated with chimeric antigen receptor T-cell therapy.

Dr. Boccia on Managing Adverse Events With CAR T-Cell Therapy

Andrew Jennis, MD a hematologist/oncologist at Hackensack Meridian Health, who specializes in the diagnosis and treatment of digestive cancers, discusses the Centers for Medicare & Medicaid Services’ Oncology Care Model (OCM), a value model in which there is the opportunity for shared savings for both oncologists and CMS, so long as oncology care is administered in a cost-efficient manner.

The OCM has yielded some success, says Jennis, but not without challenges. The biggest challenges are the volume of data being collected and understanding how that data are being analyzed and, most importantly, how that data can be integrated into oncology practices. How do oncologists change their practices to take advantage of the incentives that are incorporated into the OCM? What do oncologists do with data they receive through the OCM that may be a bit dated? Despite these ongoing issues, oncologists have been pleased with the model so far, says Jennis, and the OCM will be a big part of the future in terms of value-driven oncology care.

Andrew Jennis, MD a hematologist/oncologist at Hackensack Meridian Health, who specializes in the diagnosis and treatment of digestive cancers, discusses the Centers for Medicare & Medicaid Services’ Oncology Care Model, a value model in which there is the opportunity for shared savings for both oncologists and CMS, so long as oncology care is administered in a cost-efficient manner.