Bidirectional immuno-oncology educational program benefits community practices

Editor’s Note: This article describes the Association of Community Cancer Centers (ACCC) Immuno-Oncology Institute Visiting Experts program and was written by ACCC to appear in HemOnc Today as part of a media partnership.

Taking a groundbreaking, practice-changing treatment from clinical trials to community patients remains a challenge.

However, academic experts can share their knowledge with their community peers about what is considered the most significant advance in oncology in more than 50 years: immuno-oncology.

New approvals, challenges

Since the approval of the first immune checkpoint modulator, ipilimumab (Yervoy, Bristol-Myers Squibb), in 2011, the FDA has approved many other cancer immunotherapies, including five additional checkpoint inhibitors and two chimeric antigen receptor (CAR) T-cell therapies, with many more under investigation.

In August 2017, the FDA approved the first CAR-T therapy — the anti-CD19 T-cell therapy tisagenlecleucel (Kymriah, Novartis) — to treat children and young adults with relapsed and/or refractory B-cell acute lymphoblastic leukemia. In October, the agency granted approval to a second anti-CD19 CAR-T cell therapy, axicabtagene ciloleucel (Yescarta; Kite Pharma, Gilead), for adult patients with relapsed and/or refractory large B-cell lymphoma.

In May 2017, the FDA approved pembrolizumab (Keytruda, Merck) as the first tumor-agnostic treatment indicated for solid tumors. Since then, the immuno-oncology landscape has continued to expand with new indications, as well as approvals for therapies using a checkpoint inhibitor in combination with another treatment approach.

The FDA often grants these agents fast track status, speeding their entry into the clinical setting. These treatments also receive significant media coverage and direct-to-patient advertising — meaning patients are learning about them almost as soon as physicians and becoming more assertive about demanding access.

However, as with any relatively new, complex therapy, considerable knowledge gaps remain.

A 2016 survey by Herrmann and colleagues of 654 oncologists found that just 7% to 17% were very comfortable with prescribing checkpoint inhibitor therapies and managing their associated side effects. Almost 75% noted they were only somewhat confident or not confident in their abilities to work interprofessionally to manage patients receiving cancer immunotherapy.

The ACCC’s 2017 Trending Now in Cancer Care Survey showed that despite 96% of respondents reporting that providers are prescribing immunotherapy agents, only 33% responded they are “very comfortable” with managing immune-related adverse events.

Experts say this represents a significant gap, given that community oncologists provide the vast amount of care to patients with cancer in the U.S.

“There are so many questions to be answered, and I don’t think that clinical trials run in big cancer centers are going to be able to answer them very quickly for everybody,” Magi Khalil, MD, PhD, medical oncologist at Riverside Cancer Institute in Gloucester, Virginia, said in an interview. “If you engage oncologists, particularly in the community — where the majority of cancer care happens — you may be able to answer these questions more quickly.”

Since 2015, the ACCC Immuno-Oncology Institute has focused on optimizing the delivery of cancer immunotherapies for patients by providing clinical education, advocacy, research and practice management solutions for cancer care teams across all health care settings.

The ACCC Immuno-Oncology Institute Visiting Experts program provides an opportunity to share real-time information about patient response and adverse effects, as well as operational and management issues related to delivery of these new therapies so clinicians are prepared to administer them as they become available in the community.

The program grew out of interviews conducted with clinicians at two ACCC-member cancer programs about their real-world experiences using immunotherapy to treat patients with cancer. Members stressed the importance of “local experts,” those with more extensive experience providing immunotherapy, as a resource for community clinicians.

Rather than a one-sided, didactic approach, however, the visiting experts program is interactive, with learning occurring in a bidirectional fashion. Although community cancer teams learn more about the clinical trials and science behind the therapies, the experts learn more about what it is like to administer the therapies in a real-world environment, with a far greater number and variety of patients than are seen in clinical trials.

The curriculum focuses on evolving challenges in the field, including patient selection, management of immune-related side effects, support for patients and caregivers, and effective approaches for educating clinical colleagues in allied specialties on the unique intricacies of immunotherapy for cancer.

Two-hundred eighty-five multidisciplinary team members participated in seven visiting experts workshops in 2017 in Indiana, Pennsylvania, Maryland, New Jersey, California and Virginia. In 2018, ACCC is hosting three on-site visiting experts workshops, and a virtual program is slated for this month. The interactive virtual discussion will highlight effective practices and frequently addressed questions that arise in caring for patients treated with immunotherapy for cancer. To learn more or to register, go to accc-cancer.org.

A multidisciplinary focus

The visiting experts faculty teams are composed of an oncologist; an administrator to discuss financial and operational issues, including overcoming reimbursement challenges; a nurse to discuss optimizing patient care; and a pharmacist to discuss pharmacy management concerns.

Participating teams from the hosting institutions comprised large groups of clinical and nonclinical staff, including front-desk personnel.

“Any moment between the patient entering the clinic and going home, even when they call the center, is a critical patient care moment,” Kelsie Finch, PharmD, oncology pharmacist at Columbus Regional Health in Indiana, who participated in the visiting experts program, said in an interview.

The education, she said, provided value to everyone in the room, regardless of their role.

“Just learning or even relearning the mechanisms of action of the drugs” was helpful, she said, because patients often ask how the drugs work. “Being able to say, ‘I know exactly how it works,’ makes the patient feel more confident,” Finch said.

It also was important that a spectrum of physicians and nurses from throughout the hospital participated given the diverse range of adverse effects that may occur.

“Being able to be fluent with everything immunotherapy and what it can cause is great to know,” Finch said.

Mary Austin, MA, BSN, RN, assistant vice president of cancer services at Saint Agnes Cancer Institute in Baltimore, agreed.

The visiting experts “were able to speak to everyone in the room so everyone understood,” she said.

The workshop at Saint Agnes included emergency room physicians, endocrinologists, pulmonologists and radiologists. Primary care physicians were present at many of the workshops — a testament not only to the complex side effects that may occur with these therapies, but also to the need to work across health care siloes in caring for patients who are being treated or have been treated with immunotherapy.

“One challenge we have is getting the education out to the broader range of hematologists, hospitalists and subspecialists,” Suresh Nair, MD, medical director of Lehigh Valley Health Network Cancer Institute in Allentown, Pennsylvania, said in an interview. “For instance, the primary care physician might see a patient with symptoms but not even suspect an autoimmune reaction and consult us.”

Thus, Lehigh Valley also had as many nononcology clinicians present at the visiting experts workshop as schedules would allow.

“The visiting experts [program] recognizes that there are various stakeholders involved in delivering safe, effective and appropriate care for a patient and their family that includes, but goes beyond, the physician and nurse,” Jarushka Naidoo, MBBCh, assistant professor of oncology at Sidney Kimmel Cancer Center of Johns Hopkins University, who served as faculty for several of the workshops, said in an interview.

Education on side effects

The need for education across the clinical spectrum is critical given the vast array of systemic side effects possible with these therapies.

The clinical trials for checkpoint inhibitors and anti-PD-1 therapies demonstrated unusual immune-related adverse events, as well as neuro- and cardiotoxicities that may be unfamiliar to many oncologists. For instance, Johnson and colleagues reported life-threatening episodes of heart failure and hemodynamic compromise associated with the immune checkpoint inhibitors, particularly when used in combination.

Other adverse events include enterocolitis, pneumonitis, hepatitis, dermatitis, neuropathy, endocrinopathy, arthritis, nephritis, meningitis, pericarditis, uveitis, iritis, anemia and neutropenia. Khalil and colleagues found some adverse events necessitate permanent discontinuation of therapy, whereas others require only temporary discontinuation.

Thus, understanding when to stop treatment because of side effects is a key discussion of the workshops.

As these new therapies and new indications move from the investigative to the clinical setting, the side effect profile continues to emerge.

During a presentation at last year’s ASCO Annual Meeting, Suzanne L. Topalian, MD, associate director of Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins Medicine, described patients in whom the treatments exacerbated pre-existing, subclinical autoimmune disease or caused new autoimmune reactions.

“We really need to share with one another how best to use these therapies and monitor patients for toxicity and manage toxicities,” Missak Haigentz Jr., MD, chief of hematology and oncology at Morristown Medical Center and medical director of Atlantic Hematology and Oncology for Atlantic Medical Group at Carol G. Simon Cancer Center, said in an interview. Haigentz Jr. — who previously directed the clinical trials office at Albert Einstein Cancer Center and led many of the major trials of the compounds for immunotherapy in head and neck cancer — participated in the ACCC Immuno-Oncology Institute Visiting Experts program both as an academic educator and as part of the community cancer team.

Thus, he understands the need for bidirectional learning in the emerging sphere of immuno-oncology.

“Patients might come for a second opinion consultation at a university, but [the patients] are maintained by the community oncologist,” Haigentz Jr. said. “So, that is who is initiating and continuing to administer the agent for the patient.”

Haigentz Jr. added that this requires greater expertise in immunotherapy, not just for the oncologist, but also for the entire multidisciplinary team.

Financial challenges

Although many community cancer centers participated in and continue to participate in clinical trials for immunotherapies, they are encountering one issue that never came up in a clinical trial: the financial ramifications of the therapy.

Often these costs are not covered by health insurance, but they may be covered by the trial’s sponsor. Thus, workshop participants agreed, it was important that the experts and attendees included financial representatives.

“One aspect providers may not recognize is the financial implications of treatment, particularly [because] many of these therapies may be required indefinitely,” Naidoo said. “This has massive financial implications with patients, so engaging with a financial officer in the clinic early is very important.

“We’ve run into situations where patients no longer can afford their treatment, and we need to think outside the box about how to ensure patients continue to receive this beneficial treatment,” she added. “Listening to the financial side of the visiting experts presentation was educational even for me.”

The comments were similar on the other side of the room.

“It was very helpful for our financial folks who handle the authorizations to hear the clinical side of what’s going on, so they have more information to support the authorization,” said Melissa Kratz, RN, director of quality and innovation for Lehigh Valley Health Network Cancer Center.

“As a clinician educator from the university-based system making the transition to the community, it is a privilege and a responsibility to communicate knowledge,” Haigentz Jr. said. “This is what I really look forward to doing more and more as I practice in the community.” – by Debra Gordon, MS

References:

ASCO. J Oncol Pract. 2017;doi:10.1200/JOP.2016.020743.

ACCC. Trending Now in Cancer Care Survey. 2018. Available at: www.accc-cancer.org/home/learn/publications/Trends/2017-trending-now-in-cancer-care-survey. Accessed June 19, 2018.

Boccia RV and Choti M. NCCN clinical practice oncology forum: Fostering multidisciplinary cancer care in a community setting. Available at: www.medscape.org/viewarticle/575352. Accessed June 19, 2018.

CAR T cells — what have we learnt? Nat Rev Clin Oncol. 2017;doi:10.1038/nrclinonc.2017.196.

Heinzerling L and Goldinger SM. Curr Opin Oncol. 2017;doi:10.1097/CCO.0000000000000358.

Herrmann T, et al. J Clin Oncol. 2016;34(15_suppl):e20592-e20592.

ACCC Immuno-Oncology Institute. Immuno-oncology: There’s more to discover. Available at: accc-iclio.org/wp-content/uploads/2017/05/2016-ICLIO-White-Paper-Final-Web-Version.pdf. Accessed June 19, 2018.

ACCC Immuno-Oncology Institute. Immuno-oncology. Immunotherapy in community settings: There’s no referring it away. Available at: accc-iclio.org/resources/immunotherapy-theres-no-referring-it-away/. Accessed June 19, 2018.

Johnson DB, et al. N Engl J Med. 2016;doi:10.1056/NEJMoa1609214.

Kavekansky J and Pavlik AC. Am J Hematol Oncol. 2017;13:9-20.

Khalil DN, et al. Nat Rev Clin Oncol. 2016;doi:10.1038/nrclinonc.2016.65.

For more information:

Visit accc-cancer.org for details on the ACCC Immuno-Oncology Institute Visiting Experts program and virtual workshop.