Rate of Clinical Complete Response for 1 Year or More in Bone-Metastatic Breast Cancer after Comprehensive Treatments including Autologous Formalin-Fixed Tumor Vaccine

Table 1

Characteristics of the present cohort (cut-off, August 31, 2017).

Case #	Age, at diagnosis	Primary resection	First diagnosis of bone metastasis	Receptor status	Any metastasis before AFTV treatment	Treatments after primary resection and before diagnosis of PD	Best response of bone metastasis after AFTV treatment	Outcome by Feb & Aug 2017	OS after the first diagnosis of bone metastasis (months)
1	59	2004/4/21	2004/2/9	HER2(−), ER(++), PgR(++)	Multiple bones (more than 30), liver	Chemo, AFTV 4 cr, chemo, RT (30 Gy), aromatase inhib	SD for 5 months	Dead; 2008/02/21	49
2	74	2001/2/2	2003/1/15	HER2(−), ER(−), PgR(−)	Rib, neck, sacrum	Rib resec, RT (30 Gy), chemo, AFTV 2 cr	PD	Dead; 2009/01/15	73
3	50	1999/5/10	2005/7/11	Not tested	Brain, pelvis, sacrum	Brain operation, RT to brain (35 Gy), AFTV 1 cr, aromatase inhib, RT to sacrum (30 Gy)	SD for 12 months	Dead; 2008/05/07	34
4	56	1999/6/18	2003/3/6	HER2(+), ER(+), PgR(−)	Lymph node (19/20), sternum, lung (multiple), liver, brain (multiple), pelvis	RT (50 Gy), resec, aromatase inhib, chemo, resect, RT (35 Gy to pelvis, 35 Gy to brain), AFTV 1 cr + chemo	SD for 13 months	Dead; 2007/07/28	54
5	52	2003/7/8	2004/11/10	HER2(−), ER(−), PgR(−)	Lymph node, bone (multiple), lung	RT (30 + 30 Gy), chemo, AFTV 4 cr + RT (Th6 30 Gy, Th11 30 Gy)	PD	Dead; 2009/8/30	58
6	52	2006/8/7	2006/7/31	HER2(−), ER(−), PgR(−)	Vertebra Th7	AFTV 1 cr, RT (36 Gy), chemo, aromatase inhib (misprescription), zoledronate	CR for 50 months or more	Ongoing	128+
7	42	2004/3/5	2006/6/24	HER2(−), ER(+), PgR(+)	Liver, lung, chest wall, lymph nodes, pelvis	RT (30 Gy), chemo, resec, chemo + aromatase inhib, RT (35 Gy), zoledronate, AFTV 3 cr, chemo	PD	Dead; 2007/11/18	17
8	45	2001/3/9	2007/3/1	HER2(−), ER(−), PgR(++)	Bone (multiple)	Resec, aromatase inhib, zoledronate, AFTV 3 cr, RT (30 Gy)	PD	Dead; 2012/11/16	70
9	71	2004/3/23	2006/12/15	HER2(−), ER(+), PgR(−)	Bone (multiple), skin, lymph node, chest wall	Chemo, aromatase inhib, AFTV 1 cr, chemo	PD	Dead; 2008/7/28	20
10	62	2007/6/16	2010/1/28	HER2(−), ER(−), PgR(−)	Lymph node (2/7) [bone (multiple) after AFTV]	Chemo, AFTV 1 cr, chemo, aromatase inhib (misprescription), zoledronate	PD	Dead; 2010/9/20	8
11	46	2004/3/10	2007/5/14	HER2(−), ER(++), PgR(++)	Lymph node, lung, rib (2 sites), pedicle of thoracic vertebra	AFTV 4 cr, zoledronate, aromatase inhib, chemo	SD for 55 months	Ongoing, bearing bone-meta	118+
12	75	1992/10/7	2007/5/25	HER2(−), ER(−), PgR(−)	Rib	Chemo, resec, AFTV 1 cr	PD	Dead; 2008/5/23	12
13	64	1998/5/12	2006/6/14	HER2(+++), ER(+++), PgR(+++)	Chest wall, bone (multiple)	Resec, chemo, aromatase inhib, RT (28 Gy, 30 Gy, 30 Gy), zoledronate	SD for 25 months	Ongoing	130+
14	61	1999/6/28	2004/12/16	HER2(+++), ER(+), PgR(−)	Lung, vertebra Th10	Resec, AFTV 1 cr, TAE, chemo, zoledronate	PD	Dead; 2015/4/4	125
15	39	2007/11/9	2008/12/9	HER2(−), ER(−), PgR(+++)	Lymph node (23/24), pelvis	Chemo, AFTV 1 cr, zoledronate, RT (30 Gy)	PD	Dead; 2013/11/12	60
16	52	2000/6/30	2007/9/27	HER2(+), ER(−), PgR(++)	Lymph node (1/26), bone (multiple)	RT (60 Gy), AFTV 1 cr, zoledronate	SD for more than 80 months	Ongoing	114+
17	50	2009/3/18	2015/6/18	HER2(−), ER(+), PgR(−)	Sternum	AFTV 2 cr, aromatase inhib, RT (36 Gy), zoledronate, anti-PD-1 Ab	CR for 18 months or more	Ongoing	26+
18	56	2011/3/11	2013/8/9	HER2(++), ER(+++), PgR(+++)	Vertebra L5, lymph node (1/5)	AFTV 2 cr, RT (30 Gy to vertebra + 50 Gy to axilla), chemo, zoledronate, tumorectomy of chest wall meta, aromatase inhib, RT (40 Gy) to lymph node	Bone local control for 22 months, but clinically PD	Dead; 2016/10/17	39
19	64	2004/12/2	2013/9/4	HER2(+++), ER(−), PgR(−)	Lymph node (4/5), vertebrae L3, L5	Chemo, G-CSF, RT (60 Gy to neck lymph node), trastuzumab, AFTV 1 cr, RT (36 Gy) to vertebra L3, vertebra L5, zoledronate, resect (chest wall), RT (60 Gy) to chest wall, RT (60 Gy) to lymph node	CR for 11 months, then PD	Ongoing	42+
20	46	2000/7/14	2013/10/20	HER2(−), ER(+), PgR(++)	Sternum, lymph node	Toremifene, RT (60 Gy), AFTV 2 cr, zoledronate, anti-PD-1 Ab	CR for 17 months, then PD	Ongoing	40+

AFTV, autologous formalin-fixed tumor vaccine; chemo, chemotherapy; CR, complete response; cr, course; inhib, inhibitor; meta, metastasis; OS, overall survival; PD, progressive disease; resec, resection; RT, radiation therapy; SD, stable disease.