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Considerations for Dosing of Oral Therapies in Metastatic RCC

Considerations for Dosing of Oral Therapies in Metastatic RCC

For patients with meta­static renal cell carcinoma (mRCC), oral therapy has improved out­comes and has become a standard of care. When selecting oral therapies for mRCC, an important consideration is how well patients can tolerate optimal dosing of a particular agent.2 As Robert A. Figlin, MD, FACP, noted in an article published in the August 2013 issue of Physician’s Weekly—Oncology Edition, a key goal when initiating oral therapy in mRCC patients is to maintain the starting dose throughout the treatment course when possible. Outside of a clinical trial setting, the application of oral therapies may present some challenges when treating mRCC patients with unique needs.1 For example, some patients may be more prone than others to experience potential drug interactions or to have comorbidities that can affect how patients are managed with oral therapy. Prior to initiating oral therapy, clinicians should educate patients about the potential treatment-related adverse reactions (ARs). Patients should be made aware that some ARs, but not all, may be manageable during their treatment. Oral therapies have been shown to have serious life-threatening side effects, in addition to low-grade ARs.   Dosing regimens of oral therapy for mRCC might need to be adjusted based on individual safety and tolerability.1 When to Consider Dose Modifications or Interruptions Currently, there are no data that directly compare the relative safety and tolerability of oral therapies for mRCC.2 As a result, clinicians must rely on data provided from published studies of randomized controlled trials involving available agents, dosing recommendations in the package insert information, and their own clinical experience.1 In some patients, dose modifications or interruptions may be considered when managing treatment-related...
Analyzing Operative Outcomes for Proximal Aortic Replacement

Analyzing Operative Outcomes for Proximal Aortic Replacement

Morbidity and mortality from proximal aortic replacement remain high when compared with other surgical procedures, but research indicates that patient outcomes have improved over the last 30 years. Much of this has been attributed to advances in operative approaches, perioperative care, and increased surveillance. For patients undergoing these procedures, better character­izing outcomes and determin­ing predictors of mortality and major morbidity are important for clinicians managing this patient population. In the Journal of the American College of Cardiology, G. Chad Hughes, MD, and colleagues had an analysis published that looked at operative outcomes for ascending aorta and arch replacement on a national scale. The study also reviewed risk factors for postoperative mortality and major morbidity. “Our study provides a broad overview of the current practices and outcomes for proximal aortic replacement in North America,” says Dr. Hughes. “With more than 45,000 patients from the Society of Thoracic Surgeons Database involved in our analysis, we have the largest cohort of proximal aortic replacements that have been reported to date.”   Examining Outcomes for Proximal Aortic Replacement In the study by Dr. Hughes and colleagues, roughly 60% of proximal aortic replacement cases were elective, 20% were urgent, and 20% were emergent. From 2004 to 2009, the number of centers that reported performing aortic replacement, as well as the overall number of patients treated, increased dramatically, although the average number of patients treated per center remained relatively constant. In 2004, 285 centers in North America treated 2,121 patients. In 2008, there were 806 centers that treated 11,033 patients. “Outcomes were excellent for elective proximal aortic replacement but sharply deteriorated when the procedure was...

A Look at Partial Nephrectomy in Medicare Patients

Researchers at Fox Chase Cancer Center have found that partial nephrectomy appears to have a statistically significant survival benefit when compared with radical nephrectomy for patients older than 66 with renal cell carcinomas that are 4 cm or smaller. However, the authors noted that this benefit decreased with time, and little benefit was seen at 5 and 10 years after the procedure. Abstract: Journal of Urology, December...

High Pneumonia Risk for Transplant Recipients

Researchers in Denmark have found that the risk of first-time hospitalization for pneumonia appears to be high among renal transplant candidates and recipients. When compared with controls, incidence rate ratios of first hospitalization for pneumonia were 10.2 for renal transplant candidates, 8.02 for recipients, and 13.7 for patients with graft loss. Risk factors among renal transplant recipients included male gender, age older than 50, diabetes, chronic interstitial nephritis, polycystic kidney disease, and 1 to 3 years of prior dialysis. Abstract: Clinical Infectious Diseases, September 1,...
Medical Devices to Watch in 2012

Medical Devices to Watch in 2012

Excerpted from “Outlook for the healthcare industry in 2012” by Steven Greer, MD, The Healthcare Channel. The year 2012 might see the much-hyped therapies of stem cells and gene therapy become clinical realities. Data showing that heart-derived stem cells improved the cardiac output of heart failure patients with myocardial infarction seemed to be a true breakthrough. Likewise, the cure (for the time being) of six hemophiliac patients using viral-vector gene therapy was also a clinical breakthrough. Some of the most promising and innovative new medical devices to track in 2012: Renal artery ablation to treat hypertension: Medtronic (MDT) is in the lead with this technology and others are following. If this technique is safe, it promises to compete with multibillion-dollar drugs. Bioabsorbable coronary stents: This technology will not be approved in 2012, but any clinical trial news will be significant given the paradigm changing potential of these devices. Next-generation catheter-delivered aortic valves: The currently approved first-generation Edwards Lifesciences (EW) Sapien valve is not ready for mainstream use beyond the surgically ineligible patients. In addition, Medicare might restrict coverage of these first-generation devices. However, smaller devices, coupled with embolic filters to reduce stroke rates, might achieve broader use. Monitor any trial data of the combined use of embolic filters and the valves. Wireless Pulmonary Artery Pressure Sensor: The CardioMEMS [with investments from St Jude Medical (STJ)] was rejected by an FDA advisory committee. However, this device will likely be considered an “innovative” device as part of the new fast-track program of the FDA’s CDRH. Do not be surprised to see it approved.   Troubled devices: As described throughout this report, the...
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