Background

E-AVARE were observational studies in Austria and Switzerland investigating febrile neutropenia (FN) risk assessment and granulocyte colony-stimulating factor (G-CSF) guideline implementation in real life Non-Hodgkin-lymphoma (NHL) treatment. A combined analysis of both studies was performed to better understand the characteristics of NHL patients who receive pegfilgrastim and the outcomes of these patients in everyday clinical practice.

Methods

Eligible patients had NHL, were eligible to receive G-CSF, and were planned to receive ≥3 chemotherapy (CT) cycles. The Austrian study included pegfilgrastim treated patients only, while the Swiss study included all G-CSF formulations used. To evaluate pegfilgrastim-related outcomes, only data from patients who completed ≥3 CT cycles and who received pegfilgrastim in ≥1 cycle were included (primary analysis set). Primary outcome: proportion of patients with investigator-assessed high (≥20%) overall FN risk in cycle 1 receiving pegfilgrastim as primary prophylaxis (PP). Other outcomes: investigator-assessed CT-related FN risk, overall incidence of FN and unplanned hospitalizations. Exploratory analysis: description of age cohorts (<65 or ≥65 years [yrs]).

Results

277 patients fulfilled the inclusion criteria for the primary analysis set. Table 1 shows patient characteristics and outcomes. In cycle 1, 237 patients had an investigator-assessed ≥20% overall FN risk and of these 219 (92%) received pegfilgrastim as PP. Among all 277 patients, pegfilgrastim was administered as PP in 236 (85%); pegfilgrastim was first administered in the second or later cycle in 41 patients, of these 8 (3%) received daily G-CSF and 33 (12%) received no G-CSF in cycle 1. Older patients were less likely to receive chemotherapy with curative intent or with high FN risk; FN incidence was similar between age groups but older patients had a greater duration of hospitalization for FN. No serious adverse drug reactions were reported.

Table 1

Patient characteristics and outcomes

Baseline characteristics All ages (N=277) ≥65 yrs (N=135) <65 yrs (N=142) 
 Median age, yrs (range) 64.0 (18-89) 74.0 (65-89) 55.5 (18-64) 
 Ann-Arbor-Stage III/IV, n (%) 211 (76) 95 (70) 116 (82) 
 Prior anti-tumor treatment, n (%) 55 (20) 40 (30) 15 (11) 
 Treatment intent, n (%)    
  curative 237 (86) 104 (77) 133 (94) 
  palliative 39 (14) 30 (22)  9 (6) 
Investigator assessed FN risk    
 Overall FN risk in cycle 1, n (%)    
  ≥20% 237 (86) 112 (83) 125 (88) 
  10 to <20% 36 (13) 20 (15) 16 (11) 
  <10% 4 (1) 3 (2) 1 (1) 
 CT-related FN risk in cycle 1, n (%)    
  ≥20% 222 (80) 100 (74) 122 (86) 
  10 to <20% 50 (18) 32 (24) 18 (13) 
  <10% 5 (2) 3 (2) 2 (1) 
 CT-related FN risk of 10% to <20% and high overall risk in cycle 1, n (%)* 19 (38) n=50 13 (41) n=32 6 (33) n=18 
Outcomes    
 Investigator-assessed ≥20% overall FN risk in cycle 1 and pegfilgrastim PP, n (%) 219 (92) n=237 103 (92) n=112 116 (93) n=125 
 Unplanned hospitalizations due to FN, n =pts (%; median duration in days) 24 (9; 9.0) 12 (9; 10.0) 12 (8; 8.0) 
 FN incidence (all pts in all cycles), n (%) 33 (12) 17 (13) 16 (11) 
Baseline characteristics All ages (N=277) ≥65 yrs (N=135) <65 yrs (N=142) 
 Median age, yrs (range) 64.0 (18-89) 74.0 (65-89) 55.5 (18-64) 
 Ann-Arbor-Stage III/IV, n (%) 211 (76) 95 (70) 116 (82) 
 Prior anti-tumor treatment, n (%) 55 (20) 40 (30) 15 (11) 
 Treatment intent, n (%)    
  curative 237 (86) 104 (77) 133 (94) 
  palliative 39 (14) 30 (22)  9 (6) 
Investigator assessed FN risk    
 Overall FN risk in cycle 1, n (%)    
  ≥20% 237 (86) 112 (83) 125 (88) 
  10 to <20% 36 (13) 20 (15) 16 (11) 
  <10% 4 (1) 3 (2) 1 (1) 
 CT-related FN risk in cycle 1, n (%)    
  ≥20% 222 (80) 100 (74) 122 (86) 
  10 to <20% 50 (18) 32 (24) 18 (13) 
  <10% 5 (2) 3 (2) 2 (1) 
 CT-related FN risk of 10% to <20% and high overall risk in cycle 1, n (%)* 19 (38) n=50 13 (41) n=32 6 (33) n=18 
Outcomes    
 Investigator-assessed ≥20% overall FN risk in cycle 1 and pegfilgrastim PP, n (%) 219 (92) n=237 103 (92) n=112 116 (93) n=125 
 Unplanned hospitalizations due to FN, n =pts (%; median duration in days) 24 (9; 9.0) 12 (9; 10.0) 12 (8; 8.0) 
 FN incidence (all pts in all cycles), n (%) 33 (12) 17 (13) 16 (11) 

One patient ≥65 yrs was reported with “adjuvant treatment intent”

*

Denominator is the number of patients who received CT with 10 to <20% FN risk in cycle 1

Conclusions

In patients with NHL pegfilgrastim was used predominantly as PP in patients assessed at an overall high risk of FN, in accordance with guidelines. Older patients who received CT with intermediate FN risk were more likely than younger patients to be assessed as high overall FN risk. FN risk seemed well managed with pegfilgrastim use in both older and younger patients, but FN may carry a greater burden in patients aged ≥65 yrs, although less intensive therapies were used in this subset of patients.

Medical Writer: Margit Hemetsberger (Amgen-sponsored)

Disclosures:

Willenbacher:Amgen: Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding. Jaeger:Amgen: Employment, Equity Ownership. Bast:Amgen: Employment, Equity Ownership. Renner:Amgen: Consultancy, Honoraria, Speakers Bureau.

Author notes

*

Asterisk with author names denotes non-ASH members.

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