|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
Identity is in everything and customers are looking to their providers to ensure the security of their identities, transactions and data. With the increased reliance on cloud-based services, service providers must build security and trust into their offerings, adding value to customers and improving the user experience. Making identity, security and privacy easy for customers provides a unique advantage over the competition.
Aug. 30, 2016 08:15 PM EDT Reads: 2,487
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Aug. 30, 2016 08:00 PM EDT Reads: 2,031
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage. Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
Aug. 30, 2016 08:00 PM EDT Reads: 1,927
SYS-CON Events announced today that Pulzze Systems will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Pulzze Systems, Inc. provides infrastructure products for the Internet of Things to enable any connected device and system to carry out matched operations without programming. For more information, visit http://www.pulzzesystems.com.
Aug. 30, 2016 07:15 PM EDT Reads: 341
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
Aug. 30, 2016 07:00 PM EDT Reads: 932
Data is an unusual currency; it is not restricted by the same transactional limitations as money or people. In fact, the more that you leverage your data across multiple business use cases, the more valuable it becomes to the organization. And the same can be said about the organization’s analytics. In his session at 19th Cloud Expo, Bill Schmarzo, CTO for the Big Data Practice at EMC, will introduce a methodology for capturing, enriching and sharing data (and analytics) across the organizati...
Aug. 30, 2016 06:15 PM EDT Reads: 367
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Aug. 30, 2016 05:45 PM EDT Reads: 3,594
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Aug. 30, 2016 05:00 PM EDT Reads: 899
Fact: storage performance problems have only gotten more complicated, as applications not only have become largely virtualized, but also have moved to cloud-based infrastructures. Storage performance in virtualized environments isn’t just about IOPS anymore. Instead, you need to guarantee performance for individual VMs, helping applications maintain performance as the number of VMs continues to go up in real time. In his session at Cloud Expo, Dhiraj Sehgal, Product and Marketing at Tintri, wil...
Aug. 30, 2016 04:15 PM EDT Reads: 975
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. 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. All major researchers estimate there will be tens of billions devices - comp...
Aug. 30, 2016 03:30 PM EDT Reads: 3,781
StarNet Communications Corp has announced the addition of three Secure Remote Desktop modules to its flagship X-Win32 PC X server. The new modules enable X-Win32 to safely tunnel the remote desktops from Linux and Unix servers to the user’s PC over encrypted SSH. Traditionally, users of PC X servers deploy the XDMCP protocol to display remote desktop environments such as the Gnome and KDE desktops on Linux servers and the CDE environment on Solaris Unix machines. XDMCP is used primarily on comp...
Aug. 30, 2016 03:00 PM EDT Reads: 869
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Aug. 30, 2016 02:30 PM EDT Reads: 963
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Aug. 30, 2016 02:30 PM EDT Reads: 1,051
SYS-CON Events announced today that Adobe has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. Adobe is changing the world though digital experiences. Adobe helps customers develop and deliver high-impact experiences that differentiate brands, build loyalty, and drive revenue across every screen, including smartphones, computers, tablets and TVs. Adobe content solutions are used daily by millions of co...
Aug. 30, 2016 02:00 PM EDT Reads: 3,815
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Aug. 30, 2016 01:45 PM EDT Reads: 696