Neutropenic complications in the PANTHER phase III study of adjuvant tailored dose-dense chemotherapy in early breast cancer

Figures & data

Figure 1. CONSORT diagram of the exploratory toxicity analysis.

Table 1. G-CSF use and type of G-CSF administered according to treatment group; standard interval; versus tailored dose-dense chemotherapy.

	Tailored dose-dense chemotherapy group			Standard interval chemotherapy group
	During tdd EC			During 3-weekly FEC
	Secondary prophylaxis	Primary prophylaxis	Total	Secondary prophylaxis	Primary prophylaxis	Total
	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Type of G-CSF
Short-acting G-CSF	1	89	90	3	77	80
	(20)	(8.99)	(8.99)	(5.56)	(15.49)	(8.01)
Long-acting G-CSF	4	850	854	49	372	421
	(80)	(85.86)	(85.31)	(90.74)	(74.85)	(42.14)
Different G-CSF at times		51 (5.15)	51 (5.09)	2 (3.70)	48 (9.66)	48 (9.66)
Missing						22
None			6			426
Total	5	990	1001	54	497	999
	During tdd Docetaxel			During 3-weekly Docetaxel
	Secondary prophylaxis	Primary prophylaxis	Total	Secondary prophylaxis	Primary prophylaxis	Total
	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Short-acting G-CSF	1	111	112	6	81	87
	(50)	(11.91)		(13.64)	(12.94)
Long-acting G-CSF	1	768	769	38	500	538
	(50)	(82.40)		(86.36)	(79.87)
Different G-CSF at times	0	53 (5.69)	53	0	45 (7.19)	45
Missing			4			17
None			9			293
Total	2	922	947	44	626	980

EC: epirubicin; cyclophosphamide; FEC: 5-fluorouracil; epirubicin; cyclophosphamide; G-CSF: granulocyte-colony stimulating factor; tdd: tailored dose-dense.

Table 2. G-CSF use and neutropenic events during epirubicin (both groups combined) and docetaxel (both groups combined).

	Neutropenic events during FEC/tdd EC				Neutropenic events during Docetaxel/tdd Docetaxel
	Grade* 0	Grade 1–2	Grade 3–4	Total	Grade* 0	Grade 1–2	Grade 3–4	Total
	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Type of G-CSF
Long-acting	1180	80	145	1405	1223	26	58	1307
n (%)	(84)	(5.7)	(10.3)		( 93.6)	(2)	(4.4)
Short-acting	166	9	15	190	174	10	15	199
n (%)	(87.4)	(4.7)	(7.9)		(87.4)	(5)	(7.6)
Different G-CSF at times	16	3	5	24	78	5	15	98
	(66.7)	(12.5)	(20.8)		(79.6)	(5.1)	(15.3)
None	290	17	4	311	274	10	18	302
n (%)	(93.2)	(5.5)	(1.3)		(90.7)	(3.3)	(6)
Missing	13	3	1	17	34	2	4	40
n (%)	(76.5)	(17.6)	(5.9)		(85)	(5)	(10)
Total	1665	112	170	1947	1783	53	110	1946

EC: epirubicin; cyclophosphamide; FEC: 5-fluorouracil; epirubicin; cyclophosphamide; G-CSF: granulocyte-colony stimulating factor; tdd: tailored dose dense.

*Grade according to CTC AE 3.0.

Table 3. Febrile neutropenia, infection with low ANC count and infection with normal ANC with and without G-CSF support.

		With G-CSF		Without G-CSF		Unknown	Total	Odds Ratio
		Total cycles	%	Total cycles	%
		10,391		2950		93	13,434
Febrile neutropenia	Grade 1–2	19	0.18%	6	0.20%	0	25
	Grade 3–4	126	1.21%	87	2.95%	5	218	OR 0.40* 95% C.I. 0.30–0.54
Infection with ANC < 1.0	Grade 1–2	167	1.61%	82	2.78%	6	255	OR 0.52* 95% C.I. 0.35–0.79
	Grade 3–4	74	0.71%	40	1.36%	2	116
Infection with normal ANC	Grade 1–2	525	5.05%	102	3.46%	1	628
	Grade 3–4	158	1.52%	24	0.81%	0	182	OR 1.88* 95% C.I. 1.22–3.03

^* Fisher’s exact test, p < .01.

ANC: absolute neutrophil count; C.I.: Confidence Interval; G-CSF: granulocyte-colony stimulating factor; OR: Odds Ratio.