dr Debra Patt Highlights Payer and Education Considerations in Using Trastuzumab Deruxtecan in HER2-Low Breast Cancer – AJMC.com Managed Markets Network | Team Cansler

At Patient-Centered Oncology Care®, Debra Patt, MD, PhD, MBA of Texas Oncology discussed managed care considerations arising from the landmark DESTINY-Breast04 study presented earlier this year.

Five months after the results drew a standing ovation from the American Society of Clinical Oncology (ASCO), the results from DESTINY-Breast04 continue to make waves in breast cancer care – increasing payer considerations and the need for continuing education among physicians at Patt, according to Debra , MD, PhD, MBA, Executive Vice President of Texas Oncology, who delivered Thursday’s keynote address on Patient-Centered Oncology Care®.

Patt speaking in Nashville for the annual event presented by The American Journal of Managed Care®, highlighted the dramatic responses observed with trastuzumab deruxtecan in the study. The risk of disease progression or death decreased by 50% compared to chemotherapy in patients with low human epidermal growth factor receptor 2 (HER2) deficiency with both hormone receptor (HR)-positive and HR-negative disease.1 The therapy, marketed by AstraZeneca as Enhertu, received FDA approval for this indication on August 6, just two months after the ASCO presentation.

Practice-changing outcomes affecting so many patients require changes for providers and payers, Patt said. They’re an advance that will help achieve the dual goal of fighting cancer with less toxicity than previous treatments. This allows a doctor to “meet patients where they are — and ensure that they can not only benefit from having their cancer under control, whether it is healing control, as with a chronic disease — but also to be in their communities, so they can work at their jobs and sleep in bed next to their spouses and sit at their dining tables and pick up their kids from the soccer ball. stalemate said. “I’m really passionate about that.”

How it works. Trastuzumab deruxtecan works for a disease Classification not previously appreciated by pathologists or physicians, but could cover just over half of all patients with metastatic breast cancer. “It’s this unmet clinical need,” explained Patt.

Under the previous standard of care, there were different treatment options depending on the hormone receptor profile or BRCA status, but all paths led to chemotherapy.

“As we all know, traditional cytotoxic chemotherapy is a really powerful tool in the treatment of cancer. But it’s a blunt instrument that kills rapidly dividing cells and is associated with many toxicities,” she said. “A universal axiom we’ve learned as we get more specific and targeted therapies is that the more specific the target, the less toxicity on average.”

She explained how the antibody-drug conjugate trastuzumab-deruxtecan works: It targets HER2 by entering the cell with a cleavable linker, and then releases its topoisomerase inhibitor payload, which is stored in a so-called “bystander”. -Effect “leaking” into neighboring cells.

Dramatic results. Study results showed a 50% improvement in progression-free survival and a 36% improvement in overall survival compared to conventional chemotherapy; results were consistent across subgroups, including patients previously treated with CDK4/6 inhibitors.

The results establish trastuzumab-deruxtecan as a new standard of care for patients with HER2-low metastatic breast cancer (immunohistochemistry [IHC] 1+ and IHC 2+/ Fluorescence in situ hybridization [FISH] Negative). But this creates some new challenges, Patt said.

finding the patients. Prior to DESTINY-Breast04, the traditional classification of breast cancer patients did not include HER2-low; Now the IHC test protocols are subject to change. “This is where we really need payer-provider collaboration,” she said.

FISH testing, which checks for extra copies of the HER2 gene, has often been the norm, with IHC performed only upon request. Today, she said, all patients with localized and metastatic breast cancer should have IHC testing with FISH completed according to ASCO/College of American Pathology guidelines. This required educating some communities about the need for IHC.

Additionally, in some cases, archival tissue must be removed and retested. “So there was a logistical challenge as pathology groups experience many of the same challenges that we have in staffed clinics today. These things that would normally take days could take weeks, sometimes months,” she said. “It’s never an acceptable response to tell a patient they need another biopsy because you can’t get the pathology team to repeat testing on a specimen.”

So far, she hasn’t encountered any challenges with paying for testing, Patt said. What are you more worried about? “It is clinicians who order the appropriate testing because they are so concerned about the false negatives they might see and they might not see potential therapeutic options…. It’s really important to talk about it.”

side effects. Nausea is still a challenge. Patt said her clinic changed her antiemetic protocols to reflect the highly emetogenic chemotherapy. “It is an important intervention for patients on this therapy,” adding that measures to prevent nausea are appropriate.

“Neutropenia can happen, but it’s uncommon,” she said. Interstitial lung disease has been seen, but doctors are now better able to screen patients for signs of coughing.

Patt addressed alopecia, which occurs in 30% of patients and is successfully treated with capping at her clinic. “I’m from the great state of Texas and we love our big hair,” she said, then added a serious note, “It’s important for women to control alopecia… [of treatments for alopecia].”

It stems from her commitment to allowing patients to live their lives, she said.

“Being able to pick your kids up from school without their best friends asking, ‘What’s wrong with mommy?’ because she has no hair makes real sense and helps manage this for families and patients.”

1. Modi S, Jacot W, Yamashita J, et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl. J Med. Published online June 5, 2022. doi:10.1056/NEJMoa2203690

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