Preclinical and clinical evaluation through serial colonoscopic evaluation of neratinib-induced diarrhea in HER2-positive breast cancer-A pilot study.

The irreversible pan-HER tyrosine kinase inhibitor neratinib is approved for patients with HER2-positive, early-stage and metastatic breast cancer (BC). Neratinib-associated diarrhea is the most common reason for early discontinuation. Preclinical studies identified mechanisms of neratinib-induced diarrhea and rationale for prophylactic and preventive measures.

A Phase 2 evaluation of a new flavored peg and sulfate solution compared to an over-the-counter laxative, peg and sports drink bowel preparation combination.

Background: Acceptability and tolerance of bowel preparation is critical to overcome patient hesitancy in undergoing colon cancer screening and surveillance colonoscopy. To improve patient experience, a new sports drink-flavored bowel preparation containing polyethylene glycol (PEG) and sulfate salts (FPSS) was developed to provide a similar experience to a commonly used but not United States Food and Drug Administration (FDA) approved PEG and sports drink bowel preparation (PEG-SD), while also achieving improved cleansing efficacy.

Methods: This FPSS preparation, approved by the FDA in June 2023, was evaluated in a non-randomized Phase 2 study in which 40 patients requiring colonoscopy were prepared with FPSS and 20 with PEG-SD.

Comparison of a Novel, Flavor-optimized, Polyethylene Glycol and Sulfate Bowel Preparation With Oral Sulfate Solution in Adults Undergoing Colonoscopy.

Introduction: A new bowel preparation for colonoscopy has been developed containing poorly absorbed sulfate salts and polyethylene glycol 3350, which retain water within the intestinal lumen resulting in copious diarrhea, thereby cleansing the bowel. The product was formulated to be safe and effective with a sports drink-like flavor. This study evaluated the new flavored polyethylene glycol and sulfate solution (FPSS) compared with a Food and Drug Administration-approved bowel preparation containing sulfate salts only [oral sulfate solution (OSS)].

Optimal Strategies for Successful Initiation of Neratinib in Patients with HER2-Positive Breast Cancer.

Neratinib is an irreversible, pan-human epidermal growth factor inhibitor that has shown efficacy across human epidermal growth factor receptor 2 (HER2)-positive breast cancer settings. Neratinib is indicated for use as extended adjuvant therapy for HER2-positive early-stage breast cancer or, in combination with capecitabine, in the treatment of HER2-positive metastatic breast cancer. The primary tolerability concern with neratinib is diarrhea, and severe diarrhea early in treatment can lead to a substantial proportion of patients discontinuing neratinib, which may lead to reduced or nonexistent efficacy.

A Safety and Efficacy Comparison of a New Sulfate-Based Tablet Bowel Preparation Versus a PEG and Ascorbate Comparator in Adult Subjects Undergoing Colonoscopy.

Introduction: A new tablet-based bowel prep for colonoscopy has been developed containing poorly absorbed sulfate salts which act to retain water within the intestinal lumen resulting in a copious diarrhea, thereby cleansing the bowel. This study evaluated the safety and efficacy of these oral sulfate tablets (OST) compared with a US FDA-approved bowel prep solution containing PEG3350, electrolytes, and ascorbate (polyethylene glycol and ascorbate [PEG-EA]).

Methods: Five hundred fifteen adult patients (mean 57y) were enrolled in this single-blind, multicenter, noninferiority study.

Effect of individualized feedback on learning curves in EGD and colonoscopy: a cluster randomized controlled trial.

Background And Aims: Gastroenterology fellowships need to ensure that trainees achieve competence in upper endoscopy (EGD) and colonoscopy. Because the impact of structured feedback remains unknown in endoscopy training, this study compared the effect of structured feedback with standard feedback on trainee learning curves for EGD and colonoscopy.

Methods: In this multicenter, cluster, randomized controlled trial, trainees received either individualized quarterly learning curves or feedback standard to their fellowship.

A Prospective Multicenter Study Evaluating Endoscopy Competence Among Gastroenterology Trainees in the Era of the Next Accreditation System.

Purpose: The Next Accreditation System requires training programs to demonstrate competence among trainees. Within gastroenterology (GI), there are limited data describing learning curves and structured assessment of competence in esophagogastroduodenoscopy (EGD) and colonoscopy. In this study, the authors aimed to demonstrate the feasibility of a centralized feedback system to assess endoscopy learning curves among GI trainees in EGD and colonoscopy.

Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial.

Background: We characterized patterns of occurrence and the impact of neratinib-associated diarrhea in the absence of protocol-directed antidiarrheal prophylaxis or a formal diarrhea management plan using data from Extended Adjuvant Treatment of Breast Cancer with Neratinib (ExteNET).

Methods: ExteNET is a multicenter, double-blind, placebo-controlled, randomized phase III trial involving community-based and academic institutions in 40 countries. Women with HER2-positive early-stage breast cancer with prior standard primary therapy and trastuzumab-based (neo)adjuvant therapy were randomized to neratinib 240 mg/day or placebo for 12 months.

The characterization, management, and future considerations for ErbB-family TKI-associated diarrhea.

Purpose: Diarrhea is recognized as a common adverse event associated with tyrosine kinase inhibitors (TKIs), with those targeting the ErbB family of receptors being associated with the highest rate of diarrhea.

Methods: This paper reviews data on the incidence, timing, and duration of diarrhea associated with US Food and Drug Administration-approved ErbB family-targeted TKIs from the published literature, and sets forth recommendations for management.

Results: In the absence of anti-diarrheal prophylaxis the incidence of any-grade diarrhea varies and typically occurs early during the course of treatment.

A Survey of Social Media Use and Preferences in Patients with Inflammatory Bowel Disease.

Background: With the recent increase in the use of social media, patients with chronic illnesses are using the Internet as a resource for disease management. As the peak incidence of inflammatory bowel disease (IBD) occurs in patients between the ages of 15 and 30, IBD is a suitable condition to study social media use. The aim of this study was to assess social media usage and preferences in patients with IBD.

Faecal microbiota transplantation: applications and limitations in treating gastrointestinal disorders.

The process of stool transfer from healthy donors to the sick, known as faecal microbiota transplantation (FMT), has an ancient history. However, only recently researchers started investigating its applications in an evidence-based manner. Current knowledge of the microbiome, the concept of dysbiosis and results of preliminary research suggest that there is an association between gastrointestinal bacterial disruption and certain disorders.

Comparative Proteomic Analysis of Whole-Gut Lavage Fluid and Pancreatic Juice Reveals a Less Invasive Method of Sampling Pancreatic Secretions.

Objectives: There are currently no reliable, non-invasive screening tests for pancreatic ductal adenocarcinoma. The fluid secreted from the pancreatic ductal system ("pancreatic juice") has been well-studied as a potential source of cancer biomarkers. However, it is invasive to collect.

Does Carbohydrate Challenge Testing Predict Clinical Response in Small Intestinal Bacterial Overgrowth?

Objectives: Small intestinal bacterial overgrowth (SIBO) is considered a frequent cause of abdominal symptoms in patients with surgically altered intestinal anatomy or dysmotility conditions and is recognized as a contributing factor in the exacerbation of irritable bowel syndrome symptoms. Diagnostic testing can be used to detect the condition.

Methods: The study group comprised patients who had breath hydrogen and methane lactulose challenge testing.

A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy.

Background: There are few data comparing U.S. Food and Drug Administration-approved low-volume bowel preparations for colonoscopy.

A randomized, controlled trial of oral sulfate solution plus polyethylene glycol as a bowel preparation for colonoscopy.

Background: No bowel preparation for colonoscopy is optimal with regard to efficacy, safety, and tolerability. New options for bowel preparation are needed.

Objective: To compare a new hybrid preparation consisting of a reduced dose of oral sulfate solution (OSS) plus 2 L of sulfate-free electrolyte lavage solution (SF-ELS) with 2 low-volume preparations based on polyethylene glycol electrolyte lavage solution (PEG-ELS).

Colon cleansing for colonoscopy 2013: current status.

Colonoscopy requires adequate bowel cleansing to be safe and effective. There are a variety of options available. This review will focus on highlighting new products, administration techniques emphasizing the value of split-dose and same-day regimens, safety, and options for inadequate cleansing.

Endemic fungal infections in inflammatory bowel disease associated with anti-TNF antibody therapy.

Patients with inflammatory bowel disease are susceptible to complications from pharmacologic treatment of their disease. Tumor necrosis factor (TNF)-α inhibitors are being used increasingly in the treatment of inflammatory bowel disease and can be associated with adverse events, including common infections, and rarely the development of serious life-threatening opportunistic infections. TNF-α inhibitors have the ability to prevent an effective patient granulomatous response, and this may be associated with an increased risk of developing mycobacterial and certain fungal infections, including histoplasmosis, blastomycosis, and coccidioidomycosis, endemic in several parts of the United States.

Crohn's disease: the subsequent visit.

The diagnosis and subsequent management of Crohn's disease are challenging for both the patient and the gastroenterologist. After the initial assessment, subsequent visits should assess the patient's readiness to begin therapy, monitor progress if therapy has been initiated, assess for complications of the disease or therapy, and ensure that all appropriate health maintenance measures are current. This article is intended to be a companion to our earlier paper "Crohn's Disease: The First Visit," which was published in Gastroenterology & Hepatology in March 2011.

The role of effective clinician-patient communication in the management of irritable bowel syndrome and chronic constipation.

Irritable bowel syndrome (IBS) and chronic constipation (CC) are common functional bowel disorders that are among the most frequent reasons for referral to a gastroenterologist. Diagnosis and management of these conditions can be challenging for both the clinician and the patient for a number of reasons. Diagnosis can be complicated by the lack of a specific diagnostic test and the fact that IBS and CC are multisymptomatic conditions, whereas management can be suboptimal, because the conditions are often undiagnosed and self-managed by the patient.

"Red flag" evaluation yield in irritable bowel syndrome.

Background: The diagnosis of irritable bowel syndrome (IBS) is based on clinical criteria. Further diagnostic testing is advised for certain "red flag" alarm or warning signs.

Aim: This investigation was designed to examine the yield of testing for "red flags".

Carbohydrate challenge tests: do you need to measure methane?

Objective: Breath tests that measure hydrogen (H2) have been judged reliable for the detection of lactose maldigestion (LM) and fructose malabsorption (FM). Recently, methane (CH4) testing has been advocated and measurement of CH4 in addition to H2 has been shown to increase the diagnostic accuracy for LM.

Purpose: This study was designed to consider the additional yield from CH4 measurement in patients tested for LM and FM.

The role of capsule endoscopy in evaluating inflammatory bowel disease.

Capsule endoscopy is a relatively new technology available in the investigation of IBD. Its place in the algorithm of evaluating IBD is being refined. Capsule endoscopy has the ability to visualize the entire SB with very few complications.

Advances in bowel preparations: new formulation and clinical results.

Adequate cleansing is essential for a thorough and accurate examination of the bowel during colonoscopy. Suboptimal preparation can lead to missed diagnoses, increased costs, and safety issues. Favorable bowel preparations are efficacious, safe, and cause as little patient discomfort as possible by limiting fluid volume, intolerance, and inconvenience.