My web site is devoted to medical and treatment information about this rare cancer. My blog is devoted to sharing what has been the more difficult part of the journey for me, the emotional and spiritual road I've traveled as a rare cancer survivor.

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.


Lisa Forte said...

My husband was diagnosed with cancer on thurs, Nov 11th. We are awaiting trip to oncologist. We were told they think it is colon cancer that his in the appendix- this sounds like what you are talking about. We are scheduling an appt with Dr Edward Levine at Baptist in Winston Salem, NC. He does the intra-peritoneal Chemo. I only hope he is a candidate for it. Thank you for your info and your hope and inspiration- keep doing what you are doing.

Anonymous said...

Carolyn, Congratulations on being asked to join the board of this new organization. Very exciting! Having worked in the medical field for 3o+ years I know doctors often put their own spin on things. So getting them all to do it the same way may be close to impossible. I am grateful Anthem didn't balk at my IV chemo, including Avastin, or my heated interperitoneal chemo with Mitomycin C. It has been 2 years 2 months (but who's counting?!) since my diagnosis. This past weekend I thought the cancer had returned with a bang, but now I think it was too many peanuts and too much tofu! hehehe. Not funny at the time. My last CT scan 1 1/2 months ago was good.

Lauren Emery

Carolyn Langlie-Lesnik RN BSN said...

Hi Lauren,

I'm SO glad Anthem didn't deny you coverage, and I'm so glad your scans are good. I've been in the medical community for 30 years also, and you are right, getting all of the specialists on the same page will be tough. But I'm encouraged as many of the renowned HIPEC specialist have joined the organization.

I wish you well and totally understand the peanut and tofu episode!!

Take care!

Dr. Church said...

Lisa, my wife was treated at Wake Forest by Dr. Shen (w/Levine). We have only good things to say about the program. After the surgery and HIPEC in July she is continuing with the FOLFOX Chemo w/Avastin. Scans in January. I know that this is a scary time. Please feel free to contact Jen or me by email if you have questions -


Anonymous said...

I, unfortunately, wasn't a candidate for the HIPEC because I had too much inoperable tumor. The procedure can't be done if all visible tumor can't be removed. I'm holding my own though and feeling well. 2-1/2 years since diagnosis at Stage IV. IV chemo every 2 weeks and CAT scans every 2 months..
Lynn K.

Anonymous said...

Why does all visible tumor need to be removed in order to do HIPEC? I seem to recall my oncology surgeon saying a year and a half ago that the Mitomycin C could go through 3 mm thickness of cancerous tissue.

Lauren Emery

Carolyn Langlie-Lesnik RN BSN said...

Hi Lauren,

HIPEC can penetrate a few mm deep, so can penetrate 3mm (I think up to 5mm)? The best outcomes are with complete cytoreduction (C0) but it can be effective with C1 reductions, when cancerous tumors left are only a few mm in depth.

Hope that helps!

Dawn said...

I am new to the blog. So grateful for all the comments. Lynn K. would like to connect with you. I too have been told I am not a candidate for HIPEC. Stage 4 mucinous adenocarcinoma...Been on IV chemo since February 2010 every 2 weeks. Can we talk more. I would be interested in what Chemo regime you have had, where, etc. Thanks...Dawn

Anonymous said...

First time ever writing on a blog. I was diagnosed with low grade mucinous adenocarcinoma -stage 4. Had all gross tumors removed only small nodules left in abdominal wall and pelvic area. 2 schools of thought- IV chemo or HIPEC- candidate for both. Will start with IV chemo every 2 weeks with CAT scans every 2 months. IF not successful will do HIPEC. Is HIPEC really the standard of care for appendix cancers? Thoughts? All new to me!

Carolyn Langlie-Lesnik RN BSN said...

Dear Anonymous,

Usually the best treatment is surgical removal of all cancerous abdominal tumors followed by HIPEC and then sometimes IV chemo. IV chemo alone as a rule will slow the growth and shrink remaining tumors,but is not usually curative for tumors remaining in the abdomen.

For appendix tumors that have spread beyond the appendix, HIPEC is becoming the standard of care.

Pallavi Mishra said...

My doctor has said tha 95 % of the tumor was removed by cyteroreductive process and for the rest hipec was used .what are the chances in this case?