The word ‘Symptom’ usually means ‘Pain’ (in metastatic prostate cancer). Medical oncologists often
use the words “symptomatic” or “asymptomatic.” For the most part, they are simply referring to pain. On occasion, the word symptom may mean other things such as edema, urinary symptoms or fatigue, but mostly it means pain.
The reason this can be helpful for patients and caregivers to understand is that some advanced prostate cancer treatments are given or not given (covered by insurance or not covered), based on the patient’s level of pain.
For example, PROVENGE (sipuleucel-T) is given to patients who are asymptomatic or minimally symptomatic. That usually means it’s given to patients who have no pain or minimal pain (they cannot be on opioids, for example). The reason being is that how PROVENGE was studied in its Phase 3 clinical trials and that’s where the data came from that led to its FDA approval. Therefore, when PROVENGE was FDA approved, it was “labeled” for patients who are asymptomatic or minimally symptomatic, just like the patients in the Phase 3 clinical trials. Now, here’s the final landing place – that’s how insurance reimburses. So, insurance usually doesn’t cover or pay for a treatment when a patient doesn’t “fit” the FDA label. If PROVENGE is administered to a patient with a lot of pain or is on opioids for pain, it would be prescribed in a way that doesn’t correspond with the FDA label (i.e. the way PROVENGE was studied), so that would be considered “Off- Label.” use which is a term you may have heard before. Just to be clear, the other factors on the PROVENGE FDA label include prostate cancer patients who are (1) metastatic and (2) castrate-resistant or hormone refractory. REF
Another treatment for metastatic castrate-resistant prostate cancer (mCRPC) that has the word “symptoms” on its label is Xofigo (radium 223). Xofigo’s Phase 3 trials (called ALSYMPCA) enrolled patients who had some type of pain (symptoms), so when Xofigo was FDA approved, it was labeled according to the data submitted from the Phase 3 trial in which it was studied. The FDA label for Xofigo says it is for patients who have symptomatic bone metastases. For the most part that means bone metastases that cause any level of pain. Since this is how it is labeled, this is what insurance requires in order for them to pay for Xofigo. Just to be clear, the other factors on the Xofigo FDA label include prostate cancer patients who are (1) castrate-resistant and (2) have no known visceral metastatic disease. REF (According to the NIH, visceral means “The soft internal organs of the body, including the lungs, the heart, and the organs of the digestive, excretory, and reproductive systems.”) REF
The next time your physician asks if you have any symptoms, ask him if he means pain. If he (or she) asks you if you have any pain, ask if they mean symptoms. For us they are different words, but in the clinic they often mean the same thing.
Asking better questions always gets you better answers. Stay empowered.