Evaluation and Management of Pulmonary Hypertension in Noncardiac Surgery: A Scientific Statement From the American Heart Association
Nurses, Talk AEs, Interstitial Lung Disease, Before Treating With T-DXd
ConferencesESMO Congress
Oncology nurses should inform patients about adverse events and the signs of interstitial lung disease before treating their breast cancer with T-DXd.
Before starting them on trastuzumab deruxtecan (T-DXd; Enhertu), oncology nurses should discuss the use of anti-emetics as well as the potential for hair loss and interstitial lung disease with their patients, explained Nancy U. Lin, MD.
Lin is a professor of Medicine at Harvard Medical School and a medical oncologist at the Dana-Farber Cancer Institute in Boston. At the 2024 ESMO Congress, she discussed findings from the phase 3b/4 DESTINYBreast-12 trial, which showed that trastuzumab deruxtecan led to promising response rates and progression-free survival in patients with HER2-positive metastatic breast cancer—even in the presence of brain metastases.
READ MORE: T-DXd Demonstrated Intracranial Activity in HER2+ Breast Cancer
However, trastuzumab deruxtecan can lead to nausea/vomiting, hair loss, and interstitial lung disease. Oncology nurses can be instrumental in discussing these adverse events with patients before they start therapy so that they know what to expect. In particular, it is essential that patients and their loved ones know the signs of interstitial lung disease, which can include shortness of breath and cough, Lin said.
Transcript
Before starting a patient on [trastuzumab deruxtecan], I think some of the highlights for counseling include teaching about antiemetic regimens and antiemetic use, making sure that patients are properly pre-medicated and that they understand what to do if they have nausea following the infusion.
The other important consideration is just to remind people about the potential for hair loss with [trastuzumab deruxtecan], because that obviously, is something that you don't want patients to be surprised by. About 25 to 30% of patients will lose their hair with [trastuzumab deruxtecan]; not everybody will.
And finally, is the risk of interstitial lung disease. So the symptoms of this are shortness of breath and cough. It's very important that patients are counseled about this. If they're on vacation, if they're traveling, or they're going to an emergency room that doesn't know them or doesn't know about [trastuzumab deruxtecan] they really need to be sensitized to this, because it's so important to treat [interstitial lung disease] and manage it properly from the get go to prevent bad outcomes.
Reference
1. Lin NU, Ciruelos E, Jerusalem G, et al. Trastuzumab deruxtecan in patients with HER2+ advanced/metastatic breast cancer with or without brain metastases: DESTINY-Breast12 primary results. Presented at: 2024 ESMO Congress; September 13-17, 2024; Barcelona, Spain. Presentation LBA18.
Simple Tool Supports Frailty Screening & Management In Patients With ILD
Photo Credit: Pocketlight
Researchers reported that the Clinical Frailty Scale was useful in stratifying patients with fibrotic interstitial lung disease at risk for early mortality.
The Clinical Frailty Scale (CFS) accurately predicted pulmonary and physical function decline among people with fibrotic interstitial lung disease (ILD), researchers recently reported in CHEST.
"The [CFS] is a simple tool designed to summarize overall fitness and frailty in a person," wrote Sabina A. Guler, MD, and colleagues. "The goal of this study was to establish if the simple and practical CFS might be a valid tool to improve risk stratification in patients with fibrotic ILD. Specifically, we aimed to determine the relationship between frailty assessed by the CFS and transplant-free survival in the most common fibrotic ILDs, to determine the incremental contribution of the CFS to mortality risk prediction, and to explore ILD progression by frailty status."
In an observational cohort study, Dr. Guler and colleagues calculated CFS scores using data from patients with fibrotic ILD from the Canadian Registry for Pulmonary Fibrosis. The researchers calculated patients' scores using information recorded at initial visits to ILD clinics and then stratified them by score.
Those considered "fit" had a CFS score of 1-3, whereas those with a score of 4 were considered "vulnerable," and those with scores ranging from 5-9 were considered "frail." They used logistic regression models and Cox proportional hazards to estimate patients' time to lung transplant or death and established prognostic performance with a derivation and validation cohort.
A total of 1,587 patients in the study had fibrotic ILD. Slightly more than half (54%; n=858) were fit, whereas 25% (n=400) were vulnerable and 21% (n=329) were frail.
Frailty was a significant risk factor for early mortality (Table). The researchers reported that this association held for individual diagnoses (idiopathic pulmonary fibrosis, connective tissue disease-associated ILD, fibrotic hypersensitivity pneumonitis, and unclassifiable ILD) and the overall cohort, and after researchers adjusted for confounding factors.
In addition, over a median follow-up of 1.3 years (IQR, 0.4-2.6), mean annual FVC % predicted declined by:
Similarly, mean annual diffusing capacity of the lung for carbon monoxide (DLCO) % predicted showed respective declines of:
Lastly, mean annual 6-minute walking tests % predicted declined in each respective subgroup by:
The findings also showed that incorporating frailty boosted the prognostic performance of other established risk models. Adding frailty to age, sex, BMI, and history of smoking increased the C-index from 69.1% to 74.4%, while adding it to the ILD-Gender-Age-Physiology Index increased the C-Index from 72.9% to 76.2%.
The study was limited by missing data, which the researchers acknowledge as a common shortcoming of observational cohort studies. Missing data in this study included missing FVC information in 8.5% of patients, no DLCO tests in 14%, and 6-minute walking tests missing for about 43% of patients. The study was also limited to patients from a single country, though researchers described the population as robust. Finally, the researchers noted that more elaborate tests may provide more granular insight.
"We established the potential role of the CFS for risk stratification in patients with fibrotic ILD," Dr. Guler and colleagues concluded. "The CFS might support communication among ILD specialists, patients, and caregivers, and serve as a tool for individual allocation of disease-modifying and supportive treatments."
Nerandomilast Phase 3 Clinical Trial Meets Its Primary Goal In IPF
A Phase 3 clinical trial testing Boehringer Ingelheim's oral investigational treatment nerandomilast in people with idiopathic pulmonary fibrosis (IPF) has met its primary goal of demonstrating the therapy outperformed a placebo at improving lung function or preventing its decline after a year, recently announced top-line data shows.
FIBRONEER-IPF (NCT05321069) enrolled 1,177 patients, ages 40 and older, at several sites in the U.S., Canada, South America, Europe, Asia, and Australia. Full efficacy and safety data will be presented in the first half of 2025. The company intends to seek the nerandomilast's approval for IPF to the U.S. Food and Drug Administration (FDA) and other regulatory agencies worldwide.
"This is the first IPF phase-III-trial in a decade to meet its primary endpoint," Ioannis Sapountzis, PhD, head of global therapeutic areas at Boehringer, said in a company press release. "IPF has a high unmet need for patients and we are continuously fostering our research activities to develop more options for one of the most common interstitial lung diseases."
IPF is a type of interstitial lung disease (ILD), a group of diseases wherein inflammation and progressive scarring, or fibrosis, in the lungs make it difficult for patients to breathe. The specific underlying cause of fibrosis in IPF is unclear.
What is nerandomilast?Nerandomilast, also called BI 1015550, is designed to block the activity of phosphodiesterase 4B (PDE4B), a pro-inflammatory enzyme involved in fibrosis. This should reduce inflammation and scarring in IPF and other types of ILD.
In FIBRONEER-IPF, patients were randomly assigned to one of two doses of nerandomilast (9 or 18 mg), or a placebo, twice daily, for at least a year. Changes in lung function were assessed via forced vital capacity (FVC), the maximum amount of air patients can forcibly exhale after a deep breath.
Secondary efficacy measures included the time to the first occurrence of an acute disease exacerbation, hospitalization due to breathing problems, or death. The trial is also assessing patient-reported outcomes related to shortness of breath, cough, and fatigue.
In a previous Phase 2 clinical trial (NCT04419506), nerandomilast slowed lung function decline in adults with IPF when given at 18 mg twice daily for three months, regardless of whether they were on anti-fibrotic therapies.
Boehringer is also testing nerandomilast in a Phase 3 trial (NCT05321082) enrolling 1,178 adults, ages 18 and older, with progressive fibrosing ILDs other than IPF. Patients are receiving the same treatment regimen and its efficacy is being assessed using the same measures.
Nerandomilast has received both breakthrough therapy and orphan drug designations from the FDA. These designations are meant to accelerate the clinical development and regulatory review of new therapies intended to treat serious and rare conditions.
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