Commentary on announcement by FDA regarding cancer tests

It was a good news day when the FDA approved insurance agencies funding a suite of predictive cancer tests that may change the face of how we practice oncology.

For over 50 years the standard treatment plan for cancer has been surgery followed by chemotherapy and radiation. With a few notable exceptions, this has been spectacularly unsuccessful. Acute leukemia in children, some brain lesions, testicular cancer in young men – these are genuine success stories. However, for the vast majority of cancers the statistics are unredeemingly gloomy. Trends in the US show that five year relative survival in adults with solid cancer has increased from 49% to 68% over 40 years and most of the added years were attributed to earlier diagnosis and treatment.

The old style ‘cut, burn and poison’ oncology has largely failed to deliver. A recent article in the British Medical Journal reported that drug therapy increased five year survival by less than 2.5% – an overall survival benefit of around three months. 14 consecutive new drug regimens for adult solid cancers approved by the European Medicines Agency provided a median 1.2 months overall survival benefit against comparative regimens. 48 new regimens approved by the US Food and Drug Administration between 2002 and 2014 conferred a median 2.1 month overall survival benefit.

So as a practitioner of holistic oncology for over 15 years I am very pleased to read that the FDA in America has finally approved a panel of genetic testing that can give detailed and explicit indications of sensitivity or resistance to the new monoclonal antibody and tyrosine kinase inhibitor immune-therapies.

I and my colleagues in this field have been pressing for this for years. Patients have been paying privately for testing, using this to guide treatment planning and effectively saving the insurance agencies a whole lot of money not spent on wasted drugs that would never work for that individual.

These new drugs, the so-called immune therapies, of which there are now dozens both approved and in the pipeline, are the first truly exciting breakthrough in cancer therapy since Taxol over 40 years ago. They target specific receptor sites in cancer cells and have much less collateral damage than conventional chemo which is more like a carpet bomb that destroys every cell it meets. The tests newly approved for insurance funding will help to determine which drugs will work for a specific individual, for a person not necessarily for any particular type of cancer. In other words, it doesn’t really matter where your cancer is, if you over express the receptor sites then the drug can work for you. Equally, of course, if you do not over express the sites then the drug will not be helpful. This means that good screening can narrow the therapeutic target substantially and is expected to lead to a notable improvement in treatment outcomes.

Next we need to agitate for these tests to be offered routinely to all cancer patients, and for the drugs to be offered before conventional chemo.

Further Reading: http://www.practiceupdate.com/content/fda-announcesnbspapproval-cms-proposesnbspcoverage-of-first-breakthrough-designated-test-to-detect-extensive-number-of-cancer-biomarkers/61478/19/13/2

References:
Peter Wise, Cancer drugs, survival, and ethics, BMJ 2016;355:i5792
Richard Schilsky, Journal of Clinical Oncology, Volume 27, Page 3725, 2009

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