PRESSEPORTAL Presseportal Logo
All Stories
Subscribe to Amgen Inc.

14.06.2010 – 08:05

Amgen Inc.

New Data Confirms the Negative Impact of Febrile Neutropenia in Patients With Non-Hodgkin Lymphoma Receiving R-CHOP Chemotherapy

Barcelona, Spain, June 14, 2010 (ots/PRNewswire)

Data presented at the 15th European Hematology Association (EHA) congress in Barcelona, highlights the impact of febrile neutropenia (FN) on chemotherapy delivery in non-Hodgkin lymphoma (NHL) patients. The IMPACT NHL study showed that unplanned hospitalisations, delays in chemotherapy and reductions of chemotherapy dose leading to suboptimal relative dose intensity (RDI) of chemotherapy were more frequent in patients who experienced FN than those who did not.(i)

In the study, patients (>/= 18 years) with NHL were administered Cyclophosphamide ( ertreatment/Treatmenttypes/Chemotherapy/Individualdrugs/Cyclophospham ide.aspx ), Doxorubicin, Vincristine and Prednisolone (CHOP) chemotherapy either every two weeks (CHOP-14) or every three weeks (CHOP-21) in combination with the monoclonal antibody rituximab (R). Neutropenia management and granulocyte-colony stimulating factor (G-CSF) use were entirely at the discretion of the treating physician, in order to prevent FN. A total of 1,111 patients with diffuse large B cell lymphoma were included in the current study analysis and 214 patients experienced FN.

In the R-CHOP-21 group, optimal chemotherapy dose intensity of 90% or more was maintained by three quarters (76%) of patients who did not experience FN, but only 62% of those who did experience FN, achieved this target. For the R-CHOP-14 group this was 71% and 37%, respectively. Patients were less likely to reach or maintain optimal chemotherapy dose intensity if they experienced FN. Previous data shows that a reduction in CHOP chemotherapy dose intensity below 90%(ii) may decrease survival in patients with aggressive NHL.

"These data confirm the significant impact febrile neutropenia can have on chemotherapy delivery in NHL, possibly reducing the favourable outcome of the treatment. There is a need for early prophylaxis with G-CSFs in those patients at risk," said Dr Ruth Pettengell, presenting author of the study and Senior Lecturer in Haematology and Honorary Consultant in Oncology at St George's Hospital Medical School, University of London.

Unplanned hospitalisations were also greater in patients who experienced FN (79% versus 18% in R-CHOP-21; 78% versus 21% in R-CHOP-14).

Based on these data from everyday clinical practice, the authors conclude physicians should implement guidelines on G-CSF use and G-CSF primary prophylaxis should be considered for NHL patients receiving R-CHOP-21 chemotherapy, who are assessed as having an overall FN risk of 20% or higher, and for all patients receiving R-CHOP-14.

Use of G-CSF primary phrophylaxis to prevent FN differed between the two groups; less than half of R-CHOP-21 patients (36%) were given G-CSF primary prophylaxis, compared to 84% of the R-CHOP-14 group and incidence of FN was 19% and 20% respectively.

About the Study

The aim of the IMPACT NHL study was to assess the impact of febrile neutropenia (FN) on non-Hodgkin lymphoma (NHL) patients receiving CHOP chemotherapy in combination with rituximab(R) every two (14 days) or three (21 days) weeks (current standard of care).

The study was supported by Amgen and included a total of 1,829 patients over the age of 18 with NHL receiving either R-CHOP-14 or R-CHOP-21 chemotherapy between 2005 and 2008. Centres were based in Europe (123 sites) and Australia (5 sites), with each enrolling up to 30 patients. Participating centres recorded their assessment of patients' FN risk, G-CSF use and FN incidence, as well as related outcomes such as chemotherapy delivery and unplanned hospitalisations. This current analysis is based on data from 1,111 patients with diffuse large B cell lymphoma.

G-CSFs are indicated to shorten the duration of severe neutropenia and reduce the incidence of FN.

About CHOP Chemotherapy

CHOP chemotherapy is named after the initials of the drugs used in the chemotherapy treatment. The drugs include cyclophosphamide ( h ttp:// ttypes/Chemotherapy/Individualdrugs/Cyclophosphamide.aspx ), doxorubicin (chemical name hydoxydaunorubicin), vincristine (used to be called Oncovin(R)) and prednisolone, which is a steroid ( http:// /Supportivetherapies/Steroids.aspx ).(iii)

CHOP is given by a combination of injections into the tubing of a drip (infusion).The prednisolone is taken as tablets. In some instances CHOP chemotherapy may also be administered in combination with the monoclonal antibody rituximab (R-CHOP).

About FN

FN is an abnormally low level of neutrophils, an important infection-fighting white blood cell (WBC), in the blood stream. A low white blood cell count indicates that the immune system is not as strong as it should be, and the risk for serious infection is increased.(iv)

FN is a common and potentially dangerous side effect of myelosuppressive chemotherapy leading to a heightened risk of infection, sometimes life-threatening, among people with cancer. Severe neutropenia and/or FN may lead physicians to delay the next cycle of chemotherapy or reduce the dose given (in order to reduce further toxicity).

About G-CSFs

Granulocyte-colony stimulating factors (G-CSFs) are haematopoetic growth factors. It stimulates the bone marrow to produce more white blood cells. A major side effect of chemotherapy is the reduction in white blood cells which makes the body less able to combat infection. The use of a G-CSF after chemotherapy reduces the risk to patients of developing febrile neutropenia and reduces the duration of neutropenia.(v)

For further information please refer to the SmPC for pegfilgrastim and filgrastim - two commonly used G-CSFs.

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit

Forward-Looking Statements

This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of June 14, 2010 and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labelling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labelling for the products, and not the information discussed in this news release.

(i) Pettengell, R Johnson HE, Lugtenburg P, Salar A, Duehrsen U, Haioun C, Verhoef G, Rossi FG, Schwenkglenks M, Bendall K, Szabo Z, Jaegar U. IMPACT NHL-FN vs no FN analysis in DLBCL patients. Poster presented at EHA Congress 2010 Jun 14 2010 (Abstract no.0877)

(ii) Pettengell, R. Ann Hematol 2008; 87:429-430.

(iii) Macmillan Cancer Support. CHOP Chemotherapy. http://www.mac herapy/Combinationregimen/CHOP.aspx

(iv) Common Toxicity Criteria [electronic document]. Version 2.0. Bethesda, Md: National Cancer Institute, National Institutes of Health, Department of Health and Human Services; 2003. Available at Accessed May 28, 2003.

(v) Macmillan Cancer Support. G-CSF ancerinformation/Cancertreatment/Treatmenttypes/Supportivetherapies/H aematopoieticGrowthFactors.aspx


CONTACT: Amgen, +41-(0)41-369-25-18,

Original content of: Amgen Inc., transmitted by news aktuell

More stories: Amgen Inc.
More stories: Amgen Inc.