Sunday, November 14, 2010

An Educational Post

I hope you all will bear with me here....this is an educational post, but things we all need to know.

Many of us have sought HIPEC (surgery with heated intraperitoneal chemotherapy treatment), only to be told by our local oncologists and surgeons that it is "experimental".  Insurance companies deny coverage for the same reason. We currently don't have a universally accepted standard of care for appendix cancer. 

In the medical world, "Standard of Care" is paramount.  Insurance companies are willing to cover treatments that are  "Standard of Care".   In some ways, breast and other cancers have it made; there is a "Standard of Care" that is accepted throughout the medical and insurance community, in a sense an agreed upon and accepted "recipe" for treatment of their cancers.  Insurance companies and physicians alike recognize the standard of care for other cancers.  Every cancer treatment facility recognizes the accepted standard of care and strives to  provide that standard care for a particular cancer.  If there is an accepted standard of care a facility cannot provide, it is obligated to refer a patient to a place where they can receive the standard of care, or possibly face legal the implications of denying that standard care to their patients.

Much of standard of care is determined by FDA approval.  This comes through clinical trials.  A Phase I clinical trial uses a new treatment on patients for the first time, not so much to see if is successful in treating the cancer, but to see if the treatment is safe and not harmful.  If a treatment passes Phase I clinical trials, it goes to Phase II clinical trials, to determine if it might be an effective cancer treatment for a small population.  If it appears it might be successful, it is tested in a larger Phase III clinical trail and compared to the existing standard of care.  If the treatment proves to be more successful than the current standard of care in a Phase III clinical trial, the new treatment may be approved by the FDA and become standard of care for that cancer.

For cancers that have spread into the abdomen, there really are no phase III clinical trials to prove the effectiveness of HIPEC.  Some insurance companies have refused to pay for HIPEC as they state there are no Phase III clinical trials proving it's effectiveness, though IV chemo alone for abdominal cancers does not seem to offer any curative potential or long-term survival.  Not all HIPEC patients survive, but in my own experience with over 1000 appendix cancer patients, I personally know of long term survivors who have had surgery and HIPEC, but none who have survived long-term with chemotherapy alone.  But it's just my observation, not proven by a clinical trial.

There is currently a Phase III clinical trial in progress for colon cancer patients whose cancer has spread to the abdomen.  Half will receive surgery with  HIPEC, half will receive the current standard of care, IV chemo only.  Fortunately, those in the IV chemo only arm whose cancers progress will be able to transition to the surgery/HIPEC arm.   It will be a victory for us if HIPEC is shown to be superior to chemo only, it may become  FDA approved and no longer an "experimental" treatment. It may become standard of care.

Another thing that is against us in seeking a standard of care for surgery and HIPEC is that there are very many small variations in the treatments by the different specialists.  It might be a small variation in the temperature of the heated chemo, or the concentration or type of the chemo used, or whether the HIPEC is done via open or closed method...there are several variables.  This plays against "Standard of Care".   We really need all of the specialists to be on the same page.  We need a "recipe" for our cancer.  We can't have a "recipe" if everyone is doing it just a bit differently.

If the current Phase III clinical trial proves to be beneficial vs. IV the chemo only arm, that will be in our favor. There will be scientific proof that surgery and HIPEC has better survival rates than IV chemo alone.  But we need for all of the HIPEC treatments to be using the same "recipe".  We need research to show one HIPEC treatment to be superior to another, we need clinical trials,scientific research, to prove that.  We need a universally agreed upon "Standard of Care".

Dr. Esquivel recently founded an organization that seeks to standardize a HIPEC standard of care, the American Society of Peritoneal Surface Malignancies.  I was very privileged to asked to be on the board of his new organization and readily accepted.  Many of the prominent HIPEC specialists have joined his organization; they are listed on the web site in the Member Directory.  The specialists treating our cancer need to all be on the same page.  We need unity.

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