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

BARCELONA, Spain, June 14, 2010 - 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 (
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 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 (
www.macmillan.org.uk/Cancerinformation/Cancertreatment/Treatmenttypes/Chemotherapy/Individualdrugs/Cyclophosphamide.aspx
), doxorubicin (chemical name hydoxydaunorubicin), vincristine (used to be
called Oncovin(R)) and prednisolone, which is a steroid (
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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visit www.amgen.com.

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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.
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 of Health,
Department of Health and Human Services; 2003. Available at
ctep.cancer.gov/forms/docs/zwiebel_memo.doc. Accessed May 28, 2003.

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

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