The clinical safety and efficacy of IPI-926 was evaluated in 14 patients with myelofibrosis in a phase II study. Patients received 160 mg IPI-926 orally in continuous 28-day cycles. The median ...treatment duration was 5.1 months, and all patients had discontinued treatment by 7.5 months. Nine patients discontinued due to lack of response as determined by the treating physician, two after developing acute leukemia and one due to disease progression/loss of response. Twelve patients had slight reductions in spleen size (less than 50% from baseline), but symptoms did not improve consistently. One patient achieved transfusion independence lasting 5 months. Reductions in GLI1 mRNA and protein levels, JAK2V617F allele burden, degree of fibrosis or cytokine levels were observed in some patients, but were not significant when evaluated for the cohort. Low-grade gastrointestinal/liver abnormalities were the most common toxicities. The results did not support continued evaluation of IPI-926 as a monotherapy in myelofibrosis.
The outcome of sequential azacitidine with lenalidomide has not been reported in previously treated patients with acute myeloid leukemia (AML) and higher risk myelodysplastic syndrome (MDS). This ...study describes a phase 2 study evaluating the safety and efficacy of this combination in elderly patients with AML and MDS with prior hypomethylating agent (HMA) and/or immunomodulatory agent exposure. Patients were treated on a 42-day cycle with azacitidine at 75 mg/m
2
SQ/IV daily on days 1-7, followed by lenalidomide 50 mg orally daily on days 8-28. The median number of treatment cycles on study was two (range = 1-11). Of 32 evaluable patients, the overall response rate was 25%. Neutropenic fever was the most common serious adverse event, but overall the combination was well-tolerated. The median overall survival (OS) for responders vs non-responders was 9.8 vs 4.0 months, respectively (HR = 0.36, p = 0.016). In conclusion, this combination demonstrated modest clinical activity in this poor risk population.
Enhanced Recovery After Surgery (ERAS) protocols have been shown to increase recovery, decrease complications, and reduce length of stay. However, they are difficult to implement.
To develop and ...implement an ERAS clinical practice guideline (CPG) at multiple hospitals.
A tailored strategy based on the Knowledge-to-action (KTA) cycle was used to develop and implement an ERAS CPG at 15 academic hospitals in Canada. This included an initial audit to identify gaps and interviews to assess barriers and enablers to implementation. Implementation included development of an ERAS guideline by a multidisciplinary group, communities of practice led by multidiscipline champions (surgeons, anesthesiologists, and nurses) both provincially and locally, educational tools, and clinical pathways as well as audit and feedback.
The initial audit revealed there was greater than 75% compliance in only 2 of 18 CPG recommendations. Main themes identified by stakeholders were that the CPG must be based on best evidence, there must be increased communication and collaboration among perioperative team members, and patient education is essential. ERAS and Pain Management CPGs were developed by a multidisciplinary team and have been adopted at all hospitals. Preliminary data from more than 1000 patients show that the uptake of recommended interventions varies but despite this, mean length of stay has decreased with low readmission rates and adverse events.
On the basis of short-term findings, our results suggest that a tailored implementation strategy based on the KTA cycle can be used to successfully implement an ERAS program at multiple sites.
This systematic review explores the sociodemographic factors associated with the utilization of bariatric surgery among eligible patients. Electronic databases were searched for population-based ...studies that explored the relationship between sociodemographic characteristics of patients eligible for bariatric surgery to those who actually received the procedure. Twelve retrospective cohort studies were retrieved, of which the results of 9 studies were pooled using a random effects model. Patients who received bariatric surgery were significantly more likely to be white versus non-white (OR 1.54; 95 % CI 1.08, 2.19), female versus male (OR 2.80; 95 % CI 2.46, 3.22), and have private versus government or public insurance (OR 2.51; 95 % CI 1.04, 6.05). Prospective cohort studies are warranted to further determine the relative effect of these factors, adjusting for confounding factors.
Bariatric surgery is the only weight-loss treatment available that results in both sustained weight loss and improvements of obesity-related comorbidities. Individuals who meet the eligibility ...criteria for bariatric surgery are generally older, come from racial or ethnic minorities, are economically disadvantaged, and have low levels of education. However, the population who actually receives bariatric surgery does not reflect the individuals who need it the most. The objective is to conduct a systematic review of the literature exploring the inequities to the access of bariatric surgery.
EMBASE and Medline databases will be searched for observational studies that compared at least one of the PROGRESS-PLUS sociodemographic characteristics of patients eligible for bariatric surgery to those who actually received the procedure. Articles published in the year 1980 to present with no language restrictions will be included. For inclusion, studies must only include adults (≥18 years old) who meet National Institutes of Health (NIH) eligibility criteria for bariatric surgery defined as having either (1) a body mass index (BMI) of 40 kg/m² or greater; or (2) BMI of 35 kg/m² or greater with significant weight-related comorbidities. Eligible interventions will include malabsorptive, restrictive, and mixed bariatric procedures.
There appears to be inequities in access to bariatric surgery. In order to resolve the health inequity in the treatment of obesity, a synthesis of the literature is needed to explore and identify barriers to accessing bariatric surgery. It is anticipated that the results from this systematic review will have important implications for advancing solutions to minimize inequities in the utilization of bariatric surgery. http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42013004920.