Last week, I read a reports about a new FDA-approved treatment for advanced prostate cancer. The New York Times (17 July 2013) article has this title, New Radiation Therapy Prolongs Prostate Cancer Survival.
- A new radiation therapy can extend the lives of men with the most advanced form of prostate cancer, a large new study has found.
- Those who were given the drug saw their median survival time increase to nearly 15 months, a “substantial 30 percent improvement,” said Dr. Chris Parker, the lead author of the new study and a consultant clinical oncologist at the Royal Marsden Hospital and the Institute of Cancer Research, both in London.
Another article by Rachael Rettner, Senior Writer of Huffington Post had this headline: Xofigo, Targeted Radiation Treatment, May Help Men With Advanced Prostate Cancer Live Longer.
Wow, read the key words: Live nearly 15 months; 30 percent improvement! Great numbers. You cannot help but conclude that there is another great breakthrough which most patients are waiting for, right?
What is the treatment about?
Xofigo is given as injection into a vein, once a month. It is a radioactive drug that specifically targets tumors in the bone. The new drug, called radium-223 dichloride (marketed as Xofigo), mimics calcium, and binds to parts of the bone that are rapidly dividing — a characteristic of tumor sites. Because the radiation is targeted to the bone tumors, damage to other tissue, including bone marrow, is minimized, the researchers said.
The treatment also had the additional benefit of improving quality of life, such as relief from pain, for some patients.
FDA Approval Given Ahead of Schedule
Xofigo was approved by the US FDA under the priority review program, three months ahead of schedule. Xofigo is for
late-stage (metastatic) castration-resistant prostate cancer that has reached the bones but not other organs, i.e. with no known visceral metastatic disease.
Basis of FDA Approval
FDA experts gave their approved based on the data from ONE human study. It was tested on 809 patients with symptomatic castration-resistant prostate cancer that spread to bones but not other organs.
Patients were randomly selected into one of two groups – the Xofigo group or placebo plus best standard of care group (the second group received nothing, except best standard care).
- The main endpoint of the study was overall survival.
- Patients given Xofigo lived for an average of 14.9 months.
- Patients given Placebo lived for an average of 11.3 months.
- Meaning this new drug extended life by about 3.5 months.
The most common side effects of the drug are:
and swelling of the leg, ankle, or foot.
The most common abnormalities detected are:
low levels of red blood cells (anemia), lymphocytes (lymphocytopenia), white blood cells (leukopenia), platelets (thrombocytopenia) and infection-fighting white blood cells (neutropenia).
Is this really a breakthrough that cancer patients are hoping for?
Like all targeted therapies that came before Xofigo, the price is mind-boggling. A course of treatment, administered over roughly six months in the form of six injections, costs US$69,000 (RM 210,000). Please don’t complain because this is roughly the price tag for present day cancer treatment!
The argument often put forward to cancer patients and their families is that, for someone who is dying what is life worth? An additional time of two to three months is worth that cost? Yes, the doctors and the drug company may want us to think that the extra 3.5 months is worth more than RM 200K! Of course it is worth it if someone is paying for the bill. But if it has to come out from your own hard earned life saving would you think twice? It is not for me to comment on that. You decide whether it is worth it?
Perhaps compared to another treatment, called Sipuleucel-T (Provenge), a prostate cancer vaccine, which costs nearly US$100,000 and extends life by about four months, this new drug is a bargain?
Besides the high cost what about the side effects?