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 Sarah and Dr Monk, what strategies do you use to keep yourself up to date on all these evolving and rapidly changing data?

 Sure. Part of that is just being part of the team. Sometimes it’s an email from Dr Richardson saying, “Look what came out today.” It’s being on listservs, part of SGO [Society of Gynecologic Oncology] that sends you your daily, “Here’s what’s happening in the news in oncology,” and things of that nature. It’s going to meetings and hearing the new stuff that’s coming out. It’s keeping yourself in tune with those publications. Those outlets are going to provide that late breaking information. After that, it happens through the grapevine.

 The team for sure, but also being part of the conversation, right?

 I’ve learned a lot from you guys today.

 When you talk to smart people, you might get smarter. The other key point is research. If you invest the time to improve a patient’s life through a clinical trial, you’re very much in tune when that clinical trial reports. Being on the team and part of the conversation are important, but there’s no better way to be sharp than to enroll in a clinical trial. The NCCN [National Comprehensive Cancer Network] recommends that in platinum-resistant recurrent ovarian cancer, the first thing you should do is enroll your patient in a clinical trial. Both of your sites are very good at that. If one of our listeners want to be a GOG Foundation research site, it’s very easy to join, and we need your help.

We’re also going to have some platinum-resistant recurrent ovarian cancer studies report in 2022. You probably already heard earlier this week that in the phase 2 trial of mirvetuximab soravtansine, platinum-resistant recurrent ovarian cancer had a response rate over 30% that was durable and tolerable. That will be the next antibody-drug conjugate [ADC], the first in ovarian cancer. As you know, we’ve had tisotumab vedotin [Tivdak] in cervical cancer since September 20th. But ADCs are the next line antibody-drug conjugates. You’re pharmacists, so you see them in breast cancer, bladder cancer, and liquid tumors. But this is a big thing for us, because antibody-drug conjugates are new for us.

 Yes, and that education piece. I was giving my physicians a hard time a couple weeks ago. Obviously cervical cancer had Tivdak, and now with mirvetuximab soravtansine, they both have some eye toxicity. And physicians were like, “That’s a class effect of ADCs.” I was like, “No, that’s not a class effect of ADCs. It’s just unfortunately the 2 that you’ve seen.” But that’s where the education piece and then coming together as a team becomes really great because you can pull from other things you’ve seen. Sometimes as a pharmacist, when we’re BCOP [Board Certified Oncology Pharmacist], I still learn about what’s going on in lymphoma, breast cancer, and all other areas. It’s great to keep up with that literature.

 Because there are data or agents from there that can be helpful to you in general that might spark ideas for research like, “Why wouldn’t this work for patients with ovarian cancer?” or whatever tumor it might be. That’s obviously what they took from ovarian cancer to some degree with these PARP inhibitors. “Great, what if I use this in prostate cancer and 

-mutated?” Keeping up in general is obviously hard to do with oncology, but with other disease states, it can also be really helpful for sparking that idea or thoughts for you.

-mutated uterine serous cancer, there’s so much excitement in 

-positive breast cancer that can be extrapolated. Trastuzumab [Herceptin]/tucatinib [Tukysa] is an FDA [Food and Drug Administration] approved example, an 

 antibody-drug conjugate. Or with hormonally responsive breast cancer, there’s the aromatase inhibitor CDK4/6. We can utilize those medications or, to your point, develop clinical trials. I’m doing both to bring you better therapies than trastuzumab in 

-mutated tumors and better hormonal therapies than megestrol and letrozole. We need to work together. I love to hear what they’re doing in other tumors because they’re more common. And because they’re more common, they’re able to do clinical trials at a different scale. But we’re catching up.

 Yes, for sure. I got excited when Keytruda [pembrolizumab]/Lenvima [lenvatinib] got approved for renal cell carcinoma later. I was like, “Great for them!”

 It doesn’t happen that often, but I was so happy about that when I saw it come through.

Videos

Sarah Hayward, PharmD, BCOP, leads the discussion on strategies used to keep the healthcare team well-informed and up to date on emerging data about PARP inhibitors for the treatment of ovarian cancer.

Ovarian Cancer

Practice Pearl 3: Provider Education of Emerging PARPi Data for Ovarian Cancer

In 1919, a young child woke up on Christmas morning to sneak downstairs and see what was in store. To not wake his sleeping parents, he crawled across the living room to the tree, not making a sound.

As he wiggled his body with elegant stealth, or so he believed, he found a vibrant, red leaf-like petal on the ground beside him. Although slightly wilted, the color reminded him of one of his favorite cherry-flavored candies, so he stuck it quickly in his mouth and then continued on his way, inching toward his presents under the tree.

Several hours later, his parents woke up to find their child dead on the floor.

This story, long thought to be the source of fears surrounding the deadly nature of the poinsettia plant that commonly decorates homes around Christmas time, isn’t actually true. However, the unfounded myth of the young child dying from ingesting a poinsettia in 1919 has scared parents from keeping these plants within reach of their children for more than a century.

Upon ingestion, poinsettia can cause mild discomfort, including an itchy rash; eye irritation; a mild stomachache, vomiting, or a mild case of diarrhea; or an allergic reaction among individuals who have a latex sensitivity, which is a compound contained in the plant.

 But for the general population, poinsettia is not much of a concern. A 50-pound child would need to consume more than 500 poinsettia bracts, which are the leaves of the poinsettia that change color, before crossing a toxic threshold.

Although many of the plants used to deck the halls around Christmas, such as the poinsettia, have been feared to be deadly poisonous, these fears have been significantly exaggerated. However, there are several common houseplants present in homes year-round with a far more toxic profile than these beguiling leafy holiday villains.

With dark green leaves and simple white flowers, the peace lily is one of the most common houseplants due to its durability, tolerance for underwatering, and low to medium light requirements. However, in 2005, more individuals called poison control centers about possible poisonings following the ingestion of peace lilies than any other plant.

Containing calcium oxalates, the peace lily, if ingested by adults, can bring on skin irritation, burning of the mouth, difficulty swallowing, and nausea. However, in small children, dogs, and cats, peace lily ingestion can be far more problematic.

In children, ingestion of peace lily leaves can cause diarrhea and vomiting, but the sap can cause children to experience symptoms such as a puffy mouth, a burning sensation in the throat, and a loss of appetite, as well as nausea, headache, lethargy, and constant salivation. When consumed in excess, respiratory problems and kidney failure can also occur.

In dogs and cats, symptoms of peace lily ingestion can include oral irritation, excessive drooling, vomiting, difficulty swallowing, and intense burning and irritation of the mouth, tongue, and lips. However, symptoms tend not to be too severe or require a visit to the vet.

This vine hailing from Europe is commonly used as ground cover outdoors, but it is a common indoor potted plant. When grown inside the home, the berries of the English ivy can pose problems to those less acquainted with its poisonous nature; although bitter and not at all tasty, the berries may still invoke the curiosity of children or pets.

If ingested, these berries can lead to severe gastrointestinal problems and potential delirium or respiratory issues. Additionally, the sap from the leaves of the English ivy can lead to skin irritation and blisters.

Although not fatal, ingestion of the leaves can cause more severe symptoms in dogs and cats than in humans. Some symptoms that can occur following the ingestion of the leaves include abdominal pain, diarrhea, loss of appetite, nausea, and vomiting.

Additionally, if dogs and cats have repeated exposure to the sap of the plant, it can cause a temporary allergic dermatitis, with symptoms including blistering, redness, and swelling.

Ivylike in its appearance and growth patterns, the philodendron is native to the West Indies. Similar to the peace lily, all parts of the philodendron contain calcium oxalates. Because the leaves often trail down to the floor, they may be in quick reach of small children and pets, for whom this plant is far more toxic than it is to adults.

When struck with the urge to investigate, pets and children may only nibble upon a philodendron leaf, in which case they will commonly only experience mild burning in the mouth and/or nausea. However, ingestion of any part of the plant can cause small children, dogs, and cats severe abdominal pain, and any repeated skin contact can lead to severe allergic reactions.

In 2006 alone, poison control centers across the United States received more than 1600 calls relating to poisonings from the ingestion of the philodendron plant.

This plant, unlike others gracing this list, is referred to as the dumbcane due to historical knowledge of the effects of its ingestion. A tropical plant from South America, the dumbcane, also known as dieffenbachia, has thick, broad leaves that are usually a combination of green, white, and yellow.

If consumed, dumbcane can cause temporary inflammation of the vocal cords, leading people who have ingested it to not be able to speak. Most symptoms of poisonings from dumbcane include severe irritation of the mouth and throat, swelling of the tongue and face, and stomach problems. Additionally, the sap from the dumbcane is irritating to the skin and can cause light sensitivity and pain if it gets in the eyes.

Although not life threatening to small children, dogs, and cats, if they ingest dumbcane, it can lead to oral irritation, excessive drooling, vomiting, difficulty swallowing, and intense burning and irritation of the mouth, tongue, and lips.

The rubber tree is a very popular houseplant due to its ease of care. A species of the mulberry family, the rubber tree, or ficus elastica, has thick, waxy leaves that first emerge as a soft coral in color, but eventually deepen to a dark green as they age.

Native to southern China, Southeast Asia, and Indonesia, the rubber tree is an evergreen species that was originally used to make rubber from its latex-containing sap before the advent of synthetics. The latex in the sap is the same compound used to make products such as latex gloves, condoms, and many medical supplies. However, latex is a common irritant for many people and the sap of the rubber tree is no different.

For individuals with sensitivity to latex, adverse reactions can range from mild to severe. In its mild form, the most common symptom of sensitivity to latex is skin dermatitis, which can present as a mild rash at the site of contact. In its severe form, latex can cause reactions ranging from blistering and burning to anaphylactic shock.

For small children, if they ingest the plant, and specifically its sap, they may experience burning, itchiness, and pain in the mouth and throat, with severe cases including gastrointestinal distress, diarrhea, and vomiting.

For dogs and cats, their fur will likely prevent most problematic exposure to the sap, but problems can occur if the sap gets in contact with their nose or eyes, with common symptoms including irritations at the site of contact. If cats or dogs ingest the sap, it can lead to diarrhea or vomiting.

The ficus benjamina, commonly known as just the ficus tree or the weeping fig, is a species of fig that has glossy green ovoid leaves that taper to a point. This tear-like shape is what lends itself to its melancholic namesake, yet its stature remains strong and forever tree-like in form, regardless of its size and age.

Due to its affordability and adaptability to soil, light, and weather conditions, the ficus tree is a common houseplant that has minimal care needs. However, similar to the rubber tree, the ficus benjamina has toxic sap that can cause skin dermatitis. Specifically for the ficus tree, however, symptoms resulting from the skin’s exposure to the sap can be intensified with immediate exposure to the sun, resulting in more severe skin irritation at the site of contact.

For dogs and cats, contact with the sap of the ficus tree can lead to reactions such as decreased appetite, drooling, vomiting, diarrhea, and skin irritation. However, reactions tend to be mild and pass relatively quickly after exposure.

Stewart A. Wicked Plants. New York, NY: Algonquin Books of Chapel Hill; 2009.

Hoecker JL. Are poinsettia plants poisonous? 

October 8, 2019. Accessed January 21, 2022. 

https://www.mayoclinic.org/healthy-lifestyle/infant-and-toddler-health/expert-answers/poinsettia-plants/faq-20058304

Yang A. The Dark Myth of the Poinsettia. 

. January 1, 2015. Accessed January 21, 2022. 

https://www.nature.com/scitable/blog/plantchemcast/the_dark_myth_of_the/

Are Peace Lilies Poisonous? You’ll Be Shocked to Know. Gardenerdy. Accessed January 21, 2022. 

https://gardenerdy.com/is-peace-lily-poisonous/

English Ivy Poisoning in Dogs. Wag! Accessed January 21, 2022. 

https://wagwalking.com/condition/english-ivy-poisoning

Boone L. Dogs, cats or kids? These are the right plants for you. 

. February 28, 2020. Accessed January 21, 2022.

https://www.latimes.com/lifestyle/story/2020-02-28/plants-safe-for-pets-and-kids

The Sill staff. Rubber Tree. The Sill. Accessed January 21, 2022.

https://www.thesill.com/blogs/plants-101/how-to-care-for-rubber-tree-ficus-elastica

Worth D. How Toxic are Rubber Tree Plants? Are They Safe for Your Home? 

https://thehealthyhouseplant.com/how-toxic-are-rubber-tree-plants-are-they-safe-for-your-home/

. September 21, 2017. Accessed January 21, 2022. 

https://www.gardenguides.com/120569-toxicity-ficus-benjamina.html

Toxic Ficus Banjamina Sap. TipsPlants.com. Accessed January 21, 2022.

https://tipsplants.com/community/plant-care/toxic-ficus-benjamina-sap

Weeping Fig. Pet Poison Hotline. Accessed January 21, 2022. 

https://www.petpoisonhelpline.com/poison/weeping-fig/

Articles

Several common houseplants present in homes year-round due to their low maintenance requirements and environmental adaptability are far more toxic than many may realize.

News

Retail

Hospital

Dermatology

Pharmacy Fact: Don’t Get Burned by These Six Common Houseplants

2021 has been remarkably difficult for everybody, including women in pharmacy. They have been working throughout the COVID-19 pandemic while juggling family and/or personal responsibilities. Many pharmacist moms have done their jobs while entertaining children with pent-up emotions, facilitating remote learning, and managing tantrums. Inevitably, self-care is neglected. Here are 6 tips for starting 2022 the right way.

Embrace 1 daily, happy-making habit in the new year.

 Time is limited. Select a habit that creates happiness each day. It can be drinking a cup of your favorite coffee or hot tea in a special mug, reading a chapter of a book that has been sitting on the shelf, or stretching in the morning or before bedtime. It is amazing how a simple ritual can set the tone for the day, week, or even year.

Think of it as the art of tagging out. Make a list of ways to ask for help. Maybe it means asking a partner to take care of the kids’ bedtime for half the week or being OK with the dinner dishes sitting in the sink until the next morning. Make it a priority to either delegate tasks or cross less important ones off the list. Let go of at least 5 chores.

Have a quiet breakfast. Meditate. Or not. Bottom line: Make 10 minutes of quiet a day, with no interruptions, mandatory. During the pandemic, many women added neighborhood health care provider and therapist to the already demanding roles they have as employees, daughters, managers, mothers, owners, partners, and/or sisters. That is where 10 minutes a day comes in. Take time each day to address your own feelings. It is almost impossible to keep showing up for family members in a sustainable way without taking time for yourself. It is not selfish to take care of yourself and care for family members later.

Make time to update your resume or look for a nontraditional position. The time is now for certification, such as in a clinical field, medical affairs, medication therapy management, or prior authorization. Even though family and work can be consuming, it is important to focus on the future of your career. Take small steps if necessary but set a goal and work toward it.

Doing and having it all used to be the mantra for working, but it is unrealistic even during normal times. During the pandemic, pharmacists have been working on overdrive. It is a wonder that many of them have time to drink a glass of water, let alone log a good night’s sleep. Assess how you are feeling and set boundaries when necessary.

Never lose yourself to comparisons. Everyone is spread incredibly thin right now, which makes comparing yourself to others a slippery slope. If there is a social media platform, text chain, or recurring Zoom session with someone whose life seems fabulous while you are frazzled, log off and take a break. Those individuals will still be around afterward.

Implementing these steps will leave you feeling refreshed and better able to tackle the stress of juggling personal and professional responsibilities. Happy new year.

is the chief academic officer at the Accreditation Council for Medical Affairs and the founder of Pharmacist Moms Group, the largest group of female pharmacists in the United States, with more than 45,000 members.

2021 was almost as difficult as 2020; learn ways to start the new year with these recommendations.

Mental Health

Here Are 6 Tips for Self-Care Heading Into 2022

Joanna Lewis graduated from MUSC in 2007. Since then, she has held a variety of pharmacy practice roles, most recently a leadership position in the Department of Pharmacy at Duke University Hospital. Some of her responsibilities included medication safety, quality improvement, oversight of the financial charge capture process, and coordinating the implementation of a new technology system. She is passionate about precepting and mentoring new practitioners, as well as making the practice of pharmacy better.

is the most common type of dementia and affects an estimated 6 million individuals in the United States.

Characterized by symptoms of behavioral and cognitive impairment, it is not just a disease of older adults. Up to 200,000 individuals younger than 65 years have early-onset AD.

 AD is the fifth-leading cause of death in those 65 years or older and has an estimated annual cost of $355 billion.

Most approved medications for the treatment of AD are symptomatic therapies that work on the acetylcholine or glutamate neurotransmitters. The standard medical treatment for AD includes cholinesterase inhibitors and a partial N-methyl-D-aspartate (NMDA) antagonist that aid the symptoms of learning and memory.

 Most recently, Biogen’s aducanumab (Aduhelm) received FDA approval for patients with AD with mild cognitive impairment or mild dementia, although it has been the subject of controversy. There are no treatments that delay, prevent, or stop disease progression.

AD is a progressive neurodegenerative disorder, and the risk of developing AD doubles every 5 years after an individual turns 65 years old.

 It is characterized by a continuous decline in completion of familiar tasks, memory loss, and thinking.

 Risk factors include aging, brain trauma, diabetes, family history, high blood pressure, and smoking.

Most experts acknowledge that development of AD occurs through several mechanisms in the brain. Neuropathological changes include the appearance of extracellular amyloid plaques, neuritic plaques associated with neural injury, and neurofibrillary degeneration exemplified by neurofibrillary tangles. The pathogenesis also involves tau protein, which aids in microtubule assembly. The formation of neurofibrillary tangles involving tau protein lead to neuronal injury and the progressive loss of neurons results in cognitive impairment.

The standard of care continues to focus on the symptoms of AD. For treatment of mild to moderate AD, first-line cholinesterase inhibitors give small improvements in cognition, daily activities, and neuropsychiatric symptoms. For moderate to severe disease, the NMDA receptor antagonist memantine is recommended in combination with a cholinesterase inhibitor.

Aducanumab, a recombinant monoclonal antibody directed against amyloid-β, obtained approval in June 2021 to a mixed response from neurologists and investigators. Although aducanumab demonstrated the ability to reduce brain amyloid-β levels in research trials, other clinical end point benefits have been inconsistent and small. With controversial results and a steep price, clinical practice has been varied to date and will likely evolve over time.

Aducanumab is indicated for mild AD and is administered intravenously every 4 weeks. A recent brain MRI study is required priot to initiating treatment, and additional MRIs are required during dose escalation.

 Adverse effects include amyloid-β–related imaging abnormalities, confusion, diarrhea, falls, headaches, and hypersensitivity.

 No clear guidance has been given regarding treatment duration. Other treatments studied for their antioxidant effects in AD are vitamin E and the monoamine oxidase inhibitor selegiline. Vitamin E at a dose of 2000 IU per day has shown modest but inconclusive benefits for delaying progression in patients with mild to moderate AD. However, some studies suggest additional AD risk in patients with cardiovascular disease.

 Selegiline does not have strong long-term evidence of benefit in clinical research and is significantly more costly.

The AD pipeline continues to be robust, with 126 agents in development and 28 of those in phase 3 trials. Most of these drugs target the underlying biology of the disease.

 For example, donanemab, lecanemab, and solanezumab are monoclonal antibodies that target amyloid-β plaque and are in phase 2 and 3 trials. The remaining targets focus on enhancing cognitive abilities and reducing neuropsychiatric symptoms. New biomarker technologies are also transforming the epidemiologic study of AD. Future research will target the tau protein and brain waves and will include an antibody and vaccine.

A healthy lifestyle that includes exercise, mentally stimulating pursuits, a nutritious diet, quality sleep, and social engagement has shown to benefit individuals as they age and may also help reduce cognitive decline in AD.

 The CDC recommends that individuals 65 years or older get 30 minutes of moderate-intensity activity 5 days a week to improve their overall health.

Not only does good nutrition help with chronic disease risk factors such as cardiovascular disease and diabetes, it also may protect the brain through anti-inflammatory and antioxidant processes. So far there is no hard evidence that avoiding or eating certain foods lowers AD risk, but there are clues that show that eating fish and green, leafy vegetables, as well as following a low-salt and low-sugar diet, may lower the risk of developing dementia.

Although investigators are still debating whether dementia leads to poor sleep or poor sleep exacerbates dementia, they agree that there is a link.

In 2018, the National Institutes of Health reported that sleep deficits might increase the amyloid-β proteins in the brain linked to AD.

The results of another study that followed individuals 25 years and older showed a 30% increased dementia risk in 50-, 60-, and 70-year-old participants who slept 6 or less hours a night.

Lifelong learning and social interaction also show evidence of slowing cognitive decline. However, most of these trials need longer term follow-up.

Pharmacists should stay up-to-date on the research. Early identification is a priority. Screening patients and identifying AD earlier can have a lasting impact. Finally, there are lifestyle factors that may reduce the risk of developing AD. Pharmacists should promote healthy choices, such as cognitive engagement, diet, and exercise.

is the 340B compliance coordinator at Baptist Health in Jacksonville, Florida.

Alzheimer’s disease and healthy aging. CDC. Updated November 23, 2021. Accessed December 1, 2021. https://www.cdc.gov/aging/index.html

2021 Alzheimer’s Disease facts and figures. Alzheimer’s Association. Accessed December 20, 2021. https://www.alz.org/media/documents/alzheimers-facts-and-figures.pdf

Brookmeyer R, Abdalla N, Kawas CH, Corrada MM. Forecasting the prevalence of preclinical and clinical Alzheimer’s disease in the United States. 

t. 2018;14(2):121-129. doi:10.1016/j.jalz.2017.10.009

Massoud F, Léger GC. Pharmacological treatment of Alzheimer disease. 

. 2011;56(10):579-588. doi:10.1177/070674371105601003

Kocahan S, Doğan Z. Mechanisms of Alzheimer’s disease pathogenesis and prevention: the brain, neural pathology, N-methyl-D-aspartate receptors, tau protein and other risk factors. 

. 2017;15(1):1-8. doi:10.9758/cpn.2017.15.1.1

Winslow BT, Onysko MK, Stob CM, Hazlewood KA. Treatment of Alzheimer disease. 

Schneider L. A resurrection of aducanumab for Alzheimer’s disease. 

. 2019;19(2):111-112. doi:10.1016/S1474-4422(19)30480-6

Alexander GC, Knopman DS, Emerson SS, et al. Revisiting FDA approval of aducanumab. 

. 2021;385(9):769-771. doi:10.1056/NEJMp2110468

Aduhelm. Prescribing information. Biogen; 2021. https://www.biogencdn.com/us/aduhelm-pi.pdf

La Fata G, Weber P, Mohajeri MH. Effects of vitamin E on cognitive performance during aging and in Alzheimer’s disease. 

. 2014;6(12):5453-5472. doi:10.3390/nu6125453

Sano M, Ernesto C, Thomas RG. A controlled trial of selegiline, alpha-tocopherol, or both as treatment for Alzheimer’s disease. The Alzheimer’s Disease Cooperative Study. 

. 1997;336(17):1216- 1222. doi:10.1056/NEJM199704243361704

Cummings J, Lee G, Zhong K, Fonseca J, Taghva K. Alzheimer’s disease drug development pipeline: 2021. 

. 2021;7(1):e12179. doi:10.1002/trc2.12179

Bakrania P, Hall G, Bouter Y, et al. Discovery of a novel pseudo β-hairpin structure of N-truncated amyloid-β for use as a vaccine against Alzheimer’s disease. 

. Published online November 15, 2021. doi:10.1038/s41380-021-01385-7

Groot C, Hooghiemstra AM, Raijmakers PGHM, et al. The effect of physical activity on cognitive function in patients with dementia: a meta-analysis of randomized control trials. 

. 2016;25:13- 23. doi:10.1016/j.arr.2015.11.005

Farina N, Rusted J, Tabet N. The effect of exercise interventions on cognitive outcome in Alzheimer’s disease: a systematic review. 

2014;26(1):9-18. doi:10.1017/S1041610213001385

National Institutes of Health. Sleep deprivation increases Alzheimer’s protein. April 24, 2018. Accessed Nov 26, 2021. https://www.nih.gov/news-events/nih-research-matters/sleep-deprivation-increases-alzheimers-protein

Sabia S, Fayosse A, Dumurgier J, et al. Association of sleep duration in middle and old age with incidence of dementia. 

. 2021;12(1):2289. doi:10.1038/s41467-021-22354-2

Aguirre E, Woods RT, Spector A, Orrell M. Cognitive stimulation for dementia: a systematic review of the evidence of effectiveness from randomised controlled trials. 

. 2013;12(1):253-262. doi:10.1016/j.arr.2012.07.001

Tau protein, plaque, and brain waves maybe the solutions to treating the progressive condition.

Brain Health

Early Identification of Alzheimer Disease Is Key

New results from the pivotal phase 3 KEYNOTE-775/Study 309 found statistically significant improvements in overall survival (OS) and progression-free survival (PFS) with the combination of pembrolizumab (Keytruda; Merck) and lenvatinib (Lenvima; Eisai) in patients with advanced endometrial carcinoma following at least 1 prior platinum-based regimen in any setting.

Researchers investigated the combination of pembrolizumab plus lenvatinib versus chemotherapy. The trial had dual primary endpoints of OS and PFS, and additional data on objective response rate (ORR), efficacy, and safety were recently published in the 

“While rates of endometrial carcinoma continue to rise globally, patients with advanced or recurrent disease have limited options available to them once the disease progresses following platinum-based chemotherapy,” said Gregory Lubiniecki, MD, vice president of oncology clinical research at Merck Research Laboratories, in a press release.

Endometrial carcinoma begins in the inner lining of the uterus and is the most common type of uterine cancer. In 2020, there were an estimated 417,000 new cases of endometrial carcinoma diagnosed worldwide and more than 97,000 deaths, according to the press release. The 5-year relative survival rate for metastatic endometrial carcinoma is estimated to be approximately 17%.

KEYNOTE-775/Study 309 is a phase 3, multicenter, open-label, randomized, active-controlled trial conducted in 827 patients. Participants may have received up to 2 platinum-containing therapies in total, if 1 of the treatments was administered in the neoadjuvant or adjuvant setting. Patients were excluded if they had endometrial sarcoma, carcinosarcoma, pre-existing grade 3 or higher fistula, uncontrolled blood pressure, significant cardiovascular impairment or even within the previous 12 months, or if they had active autoimmune disease or a condition requiring immunosuppression.

Patients were randomized 1:1 to receive pembrolizumab 200 mg intravenously every 3 weeks plus lenvatinib 20 mg orally once daily or investigator’s choice of doxorubicin or paclitaxel. Treatment with pembrolizumab and lenvatinib continued until progression of disease, unacceptable toxicity, or for a maximum of 24 months with pembrolizumab.

“KEYNOTE-775/Study 309 is an important phase 3 study that supported recent approvals of Keytruda plus Lenvima for certain types of advanced endometrial carcinoma in the US and other countries around the world, where it became the first immunotherapy and tyrosine kinase inhibitor combination approved for these patients,” Lubiniecki said in the press release.

Based on the results from the phase 3 KEYNOTE-775/Study 309 trial, the FDA approved pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or deficient mismatch repair, who have disease progression following prior systemic therapy in any setting, and who are not candidates for curative surgery or radiation. Researchers are continuing to investigate the combination in more than 10 different tumor types across more than 20 clinical trials, according to the press release.

Results from pivotal phase 3 KEYNOTE-775/Study 309 trial of Keytruda (pembrolizumab) plus Lenvima (lenvatinib) in advanced endometrial carcinoma published in the New England Journal of Medicine. News release. Merck; January 20, 2022. Accessed January 20, 2022. 

https://www.merck.com/news/results-from-pivotal-phase-3-keynote-775-study-309-trial-of-keytruda-pembrolizumab-plus-lenvima-lenvatinib-in-advanced-endometrial-carcinoma-published-in-the-new-england-journal-of-med/

New trial results showed statistically significant improvements in overall survival and progression-free survival. 

Women's Health

Oncology

Specialty Pharmacy

Pembrolizumab Plus Lenvatinib Show Promise in Advanced Endometrial Carcinoma

Positive results from the TOPAZ-1 phase 3 trial showed durvalumab (Imfinzi, AstraZeneca) in combination with standard-of-care chemotherapy demonstrated a statistically significant improvement in overall survival and progression-free survival versus chemotherapy alone as a first-line treatment for patients with advanced biliary tract cancer (BTC), according to an AstraZeneca press release.

Patients with BTC—a group of rare, aggressive cancers that occur in the bile ducts and gallbladder—have a poor prognosis with approximately 5% to 15% of all patients with BTC surviving 5 years, according to AstraZeneca.

“After minimal progress for more than a decade in advanced biliary tract cancer, the TOPAZ-1 results are a tremendous advance for our patients, showing a clear survival benefit for Imfinzi added to chemotherapy compared to standard of care with a remarkable safety profile,” said principal investigator Do-Youn Oh, MD, PhD, in the press release. “This combination will provide a desperately needed and potentially practice-changing new treatment option in a setting where the current prognosis is devastating.”

Patients treated with durvalumab in combination with standard-of-care chemotherapy experienced a 20% reduction in the risk of death versus chemotherapy alone, and an estimated 25% of patients were still alive at 2 years versus 10% for chemotherapy. Additionally, the results also showed a 25% reduction in the risk of disease progression or death with durvalumab plus chemotherapy. The patients who were treated with durvalumab plus chemotherapy achieved an objective response rate (ORR) of 26.7% versus an ORR of 18.7% for patients treated with chemotherapy alone.

Further, durvalumab plus chemotherapy did not increase the discontinuation rate due to adverse events (AEs) compared to chemotherapy alone. Grade 3 or 4 treatment-related AEs (TRAEs) were experienced by 62.7% of patients administered durvalumab and chemotherapy, and by 64.9% of patients administered chemotherapy alone. TRAEs led to a discontinuation of therapy in 8.9% of patients treated with the durvalumab combination versus 11.4% of patients receiving chemotherapy.

Imfinzi plus chemotherapy reduced risk of death by 20% in 1st-line advanced biliary tract cancer. AstraZeneca. January 18, 2022. Accessed January 19, 2022. 

https://www.astrazeneca.com/media-centre/press-releases/2022/imfinzi-plus-chemotherapy-reduced-risk-of-death-by-20-in-1st-line-advanced-biliary-tract-cancer.html

Additionally, the results also showed a 25% reduction in the risk of disease progression or death with durvalumab plus chemotherapy. 

Durvalumab Plus Chemotherapy Reduced Risk of Death by 20% in First-Line Advanced Biliary Tract Cancer

Nature’s Bounty is getting creative with some new vitamins. As part of a new launch, the company has unveiled 6 new jelly bean vitamins. Energy Jelly Beans contain vitamin B12 to help convert food into cellular energy. Immune Jelly Beans contain vitamins C and D, as well as zinc, to aid the immune system. Kids Immune Jelly Beans are formulated with vitamins C and D, as well as zinc, to help the immune system of children. Kids Multi Jelly Beans contain 10 essential minerals and vitamins to support the development and health of children. Multi Jelly Beans are multivitamins that contain essential vitamins and zinc. Finally, Sleep Jelly Beans contain melatonin for a nondrug sleep aid.

Originally launched as a hangover relief, Blowfish for Headaches is a migraine OTC tablet combination of maximum-strength aspirin and caffeine. The effervescent tablets work twice as fast as other medications without the adverse effects of prescription medication, according to the company. The brand also has other products for different uses, such as for athletic pain relief and hangovers.

Opti-Nail 2-in-1 Fungal Nail Repair + Antifungal

Manufactured by Arcadia Consumer Healthcare

The formula is designed to be a 2-step treatment for nails and the skin around the nails. It is a triple- action formula intended to kill athlete’s foot and fungus, restore and smooth skin, and stop burning and itching. It comes in a 2-part system and a 0.169-oz bottle, and the formula can improve nail and skin appearance in as little as 2 days.

Mucinex has released Mucinex InstaSoothe, a line of lozenges and sprays designed to numb, relieve, and soothe pain associated with a sore throat. Sore Throat + Cough Relief Lozenges are made with dextromethorphan HBr and hexylresorcinol to help provide relief and quiet coughs for up to 2 hours. Sore Throat + Pain Relief Spray is made with benzocaine and menthol to temporarily relieve pain associated with a sore throat. Sore Throat + Soothing Comfort Lozenges are formulated with 2.4 mg of hexylresorcinol and are made with honey to relieve pain and soothe the throat for up to 2 hours.

This month's products features jelly bean vitamins, nail repair, and Mucinex InstaSoothe.

OTC Product News: January 2022

Blood drawn from individuals shortly after they were infected with SARS-CoV-2 may indicate who is most likely to become hospitalized, results of a study from Stanford Medicine show.

“We’ve identified an early biomarker of risk for progression to severe symptoms,” Taia Wang, MD, PhD, assistant professor of infectious diseases and of microbiology and immunology at Stanford University, said in a statement.

“And we found that antibodies elicited by an mRNA vaccine, in this case, Pfizer’s, differ in important, beneficial ways from those in people infected with SARS-CoV-2 who later progress to severe symptoms.”

 suggest that there could eventually be a test, given soon after a positive COVID-19 result, that would help clinicians focus attention on individuals likely to need it most, according to the statement.

Investigators collected blood samples from 178 individuals who had tested positive for COVID-19 upon visiting a Stanford Health Care clinic or hospital. At the time of testing, the symptoms were universally mild. However, as time passed 15 individuals developed symptoms severe enough to land them in the emergency department.

Investigators analyzed the antibodies in the blood samples taken from study participants on the day of their positive COVID-19 tests and then again 28 days later.

Antibodies are proteins produced by immune cells that secrete a response when the body senses a foreign presence, like microbial pathogens. They are shaped, approximately, like 2-branched trees, where the branches can assume multiple shapes. The resulting electrochemical and spatial diversity of the areas defined by antibodies’ branches and their intersection is so great that, in the aggregate, antibodies take on all foreign presences.

When an antibody’s shape and electrochemistry is complementary to a feature of a pathogen, it gloms on tightly. Antibodies that bind pathogens in just the right places, preventing infection, are called neutralizing antibodies.

The resulting adhesion generates what is called an immune complex, drawing immune cells to the site.

The investigators found that though many participants whose symptoms remained mild had healthy levels of neutralizing antibodies to SARS-CoV-2 from day 1, those who ended up hospitalized initially had minimal or undetectable levels of neutralizing antibodies, though their immune cells started pumping them out later during the infection’s course.

A second finding shows that the antibody “trunks” contain chains of various sugar molecules linked together. These sugar chains influence how inflammatory an immune complex will be.

Investigators found that individuals who progressed to severe COVID-19 had sugar chains on certain antibodies targeting SARS-CoV-2 and were deficient in a variety of sugar called fucose. The deficiency was evident on the day individuals first tested positive.

Furthermore, immune cells in these patients featured inordinately high levels of receptors for these fucose-lacking types of antibodies. Such receptors, called CD16a, are known to boost immune cells’ inflammatory activity.

“Some inflammation is absolutely necessary to an effective immune response,” Wang said. “But too much can cause trouble, as in the massive inflammation we see in the lungs of people whose immune systems have failed to block SARS-CoV-2 quickly upon getting infected.”

Stanford Medicine investigators were able to estimate who is most likely to land in the hospital.

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