2010-06-14

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 the15th European Hematology Association (EHA) congress in Barcelona,highlights the impact of febrile neutropenia (FN) on chemotherapydelivery in non-Hodgkin lymphoma (NHL) patients. The IMPACT NHL studyshowed that unplanned hospitalisations, delays in chemotherapy andreductions of chemotherapy dose leading to suboptimal relative doseintensity (RDI) of chemotherapy were more frequent in patients whoexperienced FN than those who did not.(i)

In the study, patients (>/= 18 years) with NHL were administeredCyclophosphamide ( http://www.macmillan.org.uk/Cancerinformation/Cancertreatment/Treatmenttypes/Chemotherapy/Individualdrugs/Cyclophosphamide.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 treatingphysician, in order to prevent FN. A total of 1,111 patients withdiffuse large B cell lymphoma were included in the current studyanalysis and 214 patients experienced FN.

In the R-CHOP-21 group, optimal chemotherapy dose intensity of90% or more was maintained by three quarters (76%) of patients whodid 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 optimalchemotherapy dose intensity if they experienced FN. Previous datashows that a reduction in CHOP chemotherapy dose intensity below90%(ii) may decrease survival in patients with aggressive NHL.

"These data confirm the significant impact febrile neutropeniacan have on chemotherapy delivery in NHL, possibly reducing thefavourable outcome of the treatment. There is a need for earlyprophylaxis with G-CSFs in those patients at risk," said Dr RuthPettengell, presenting author of the study and Senior Lecturer inHaematology and Honorary Consultant in Oncology at St George'sHospital Medical School, University of London.

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

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

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

About the Study

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

The study was supported by Amgen and included a total of 1,829patients over the age of 18 with NHL receiving either R-CHOP-14 orR-CHOP-21 chemotherapy between 2005 and 2008. Centres were based inEurope (123 sites) and Australia (5 sites), with each enrolling up to30 patients. Participating centres recorded their assessment ofpatients' FN risk, G-CSF use and FN incidence, as well as relatedoutcomes such as chemotherapy delivery and unplannedhospitalisations. This current analysis is based on data from 1,111patients with diffuse large B cell lymphoma.

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

About CHOP Chemotherapy

CHOP chemotherapy is named after the initials of the drugs usedin the chemotherapy treatment. The drugs include cyclophosphamide ( http://www.macmillan.org.uk/Cancerinformation/Cancertreatment/Treatmenttypes/Chemotherapy/Individualdrugs/Cyclophosphamide.aspx ),doxorubicin (chemical name hydoxydaunorubicin), vincristine (used tobe called Oncovin(R)) and prednisolone, which is a steroid ( http://www.macmillan.org.uk/Cancerinformation/Cancertreatment/Treatmenttypes/Supportivetherapies/Steroids.aspx ).(iii)

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

About FN

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

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

About G-CSFs

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

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

About Amgen

Amgen discovers, develops and delivers innovative humantherapeutics. A biotechnology pioneer since 1980, Amgen was one ofthe first companies to realise the new science's promise by bringingsafe and effective medicines from lab, to manufacturing plant, topatient. Amgen therapeutics have changed the practice of medicine,helping millions of people around the world in the fight againstcancer, kidney disease, rheumatoid arthritis, and other seriousillnesses. With a deep and broad pipeline of potential new medicines,Amgen remains committed to advancing science to dramatically improvepeople's lives. To learn more about our pioneering science and ourvital medicines, visit http://www.amgen.com.

Forward-Looking Statements

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(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. Posterpresented 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.macmillan.org.uk/Cancerinformation/Cancertreatment/Treatmenttypes/Chemotherapy/Combinationregimen/CHOP.aspx

(iv) Common Toxicity Criteria [electronic document]. Version 2.0.Bethesda, Md: National Cancer Institute, National Institutes ofHealth, Department of Health and Human Services; 2003. Available athttp://ctep.cancer.gov/forms/docs/zwiebel_memo.doc. Accessed May 28,2003.

(v) Macmillan Cancer Support. G-CSF http://www.macmillan.org.uk/Cancerinformation/Cancertreatment/Treatmenttypes/Supportivetherapies/HaematopoieticGrowthFactors.aspx

ots Originaltext: AmgenIm Internet recherchierbar: http://www.presseportal.de

Contact:CONTACT: Amgen, +41-(0)41-369-25-18, tviering@amgen.com

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

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