Cancer Basket Therapy

Effects of Molecularly Targeted Therapies On SSA Cancer Listings

Current cancer SSA Listings are largely based on the site of origin and stage which corresponds to the system used by the NCI and Oncologists for classifying cancers. Historically, this system provided a logical, data based classification that accurately predicted the natural history and response to therapy of cancers. Other information like

markers, e.g. , PSA,CEA, CA-125 , have supplemented the cancer profile, but are not officially used to stage and prognosticate or to guide selection of therapy. Now, genetic profiling has emerged and is likely to become a major component of the cancer classification system . Genetic alterations that may determine the natural history and response to therapy are frequently not cancer type or stage specific. For example, the Her-2- Neu mutation, typically associated with breast cancer, can also occur in gastric cancer and be successfully used as a therapy target for the monoclonal antibody Herceptin. Likewise, numerous different types of cancers have the same mutations that makes them susceptible to immunotherapy, regardless of tumor site of origin or stage. In some instances this approach has already dramatically changed outcomes, to include unexpected cures. Accordingly, it would seem that the SSA classification system for Listings will eventually need to incorporate the cancer

genetic profile.

One option would be to collaborate with the cancer experts that will be organizing this information for the medical profession. Currently, the National Comprehensive Cancer Network (NCCN) provides Oncologist with updated

guidelines for treating cancers base on the site of origin, stage, and previous treatment history. Genetic profiling is already

being incorporated into their algorithms, which will undoubtedly require ongoing modifications. SSA could contract with them

for an intermittent update, possibly semiannually, that could be analyzed by SSA authorities to determine the applicability

to the Listings. Given the importance and magnitude of this issue SSA would probably want to have a committee of medical experts and SSA policy experts dedicated to this project.

Based on progress to date it appears cancer genetic profiles will be a major determinant of cancer classification and therapy that will have an impact in the SSA Listings and warrants development of a program to insure an optimum transition.

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Idea No. 88