Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Less painful drug delivery for pediatric leukemia patients is safe, effective

11.12.2013
5 years of clinical data indicate IV PEG-asparaginase matches IM injection of native form

Children with acute lymphoblastic leukemia (ALL), the most common form of pediatric cancer, can safely receive intravenous infusions of a reformulated mainstay of chemotherapy that has been delivered via painful intramuscular injection for more than 40 years, research suggests.

Researchers looked at the four-year, event-free survival and toxicity of E. coli L-asparaginase delivered via IV in its polyethylene glycol (PEG)-conjugated formulation or through IM injection in its native formulation. Clinicians had been delivering the drug via injection because of serious allergic reactions previously linked with IV infusion of the drug in its native form.

The clinical trial is one of the largest to compare the safety, efficacy and pharmokinetics of the two formulations of the bacteria-based enzyme. Findings from the study, DFCI ALL Consortium Protocol 05-001, were presented at the 55th annual meeting of the American Society of Hematology. Data came from 551 patients, 1 to18 years old, who were treated for pediatric ALL at 11 centers in the United States and Canada between 2005 and 2010. The findings take on particular relevance now that native L-asparaginase is no longer available in the U.S.

"Demonstrating that this important agent can be safely administered intravenously should help to provide clinicians peace of mind that they can decrease patient discomfort without increasing risk," said Lewis B. Silverman, MD, director of the Hematologic Malignancy Center at Dana-Farber/Boston Children's Cancer and Blood Disorders Center, who presented the data on behalf of the Dana-Farber Cancer Institute ALL Consortium.

The overall four-year event-free survival rate for all patients enrolled on the protocol was 86 percent, among the highest rates ever reported in a pediatric ALL trial. There was no statistically significant difference in event-free survival between patients in the trial's IV PEG-asparaginase and IM native L-asparaginase arms (92 and 90 percent, respectively). Nor were there significant differences in the rates of allergic reactions (12 and 9 percent, respectively), pancreatitis (11 and 9 percent, respectively) or clotting (6 and 11 percent, respectively), all of which are potential side effects of L-asparaginase.

PEG-asparaginase remains in the blood stream longer than L-asparaginase, which means patients can be treated less frequently. Researchers found that the lowest concentrations of drug in the blood of patients in the study's IV PEG-asparaginase arm were nearly eight times higher than those in the IM native E. coli L-asparaginase group.

Through patient and parent surveys, the study also demonstrated that pediatric patients experienced less pain and anxiety with IV administration of PEG-asparaginase.

PEG-asparaginase is a modified formulation of E. coli-derived L-asparaginase. Previous studies had indicated that PEG-asparaginase may be less allergenic, suggesting that IV administration of the drug might be more feasible than the native E. coli preparation. However, when Protocol 05-001 opened, most oncologists were continuing to administer PEG-asparaginase as an IM injection. At that time, no large trial had directly compared the efficacy of the IV versus IM administration of asparaginase.

Protocol 05-001 also investigated an intensified treatment regimen for children with B cell ALL who showed evidence of high levels of minimal residual disease following initial treatment, who tend to have relatively poor outcomes. The intensified regimen was associated with a four-year event-free survival rate of 77 percent, a large improvement over outcomes reported in the past for this group of patients.

The study was supported by the National Cancer Institute (grant number P01CA068484) and in part by Enzon Pharmaceuticals, which made PEG-asparaginase (Oncaspar) at the time of the trial. Silverman and several co-authors have served on advisory boards for Signma Tau Pharmaceuticals, which currently manufactures Oncaspar.

The Dana-Farber/Boston Children's Cancer and Blood Disorders Center brings together two internationally known research and teaching institutions that have provided comprehensive care for pediatric oncology and hematology patients since 1947. The Harvard Medical School affiliates share a clinical staff that delivers inpatient care at Boston Children's Hospital and outpatient care at the Dana-Farber Cancer Institute's Jimmy Fund Clinic. Dana-Farber/Boston Children's brings the results of its pioneering research and clinical trials to patients' bedsides through five clinical centers: the Blood Disorders Center, the Brain Tumor Center, the Hematologic Malignancies Center, the Solid Tumors Center, and the Stem Cell Transplant Center.

Irene Sege | EurekAlert!
Further information:
http://www.dana-farber.org/

More articles from Health and Medicine:

nachricht Study suggests possible new target for treating and preventing Alzheimer's
02.12.2016 | Oregon Health & Science University

nachricht The first analysis of Ewing's sarcoma methyloma opens doors to new treatments
01.12.2016 | IDIBELL-Bellvitge Biomedical Research Institute

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Novel silicon etching technique crafts 3-D gradient refractive index micro-optics

A multi-institutional research collaboration has created a novel approach for fabricating three-dimensional micro-optics through the shape-defined formation of porous silicon (PSi), with broad impacts in integrated optoelectronics, imaging, and photovoltaics.

Working with colleagues at Stanford and The Dow Chemical Company, researchers at the University of Illinois at Urbana-Champaign fabricated 3-D birefringent...

Im Focus: Quantum Particles Form Droplets

In experiments with magnetic atoms conducted at extremely low temperatures, scientists have demonstrated a unique phase of matter: The atoms form a new type of quantum liquid or quantum droplet state. These so called quantum droplets may preserve their form in absence of external confinement because of quantum effects. The joint team of experimental physicists from Innsbruck and theoretical physicists from Hannover report on their findings in the journal Physical Review X.

“Our Quantum droplets are in the gas phase but they still drop like a rock,” explains experimental physicist Francesca Ferlaino when talking about the...

Im Focus: MADMAX: Max Planck Institute for Physics takes up axion research

The Max Planck Institute for Physics (MPP) is opening up a new research field. A workshop from November 21 - 22, 2016 will mark the start of activities for an innovative axion experiment. Axions are still only purely hypothetical particles. Their detection could solve two fundamental problems in particle physics: What dark matter consists of and why it has not yet been possible to directly observe a CP violation for the strong interaction.

The “MADMAX” project is the MPP’s commitment to axion research. Axions are so far only a theoretical prediction and are difficult to detect: on the one hand,...

Im Focus: Molecules change shape when wet

Broadband rotational spectroscopy unravels structural reshaping of isolated molecules in the gas phase to accommodate water

In two recent publications in the Journal of Chemical Physics and in the Journal of Physical Chemistry Letters, researchers around Melanie Schnell from the Max...

Im Focus: Fraunhofer ISE Develops Highly Compact, High Frequency DC/DC Converter for Aviation

The efficiency of power electronic systems is not solely dependent on electrical efficiency but also on weight, for example, in mobile systems. When the weight of relevant components and devices in airplanes, for instance, is reduced, fuel savings can be achieved and correspondingly greenhouse gas emissions decreased. New materials and components based on gallium nitride (GaN) can help to reduce weight and increase the efficiency. With these new materials, power electronic switches can be operated at higher switching frequency, resulting in higher power density and lower material costs.

Researchers at the Fraunhofer Institute for Solar Energy Systems ISE together with partners have investigated how these materials can be used to make power...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

ICTM Conference 2017: Production technology for turbomachine manufacturing of the future

16.11.2016 | Event News

Innovation Day Laser Technology – Laser Additive Manufacturing

01.11.2016 | Event News

#IC2S2: When Social Science meets Computer Science - GESIS will host the IC2S2 conference 2017

14.10.2016 | Event News

 
Latest News

UTSA study describes new minimally invasive device to treat cancer and other illnesses

02.12.2016 | Medical Engineering

Plasma-zapping process could yield trans fat-free soybean oil product

02.12.2016 | Agricultural and Forestry Science

What do Netflix, Google and planetary systems have in common?

02.12.2016 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>