1547PD - G-csf as secondary prophylaxis of chemotherapy-induced neutropenia in patients with solid tumors: results of a prospective, observational study

Date 30 September 2012
Event ESMO Congress 2012
Session Supportive and palliative care: Controlling disease and treatment side-effects
Topics Complications of Treatment
Presenter Gilles Freyer
Authors G. Freyer1, N. Jovenin2, G. Yazbek2, C.B. Villanueva3, A. Hussain4, A. Bethune5, M. Rotarski6, H. Simon7, V. Boulanger8, M. Hummerlsberger9
  • 1Medical Oncology, Centre Hospitalier Lyon Sud, 69310 - Pierre- Bénite/FR
  • 2Medical Oncology, Institut Jean Godinot, 51056 - Reims/FR
  • 3Service Oncologie Medicale, Centre Hospitalier Universitaire, 25030 - Besançon/FR
  • 4Medical Oncology, Centre Hospitalier Quimper, 29000 - Quimper/FR
  • 5Medical Oncology, Centre René Huguenin, 92210 - Saint Cloud/FR
  • 6Medical Oncology, Centre Oncologie du Pays Basque, 64100 - Bayonne/FR
  • 7Oncologie Médicale, Hôpital Augustin Morvan, Brest/FR
  • 8Medical Oncology, Centre Hospitalier de Carcassonne, 11890 - Carcassonne/FR
  • 9Medical Oncology, Centre de Radiothérapie et Oncologie médicale, Béziers/FR

Abstract

Background

There are little available data on secondary prophylaxis of chemo-induced neutropenia. We designed this multicentre, prospective and observational study to identify predictive factors of occurrence of neutropenic events (NE) subsequent to a previous episode, in patients with solid tumors (primary objective). Secondary objectives were to determine the incidence of NE, describe prophylactic strategy: cycle delay, dose reduction, G-CSF prescription, and its impact on the recurrence of NE.

Patients and methods

Patients ≥ 18 years were included if they experienced a NE during any previous cycle (reference cycle A), with no prior G-CSF administration. Neutropenic events were defined as any neutropenia grade 1-4, febrile or not, that impacts on the subsequent cycles (cycle delay and/or dose reduction and/or use of G-CSF). Patients were followed for a total of 5 cycles. Risk factors of febrile neutropenia (FN), and prophylactic strategies (with or without G-CSF) were included in univariate and multivariate analyses to assess their predictive value on recurrence of NE.

Results

625 patients included, 548 (87.7%) evaluable.378 (69%) female, mean (SD) age (years) 61.7 (12.3), WHO PS 0-1 88.3%, breast: 40%, colorectal: 15.7%, lung: 11.9%. Metastatic disease: 53.3%. During cycle A, 88 patients (16.1%) experienced FN, 42 (7.7%) neutropenic fever and 418 (76.3%) neutropenia (any grade w/o fever). 44.5% had cycle delay, 22.3% dose reduction and 466 (85%) received prophylactic G-CSF (pegfilgrastim 59.7%, lenograstim 27.3%, filgrastim 10.3% and biosimilar 2.1%). Incidence of NE in subsequent cycles and prophylactic strategies are shown in the table below. In multivariate analysis, G-CSF use (HR:0.32 (0.24; 0.43; p < 0.001) was an independent predictor of 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.