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 ( http://www.macmillan.org.uk/Cancerinformation/Canc
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://www.macmillan.org.uk/Cancerinformation/Cancertreatment/Treatmen
ttypes/Chemotherapy/Individualdrugs/Cyclophosphamide.aspx ),
doxorubicin (chemical name hydoxydaunorubicin), vincristine (used to
be 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 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.

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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. 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
millan.org.uk/Cancerinformation/Cancertreatment/Treatmenttypes/Chemot
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
http://ctep.cancer.gov/forms/docs/zwiebel_memo.doc. Accessed May 28,
2003.

(v) Macmillan Cancer Support. G-CSF http://www.macmillan.org.uk/C
ancerinformation/Cancertreatment/Treatmenttypes/Supportivetherapies/H
aematopoieticGrowthFactors.aspx

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