Home administration of filgrastim (Nivestim™) in primary prophylaxis of chemotherapy-induced febrile neutropenia

Figures & data

Table 1 Reasons for treatment discontinuation

Reasons	Patients, n (%) N=171
Termination of chemotherapy	10 (5.8)
Reasons not related to neutropenia	10 (5.8)
Termination of filgrastim	29 (17.0)
Tolerability	2 (1.2)
Patient’s request	2 (1.2)
Physician’s decision	18 (10.5)
Other G-CSF prescribed	4 (2.3)
Unknown	3 (1.8)
Lost to follow-up	5 (2.9)
Adverse event	3 (1.8)
Causality to filgrastim: probable	2 (1.2)
Causality to filgrastim: not related	1 (0.6)
Missing	1 (0.6)

Abbreviation: G-CSF, granulocyte-colony stimulating factor.

Table 2 Patient characteristics at baseline

Characteristics	Patients, n (%) N=171	Mean ± SD	Median
Sex
Male	28 (16.4)
Female	143 (83.6)
Prior G-CSF treatment
G-CSF-naïve	163 (95.3)
Pretreated with G-CSF	8 (4.7)
Age
≤65 years	119 (69.6)
.65 years	52 (30.4)
BMI, kg/m^2		26.0±5.5	25.3
Systolic blood pressure, mmHg		133.7±13.7	133.5
Diastolic blood pressure, mmHg		82.1±9.7	82.0
Laboratory data
Hemoglobin, g/L		122.1±14.6	122.4
Thrombocytes, 10^9/L		235.4±90.8	240.5
Leukocytes, 10^9/L		5.4±3.6	5.2
Neutrophils, 10^9/L		3.4±3.0	3.2
CRP, 10^9/L		3.9±3.9	3.0
Cancer pathology
Solid tumors	164 (95.9)
Digestive organs	17 (9.9)
Gynecological	123 (71.9)
Lungs	10 (5.8)
Urological	7 (4.1)
Others	7 (4.1)
Malignant hematological diseases	8 (4.7)
Hodgkin’s lymphoma	1 (0.6)
Chronic lymphocytic leukemia	2 (1.2)
Non-Hodgkin’s lymphoma	3 (1.8)
Others	2 (1.2)

Abbreviations: BMI, body mass index; CRP, C-reactive protein; G-CSF, granulocyte- colony stimulating factor.

Table 3 Previous or concomitant significant comorbidities

Concomitant diseases	Total patients, N (%)	Subgroup by age, n (%)		Subgroup by sex, n (%)		Subgroup by prior G-CSF treatment, n (%)
	(N=171)	≤65 years (N=119)	>65 years (N=52)	Female (N=143)	Male (N=28)	G-CSF naïve (N=163)	Prior G-CSF (N=8)
Previous/concomitant diseases	73 (42.7)	42 (35.3)	31 (59.6)	63 (44.1)	10 (35.7)	68 (41.7)	5 (62.5)
Cardiovascular diseases	55 (32.2)	27 (22.7)	28 (53.8)	47 (32.9)	8 (28.6)	51 (31.3)	4 (50.0)
Liver failure	1 (0.6)	1 (0.8)	0 (0.0)	1 (0.7)	0 (0.0)	1 (0.6)	0 (0.0)
Other infections*	4 (2.3)	3 (2.5)	1 (1.9)	2 (1.4)	2 (7.1)	4 (2.5)	0 (0.0)
Respiratory tract	1 (0.6)	1 (0.8)	0 (0.0)	0 (0.0)	1 (3.6)	1 (0.6)	0 (0.0)
Systemic	4 (2.3)	3 (2.5)	1 (1.9)	2 (1.4)	2 (7.1)	4 (2.5)	0 (0.0)
Urogenital	1 (0.6)	0 (0.0)	1 (1.9)	1 (0.7)	0 (0.0)	1 (0.6)	0 (0.0)
Others	2 (1.2)	2 (1.7)	0 (0.0)	1 (0.7)	1 (3.6)	2 (1.2)	0 (0.0)
Psychological disorders	11 (6.4)	7 (5.9)	4 (7.7)	11 (7.7)	0 (0.0)	10 (6.1)	1 (12.5)
Respiratory disease	10 (5.8)	9 (7.6)	1 (1.9)	9 (6.3)	1 (3.6)	9 (5.5)	1 (12.5)
Viral infections	1 (0.6)	0 (0.0)	1 (1.9)	1 (0.7)	0 (0.0)	1 (0.6)	0 (0.0)
Systemic	1 (0.6)	0 (0.0)	1 (1.9)	1 (0.7)	0 (0.0)	1 (0.6)	0 (0.0)
Others	1 (0.6)	0 (0.0)	1 (1.9)	1 (0.7)	0 (0.0)	1 (0.6)	0 (0.0)
Missing	4 (2.3)	3 (2.5)	1 (1.9)	3 (2.1)	1 (3.6)	4 (2.5)	0 (0.0)

Notes: Multiple answers were possible.

* “Other infections” are those not classified as viral, fungal, or bacterial.

Abbreviation: G-CSF, granulocyte-colony stimulating factor.

Table 4 ANC during the course of the study

Treatment cycle (N=total number of patients per cycle)	ANC nadir (10^9/L), mean ± SD	ANC at the end of filgrastim treatment (10^9/L), mean ± SD	Within-patient difference* (10^9/L), mean ± SD	Duration ANC nadir to end of filgrastim treatment (days), mean ± SD
1 (N=171)	2.5±3.3 (n=89)	8.2±9.9 (n=71)	6.2±9.5 (n=66)	4.4±5.2 (n=90)
2 (N=154)	3.1±3.5 (n=65)	6.5±6.3 (n=62)	3.3±5.9 (n=58)	5.1±8.5 (n=65)
3 (N=144)	2.95±3.0 (n=66)	6.5±7.6 (n=65)	3.7±7.5 (n=59)	3.1±6.3 (n=69)
4 (N=9)	4.9±1.9 (n=4)	1.8±0.9 (n=4)	−3.1±2.7 (n=4)	6.0±1.0 (n=3)
5 (N=3)	9.2 (n=1)	0.7 (n=1)	−8.5 (n=1)	9.0 (n=1)
6 (N=2)	4.2±0.4 (n=2)	46.2±51.8 (n=2)	42.0±52.2 (n=2)	5.5±0.7 (n=2)

Notes:

* Difference in ANC at nadir vs ANC at end of filgrastim treatment; positive values indicate an increase from nadir to end of treatment.

Abbreviations: ANC, absolute neutrophil count; n, number of patients analyzed.

Table 5 Tolerability of filgrastim in the home-administration setting

Tolerability of filgrastim administered at home	Total patients, N* (%) (N=169)	Subgroup by age, n* (%)		Subgroup by sex, n* (%)		Subgroup by prior G-CSF treatment, n* (%)
		≤65 years (N=118)	>65 years (N=51)	Female (N=142)	Male (N=27)	G-CSF naïve (N=161)	Prior G-CSF (N=8)
Tolerability at injection site
Very good	107 (63.3)	80 (67.8)	27 (52.9)	92 (64.8)	15 (55.6)	102 (63.4)	5 (62.5)
Good	106 (62.7)	73 (61.9)	33 (64.7)	92 (64.8)	14 (51.9)	101 (62.7)	5 (62.5)
Satisfactory	12 (7.1)	9 (7.6)	3 (5.9)	8 (5.6)	4 (14.8)	11 (6.8)	1 (12.5)
Did not tolerate well	4 (2.4)	4 (3.4)	0	4 (2.8)	0	4 (2.5)	0
Did not tolerate at all	0	0	0	0	0	0	0
Painfulness of the needle insertion
Did not feel anything	53 (31.4)	33 (28.0)	20 (39.2)	45 (31.7)	8 (29.6)	51 (31.7)	2 (25.0)
Did not feel much	128 (75.7)	91 (77.1)	37 (72.5)	110 (77.5)	18 (66.7)	122 (75.8)	6 (75.0)
Light stitch	42 (24.9)	29 (24.6)	13 (25.5)	33 (23.2)	9 (33.3)	38 (23.6)	4 (50.0)
Painful	4 (2.4)	3 (2.5)	1 (2.0)	4 (2.8)	0	4 (2.5)	0
Very painful	0	0	0	0	0	0	0
Overall tolerability of injection
Very good	75 (44.4)	57 (48.3)	18 (35.3)	64 (45.1)	11 (40.7)	73 (45.3)	2 (25.0)
Good	117 (69.2)	83 (70.3)	34 (66.7)	98 (69.0)	19 (70.4)	111 (68.9)	6 (75.0)
Satisfactory	20 (11.8)	13 (11.0)	7 (13.7)	16 (11.3)	4 (14.8)	18 (11.2)	2 (25.0)
Did not tolerate well	14 (8.3)	8 (6.8)	6 (11.8)	14 (9.9)	0	12 (7.5)	2 (25.0)
Did not tolerate at all	3 (1.8)	2 (1.7)	1 (2.0)	3 (2.1)	0	3 (1.9)	0
Not specified/do not know	2 (1.2)	1 (0.8)	1 (2.0)	2 (1.4)	0	2 (1.2)	0
Missing	1 (0.6)	0	1 (2.0)	1 (0.7)	0	1 (0.6)	0

Note:

* Number of patients with an evaluation on at least one questionnaire.

Abbreviations: N, number of patients for whom Questionnaires 1, 2, and 3 were evaluated; G-CSF, granulocyte-colony stimulating factor.

Table 6 Summary of ADRs

Types of events	Number of events	Patients, n (%)(N=171)
ADRs	40	34 (19.9)
ADRs of CTCAE grade ≥3	6	6 (3.5)
Serious ADRs	5	5 (2.9)
ADRs leading to filgrastim discontinuation	8	8 (4.7)
ADRs leading to death	0	0

Abbreviations: ADRs, adverse drug reactions; CTCAE, common terminology criteria for adverse events.