Updated guidelines, treatment options, FDA news and more

Apr 23, 2022

5 minutes reading

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Esophageal cancer is one of the deadliest cancers with an estimated 19,260 diagnoses and 15,530 deaths in the United States last year, the American Association for Cancer Research reported.

Although in 2021 both the FDA and the European Commission granted approvals for nivolumab with chemotherapy for the treatment of gastric and esophageal cancer, regardless of PD-L1 expression status, and pembrolizumab with chemotherapy for HER2-negative advanced cancers, the burden of disease remains high.

Signs, Symptoms, and Risk Factors of Esophageal Cancer

The AACR reminds patients and caregivers of common signs and symptoms of esophageal cancer, including painful or difficult swallowing, weight loss, pain behind the sternum, hoarseness or cough, indigestion, and heartburn. Additional risk factors include smoking, heavy alcohol use, and Barrett’s esophagus, as well as older age, male gender, and African-American descent.

Throughout April, esophageal cancer month emphasizes the importance of screening and early intervention. Healio has compiled ten recent reports on FDA news, common conditions, updated guidelines, and treatment options.

FDA Accepts Additional Biological License Application for Dupixent for EoE

Regeneron Pharmaceuticals Inc. and Sanofi announced that the FDA has accepted an application for an additional biologic authorization for Dupixent 300 mg for adults and children 12 years of age and older with eosinophilic esophagitis for priority review.

“This news is very welcome and encouraging as there are no FDA-approved drugs for eosinophilic esophagitis and there is a significant unmet need,” Evan S. Dellon, MD, MPH, professor of medicine, division of gastroenterology and hepatology at the University of North Carolina School of Medicine and co-principal investigator of the pivotal studies, Healio told me. “EoE is a chronic and progressive inflammatory disease that causes esophageal injury and remodeling. This ultimately places a heavy burden on patients, for whom swallowing food can be difficult, painful and worrisome. If approved, dupilumab would be the first drug indicated for treatment of EoE in the United States and has the potential to reduce underlying inflammation and help improve patients’ swallowing ability.” Read more.

VIDEO: What’s in a name? How a premalignant esophageal condition goes by the name of Barrett

In this Endo-Sketch, a Healio video series on clinical conditions named after famous colleagues, Klaus Mergener, M.D., from the University of Washington School of Medicine, discusses the origin of Barrett’s esophagus.

According to Mergener, the condition is named after British surgeon Norman Rupert Barrett, who was born in Adelaide, Australia in 1903 and attended Eton and Trinity colleges in the United Kingdom. After medical training, he went to St Thomas Hospital in London to pursue a postgraduate degree in surgery and remained there throughout his career. Read more.

ACG Updates Guidelines for Diagnosis, Treatment of Barrett’s Esophagus

The ACG has issued revised clinical guidelines for the diagnosis and treatment of patients with Barrett’s esophagus, published in the American Journal of Gastroenterology.

The guidelines implement the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology to propose 21 recommendations for the definition and diagnosis of BE, screening for both BE and esophageal adenocarcinoma (EAC), surveillance and treatment. Note that the updates broaden the acceptable screening modalities to include non-endoscopic methods, liberalized screening intervals, and volume criteria for therapy centers. Read more.

Is FDA approval in sight for emerging EoE therapies?

Over the years, much progress has been made in the pathological understanding of eosinophilic esophagitis, but FDA-approved treatment options have lagged behind.

In a review published in the Journal of Allergy and Clinical Immunology, researchers noted that current treatments are considered off-label and include the three Ds: drugs, dietary elimination, and endoscopic dilation. Read more.

New risk model predicts treatment complexity in BE after radiofrequency ablation

A new risk model predicted treatment complexity in patients with Barrett’s esophagus after initial radiofrequency ablation treatment, according to research published in Clinical gastroenterology and hepatology.

“Endoscopic eradication therapy (EET) is well established for Barrett’s with early neoplasia. EET usually consists of endoscopic resection of visible abnormalities, followed by radiofrequency ablation (RFA),” Sanne van Munster, MD, of the Gastroenterology and Hepatology Department of the UMCs of Amsterdam, and colleagues wrote. “This two-modal treatment has been shown to be safe and results in complete eradication of BE (CE-BE) in 74% to 98% of patients. … However, a subgroup of patients will experience a more complex treatment trajectory.” Read more.

New ACG, CAG Guidelines for Antithrombotic Therapy in Acute Gastrointestinal Bleeding, Periendoscopy

The ACG and the Canadian Association of Gastroenterology have developed recommendations for the treatment of anticoagulants and antiplatelet agents during acute gastrointestinal bleeding and the elective periendoscopic period.

“We wanted to bring together clinical content and methodological experts in gastrointestinal endoscopy and GI bleeding, hematology and cardiology to create pragmatic, principle-based guidelines regarding the administration of antiplatelet agents and anticoagulants before endoscopy and in the setting of gastrointestinal bleeding,” Neena S. Abraham, MD, MSc (Epi), FACG, from the Mayo Clinic in Scottsdale, Arizona, to Healio. “In this important update, we critically reviewed the published literature regarding temporary interruption and resumption of these agents and the use of reversal agents. Clinicians can rely on our recommendations based on the unprecedented accuracy used in evaluating the literature and the multidisciplinary perspective of common clinical scenarios.” Read more.

Long-term PPI therapy: ‘write off’ or continue with lowest effective dose, expert advises

According to a Guild 2022 expert, doctors should “rethink” their approach to long-term use of proton pump inhibitors and consider data-based recommendations about the indications, known benefits and risks.

“There is a tremendous amount of information about proton pump inhibitors — not just for us, but for our patients as well,” Doug A. Corley, MD, PhD, researcher at Kaiser Permanente of Northern California and clinical professor of medicine at the University of California, San Francisco, during the presentation. Read more.

Nivolumab bests chemotherapy in the treatment of squamous cell carcinoma of the esophagus

First-line treatment with nivolumab in patients with advanced squamous cell carcinoma of the esophagus, according to research, resulted in longer overall survival compared to chemotherapy alone.

“While chemotherapy has been a widely used first-line treatment for decades, clinical benefit has recently been reported with inhibitors of programmed death 1 (PD-1) in combination with chemotherapy rather than chemotherapy alone,” Yuichiro HorseMD, from the Osaka University Graduate School of Medicine, and colleagues wrote in the: New England Journal of Medicine. “Treatment with the anti-PD-1 monoclonal antibody nivolumab has been reported to result in significantly longer overall survival than chemotherapy in previously treated patients with advanced esophageal squamous cell carcinoma and is approved for this indication regardless of programmed death ligand 1 (PD-L1) expression status. .” Read more.

Camrelizumab, safe for apatinib, effective in advanced squamous cell carcinoma of the esophagus

According to Phase 2 results published in The Lancet Gastroenterology & Hepatology.

“Second-line or later-line therapy with apatinib, a selective tyrosine kinase inhibitor of VEGF [receptor 2]showed antitumor activity in patients with advanced squamous cell carcinoma of the esophagus, with acceptable toxicity,” Xiangru mix, of the first affiliated hospital of Zhengzhou University in China, and colleagues wrote. “A phase 1 study recommended apatinib at a dose of 250 mg in combination with camrelizumab in advanced cancers. Phase 2 studies of camrelizumab plus apatinib have continued in many solid tumors with encouraging efficacy and manageable safety.” Read more.

Budesonide improves histological, symptom response in pediatric EoE

According to a study, budesonide oral suspension improved histological, endoscopic, and symptom response compared to placebo in pediatric patients with eosinophilic esophagitis.

“Budesonide oral suspension (BOS) is an immediate-release ingested topical corticosteroid optimized as a viscous suspension for patients with EoE,” Sandeep K. Gupta, MD, of the division of gastroenterology, hepatology, and nutrition at Indiana University School of Medicine, and colleagues wrote. “Previous studies have shown that BOS improves symptomatic, histological and endoscopic outcomes in adolescents and adults with EoE.” Read more.


American Association for Cancer Research. Esophageal Cancer Awareness Month. Available at: https://www.aacr.org/patients-caregivers/awareness-months/esophageal-cancer-awareness-month/#:~:text=April%20is%20Esophageal%20Cancer%20Awareness%20Month. Accessed: April 20, 2022.

Institute of Cancer Research. Esophageal Cancer Awareness Month: 2022 Immunotherapy Research Updates. Available at: https://www.cancerresearch.org/en-us/blog/april-2022/esophageal-cancer-awareness-month-2022-immunothera. Accessed: April 20, 2022.

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