Updated guidance, treatment options, FDA news and more

April 23, 2022

5 min read


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

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


Esophageal cancer signs, symptoms and risk factors



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

Throughout April, Esophageal Cancer Awareness Month highlights the importance of screening and early intervention. Healio compiled ten recent reports on FDA news, common conditions, updated guidance and treatment options.

FDA accepts supplemental biologics license application for Dupixent for EoE

Regeneron Pharmaceuticals Inc. and Sanofi announced that the FDA accepted for priority review a supplemental biologics license application for Dupixent 300 mg for adults and children aged 12 years and older with eosinophilic esophagitis.

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

VIDEO: What’s in a name? How a premalignant esophageal condition bears the name Barrett

In this Endo-Sketch, a Healio video series on clinical conditions named after famous colleagues, Klaus Mergener, MD, of 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. He joined St. Thomas Hospital in London after medical school to pursue postgraduate training in surgery and remained there for his entire career. Read more.

ACG updates guidance for diagnosis, management of Barrett’s esophagus

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

The guidelines implement 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. Of note, the updates broaden acceptable screening modalities to include nonendoscopic methods, liberalized screening intervals and volume criteria for therapy centers. Read more.

Is FDA approval in sight for emerging EoE therapies?

Over the years, there have been many advances in the pathologic understanding of eosinophilic esophagitis, but FDA-approved treatment options have lagged.

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.

Novel risk model predicts treatment complexity in BE after radiofrequency ablation

A novel risk model predicted treatment complexity among patients with Barrett’s esophagus following 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 typically consists of endoscopic resection of visible abnormalities, followed by radiofrequency ablation (RFA), ” Sanne van Munster, MD, of the department of gastroenterology and hepatology at Amsterdam University Medical Centers, and colleagues wrote. “This dual modality treatment has been proven safe and results in a complete eradication of BE (CE-BE) in 74% to 98% of patients. … However, a subgroup of patients will experience a more complex treatment course. ” Read more.

New ACG, CAG guidelines for antithrombotic therapy in acute GI bleeding, periendoscopy

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

“We aimed to bring together clinical content and methodological experts in gastrointestinal endoscopy and GI bleeding, hematology, and cardiology to create pragmatic, principle-based guidance related to managing antiplatelet and anticoagulant drugs before endoscopy and in the setting of gastrointestinal bleeding,” Neena S. Abraham, MD, MSc (Epi), FACG, of the Mayo Clinic in Scottsdale, Arizona, told Healio. “In this important update, we critically evaluated the published literature related to temporary interruption and resumption of these agents and the use of reversal agents. Clinicians can have confidence in our recommendations based on the unprecedented rigor used in evaluating the literature and the multidisciplinary perspective addressing common clinical scenarios. ” Read more.

Long-term PPI therapy: ‘Deprescribe’ or continue at lowest effective dose, expert advises

According to one expert at Guild 2022, physicians should “re-ground” their approach to long-term proton pump inhibitor use and consider data-driven recommendations about its indications, known benefits and risks.

“There is a firehose of information about proton pump inhibitors – not only for us but also for our patients,” Doug A. Corley, MD, PhD, research scientist at Kaiser Permanente of Northern California and clinical professor of medicine at University of California, San Francisco, said during the presentation. Read more.

Nivolumab bests chemotherapy in esophageal squamous cell carcinoma treatment

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

“Although chemotherapy has been a widely used first-line treatment for decades, clinical benefit was recently reported with programmed death 1 (PD-1) inhibitors in combination with chemotherapy over chemotherapy alone,” Yuichiro DokiMD, of 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, irrespective of programmed death ligand 1 (PD- L1) expression status. ” Read more.

Camrelizumab, apatinib safe, efficacious in advanced esophageal squamous cell carcinoma

Camrelizumab combined with apatinib may potentially be used as a second-line treatment for advanced esophageal squamous cell carcinoma, 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 esophageal squamous cell carcinoma, with acceptable toxicity, ” Xiangrui Meng, 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 when combined with camrelizumab in advanced cancers. Phase 2 studies of camrelizumab plus apatinib have been further conducted in many solid tumors with encouraging efficacy and manageable safety. ” Read more.

Budesonide improves histologic, symptom response in pediatric EoE

Budesonide oral suspension improved histologic, endoscopic and symptom response compared with placebo among pediatric patients with eosinophilic esophagitis, according to a study.

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

Resources:

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.

Cancer Research Institute. 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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