The gist: The drug sipuleucel-T (Provenge) may be no better than watchful waiting and standard androgen deprivation therapy for certain prostate cancer patients. That was the conclusion of the German Institute for Quality and Efficiency in Health Care (IQWiG). The IQWiG analyzed data on men with metastatic prostate cancer who had few or no symptoms and did not yet need chemotherapy.
“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 in a dossier assessment whether the drug offers patients an added benefit over one of the appropriate comparator therapies.
“According to the findings, an added benefit is not proven: The data on mortality were not evaluable because differences between the treatment groups might have been caused by the circumstances of the subsequent therapies. At the same time, certain side effects such as fever occur more frequently.
“Treatment with sipuleucel-T aims to stimulate the immune system to kill cancer cells. Immune cells are extracted from the patient’s blood and treated with a protein in a laboratory. These treated cells are then injected back into the patient’s blood where they are supposed to better recognize cancer cells and stimulate the immune system to fight the prostate cancer.
“Sipuleucel-T is an option for patients whose cancer has already formed metastases and can also no longer be influenced by blocking the hormone testosterone (hormone refractory).”