|By PR Newswire||
|December 26, 2012 05:00 PM EST||
National study connects higher rates of relapse in pediatric cancer patients to drug shortage, offering first example of patients hurt by shortages and renewing calls to protect patient access to lifesaving treatments
MEMPHIS, Tenn., Dec. 26, 2012 /PRNewswire-USNewswire/ -- A national drug shortage has been linked to a higher rate of relapse among children, teenagers and young adults with Hodgkin lymphoma enrolled in a national clinical trial, according to research led by St. Jude Children's Research Hospital.
Estimated two-year cancer-free survival for patients enrolled in the study fell from 88 to 75 percent after the drug cyclophosphamide was substituted for mechlorethamine for treatment of patients with intermediate- or high-risk Hodgkin lymphoma. The study was launched before the drug shortages began. The change occurred after a mechlorethamine shortage that began in 2009. No study patients have died, but those who relapsed received additional intensive therapy that is associated with higher odds for infertility and other health problems later.
An analysis comparing how patients in each group were faring two years after their cancer diagnoses appears in the December 27 edition of the New England Journal of Medicine. The report provides the first evidence of a drug shortage adversely impacting treatment outcomes in specific patients. St. Jude led the study for a national group that includes the Stanford University School of Medicine and Lucile Packard Children's Hospital at Stanford; Dana-Farber Cancer Institute and Boston Children's Hospital; Massachusetts General Hospital; and Maine Medical Center.
In recent years, many patients and caregivers have had their medical care complicated by drug shortages, primarily of generic injectable drugs like mechlorethamine. Mechlorethamine, which has been used in cancer treatment since the 1960s, has only recently become available again.
Cyclophosphamide has been widely used in treatment of both adults and children with Hodgkin lymphoma. Based on earlier studies, the drug was considered a safe and effective alternative to mechlorethamine.
"This is a devastating example of how drug shortages affect patients and why these shortages must be prevented," said Monika Metzger, M.D., an associate member of the St. Jude Department of Oncology and the study's principal investigator. "Our results demonstrate that, for many chemotherapy drugs, there are no adequate substitute drugs available."
Past shortages have been resolved in a variety of ways and always before a drug substitution became necessary, said Michael Link, M.D., the senior author of the new report. Link is a professor of pediatrics in hematology-oncology at Stanford and a member of the pediatric hematology-oncology service at Packard Children's Hospital. He is also immediate past president of the American Society of Clinical Oncology. "This puts a face on the problem of drug shortages and shows that the problem is real, not theoretical. This is about a curative therapy that we were unable to administer because the drug we needed was not available," Link said. "Despite heroic efforts by the drug shortage office of the Food and Drug Administration to solve the shortages of a number of medically necessary drugs, it is clear that patients are still suffering from the unavailability of life-saving drugs. A more systematic solution to the problem is needed."
Amy Billett, M.D., a pediatric oncologist at Dana-Farber/Children's Hospital Cancer Center in Boston is the paper's other author.
Hodgkin lymphoma is a cancer of the lymph system and accounts for about 6 percent of childhood cancers. In the United States, about 90 percent of patients will become long-term survivors. Working as the Pediatric Hodgkin Consortium, in 2002 the five institutions involved in this study adopted a seven-drug chemotherapy regimen that included mechlorethamine for the treatment of high-risk pediatric patients. The goal was to preserve high cure rates, but to reduce the risk of second cancers, infertility and other problems associated with the earlier treatments. In 2006, a parallel study was opened for patients with intermediate-risk disease. The risk categories reflect the extent to which cancer has spread, particularly the number and location of lymph nodes involved, plus the presence of unfavorable symptoms of fever, night sweats and unexplained weight loss.
The strategy involved 12 weeks of the seven-drug chemotherapy regimen. Patients also received radiotherapy with the dose based on their response to chemotherapy. When mechlorethamine became unavailable, the protocol was revised to allow the cyclophosphamide substitution.
Outcomes for cancer patients are often measured in terms of cancer-free survival, which is the number of years patients remain free of the disease. When researchers assessed the substitution's impact, they found that estimated disease-free survival was 88 percent for the 181 patients whose treatment included mechlorethamine. It was 75 percent for the 40 patients who received cyclophosphamide instead. The difference led researchers to stop enrolling new patients in the trials.
"We can think of no credible explanation for this dramatic difference in event-free survival other than the drug substitution," the researchers noted. The analysis found that, as a group, patients who received cyclophosphamide had fewer unfavorable symptoms and were more likely to have intermediate-risk, rather than high-risk Hodgkin lymphoma. The patients ranged in age from 3 to 21. Half were age 14 or younger.
Patients who relapsed received additional therapy. Researchers said it is too soon to know if these patients will have the same long-term survival rates as those whose did not relapse. The additional treatment included intensive chemotherapy followed by a stem cell transplant using the patient's own blood-producing stem cells.
St. Jude Children's Research Hospital
Since opening 50 years ago, St. Jude Children's Research Hospital has played a pivotal role in pushing overall U.S. pediatric cancer survival rates from 20 to 80 percent. Founded by the late entertainer Danny Thomas, St. Jude is the first and only National Cancer Institute-designated Comprehensive Cancer Center devoted solely to children. St. Jude is also a leader in research and treatment of life-threatening blood disorders and infectious diseases in children. No family ever pays St. Jude for the care their child receives. To learn more, visit www.stjude.org. Follow us on Twitter @StJudeResearch.
The Stanford University School of Medicine
The Stanford University School of Medicine consistently ranks among the nation's top medical schools, integrating research, medical education, patient care and community service. For more news about the school, please visit http://mednews.stanford.edu.
Lucile Packard Children's Hospital
Lucile Packard Children's Hospital at Stanford is an internationally recognized 311-bed hospital, research center and leading regional medical network providing the full complement of services for the health of children and expectant mothers. In partnership with the Stanford University School of Medicine, our world-class doctors and nurses deliver innovative, family-centered care in every pediatric and obstetric specialty, tailored to every patient. Packard Children's is annually ranked as one of the nation's best pediatric hospitals by U.S. News & World Report and is the only Northern California children's hospital with specialty programs ranked in the U.S. News Top 10. Learn more about us at www.lpch.org and about our continuing growth at growing.lpch.org. Like us on Facebook, watch us on YouTube and follow us on Twitter.
Dana-Farber/Children's Hospital Cancer Center
Since 1947, Boston Children's Hospital and Dana-Farber Cancer Institute have provided comprehensive care for children and adolescents with cancer through Dana-Farber/Children's Hospital Cancer Center. The two Harvard Medical School affiliates share a clinical staff that delivers inpatient care at Boston Children's and outpatient therapies at Dana-Farber's Jimmy Fund Clinic. The Boston Children's inpatient pediatric cancer service has 33 beds, including 13 designated for stem cell transplant patients.
SOURCE St. Jude Children's Research Hospital
SYS-CON Events announced today the IoT Bootcamp – Jumpstart Your IoT Strategy, being held June 9–10, 2015, in conjunction with 16th Cloud Expo and Internet of @ThingsExpo at the Javits Center in New York City. This is your chance to jumpstart your IoT strategy. Combined with real-world scenarios and use cases, the IoT Bootcamp is not just based on presentations but includes hands-on demos and walkthroughs. We will introduce you to a variety of Do-It-Yourself IoT platforms including Arduino, Raspberry Pi, BeagleBone, Spark and Intel Edison. You will also get an overview of cloud technologies s...
Apr. 25, 2015 07:15 PM EDT Reads: 3,026
“In the past year we've seen a lot of stabilization of WebRTC. You can now use it in production with a far greater degree of certainty. A lot of the real developments in the past year have been in things like the data channel, which will enable a whole new type of application," explained Peter Dunkley, Technical Director at Acision, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Apr. 25, 2015 04:00 PM EDT Reads: 4,480
The best mobile applications are augmented by dedicated servers, the Internet and Cloud services. Mobile developers should focus on one thing: writing the next socially disruptive viral app. Thanks to the cloud, they can focus on the overall solution, not the underlying plumbing. From iOS to Android and Windows, developers can leverage cloud services to create a common cross-platform backend to persist user settings, app data, broadcast notifications, run jobs, etc. This session provides a high level technical overview of many cloud services available to mobile app developers, includi...
Apr. 25, 2015 04:00 PM EDT Reads: 1,414
SYS-CON Events announced today that Ciqada will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Ciqada™ makes it easy to connect your products to the Internet. By integrating key components - hardware, servers, dashboards, and mobile apps - into an easy-to-use, configurable system, your products can quickly and securely join the internet of things. With remote monitoring, control, and alert messaging capability, you will meet your customers' needs of tomorrow - today! Ciqada. Let your products take flight. For more inform...
Apr. 25, 2015 03:00 PM EDT Reads: 1,929
Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 16th Cloud Expo at the Javits Center in New York June 9-11 will find fresh new content in a new track called PaaS | Containers & Microservices Containers are not being considered for the first time by the cloud community, but a current era of re-consideration has pushed them to the top of the cloud agenda. With the launch of Docker's initial release in March of 2013, interest was revved up several notches. Then late last...
Apr. 25, 2015 03:00 PM EDT Reads: 2,878
Health care systems across the globe are under enormous strain, as facilities reach capacity and costs continue to rise. M2M and the Internet of Things have the potential to transform the industry through connected health solutions that can make care more efficient while reducing costs. In fact, Vodafone's annual M2M Barometer Report forecasts M2M applications rising to 57 percent in health care and life sciences by 2016. Lively is one of Vodafone's health care partners, whose solutions enable older adults to live independent lives while staying connected to loved ones. M2M will continue to gr...
Apr. 25, 2015 03:00 PM EDT Reads: 1,528
Dave will share his insights on how Internet of Things for Enterprises are transforming and making more productive and efficient operations and maintenance (O&M) procedures in the cleantech industry and beyond. Speaker Bio: Dave Landa is chief operating officer of Cybozu Corp (kintone US). Based in the San Francisco Bay Area, Dave has been on the forefront of the Cloud revolution driving strategic business development on the executive teams of multiple leading Software as a Services (SaaS) application providers dating back to 2004. Cybozu's kintone.com is a leading global BYOA (Build Your O...
Apr. 25, 2015 02:00 PM EDT Reads: 1,574
While not quite mainstream yet, WebRTC is starting to gain ground with Carriers, Enterprises and Independent Software Vendors (ISV’s) alike. WebRTC makes it easy for developers to add audio and video communications into their applications by using Web browsers as their platform. But like any market, every customer engagement has unique requirements, as well as constraints. And of course, one size does not fit all. In her session at WebRTC Summit, Dr. Natasha Tamaskar, Vice President, Head of Cloud and Mobile Strategy at GENBAND, will explore what is needed to take a real time communications ...
Apr. 25, 2015 02:00 PM EDT Reads: 1,794
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
Apr. 25, 2015 02:00 PM EDT Reads: 2,508
SYS-CON Events announced today that GENBAND, a leading developer of real time communications software solutions, has been named “Silver Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. The GENBAND team will be on hand to demonstrate their newest product, Kandy. Kandy is a communications Platform-as-a-Service (PaaS) that enables companies to seamlessly integrate more human communications into their Web and mobile applications - creating more engaging experiences for their customers and boosting collaboration and productiv...
Apr. 25, 2015 01:00 PM EDT Reads: 2,743
SYS-CON Events announced today that BroadSoft, the leading global provider of Unified Communications and Collaboration (UCC) services to operators worldwide, has been named “Gold Sponsor” of SYS-CON's WebRTC Summit, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BroadSoft is the leading provider of software and services that enable mobile, fixed-line and cable service providers to offer Unified Communications over their Internet Protocol networks. The Company’s core communications platform enables the delivery of a range of enterprise and consumer calling...
Apr. 25, 2015 12:30 PM EDT Reads: 2,555
What exactly is a cognitive application? In her session at 16th Cloud Expo, Ashley Hathaway, Product Manager at IBM Watson, will look at the services being offered by the IBM Watson Developer Cloud and what that means for developers and Big Data. She'll explore how IBM Watson and its partnerships will continue to grow and help define what it means to be a cognitive service, as well as take a look at the offerings on Bluemix. She will also check out how Watson and the Alchemy API team up to offer disruptive APIs to developers.
Apr. 25, 2015 12:00 PM EDT Reads: 1,856
The IoT Bootcamp is coming to Cloud Expo | @ThingsExpo on June 9-10 at the Javits Center in New York. Instructor. Registration is now available at http://iotbootcamp.sys-con.com/ Instructor Janakiram MSV previously taught the famously successful Multi-Cloud Bootcamp at Cloud Expo | @ThingsExpo in November in Santa Clara. Now he is expanding the focus to Janakiram is the founder and CTO of Get Cloud Ready Consulting, a niche Cloud Migration and Cloud Operations firm that recently got acquired by Aditi Technologies. He is a Microsoft Regional Director for Hyderabad, India, and one of the f...
Apr. 25, 2015 12:00 PM EDT Reads: 1,669
The 17th International Cloud Expo has announced that its Call for Papers is open. 17th International Cloud Expo, to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, APM, APIs, Microservices, Security, Big Data, Internet of Things, DevOps and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal today!
Apr. 25, 2015 12:00 PM EDT Reads: 2,316
So I guess we’ve officially entered a new era of lean and mean. I say this with the announcement of Ubuntu Snappy Core, “designed for lightweight cloud container hosts running Docker and for smart devices,” according to Canonical. “Snappy Ubuntu Core is the smallest Ubuntu available, designed for security and efficiency in devices or on the cloud.” This first version of Snappy Ubuntu Core features secure app containment and Docker 1.6 (1.5 in main release), is available on public clouds, and for ARM and x86 devices on several IoT boards. It’s a Trend! This announcement comes just as...
Apr. 25, 2015 12:00 PM EDT Reads: 1,415
SYS-CON Media announced today that @ThingsExpo Blog launched with 7,788 original stories. @ThingsExpo Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @ThingsExpo Blog can be bookmarked. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago.
Apr. 25, 2015 11:00 AM EDT Reads: 2,561
The world's leading Cloud event, Cloud Expo has launched Microservices Journal on the SYS-CON.com portal, featuring over 19,000 original articles, news stories, features, and blog entries. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. Microservices Journal offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. Follow new article posts on Twitter at @MicroservicesE
Apr. 25, 2015 11:00 AM EDT Reads: 2,107
SYS-CON Events announced today that robomq.io will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. robomq.io is an interoperable and composable platform that connects any device to any application. It helps systems integrators and the solution providers build new and innovative products and service for industries requiring monitoring or intelligence from devices and sensors.
Apr. 25, 2015 11:00 AM EDT Reads: 2,095
Wearable technology was dominant at this year’s International Consumer Electronics Show (CES) , and MWC was no exception to this trend. New versions of favorites, such as the Samsung Gear (three new products were released: the Gear 2, the Gear 2 Neo and the Gear Fit), shared the limelight with new wearables like Pebble Time Steel (the new premium version of the company’s previously released smartwatch) and the LG Watch Urbane. The most dramatic difference at MWC was an emphasis on presenting wearables as fashion accessories and moving away from the original clunky technology associated with t...
Apr. 25, 2015 11:00 AM EDT Reads: 2,105
SYS-CON Events announced today that Litmus Automation will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Litmus Automation’s vision is to provide a solution for companies that are in a rush to embrace the disruptive Internet of Things technology and leverage it for real business challenges. Litmus Automation simplifies the complexity of connected devices applications with Loop, a secure and scalable cloud platform.
Apr. 25, 2015 11:00 AM EDT Reads: 1,750