Sipuleucel-T in prostate cancer: More harm than good

8 Jan 2015

Sipuleucel-T (trade name: Provenge) has been approved since September 2014 for men with metastatic prostate cancer who have few or no symptoms and do not yet require chemotherapy. The German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether the drug offers patients an added benefit over one of the appropriate comparator therapies.


The manufacturer included three randomized, double-blind and multicenter approval studies, in which the new treatment was compared with a placebo equivalent. However, the reliability of the results is limited as no group differences were measured in many outcomes. With regard to mortality, IQWiG assessed the risk of bias as being so high that the results are no longer meaningfully interpretable. This is supported by the finding that the data showed no differences between Sipuleucel-T and the placebo equivalent.

No health-related quality of life recorded

None of the three studies recorded health-related quality of life. The study data showed no statistically significant differences between the treatment groups for further patient-relevant outcomes: This applied to morbidity and to serious and severe adverse events as well as to treatment discontinuation and follow-up because of such side effects. Hence there is no proof of added benefit regarding these outcomes either.

More harm than good

However, according to the findings, there are also side effects measured only to the Sipuleucel-T group, such as fever, headache and chills. Under consideration of the potential bias of the results, IQWiG sees an indication of greater harm regarding these side effects.

No overall weighing of the effects possible

The negative effects do not result in "lesser benefit," however, because the high uncertainty in the outcome "overall survival" is such that no conclusive weighing is possible.


Source: Science Daily
No Comment