|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
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Arch...
Jul. 30, 2015 07:30 PM EDT Reads: 1,395
For IoT to grow as quickly as analyst firms’ project, a lot is going to fall on developers to quickly bring applications to market. But the lack of a standard development platform threatens to slow growth and make application development more time consuming and costly, much like we’ve seen in the mobile space. In his session at @ThingsExpo, Mike Weiner, Product Manager of the Omega DevCloud with KORE Telematics Inc., discussed the evolving requirements for developers as IoT matures and conducte...
Jul. 30, 2015 07:15 PM EDT Reads: 299
Providing the needed data for application development and testing is a huge headache for most organizations. The problems are often the same across companies - speed, quality, cost, and control. Provisioning data can take days or weeks, every time a refresh is required. Using dummy data leads to quality problems. Creating physical copies of large data sets and sending them to distributed teams of developers eats up expensive storage and bandwidth resources. And, all of these copies proliferating...
Jul. 30, 2015 06:30 PM EDT Reads: 887
Malicious agents are moving faster than the speed of business. Even more worrisome, most companies are relying on legacy approaches to security that are no longer capable of meeting current threats. In the modern cloud, threat diversity is rapidly expanding, necessitating more sophisticated security protocols than those used in the past or in desktop environments. Yet companies are falling for cloud security myths that were truths at one time but have evolved out of existence.
Jul. 30, 2015 06:00 PM EDT Reads: 1,801
Digital Transformation is the ultimate goal of cloud computing and related initiatives. The phrase is certainly not a precise one, and as subject to hand-waving and distortion as any high-falutin' terminology in the world of information technology. Yet it is an excellent choice of words to describe what enterprise IT—and by extension, organizations in general—should be working to achieve. Digital Transformation means: handling all the data types being found and created in the organizat...
Jul. 30, 2015 05:00 PM EDT Reads: 1,089
Public Cloud IaaS started its life in the developer and startup communities and has grown rapidly to a $20B+ industry, but it still pales in comparison to how much is spent worldwide on IT: $3.6 trillion. In fact, there are 8.6 million data centers worldwide, the reality is many small and medium sized business have server closets and colocation footprints filled with servers and storage gear. While on-premise environment virtualization may have peaked at 75%, the Public Cloud has lagged in adop...
Jul. 30, 2015 04:00 PM EDT Reads: 2,202
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Jul. 30, 2015 03:45 PM EDT Reads: 448
The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016. Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one. In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...
Jul. 30, 2015 03:00 PM EDT Reads: 487
The time is ripe for high speed resilient software defined storage solutions with unlimited scalability. ISS has been working with the leading open source projects and developed a commercial high performance solution that is able to grow forever without performance limitations. In his session at Cloud Expo, Alex Gorbachev, President of Intelligent Systems Services Inc., shared foundation principles of Ceph architecture, as well as the design to deliver this storage to traditional SAN storage co...
Jul. 30, 2015 03:00 PM EDT Reads: 1,740
MuleSoft has announced the findings of its 2015 Connectivity Benchmark Report on the adoption and business impact of APIs. The findings suggest traditional businesses are quickly evolving into "composable enterprises" built out of hundreds of connected software services, applications and devices. Most are embracing the Internet of Things (IoT) and microservices technologies like Docker. A majority are integrating wearables, like smart watches, and more than half plan to generate revenue with ...
Jul. 30, 2015 02:30 PM EDT
The Cloud industry has moved from being more than just being able to provide infrastructure and management services on the Cloud. Enter a new era of Cloud computing where monetization’s services through the Cloud are an essential piece of strategy to feed your organizations bottom-line, your revenue and Profitability. In their session at 16th Cloud Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia, discussed how to easily o...
Jul. 30, 2015 01:45 PM EDT Reads: 377
The Internet of Everything (IoE) brings together people, process, data and things to make networked connections more relevant and valuable than ever before – transforming information into knowledge and knowledge into wisdom. IoE creates new capabilities, richer experiences, and unprecedented opportunities to improve business and government operations, decision making and mission support capabilities.
Jul. 30, 2015 01:45 PM EDT Reads: 266
In their session at 17th Cloud Expo, Hal Schwartz, CEO of Secure Infrastructure & Services (SIAS), and Chuck Paolillo, CTO of Secure Infrastructure & Services (SIAS), provide a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. In his role as CEO of Secure Infrastructure & Services (SIAS), Hal Schwartz provides leadership and direction for the company.
Jul. 30, 2015 01:30 PM EDT
Rapid innovation, changing business landscapes, and new IT demands force businesses to make changes quickly. The DevOps approach is a way to increase business agility through collaboration, communication, and integration across different teams in the IT organization. In his session at DevOps Summit, Chris Van Tuin, Chief Technologist for the Western US at Red Hat, will discuss: The acceleration of application delivery for the business with DevOps
Jul. 30, 2015 12:45 PM EDT Reads: 1,114
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, S...
Jul. 30, 2015 12:00 PM EDT Reads: 2,051