355Testing for Prognosis of Lung Cancer
A substantial number of studies have reported the development of gene expression-
based prognostic signatures for lung cancer. The ultimate aim of such studies should
be the development of well-validated clinically useful prognostic signatures that
improve therapeutic decision making beyond current practice standards. A review
of published articles on gene expression based prognostic signatures in lung cancer
reveals little evidence that any of the signatures are ready for clinical use.
Life Technologies’ Pervenio™ Lung RS (originally Pinpoint Dx Lung™ Assay
developed by Pinpoint Genomics Inc), a 14-gene expression assay that uses real-
time qPCR and runs on FFPE tissue samples to differentiate patients with heteroge-
neous statistical prognoses, has been developed for patients with non-squamous
NSCLC (Kratz et al. 2012 ). Among patients whom the assay identifi ed as low-risk
for recurrence, 71.4 % were still alive after 5 years, and among patients it deter-
mined to be at intermediate risk for recurrence 58.3 % survived >5 years. Among
high-risk patients, 49.2 % survived >5 years. It reliably identifi es patients with
early-stage non-squamous NSCLC at high risk for mortality after surgical resection,
and it provides prognostic differentiation of patients with early-stage disease and
might be helpful in the identifi cation of the most appropriate application of treat-
ment guidelines to improve clinical outcomes. Life Technologies’ CLIA laboratory,
obtained through the acquisition of Navigenics, is licensed in the US and has cur-
rently validated Pervenio™ in most states.
Sixteen genes that correlated with survival among patients with NSCLC were
identifi ed by analyzing microarray data and risk scores (DUSP6, MMD, STAT1,
ERBB3, and LCK) were selected for RT-PCR and decision-tree analysis (Chen
et al. 2007 ). The fi ve-gene signature is closely associated with relapse-free and
overall survival among patients with NSCLC.
Personalized Management of Malignant Melanoma
The incidence of melanoma is rising at an alarming rate and has become an impor-
tant public health concern. If detected early, melanoma carries an excellent progno-
sis after appropriate surgical resection. Unfortunately, advanced melanoma has a
poor prognosis and is notoriously resistant to radiation and chemotherapy. There are
few effective therapies for metastatic melanoma. The two therapies approved by the
FDA, high dose IL-2 and dacarbazine, are each associated with response rates of
10–20 % and a small percentage of complete responses; neither improves overall
survival. The relative resistance of melanoma to a wide-range of chemotherapeutic
agents and high toxicity of current therapies has prompted a search for effective
alternative treatments that would improve prognosis and limit side effects.
Personalized medicine has long been a mainstay of the treatment of localized
melanoma, involving surgical decisions that are individualized on the basis of mea-
sured differences as small as 0.01 mm, as well as other biomarkers of metastatic
Personalized Management of Cancers of Various Organs