Table 2.

Summary of reports of clinical application of molecular profiling

Author, year of publication	N	Type of study	Patient characteristics	Tissue used	Targets interrogated	Technology used	Median turnaround time (TAT) in weeks	Success rate (all proposed tests carried out) (%)	Frequency of at least one genetic alteration (%)	Treated with a matched- targeted agent (%)
Metastatic malignancies
Von Hoff et al. 2010 [2]	86	Prospective multi-institutional trial with central laboratory	Refractory metastatic cancers	Mandatory fresh biopsy	11 proteins 51 genes	IHC, FISH, Gene expression microarray	NR	98	98	77
Tsimberidou et al. 2011 [3]*	955	Prospective single institution trial	Refractory metastatic cancers	NR	NR	PCR, IHC, FISH	NR	89	41.5	19
Non-small-cell lung cancer
Kris, 2010 [5]*	301	Prospective single institution trial	Adenocarcinoma	Previously obtained tissue	EGFR, KRAS, BRAF, HER2, PIK3CA, MEK1 AKT1, ALK	PCR-based direct sequencing and Sequenoma, FISH	NR	92	58	17
Ortiz et al. 2011 [6]*	226	Prospective single institution trial	Non-squamous NSCLC	NR	EGFR, KRAS, BRAF, PIK3CA, HER2, ALK	PCR-based direct sequencing, FISH	4	89	54	14
Sequist et al. 2011 [4]	589	Retrospective single institution experience	NSCLC	NR	AKT1, APC, BRAF, CTNNB1, EGFR, ERBB2, FLT3, IDH1, JAK2, KIT, KRAS, NOTCH1, NRAS, PIK3CA, PTEN, TP53, ALK	SNaPshotb, FISH	2.8 (range 1.0–8.9 weeks)	95	51	22c
Kim et al. 2011 [7]	255	Prospective single-institution-randomized trial	Advanced pre-treated NSCLC	Mandatory fresh biopsy	EGFR,KRAS, BRAF, Cyclin D1, VEGF, VEGFR-2, RXRs α, β, γ	PCR-based direct sequencing, FISH, IHC	<2	NR	84	93

*Abstract only.

^aSequenom: a multiplexed mass spectrometry-based assay.

^bSNaPshot: multiplexed PCR-based assay.

^c78 (22%) of the 353 patients with advanced disease were candidates for targeted therapy.

N, number of patients; PCR, polymerase chain reaction; NSCLC, non-small-cell carcinoma; NR, not reported.