Gemcitabine and capecitabine in combination for advanced anthracycline and taxane pre-treated breast cancer patients: A phase II study

Figures & data

Table I. Patient characteristics at baseline

	n	%
Entered and received GC-treatment	34	100
Eligible for the ITT and toxicity analyses	34	100
Eligible for the PP analysis	29	85
Age (years)
Median and Mean	55
Range	27–70
No. of previous Chemo. for advanced disease
0	1	3
1	9	26
2	15	45
3	9	26
Previous treatment
Adjuvant anthracyclines	16	47
Adjuvant taxanes	2	6
Adjuvant other cytotoxics	6	18
Adjuvant endocrine	17	50
Metastatic anthracyclines	22	65
Metastatic taxanes	31	91
Metastatic trastuzumab	4	12
Metastatic other cytotoxics	14	41
Metastatic endocrine	22	65
Involved tumor sites
Bone	23	68
Liver	21	62
Lymph nodes	10	29
Lung	10	29
Pleura	8	24
Skin	7	21
Peritoneum	1	3
No. of involved tumor sites per patient
1	6	18
2	14	41
3	10	29
4	3	9
5	1	3
Performance status (WHO)
0	8	23
1	19	56
2	7	21

GC=gemcitabine plus capecitabine; ITT=Intention–to–treat analysis PP=Per protocol analysis; Chemo=Chemotherapy regimens

Table II. Response rates

Response category	All patients n (%)	95% - CI	Eval. patients n (%)	95% - CI
CR	0 (0.0)		0 (0.0)
PR	12 (35.3)	20.3–53.5	12 (41.4)	24.1–60.9
SD	9 (26.5)		9 (31.0)
PD	8 (23.5)		8 (27.6)
NE	5 (14.7)		-
Total	34 (100.0)		29 (100.0)

CR=Complete Response; PR=Partial Response; SD=Stable Disease PD=Progressive Disease; NE=Not Evaluable

Figure 1. Time to progression (TTP)

Figure 2. Overall survival (OS)

Table III. NCI – CTC toxicities in 34 patients

Toxicity	% of patients with grade 3	% of patients with grade 4
Hematological
Leucopenia	44	0
Granulocytopenia	44	15
Thrombocytopenia	3	3
Non-hematological
Fatigue	21	0
Hand-foot syndrome	15	0
Nausea/Vomiting	6	3
Stomatitis	6	3
Diarrhea	3	3
Anorexia	3	0
Obstipation	3	0
Infection	3	3
Fever	3	0
Thrombosis	6	0
Neuropathy	6	0

Table IV. Compilation table of GC phase II data in advanced breast cancer

Author	G and C doses (mg/m^2) and schedule (q=21d)	Eval n	ORR %	SD %	TTP mo	OS mo
Andres [4]	G: 2 000 day 1 C: 1 250 ×2 d1-14	39	49	18	5	10
Benekli [5]	G: 1 000 d1+8 C: 750 ×2 d1-14	31	10	26	6	18
Giannessi [6]	G: 1 500 d1+8 C: 1 000 ×2 d1-14	22	41	55	7+PFS	N/A
Sikov [7]	G: 1 000 d1+8 C: 830 ×2 d1-14	20	50	35	5	12+
Ahn [8]	G: 1 000 d1+8 C: 1 000 ×2 d1-14	14	21	36	4.2PFS	N/A
Teletaeva [9]	G: 750 d1+8 C: 825 ×2 d1-14	9	33	56	N/A	N/A
Pérez-Manga [10]	G: 800 d1+8 C: 750 ×2 d1-14	36	33	33	8.8	17
Present study	G: 1 000 d1+8 C: 800 ×2 d1-14	29	41	31	4.3	14

G=gemcitabine; C=Capecitabine; PFS=Progression-free survival; N/A=Not Available