Phase I/II clinical trial using HLA-A24-restricted peptide vaccine derived from KIF20A for patients with advanced pancreatic cancer

Asahara, Shingo; Takeda, Kazuyoshi; Yamao, Kenji; Maguchi, Hiroyuki; Yamaue, Hiroki

doi:10.1186/1479-5876-11-291

Table 2 Patient characteristics and clinical responses

From: Phase I/II clinical trial using HLA-A24-restricted peptide vaccine derived from KIF20A for patients with advanced pancreatic cancer

No.	Age	Sex	Target lesion	Dose of peptide (mg)	Number of injection	Clinical response*	Objective Response	Response lesion	Injection site reaction(Grade)	CTL response		PFS(day)	OS (day)	Pre-vaccination			Post-vaccination
No.	Age	Sex	Target lesion	Dose of peptide (mg)	Number of injection	Clinical response*	Objective Response	Response lesion	Injection site reaction(Grade)	Pre-vaccination	Post-vaccination**			WBC(/mm³)	Lymphocyte (%)	Lymphocyte (/mm³)	WBC(/mm³)	Lymphocyte (%)	Lymphocyte (/mm³)
1	75	M	Local LNs	1	4	PD			0	N.A.	+	36	36	7300	7	511	5300	10.5	557
2	57	F	Local	1	11	PD			1	++	++	26	108	7400	13	962	7900	8	632
3	72	M	Liver	1	3	-			0	N.T.	N.T.	31	31	7800	11	858	16200	10.5	1701
4	60	M	Lung, local LNs	1	19	SD	Yes	Lung metastasis	2	+	-	223	283	5100	21	1071	5200	10.5	546
5	72	F	Primary , liver	1	12	PD			1	+	+++	24	128	2400	25.5	612	4200	10.8	454
6	65	F	Liver	1	4	PD			0	+	+	26	40	4500	16.5	743	8000	4.1	328
7	61	F	Local , liver	3	14	SD			2	+	+++	55	155	4000	25	1000	6400	18.3	1171
8	57	F	Primary, liver	3	10	SD			2	++	+++	56	145	4500	33	1485	14100	16	2256
9	33	F	Paraaortic LNs	3	29	SD	Yes(CR)	Liver metastasis	3	N.A.	+++	>1219	>1219	2500	44.5	1113	3600	33	1188
10	76	M	Liver	3	12	PD			2	-	++	27	142	2300	29.5	679	5800	11.5	667
11	55	F	Primary, lung	3	17	SD			1	+	-	112	225	2600	9	234	2200	11.5	253
12	58	M	Primary	3	5	PD			0	-	-	32	32	4500	30	1350	2400	10.7	257
13	58	F	Live, lung, LNs	3	10	SD			1	-	++	57	97	7100	15.5	1101	9100	10.5	956
14	60	M	Liver, LNs	3	17	SD	Yes	Liver metastasis, LNs	2	+++	+++	169	220	2300	27	621	4100	19.5	800
15	80	F	Liver, LNs, lung	3	5	PD			0	-	+	24	44	8500	9.5	808	13300	4.8	638
16	58	M	Primary, liver, lung	3	13	PD			1	-	++	28	182	4800	27	1296	6400	19.3	1235
17	49	M	Parimary	3	17	SD			2	+	+++	169	309	6200	26.5	1643	7900	17.5	1383
18	62	M	Primary, liver, LNs	3	7	SD			1	-	+++	93	93	4200	28	1176	6600	18.6	1228
19	61	M	Primarym, liver, lung, LNs	3	11	SD			2	-	+	57	105	10200	20.5	2091	28700	9	2583
20	58	M	LNs, lung	3	25	SD			2	+	+++	169	332	10100	34	3434	7600	19.5	1482
21	47	M	Primary, liver	3	13	SD			1	-	+	56	249	6000	27.5	1650	9600	8	768
22	71	F	Liver, local LNs	3	7	SD	Yes	Liver metastasis	2	N.A.	++	89	89	7000	11.5	805	5200	20	1040
23	50	M	Local, LNs	3	6	SD			0	N.A.	-	148	148	7900	20	1580	11200	19	2128
24	74	M	Bone	3	21	SD	Yes	Bone metastasis	2	N.A.	+++	415	495	3800	16	608	5600	17.8	997
25	69	F	Primary	3	2	-			0	N.T.	N.T.	11	11	7600	21.5	1634	7400	20.5	1517
26	80	M	Liver, lung	3	18	SD			1	+	+++	112	207	6600	24	1584	7500	21.5	1613
27	44	M	Liver, lung, local LNs	3	24	SD	Yes	Lung and liver metastasis	1	+	-	115	317	2900	23.5	682	4000	25.5	1020
28	61	F	Peritoneal, local LNs	3	9	SD	Yes	Peritoneal metastasis	0	-	-	69	69	9000	26.5	2385	11200	7.5	840
29	46	M	Liver	3	10	SD			2	-	+++	52	388	4000	26	1040	5600	24.6	1378
30	64	F	Liver	3	9	SD			2	-	+++	56	69	4800	26.5	1272	8900	7.1	632
31	68	F	Liver	3	9	SD	Yes	Liver metastasis	2	+	+++	56	82	6800	33	2244	8300	19.5	1619

*Clinical response was evaluated one month after vaccination. PD, Progressive disease; SD, Stable disease; CR, Complete response; OR, Objective response.
**Best CTL response after vaccination. CTL responses were evaluated and classified based on the algorithm as described in Methods.
N.T. (Not Tested); CTL response was not tested in the samples in which PD was observed within one course of the treatment.
N.A. (Not Analyzed); CTL response was not analyzed because of the poor viability during the in vitro stimulation.

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ISSN: 1479-5876

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