All of us at  Fibrofighters hope you and your families are enjoying the summer holidays.  We continue to work hard on behalf of all our FLC patients and families, and want to share some updates and examples with you.

  • We began our collaboration with xCures over two years ago, and we now have close to 100 participants offering real world data to be used by any research organization.  Patients do not have to spend valuable time self-reporting it is all performed seamlessly for them.  
  • Using consents from this deidentified IRB approved platform we have been able to discuss over 150 FLC cases from around the globe with our multidisciplinary team allowing patients options they did not believe existed.  (Abstract written on preliminary results)
  • Over the past year we have been extremely happy with our collaboration with BostonGene.  Thus far we have evaluated 35 patients tissue exploring their unique tumor microenvironments and supplying clinicians with patients tumor portraits to help guide the best treatment plans.   This program will be expanding soon, being more customized for Fibrolamellar.
  • In addition, with the help of Natera we have processed hundreds of Signatera ctDNA circulating tumor monitoring tests to help determine tumor burden.  (Presented abstract at ASCO 23)
  • This month we will reach our 50th  Nagourney Cancer Institute’s functional tumor profile tests specifically designed for FLC.  We have seen many drugs and more importantly combination of drugs showing synergies for our patients.  (Abstract Presented at ASCO 23)
  • Abstract shared about 29 patients early experience with the combination of Gemcitabine-Lenvima-Nivolumab (Presented at ASCO 23)

Each of the labs our foundation collaborates with are all CLIA certified and approved.  We find this certification to be diagnostically important to patient care as clinicians and insurance companies can act upon these reports provided their findings provide appropriate options for their patient.  Why is the distinction between CLIA approved labs and research labs important? The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the center before they can accept human samples for diagnostic testing.  CLIA regulations include federal standards applicable to all U.S. facilities or sites that evaluate human specimens for health assessment or to diagnose, prevent, or treat disease. Very few researchers are medical doctors; unless a research center is a fully certified CLIA approved lab, caution should be exercised with what might be shared by such facilities legally and ethically. 

At Fibrofighters we are genuinely concerned when a paper is published by any researcher claiming that the clinical utility is 100% actionable. No one can make this claim without considering a patient’s specific history.  We have unfortunately witnessed several near-disastrous situations because clinicians are obtaining advice from a research paper or directly from a Ph.D. rather than an MD.  As a parent who lost a child to FLC over six years ago I certainly understand we all want the magic bullet to be discovered and implemented tomorrow. However, the reality is the process from the scientific bench, to paper, to trial approval, to ultimately the results being shared and receiving FDA approval is a tedious and sluggish process at best.  Our approach is looking at the potential of “N of One” studies; using every tool at our disposal to determine the best possible treatment option for each patient so one day they can reap the rewards of the tremendous work being performed by multiple research centers.

To combat misinformation disseminated by researchers without a proven clinical medical basis, FibroFighters gathered a group of multidisciplinary experts from institutions throughout the U.S. and world to participate in a weekly International Tumor Board. The group reviews patient-specific reports, such as  scans, CLIA approved lab results, and what form of local therapy might be appropriate before reaching a consensus on the best approach moving forward. These are recommendations made directly to the local team caring for their FLC patients.  The patients’ local oncologists join our board and present their patients case over 80% of the time.  Often local oncologists are very open and appreciative of the Tumor Board as a resource, especially if these clinicians have little to no experience with Fibrolamellar.  We are proud to be filling the knowledge gap one patient at a time!

We are proud to be filling the knowledge gap one patient at a time!

I cannot emphasize enough our continued support and applaud the magnificent work being done by all the researchers and clinicians around the world who are all looking for the curative answer.  A special thank you to our Tumor Board members for their ongoing contributions.  In the interim, we will continue to help each patient maximize all their treatment options while these amazing professionals continue their research and clinical work.  

I recently attended the ASCO Conference in Chicago the first week of June along with Dr. Paul Kent, our Medical Director, and Laura Golian, one of our key patient advocates.  Dr Kent’s message will highlight more about the poster presentations and our ASCO experience.  

If you have any questions or you would like yours or a loved one’s case discussed during one of our upcoming tumor boards, please let Dr. Kent or myself know. or