Submitted by Dr.Kattlove’s Cancer Blog

Today, I read two articles that connected these two. The first was in today’s LA Times and talked about the controversy over Provenge, a new treatment for advanced prostate cancer. The FDA has held up its approval in spite of a study that showed that patients who received the treatment lived, on average, 4½ months longer. Many prostate cancer patients are protesting this decision and asking that it be overturned. There have even been death threats against members of the committee that made the decision.

The second article was in the January 1 issue of the Journal of Clinical Oncology. It reported on the negative results of a study using high dose chemotherapy and stem cell replacement treatment for widespread breast cancer. The patients didn’t live any longer, in spite of this extremely toxic treatment. The theory behind the treatment is that if patients are given massive doses of chemotherapy, this can wipe out the cancer cells.
The chemotherapy also wipes out the blood-forming cells in the bone marrow, so these have to be replaced. Before the chemotherapy, blood-forming stem cells are taken from the patient either from their bone marrow, or more commonly, from their blood stream. These are given to the patient after the treatment to allow them to begin making blood again.

There was a time, when there was little information on the outcomes of this treatment and women who had advanced breast cancer, in desperation, asked for it even though it hadn’t yet proven itself. If insurance companies denied the treatment because it was not proven effective and, by the way cost around$100,000, the women would sue the insurers. They usually won so that eventually many insurers gave in and paid for the procedure. Eventually, the outcome data rolled in and it became clear that the treatment didn’t work. Today’s JCO article just verifies this.

The same thing is happening with Provenge for prostate cancer. Patients, in desperation, are clamoring for its approval. Didn’t it prolong lives by 4.5 months, they ask? Yes it did, but if you read the article closely you see that the cancer grew just as quickly in the Provenge-treated patients as in those given a placebo. There’s a disconnect here. If the cancer grows as quickly in one group as in another, shouldn’t the cancer take its toll just as quickly? That is what most cancer specialists assume to be true. For a treatment to really help, it has to slow down the growth of the cancer. But it didn’t in this case and that is why the FDA has asked for more studies. The results just don’t make sense.

But patients with advanced prostate cancer are desperate for treatment, as were women with breast cancer in the past. But the FDA has the job of preventing ineffective treatment that may be toxic and certainly very expensive. So, let us hope that people have the good sense to wait for more information before going overboard with death threats and protests.

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