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AUA 2015: New Studies May Enhance Ability to Predict Renal Cell Carcinoma ... - Cancer Therapy Advisor |
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According to research recently presented at the American Urological Association annual meeting, clinicians may have an improved ability to predict treatment outcomes in patients with renal cell carcinoma (RCC).
The studies presented either build on or confirm previous research or identify novel prognostic markers, which include tumor shrinkage, preoperative C-reactive protein levels, or preoperative nutritional screening.
Tumor Shrinkage
Takafumi Yagisawa, MD, and colleagues at Tokyo Women's Medical University, presented the findings of a study looking at the outcomes of 199 patients with metastatic RCC (mRCC) who recieved first-line systemic therapy with sunitinib (71 patients), sorafenib (47 patients), pazopanib (4 patients), or temsirolimus (7 patients).1
The study showed that the 81 patients who had maximum tumor shrinkage within 3 months—as measured by computed tomography (CT)—had significantly longer overall survival than the 48 patients who had maximum shrinkage after 3 months (22.8 vs. 14.3 months, respectively).1
In another study, investigators led by Hideaki Miyake, MD, of Kobe University Graduate School of Medicine in Japan, examined tumor shrinkage as a predictor of overall survival among 185 patients with mRCC who received first-line therapy with sunitinib (120 patients) or sorafenib (65 patients) for 3 or more months.2
Three patients had a complete response to therapy and 40 had a partial response. Another 105 patients showed stable disease, while 37 experienced disease progression. The median progression-free survival was 7.3 months, and overall survival was 33.6 months.2
After 3 months on the medications, 9 patients experienced tumor shrinkage of 50% to 100%; 43 patients had tumor shrinkage ranging from 25% to 49%; and 61 patients had 0% to 24% tumor shrinkage. The remaining 72 patients had tumor enlargement or new metastatic lesions.
Overall survival rates by level of tumor shrinkage (from greatest to least) were 59 months, 39 months, 31 months, and 16 months, respectively.2
In multivariate analysis, Memorial Sloan Kettering Cancer Center classification, C-reactive protein level, liver metastasis, and early tumor shrinkage were significantly and independently associated with overall survival.2
“Considering the potential impact of early tumor shrinkage on the subsequent prognosis of patients with mRCC, it is very important to select first-line agents with an ability to induce prompt tumor remission in order to achieve a favorable prognosis,” Dr. Miyake said.
Meanwhile, Viktor Gruenwald, MD, and colleagues presented findings at the 2015 American Society of Clinical Oncology annual meeting in Chicago, IL, that reported on a study of 4,736 patients with mRCC.
RELATED: ASPEN Compares Sunitinib, Everolimus in Metastatic Non-Clear Cell Renal Cell Carcinoma
Their research demonstrated that RCC early tumor shrinkage of 7% or 8% provides the optimal cut-off for predicting progression-free and overall survival, and that the conventional 30% tumor shrinkage threshold is too high.3
The researchers used data from Pfizer-sponsored clinical trials with sorafinib, axitinib, sunitinib, interferon-alfa, and temsirolimus.
The researchers evaluated early tumor shrinkage at the first post-baseline scan. They classified patients as responders if progression-free and overall survival times (7 months and 20 months, respectively) were above the median.3
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New Study Finds Home Hemodialysis Patient Survival Rates Nearly Double ... - Satellite PR News (press release) |
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LAWRENCE, Mass., June 18, 2015 /PRNewswire/ — NxStage Medical, Inc. (Nasdaq: NXTM) is encouraging patients to take control of their dialysis therapy and consider home hemodialysis in the wake of a new study that found patient survivability rates are significantly higher with home hemodialysis (HHD) than peritoneal dialysis (PD). The Incident Cohort Study, the first of its size, was completed by the Australian and New Zealand Dialysis and Transplantation Registry and shows that the five-year survival rate for HHD is at 85 percent while the survival rate for PD patients is just 44 percent. A leading manufacturer of dialysis products, NxStage, believes the recent findings should inspire dialysis patients to ask their healthcare providers about home hemodialysis therapy with the System One. Currently, less than two percent of dialysis patients in the U.S. are performing HHD, versus approximately 9% performing PD.
“These data clearly show that excellent long-term survival can be achieved in patients that are prescribed home hemodialysis within 90 days of starting maintenance dialysis,” said Dr. Eric Weinhandl, epidemiologist and lead investigator on multiple published studies on home dialysis clinical outcomes as part of the Chronic Disease Research Group. “Interestingly, the survival advantage of HHD over PD was evident in multiple frames, including younger and older patients, non-diabetics and diabetics, and early and late follow-up.”
Historically, studies comparing clinical outcomes between peritoneal dialysis and home hemodialysis have been limited. The Incident Cohort Study was the largest of its kind and assessed all Australian and New Zealand adult patients receiving home dialysis on day 90 after initiation of renal replacement therapy between 2000 and 2012. It included 10,710 patients on incident peritoneal dialysis and 706 patients on incident home hemodialysis and found that the risk of death-censored technique failure for HHD was 66 percent lower than PD. Directionally, these results were very consistent with recent presentations of survival and technique survival on NxStage HHD patients vs. PD in the US published by Weinhandl at the 2014 ASN Renal Week and 2015 NKC Spring Clinical Meeting.
“This strong clinical data backs the efficacy of HHD and affirms the results of recent studies,” said NxStage President, Joe Turk. “These results further reinforce the need for clinicians to consider HHD as a first strategy for incident patients, not just when PD fails.”
To learn more about NxStage and the System One, please visit NxStage.com.
Despite the health benefits that home hemodialysis may provide to those with chronic kidney disease, this form of therapy is not for everyone. The reported benefits of home hemodialysis may not be experienced by all patients. The risks associated with hemodialysis treatments in any environment include, but are not limited to, high blood pressure, fluid overload, low blood pressure, heart-related issues, and vascular access complications. The medical devices used in hemodialysis therapies may add additional risks including air entering the bloodstream and blood loss due to clotting or accidental disconnection of the blood tubing set. Certain risks are unique to the home. Treatments at home are done without the presence of medical personnel and on-site technical support. Patients and their partners must be trained on what to do and how to get medical or technical help if needed.
About the NxStage System One
The NxStage System One is the first and only truly portable hemodialysis system cleared specifically by the FDA for home hemodialysis and home nocturnal hemodialysis. Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients’ homes and give patients the freedom to travel with their therapy. When combined with the NxStage PureFlow SL Dialysis Preparation System, patients are able to further simplify, using ordinary tap water to create dialysis fluid on demand. Unlike conventional hemodialysis systems, the System One requires no special infrastructure to operate. Under the guidance of their physician, patients can use the NxStage System One, with their trained partners, where, how and when it best meets their needs, including while they are sleeping – at home or on vacation and at a medically appropriate treatment frequency. http://www.nxstage.com/.
About NxStage Medical
NxStage Medical Inc. (Nasdaq: NXTM) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of ESRD and acute kidney failure. For more information on NxStage and its products, please visit the Company’s website at www.nxstage.com.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words “anticipate,” “believe,” “expect,” “estimate,” “plan,” and similar expressions are generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those that are discussed in NxStage’s filings with the Securities and Exchange Commission, including the Quarterly Report on Form 10-Q for the quarter ended March 31, 2015. NxStage is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Media contact:
Kristen K. Sheppard, Esq.
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Tel: (978) 332-5923
Logo – http://photos.prnewswire.com/prnh/20110503/MM94799LOGO
Source: PrNewsWire All
New Study Finds Home Hemodialysis Patient Survival Rates Nearly Double Those of Peritoneal Dialysis
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Health Clinic Refuses To Give Undocumented Immigrant A Kidney Transplant ... - ThinkProgress |
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Immigration
by Esther Yu-Hsi Lee Posted on June 18, 2015 at 8:00 am
CREDIT: Shutterstock
Comment Ruth Villalta has end-stage renal disease. Her husband’s kidney could be a match for her — but the Long Island, New York clinic where she gets her dialysis treatment won’t allow her to receive a kidney transplant. That’s because both Villalta and her husband are undocumented immigrants. As the New York Daily News reports, “doctors at her dialysis clinic in Lindenhurst, run by Good Samaritan Hospital, initially discussed a transplant with her, but stopped the process when she said she was here illegally.” A Good Samaritan Hospital spokeswoman told ThinkProgress that officials could not comment on the case because, as of January 2015, a different organization took over responsibility of the dialysis center. Villalta came to the United States in 2009 with her husband and worked at a pharmaceutical factory before she became sick. When she had a miscarriage when she was five months pregnant in 2013, she discovered that she had renal failure in both kidneys. She’s been dependent on dialysis treatment ever since. Like Villalta, about 6,000 undocumented immigrants have end stage renal disease (ESRD). But there is a lack of uniform national policy when it comes to their dialysis treatment, varying even within cities in the same state and hospitals in the same city. New York State, for instance, extends regularly scheduled dialysis treatments to undocumented immigrants. But individuals living in states like Texas sometimes only qualify for emergency dialysis. In Dallas, patients can only receive emergency dialysis treatment; in San Antonio, patients can receive scheduled dialysis. The Emergency Medical Treatment and Labor Act (EMTALA) of 1986 requires emergency rooms to medically stabilize patients, regardless of legal status, before discharge or transfer. Many hospitals interpret the EMTALA by practicing “emergent dialysis” on undocumented immigrants by evaluating the patient in the emergency room and only giving treatment if a life-threatening symptom presents itself, like shortness of breath, feeling poorly, or a high potassium level, according to a 2014 Texas Med report. In contrast, scheduled dialysis happens regularly either at home or at a center. In New York State, emergency Medicaid and charity care is available for undocumented immigrants like Villalta. Emergency Medicaid coverage includes a twice-weekly dialysis treatment needed to flush out toxins and remove excess salt and water from the body. The treatment “may end up costing the state and federal government far more than the price of transplant surgery. Costs vary, but the federal government’s Medicare program spends about $106,000 for a kidney transplant per patient and $72,000 each year on someone getting dialysis,” New York Daily News stated, using data from the U.S. Renal Data System. Especially when immigrants have to wait until they’re seriously sick to get help, dialysis often isn’t enough. As Claudia Calhoon, the Director of Health Advocacy at the New York Immigrant Coalition, told ThinkProgress, the treatments are “not sufficient to help someone be healthy” because immigrants aren’t able to access primary care providers or get follow-up care on an ongoing basis. This approach also isn’t good for the health care system in the long run. The Texas Med report found that emergent dialysis is 3.7 times more expensive than scheduled dialysis because of the costs associated with emergency room care. Calhoon stated that Villalta’s case presents “a really good example of how not having coverage for undocumented immigrants creates these cost inefficiencies because it would really be, in the end, much cheaper to the health care system for her to have a transplant than for her to have dialysis for years to come.” Villalta isn’t the only undocumented immigrant caught up in this healthcare paradox. Angel, an undocumented waiter in New York City was denied a transplant in 2011 despite his brother qualifying as a donor. And Jesus Navarro, an undocumented immigrant taken off a kidney transplant waiting list was only put back on under heavy media pressure. The hospital initially justified denying him a transplant because “immigration status is among many factors taken into consideration,” the University of California at San Francisco Medical Center director of transplantation told the Contra Costa Times in 2012. UCSF also didn’t think that Navarro could afford the drugs and aftercare associated with his organ transplant. Navarro had private insurance, but likely would have also lost his insurance coverage after losing his job. He would have rolled over to California’s Medi-Cal program, which would have paid for his dialysis, but not the transplant and the drugs needed after the surgery. Some critics believe that granting undocumented immigrants the ability to receive transplants would take “precious organs away from American citizens waiting for a kidney transplant,” a 2014 Health Affairs report commented. But undocumented immigrants still make up a tiny portion of people receiving organs overall. A 2008 American Medical Association Journal of Ethics report found that undocumented immigrants made up less than one percent of all transplants between 1988 and 2007. And there’s some evidence that immigrants pay into the donor system. The same American Medical Association Journal of Ethics report found that during the same time period, about 2.5 percent of all organ donations came from people of unknown citizenship or with unreported citizenship status. And according to a 2014 Chicago Tribune report, about 45 percent of all undocumented immigrants who signed up for driver’s licenses also signed up to be organ donors. A few states are attempting to make progress in this area. Just last year, Illinois passed a state law that would provide funding for kidney transplants and associated drugs needed to maintain the organs for immigrants, regardless of legal status. “You have many good protections to help a lot of people, but even with that, you have these enormous gaps that play themselves out in these tragic ways,” Calhoon said. “Transplants are one of the toughest areas.” Comment
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Quality Care Dialysis $1.05 million Fundraising. Suresh Vasu Submitted Jun 17 ... - OctaFinance.com |
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Quality Care Dialysis Financing
Quality Care Dialysis Llc, Limited Liability Company just filed form D about $1.05 million equity and debt financing. The date of first sale was 2013-01-20. Quality Care Dialysis was able to fundraise $1.05 million. That is 100.00% of the financing round. The total offering amount was $1.05 million. The form was filled on 2015-06-17. The reason for the financing was: unspecified.
Quality Care Dialysis is based in Alabama. The filler’s business is Other Health Care. The SEC form was signed by Suresh Vasu Chairman. The company was incorporated in 2010. The filler’s address is: 12 Penns Trail, Newtown, Pa, Pennsylvania, 18940. Suresh Vasu is the related person in the form and it has address: 2 Bonner Court, Pennington, Nj, New Jersey, 08534. Link to Quality Care Dialysis Filing: 000156820315000004.
Analysis of Quality Care Dialysis Offering
On average, startups in the Other Health Care sector, sell 68.60% of the total offering amount. Quality Care Dialysis sold 100.00% of the offering. Could this mean that the trust in Quality Care Dialysis is high?The average fundraising amount for companies in the Other Health Care industry is $1.16 million. The offering was 9.70% smaller than the average of $1.16 million. Of course this should not be taken as negative. Firms get financed for a variety of reasons and needs. The minimum investment for this offering is set at $10000. If you know more about the reasons for the financing, please comment below.
What is Form D? What It Is Used For
Form D disclosures could be used to track and understand better your competitors. The information in Form D is usually highly confidential for ventures and startups and they don’t like revealing it. This is because it reveals amount raised or planned to be raised as well as reasons for the financing. This could help competitors. Entrepreneurs usually want to keep their financing a ‘secret’ so they can stay in stealth mode for longer.
Why Fundraising Reporting Is Good For Quality Care Dialysis Also
The Form D signed by Suresh Vasu might help Quality Care Dialysis Llc’s business. First, it helps potential customers feel more safe to deal with a firm that is well financed. The odds are higher that it will stay in the business. Second, this could attract other investors such as venture-capital firms, funds and angels. Third, positive PR effects could even bring leasing firms and venture lenders.
Tagged: Fundraising $1m+Other Health Care
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Food Producers to Remove Trans Fats, Per FDA - Renal and Urology News |
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