Treatment with 6-12 months of anastrozole or letrozole was associated with decreases in BPE, which occurred in a greater proportion of women than decreases in FGT.
Preclinical data have demonstrated that the combination of antihuman epidermal growth factor receptor-2 (anti-HER2) and antivascular endothelial growth factor (anti-VEGF)—targeted agents has antitumor activity; these data indicate certain patients with HER2-overexpressing breast cancer may derive clinical benefit from this combination. The purpose of this single-arm phase II study was to determine the efficacy and safety of the dual-targeting combination of lapatinib and bevacizumab. Women with HER2-overexpressing advanced breast cancer received 1,500 mg oral lapatinib daily plus 10 mg/kg IV bevacizumab every 2 weeks. The primary endpoint was progression-free survival (PFS) at week 12; secondary endpoints included overall tumor response rate (ORR), clinical benefit rate (CBR), duration of response, time-to-response, PFS, and safety. Circulating tumor cells (CTC) and circulating endothelial cells (CEC) were measured at baseline and during study treatment as potential response markers. Fifty-two patients with stage IV disease were enrolled. The 12-week investigator-assessed PFS rate was 69.2% (95% confidence interval [CI]: 54.9, 81.3). Median PFS was 24.7 weeks (95% CI: 20.4, 35.1), and the CBR was 30.8% (95% CI: 18.7, 45.1). Of 45 patients with measurable disease, 6 were determined to have a partial response per Response Evaluation Criteria in Solid Tumors (ORR: 13.3%; 95% CI: 5.1, 26.8). The most common adverse events (AEs) included diarrhea, rash, and fatigue; most of these were either grade 1 or 2. Clinical responses were correlated with decreases in CTC and CEC. Lapatinib plus bevacizumab was active in patients with HER2-overexpressing breast cancer. The AE profile of the combination was consistent with the known profiles for these agents.
Summary
Background
Central neuromodulators are an effective treatment for irritable bowel syndrome (IBS) but may be used less frequently than other therapies.
Aims
To survey gastroenterologists in the United States (US) about their use of neuromodulators in patients with IBS.
Methods
A 23‐question survey was distributed to gastroenterologists in the United States. Comparisons in prescribing practices were conducted between (a) gastroenterologists who were “high prescribers” versus “low prescribers” of neuromodulators in patients with IBS and (b) gastroenterologists and “gastroenterology experts” in the use of neuromodulators using descriptive statistics and multivariable logistic regression analyses.
Results
The 525 gastroenterologists who were surveyed used neuromodulators for a median range of 21%‐30% of their patients with IBS. Neuromodulators were described as extremely/very important in managing IBS by 55% of clinicians. Significant predictors of high‐prescribing behaviour were academic versus clinical practice setting (odds ratio [OR] 2.60 [95% CI 1.61‐4.20]), disorders of brain‐gut interaction focused practice (OR 4.80 [2.60‐8.84]), and greater perceived effectiveness of neuromodulators (OR 2.75 [1.30‐5.84]). Compared to gastroenterologists, experts prescribed neuromodulators to a higher percentage of their patients with IBS (41%‐50% vs 21%‐30%; P = 0.019) and more frequently found neuromodulators effective (70% vs 27%; P = 0.003). However, concern about side effects was the most common barrier to neuromodulator use (59%).
Conclusions
The majority of US gastroenterologists believe central neuromodulators are important in treating IBS, and 27% believe they are effective in most patients. High prescribers are in academic practice, focus in IBS and perceive central neuromodulators as effective. Education is needed to improve gastroenterologists' prescribing behaviour.
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