Author Archives: Joseph Gulfo

Epigenetic signature in blood for breast cancer risk

As reported in Genomic Medicine on June 27, an epigenetic signature in patients with BRCA1 and BRCA2 mutations was found by examining DNA methylation (DNAme) patterns on whole blood samples.  Importantly, this signature predicted for a high risk of developing breast cancer even in those patients who did NOT have BRCA1 and BRCA2 mutations. Continue reading

PARP inhibitor rejected by FDA Advisory Committee, then Approved for refractory patients

In June 2014, the FDA Oncology Drug Advisory Committee voted 11-2 to delay approval of AstraZeneca’s olaparib, a PARP (poly-ADP ribose polymerase) inhibitor for maintenance therapy in patients with ovarian cancer.  The product received Accelerate Approval designation from the FDA, which provides for conditional approval pending follow-up studies, based on surrogate endpoints from Phase 2 trials, in this case, progression-free survival (PFS).  Continue reading

Nivolumab Phase 3 study stopped early for efficacy

Great news – nivolumab, BMS’ PD-1 immune checkpoint control inhibitor was shown to prolong overall survival when used front-line in patients with advanced melanoma.  The study was stopped early, that is before it fully enrolled the planned number of patients, by an independent data monitoring committee because it was shown to be quite effective. Continue reading

Genetic Analyses of Cancer – Precision Medicine a New Standard

Memorial Sloan Kettering has started testing the cancers of its patients for 341 cancer-related genes.  It is collaborating with Quest Diagnostics to perform the analyses in an effort to identify biomarkers that can best guide appropriate therapy.  This is precision medicine, and it is happening at other major cancer centers, as well… Continue reading

HPV DNA Test and Experimental DNA Vaccine

The National Cancer Institute states that “virtually all” cervical cancers are caused by HPV infection.  The association is so strong that the FDA recently approved a DNA test for HPV that many believe could supplant PAP smear.  This is great news for patients who do not have cervical cancer, yet.  But what if you do?… Continue reading

Precision Medicine: SWOG Lung-MAP study – unique public/private collaboration

Using genomics to take-on advanced non-small cell lung cancer, the Southwest Oncology Group announced the start of a master protocol that will screen patients for optimal eligibility into one of five clinical trials with experimental drugs… Continue reading

Genomic and Exomic Diagnostic Testing – ready for the doctor’s office?

This is an article from the National Institutes of Health that discusses the opportunities and challenges for making genomic (sequencing all 3 billion base pairs) or exomic (sequencing the 1-2% of the genome that contains the 20,000 genes that encode proteins) a routine test in the doctor’s office.  The study was conducted by the National Human Genomic Research Institute – see report. Continue reading

Epigenetic-modulation in myelodysplastic syndrome – DNA methylation and histone acetylation

Epigenetic regulation is critical for gene expression.  Epigenetic pathways are frequently dysregulated in cancer, which can lead to suppression of tumor suppressor genes and expression of oncogenes. Continue reading