Prostrate Cancer Vaccine-Mixed Review

November 13th, 2010, Posted by admin / Leave a comment

Prostrate cancer is among the most common male cancers in the United States. Considering the fact that the symptoms of this cancer are vague, it gets diagnosed usually at the terminal stage. In a an attempt to decrease the fatalities due to this cancer, medical fraternities worldwide are promoting unawareness and at the same time, trying to come up with a vaccine and a possible cure for this disease.

In an attempt to create an effective vaccine, Sipuleucel-T was introduced. This is a cancer vaccine, which was believed to help men in increase the overall survival against this disease. However latest reports question the efficacy of this drug and it has received mixed reviews.

Researchers and doctors believe that the evidence to prove that Sipuleucel-T effective is far fetched and theoretical without the backing of a medical proof. As of now, there is no concrete evidence regarding adverse events that are associated with this treatment, no proof for off label indications and no evidence regarding clinical outcomes for the agent’s approved indication. With these many incomplete answers, the efficacy and safety of this drug is bound to raise questions.

Research results

This mixed reaction stems from the fact that two of the three randomized clinical trials of sipuleucel-T resulted in a significant survival advantage. However, the third trial did show the same level of efficacy but the difference was not significant enough to call it a successful drug.

Another factor was that none of these trials displayed a significant effect on endpoints related to disease progression. Due to this the effect of this drug was rated as moderate.

The fact that the evidence of this trial were assumed to be inaccurate were due to the following reasons:

• The number of sample size of the trials was small.
• There was possibility of bias which was related to the chances of confounding effects of post-progression variation in treatment and research for salvage therapy with this vaccine for patients who were on placebo leading to progression of this disease.

In a study of the adverse reactions of this drug, reviewers studied the adverse events that were associated with this vaccine. It was found that administration of sipuleucel-T lead to infusion reactions and infections. However, post these evaluations, reviewers felt that these evidences were not enough to evaluate outcomes for the off label uses.

Another factor that is yet not clear is in case of pos-progression chemotherapy; it is yet to be seen if sipuleucel-T is effective when administered without chemotherapy or if it is effective only along with chemotherapy.

Another factor that may not go down well with the general population is that it has been priced at $93,000 which makes it a very expensive drug and may keep it out if reach of the common man. As the line goes….the debate continues.