Download the ESMO 2012 Abstract Book - Oxford Journals

lower recurrence rate of NE. Pegfilgrastim seemed to offer the highest protection
(HR: 0.23 (0.16; 0.32; p < 0.001).
Conclusion: Prophylactic strategy with G-CSF has significant efficacy in reducing the
incidence of NE, and should be considered as the best option in the secondary
prophyalxis setting.
Cycle A
(no G-CSF)
N = 548
Cycle B
N = 548
Cycle C
N = 548
CycleD
N = 442
Cycle E
N = 344
Febrile
neutropenia
88 (16.1%) 3 (0.5%) 4 (0.7%) 0 1 (0.3%)
Neutropenic fever 42 (7.7%) 2 (0.4%) 4 (0.7%) 1 (0.2%) 0
Neutropenia w/o
fever
418 (76.3%) 111 (20.3)% 95 (17.3%) 50 (11.3%) 47 (13.7%)
Cycle delay - 244 (44.5%) 44 (8.0%) 23 (5.2%) 18 (5.2%)
Dose reduction - 122 (22.3%) 27 (4.9%) 17 (3.8%) 12 (3.5%)
use of
Prophylactic
G-CSF
- 466 (85.0%) 413 (75.4%) 332 (75.0%) 247 (71.8%)
Disclosure: G. Freyer: Consultant for Amgen. All other authors have declared no
conflicts of interest.
1548PD ABSOLUTE NEUTROPHIL COUNTS IN A STUDY OF
LIPEGFILGRASTIM COMPARED WITH PEGFILGRASTIM IN
PATIENTS WITH BREAST CANCER WHO ARE RECEIVING
CHEMOTHERAPY
O.A. Gladkov 1 , I.M. Bondarenko 2 , R. Elsaesser 3 , A. Buchner 4 and P. Bias 4
1 Chemotherapy, Regional Oncology Center, Chelyabinsk, RUSSIAN
FEDERATION, 2 Oncology, Dnipropetrovsk State Medical Academy,
Dnipropetrovsk, UKRAINE, 3 Biostatistics, Teva Ratiopharm, Ulm, GERMANY,
4 Clinical Research, Teva Ratiopharm, Ulm, GERMANY
Background: Cancer chemotherapy frequently causes neutropenia, leading to an
increased risk of infections and delays in subsequent chemotherapy treatments. In a
randomized, double-blind, phase 3, active-controlled, noninferiority trial, the efficacy
and safety of lipegfilgrastim, a glycosylated and pegylated recombinant granulocyte
colony stimulating factor (G-CSF), was compared with pegfilgrastim, a pegylated
recombinant G-CSF. Here we report the results of the absolute neutrophil counts
(ANC) from this study.
Methods: Patients with high-risk stage II, III, or IV breast cancer and an absolute
neutrophil count ≥1.5x10 9 cells/L were randomly assigned to lipegfilgrastim 6 mg (n
= 101) or pegfilgrastim 6 mg (n = 101). Study medication was injected
subcutaneously on day 2 of the chemotherapy cycle (4 cycles maximum). The
primary efficacy endpoint, the duration of severe neutropenia, was reported
previously. Secondary endpoints included ANC nadir and time to ANC recovery and
were analyzed using a Poisson regression. The intent-to-treat (ITT) analysis
population included all randomized patients.
Results: ANC nadir and time to ANC recovery for cycle 1 (ITT population) are
summarized in the table.
Measurement
Lipegfilgrastim
(n = 101)
Pegfilgrastim
(n = 101)
LS Mean Difference
(95% CI), p value
Depth of ANC nadir
(10 9 /L)
Mean (SD) 1.2 (1.3) 1.0 (1.2) 0.146 (-0.169 to 0.461)
Median (range) 0.6 (0.0 to 5.5) 0.4 (0.0 to 5.2) p = 0.3610
Time to ANC
recovery (days)
Mean (SD) 5.8 (3.3) 7.4 (3.6) −1.570 (-2.547 to −0.592)
Median (range) 7.0 (0.0 to 12.0) 8.0 (0.0 to 21.0) p = 0.0018
Conclusions: Patients who received lipegfilgrastim had significantly faster time to
ANC recovery than those who received pegfilgrastim.
Disclosure: O.A. Gladkov: Investigator in Teva-sponsored studies, I.M. Bondarenko:
Investigator in Teva-sponsored studiesR. Elsaesser: Employee of Teva
Pharmaceuticals and own Teva Pharmaceuticals stock, A. Buchner: Employee of Teva
Pharmaceuticals and own Teva Pharmaceuticals stock, P. Bias: Employee of Teva
Pharmaceuticals and own Teva Pharmaceuticals stock.
Annals of Oncology
1549PD TREATING DIABETIC PATIENTS WITH CHEMOTHERAPY:
SINGLE CENTRE EXPERIENCE OF TOXICITY AND
OUTCOMES
J.F. Seligmann1 , A. Young2 , G. Heath2 , D. Cairns3 , A. Anthoney2 , G. Hall2 ,
M. Seymour2 and D. Swinson2 1
Medical Oncology, St. James Institute of Oncology, Leeds Teaching Hospitals
NHS Trust, Leeds, UNITED KINGDOM, 2 Medical Oncology, The Leeds Teaching
Hospital NHS Trust St. James University Hospital, Leeds, UNITED KINGDOM,
3
Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UNITED
KINGDOM
Background: Diabetes is a common comorbidity in cancer patients, and is associated
with poorer survival in colorectal cancer (CRC). However, there is little data to
describe the experience of diabetic patients during chemotherapy. We have compared
a diabetic population of cancer patients with matched controls receiving
chemotherapy in a single centre.
Methods: We performed a retrospective case note analysis using an electronic patient
record database (Patient Pathway Manager) and chemotherapy prescription software
(ChemoCare) between 2001 and 2011. Diabetic patients starting first line
chemotherapy for advanced CRC and advanced gynaecological cancers (GC) were
identified. For each case a non-diabetic control was selected, matched for age (