Takeaways from FDA's March 2019 CNS Mets Workshop

Bestbird

Greetings,

I hope these key learnings from the FDA's March 2019 CNS Metastases workshop may be helpful for those dealing with brain mets. This new information has been incorporated into my book, "The Insider's Guide to Metastatic Breast Cancer" which is avaihttps://www.amazon.com/Insiders-Guide-Metastatic-Breast-Cancer/dp/179586060Xlable in eBook and paperback formats on Amazon at https://www.amazon.com/Insiders-Guide-Metastatic-Breast-Cancer/dp/179586060X and in .pdf format (on a complimentary basis) by emailing me at bestbird@hotmail.com

At the FDA's March 22, 2019 forum entitled, "Product Development for Central Nervous System (CNS) Metastases," it was disclosed that penetration across the intact BBB is not required for a drug to exhibit a degree of efficacy in treating brain metastases.This represents a considerable paradigm shift, and several drugs that do not freely penetrate an intact BBB yet display antitumor efficacy were used as examples (including Lapatinib, Pembrolizumab, Capecitabine, TDM-1, and others).

In an excellent 2019 video about the use of radiotherapy for brain metastasis, Dr. Paul Brown, Professor of Radiation Oncology at the Mayo Clinic, suggested the following guidelines for radiation treatment irrespective of where the cancer originated (breast, lung, colon, etc.).Those wishing to view the video may visit: https://player.vimeo.com/video/321234317

• For patients with oligometastases (defined in the video as one to four brain metastases), Stereotactic RadioSurgery (SRS) is recommended.Adding Whole Brain Radiation Therapy (WBRT) thereafter helps to prevent additional brain metastases, but does not improve Overall Survival (OS) and can significantly degrade cognitive abilities and Quality Of Life (QOL).Therefore, SRS is considered the standard of care for these patients.
• For patients with a single large brain metastasis, surgery plus SRS is considered the standard of care.(Adding WBRT can help prevent additional brain metastases, but it fails to improve OS and can significantly diminish cognitive capabilities and QOL).
• For patients with multiple (widespread) brain metastases, or patients who have a rapid recurrence (i.e. within a few months) of brain metastases treated with SRS, Hippocampal Avoidance (HA) WBRT with Memantine HCL is recommended, although using SRS alone for patients with up to 10 brain metastases may also be a viable option. (The role of systemic therapy in this context is still being explored).

HA (or Hippocampus-sparing) WBRT is a special form of WBRT that spares the hippocampus (a small region of the brain that is primarily associated with memory and spatial navigation) from being targeted by radiation.HA WBRT is accomplished by using Intensity-Modulated Radiation Therapy (IMRT), which is an advanced mode of high-precision radiotherapy that uses computer-controlled linear accelerators to deliver precise radiation doses to a malignant tumor or specific areas within the tumor.Memantine HCL is an Alzheimer's drug that can help prevent cognitive decline.

Daniel86

Thank you for this account! That is a very remarkable paradigm shift indeed!!!!!

Bestbird

Daniel86, I agree! If I hadn't seen it in the presentation firsthand, I wouldn't have believed it!