Chemotherapy-Induced Neutropenia/Febrile Neutropenia Prophylaxis with Biosimilar Filgrastim in Solid Tumors Versus Hematological Malignancies: MONITOR-GCSF Study

Figures & data

Table 1. Patient demographics and clinical status; cancer and chemotherapy-induced neutropenia/febrile neutropenia history and management.

Demographic/characteristic	Solid tumor^† 1117 (77.2%)	Hematological malignancy^‡ 330 (22.8%)	p-value
Demographics and clinical status
Gender:
– Male	34.5%	53.3%	0.0001
– Female	65.5%	46.7%
Age (M ± SD, Mdn)	60.8 ± 11.1, 61	63.0 ± 13.7, 64	n.s.
ECOG performance status:
– 0	44.0%	30.6%	0.011
– 1	46.7%	53.2%
– 2	7.7%	13.0%
– 3	1.5%	3.2%
– 4	0.1%	0.0%
History of repeated infections	2.2%	4.1%	n.s.
FN risk factors (EORTC)
High risk:
– Age ≥65 years	38.9%	49.7%	0.022
Increased risk:
– Advanced disease^§	16.3%	3.5%	<0.001
– History of FN	2.2%	1.4%	n.s.
– No antibiotic prophylaxis	94.9%	63.8%	0.006
Other factors:
– Poor performance and/or nutritional status	11.9%	18.2%	n.s.
– Female gender	65.5%	46.7%	0.001
– Hemoglobin <12 g/dl	37.2%	51.0%	0.005
– Renal, cardiovascular or liver disease	21.4%	28.5%	n.s.
Patient risk score (M ± SD, Mdn)	2.8 ± 1.9, 2.5	2.9 ± 2.1, 3.1	n.s.
Cancer
Prior treatments:
Chemotherapy	32.4%	29.7%	n.s.
– 1 Prior line	52.7%	36.4%
– 2 Prior lines	27.1%	27.2%	n.s.
– ≥3 Prior lines	20.2%	36.4%
Radiation therapy	23.3%	4.2%	<0.001
Chemotoxicity
<10%	12.8%	3.7%	<0.001
10–20%	50.9%	24.9%
≥20%	36.3%	71.4%

Valid % used.

† Stage 3 or 4 breast, ovarian, bladder or lung cancer; or metastatic prostate cancer.

‡ Stage 3 or 4 DLBCL or MM.

§ Stage 4 (stage 3 if MM) and prior chemotherapy in metastatic setting.

DLBCL: Diffuse large B-cell lymphoma; ECOG: Eastern Cooperative Oncology Group; EORTC: European Organisation for Research and Treatment of Cancer; FN: Febrile neutropenia; M: Mean; Mdn: Median; MM: Multiple myeloma; n.s.: Not significant; SD: Standard deviation.

Table 2. Zarzio^® prophylaxis patterns.

Prophylaxis characteristic	Solid tumor^†	Hematological malignancy^‡		p-value
Type of prophylaxis
Primary	71.7%	74.2%		n.s.
Secondary	28.3%	25.8%
Prophylaxis pattern
Under-prophylacted	16.3%	21.0%		0.009
Correctly-prophylacted	54.0%	65.3%
Over-prophylacted	29.7%	13.7%
Dose
30 MIU/day	49.8%	66.7%		<0.001
48 MIU/day	50.2%	33.3%
Initiation of Zarzio^®
Early (during CT)	16.0%	4.2%		<0.001
Per guidelines (1–3 days after CT)^§	60.0%	42.0%
Late (≥4 days after CT)	24.0%	53.8%
Duration of prophylaxis (days)
1	2.4%	7.5%
2	5.7%	5.8%
3	12.7%	10.7%
4	7.6%	5.3%
5	45.8%	45.7%
6	6.4%	6.8%
7	12.2%	9.1%
8	1.9%	2.0%
9	0.5%	2.3%
10	2.0%	2.0%
11	0.1%	0.5%
12	0.2%	0.8%
13	0.1%	0.3%
14	2.2%	0.1%
≥15	0.2%	1.1%
Tumor type	Mean	SD	Median	p-value
Solid tumor	5.14	2.24	5	n.s.
Hematological malignancy	5.03	2.56	5
Duration	Solid tumor	Hematological malignancy		p-value
1–3 days	20.8%	24.0%		n.s.
4–5 days	53.4%	51.0%
≥6 days	25.8%	25.0%

† Stage 3 or 4 breast, ovarian, bladder or lung cancer; or metastatic prostate cancer.

‡ Stage 3 or 4 DLBCL or MM.

§ 168 cycles were recorded from ‘late’ to ‘per guidelines’ for patients on regimens (e.g., etoposide) deemed to be appropriate for GCSF initiation on any day of the cycle, per consensus of Steering Committee.

CT: Chemotherapy; DLBCL: Diffuse large B-cell lymphoma; MIU: Million international units; MM: Multiple myeloma; n.s.: Not significant; SD: Standard deviation.

Figure 1. Treatment decision relative to European Organisation for Research and Treatment of Cancer guidelines by cohort.

^†Secondary prophylaxis started in cycle 2 or later despite no CIN/FN in prior cycle.

C: Correctly-prophylacted; CIN: Chemotherapy-induced neutropenia; DLBCL: Diffuse large B-cell lymphoma; FN: Febrile neutropenia; MM: Multiple myeloma; O: Over-prophylacted; U: Under-prophylacted.

Figure 2. Clinical outcomes by cohort.

Solid tumor: stage 3 or 4 breast, ovarian, bladder or lung cancer; or metastatic prostate cancer. Hematological malignancy: stage 3 or 4 diffuse large B-cell lymphoma or multiple myeloma. CIN grades 1–4, grades 3 or 4, grade 4 and FN not mutually exclusive.

^†Chemotherapy disturbance includes dose reduction, discontinuation or delay. Measured with one-cycle lag.

^‡Includes any occurrence of CIN grade 4, FN, CIN/FN-related hospitalization and/or CIN/FN-related chemotherapy disturbance.

* Difference between solid tumor and hematological malignancy cohorts significant at p < 0.05.

CIN: Chemotherapy-induced neutropenia; FN: Febrile neutropenia.

Data sharing statement

The authors certify that this manuscript reports the secondary analysis of clinical trial data that have been shared with them, and that the use of this shared data is in accordance with the terms (if any) agreed upon their receipt. The source of this data is: NCT01459653.