Vaccination with a plasmid DNA encoding HER-2/neu together with low doses of GM-CSF and IL-2 in patients with metastatic breast carcinoma: a pilot clinical trial

Table 1 Patient characteristics

Patient #	Age [years]^ǂ	Disease status	Site of metastasis	Previous treatments (abbreviations explained below)	ER/PR^▫	Vaccine cycles	Side effects	Trastuzumab and pDNA vaccine concurrence	Survival [month] from diagnosis*,⁺	Survival [month] after first vaccine	Alive/dead at last follow up*
1	60	PD^Δ	bone	Surgery, FEC, DO/T, T, RT, PA/T, VI/T, RT	-/-	3	-	No	46	9	Dead
2	44	PD	skin	FEC, surgery, FEC, RT, PA/T, DO/T, VI/T, CP/T, surgery, T	-/-	1	-	Yes	90	42	Dead
3	53	PD	Bone, LN°	surgery, T, CA/T, T	-/-	3	-	Yes	80	58.5	Alive
4	64	PD	LN	(surgery, 5-FU, OP, RT, FEC, DO, Platinol/CA, VI/T, PA/T, surgery	?	3	-	Yes	96	55	Alive
5	61	PD	Bone, lung, liver	Surgery, FEC, RT, TA, CA/T, PA/T, RT, T	+/+	1	-	Yes	62	14	Dead
6	64	PD	LN, liver	FEC, DO, surgery, RT, surgery, VI/T, CA/T	-/- +/+^∞	3	-	Yes	72	21.5	Dead
7	47	PD	Liver, lung	Surgery, FEC, RT, TA/GHRH analog, DO/T, CA/T, IX, VI/T, T	-/+	3	-	Yes	58	6.5	Dead
8	67	PD	LN	Surgery, FEC, RT, TA, PA, DO, CA, CM/T/MT, CM/BV, VI/T	-/+	3	-	Yes	92.5	28	Dead

BV -- Bevacizumab, CA -- Capecitabine, CM -- Cyclophosphamide, CP -- Carboplatin, DO -- Docetaxel, 5-FU -- 5-Fluorouracil, FEC -- epirubicine, cyclosphamide, 5-FU, IX -- Ixabepilon, MT -- Methotrexat, OP -- Oxaliplatin, PA -- Paclitaxel, RT -- radiotherapy, T -- Trastuzumab, TA -- Tamoxifen, VI -- Vinorelbine
^ǂ at enrolment, ^ΔPD -- progressive disease, ° LN -- lymph node, ^▫ER/PR - estrogen/progesteron receptor, ^∞expression site dependent,
*latest follow up July 2009, 87 month after study initiation, ⁺median survival 76 month

ISSN: 1479-5876