The Dallas RO, CFD policy staff and medical consultants are submitting the following comments about the above topic: #1 Although, clinical trials are under way each tumor must be sequenced in “precision medicine”, and large trials of treatment of a certain mutation are far from reality. Only anecdotal successes/failures will be known for some time, which cannot be translated to overall effectiveness of an agent for that ...more »
Cancer Basket Therapy
Cancer Basket Therapy
Traditionally, cancer treatment relies on a malignancy’s site of origin—the organ or tissue where the cancer started growing. Therefore, doctors treat a malignancy that originated in the brain with therapies reserved for brain cancer, whereas they treat malignancies that originated in the breast with therapies developed for breast cancer. Unfortunately, patients respond to traditional treatments differently: some have complete responses but others respond only partially or not at all.
Currently, a new approach in clinical trials is testing drugs or drug combinations based on the genetic profiles of patients’ malignancies— that is, the specific gene(s) harboring mutations that are driving the cancer. With this new approach, it does not matter where in the body a cancer originates. For example, one patient’s melanoma may be due to mutations in the same gene that is responsible for another patient’s colon cancer. Some clinical trials group these patients with mutations in the same gene into “baskets” to receive the same drug or drug combinations. These basket trials build on a hypothesis that a cancer’s mutations predict the success of the targeted drug or combination, regardless of the cancer’s site of origin.
The medical community frequently refers to this basket therapy as “precision medicine” and “molecularly informed” clinical trials. SSA is exploring what effect, if any, such treatment may have on its Listing of Impairments (listings) for determining when cancer is disabling under the titles II and XVI disability programs. The Listing of Impairments (listings) designates medical conditions that are severe enough for SSA to consider a person to be disabled. More information about the listings may be found Here. Learn more about basket trials from the National Cancer Institute Here.
Please see the issues below for your comment
Many SSA listings criteria allow a finding of disabled if the cancer is persistent or progressive after initial anticancer treatment. Should basket treatment be considered the initial anticancer therapy if it is not effective, but traditional anticancer treatment (for example, surgery or radiation therapy) tried later is effective?
Some SSA listings criteria allow a finding of disabled based on the site or origin of the cancer. For example, liver, bile duct, and gallbladder cancers have very poor prognoses. These malignancies are usually diagnosed late, when they are already at an advanced stage, making them very difficult to treat. The listings find people with these cancers disabled solely upon confirmed diagnosis. The same is true for cancer ...more »
Will the use of basket therapies mean certain SSA listings criteria will become less relevant? For example, basket clinical trials have had remarkable success. The drugs and drug combinations they test have shown remarkable success managing cancers that doctors consider inoperable or unresectable. Are current SSA listings requiring a cancer to be inoperable or unresectable still relevant if drugs that target the cancer’s ...more »
What criteria should SSA use in such a listing or listings, and how might the listing or listings be structured?
Currently, SSA’s listings identify cancer types by site of origin. For example, SSA evaluates a malignancy originating in the brain under its listing for cancer of the central nervous system, and it evaluates a malignancy that originates in the breast under its breast cancer listing, and so on. Should SSA also have a listing, or listings, that account for the “basket” treatment approach (does not rely on a cancer’s site ...more »
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 ...more »
The research study is for “adults 18 years of age and older with solid tumors or lymphomas that have advanced following at least one line of standard systemic therapy, or with tumors for which there is no standard treatment, will be eligible”. The study participants will have cancer that has advanced past the initial treatment. It appears that most of the participants in the study would already meet the SSA guidelines ...more »
The results from targeted therapy drugs for cancer will change how we adjudicate and assess neoplastic diseases in the Listing of Impairments.