Sequential gene profiling of basal cell carcinomas treated with imiquimod in a placebo-controlled study defines the requirements for tissue rejection

Panelli, Monica C; Stashower, Mitchell E; Slade, Herbert B; Smith, Kina; Norwood, Christopher; Abati, Andrea; Fetsch, Patricia; Filie, Armando; Walters, Shelley-Ann; Astry, Calvin; Aricó, Eleonora; Zhao, Yingdong; Selleri, Silvia; Wang, Ena; Marincola, Francesco M

doi:10.1186/gb-2007-8-1-r8

Table 1 Composition of study cohorts

From: Sequential gene profiling of basal cell carcinomas treated with imiquimod in a placebo-controlled study defines the requirements for tissue rejection

Patient ID	Cohort	Doses received	EOT → B× time lapse (hours)	Histology	ΔCD8	ΔCD56	Tumor at EOT
P5	Imiq q12 × 2 days	4	13	Nodular	0	-1	+
P6	Imiq q12 × 2 days	4	14	Undetermined	0	0	+
P17	Imiq q12 × 2 days	4	36	Undetermined	NE	NE	-
P18	Imiq q12 × 2 days	4	33	Nodular	+1	0	+
P30	Imiq q12 × 2 days	4	16	Nodular	0	0	-
P38	Imiq q12 × 2 days	4	17	Nodular	0	0	+
P231	Imiq q12 × 2 days	4	22	Undetermined	+1	0	+
P10	Vehic q12 × 2 days	4	12	Nodular	0	0	+
P23	Vehic q12 × 2 days	2	15	Nodular	+2	0	+
P26	Vehic q12 × 2 days	4	45	Nodular	0	0	+
			Mean ± SD = 22 ± 11.5
P1	Imiq q12 × 4 days	8	8	Nodular	0	0	+
P21	Imiq q12 × 4 days	8	41	Nodular	0	+1	+
P22	Imiq q12 × 4 days	8	11	Nodular	+1	0	-
P40	Imiq q12 × 4 days	8	17	Nodular	+1	+1	-
P42	Imiq q12 × 4 days	8	3	Undetermined	+3	0	-
P129	Imiq q12 × 4 days	8	19	Nodular	+1	0	+
P135	Imiq q12 × 4 days	8	21	Superficial	+1	+1	-
P41	Vehic q12 × 4 days	8	28	Nodular	+1	0	+
P134	Vehic q12 × 4 days	8	19	Nodular	+2	0	+
P8	Vehic q12 × 4 days	8	20	Nodular	0	0	+
P20	Vehic q12 × 4 days	8	16	Superficial	0	0	+
			Mean ± SD = 18 ± 10.2
P11	Imiq q24 × 4 days	4	26	Nodular	0	+1	+
P28	Imiq q24 × 4 days	3	20	Nodular	NE	NE	+
P112	Imiq q24 × 4 days	4	44	Nodular	0	0	+
P214	Imiq q24 × 4 days	4	51	Nodular	+2	+1	-
P4	Vehic q24 × 4 days	4	16	Superficial	NE	-1	-
P13	Vehic q24 × 4 days	4	30	Nodular	0	0	+
P36	Vehic q24 × 4 days	4	25	Superficial	0	0	+
			Mean ± SD = 30 ± 12.8
P233	Imiq q24 × 8 days	8	32	Undetermined	0	+1	+
P132	Imiq q24 × 8 days	8	159	Undetermined	0	+2	-
P24	Imiq q24 × 8 days	8	48	Superficial	+1	0	-
P3	Imiq q24 × 8 days	8	12	Undetermined	-1	0	+
P2	Vehic q24 × 8 days	8	6	Undetermined	0	-1	+
P15	Vehic q24 × 8 days	8	21	Nodular	0	0	+
P27	Vehic q24 × 8 days	8	26	Nodular	NE	NE	+
P137	Vehic q24 × 8 days	8	11	Superficial	0	0	+
			Mean ± SD = 39 ± 50.3

Punch biopsies are labeled according to patient number (P1 to P42) and timing of excision: PB0, pre-enrollment; PB1 and PB2, pre-treatment; PB3 and PB4, post-treatment. Biopsies from patients replacing drop-outs were labeled one digit to the serial number (that is, P101 to P142 or P201 to P242. PB1 and PB3 were collected for total RNA isolation; PB2 and PB4 for IHC. Undetermined refers to a BCC histology in-between superficial and nodular. ΔCD8 and ΔCD56 scores differences in infiltrate between EOT and pre-treatment samples (see Materials and methods). Tumor at EOT: identifiable (+) or not identifiable (-) tumor cells in the hematoxylin eosin stained EOT biopsy. Imiq, imiquimod; NE, not evaluated; Vehic, vehicle.

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ISSN: 1474-760X

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