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Hydroxyethyl Starch Solutions Removed From Formulary

Pharmacy Focus

Due to the risks associated with the use of hydroxyethyl starch (HES) solutions, and the availability of safer and equally efficacious alternatives, the Pharmacy and Therapeutics Committee has approved the removal of Hespan from the formulary.

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CME Newsletter - October 2013 (PDF)

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New Cancer Genome Sequencing Offers Physicians Ability to Tailor Treatments

A new DNA sequencing test that scans 50 genes for 2,800 cancer-related mutations – thus offering oncologists greater precision in the selection of treatment options – is now available at Cedars-Sinai.

The next-generation sequencing cancer panel was launched at Cedars-Sinai and is performed on DNA that has been extracted from formalin-fixed, paraffin-embedded tumor tissue, said Jean Lopategui, MD, medical director of Molecular Pathology and Clinical Cytogenetics and director of the Molecular Genetics Pathology Fellowship.

The test, which has a turnaround time of five weeks, essentially creates a genetic fingerprint of the cancer and will identify the tumors that are likely to respond to existing or developing targeted therapies.

The test uses advanced semiconductor technology. For more information, click here. Photo from Ion Torrent.

"In this novel paradigm, we identify the mutation and then see if there's an FDA-approved drug that is applicable specifically to the mutation," Lopategui said. For instance, in non-small cell lung cancer, about 20 percent of tumors presently fall under this category, he said.

If the test shows that the patient's lung tumor is among the 80 percent that do not presently have an FDA-approved treatment that matches the mutation, the scope of the test makes it possible to scan for other mutations. The detailed results can then allow doctors to search for an appropriate clinical trial, and thus match a patient to an alternative avenue of treatment.

"This is where next generation sequencing is so helpful," Lopategui said. "We can scan for multiple mutations in a single test."

Next generation sequencing offers hope to identify precise molecular pathway-based treatment targets to patients with tumors that have fewer traditional treatment options. It complements traditional cancer classification (i.e., by their location in the body, by tumor size, or by how far the disease has progressed) by providing the genetic signature that itself provides the additional information to help guide therapy. The 50-gene test advances the cancer science beyond single-gene testing and moves it in the direction of characterizing the entire exome and genome.

In alignment with the institutional vision of Precision Medicine and under the leadership of Mahul Amin, MD, chair of the department of Pathology and Laboratory Medicine, exhaustive validation of this deep sequencing assay began in March 2013 in Cedars-Sinai's CAP/CLIA-certified Molecular Pathology laboratory. The test uses advanced semiconductor technology for next generation sequencing.

Under the supervision of Raju Pillai, MD, director of Pathology Bioinformatics, the data generated is then analyzed by sophisticated bioinformatics softwares that identify mutations. Specific targeted therapies are then searched in available databases for optimal drug selection. Although it has been released nationally, availability of the test is limited.

"Cedars-Sinai is one of less than 25 academic centers in the entire country that is offering it," Lopategui said. "This is a cutting-edge test that is emerging from research and just now going into clinical use." We anticipate this test to become a novel standard of care paradigm to expand therapeutic options for oncologists and their patients by providing the genetically based evidence to tailor treatments.

This strategy in the fight against cancer will also open great opportunities for novel treatments at the Samuel Oschin Comprehensive Cancer Institute. This approach has already been shown to result in a higher response rate and a longer survival time in cancer patients.