A recent study compared Zytiga (abiraterone acetate) plus prednisolone (AAP) versus Taxotere (docetaxel). The study analysed data gathered in STAMPEDE, a Phase 2/3 trial, which has prospectively studied more than 9,000 patients and includes six different approaches to treating high-risk or metastatic hormone sensitive prostate cancer.
Two of the treatments included in STAMPEDE were AAP and Taxotere added to the standard hormone deprivation therapy, with 377 patients randomly assigned into the AAP treatment group and 189 into the Taxotere group. Both drugs had previously shown promise in improving survival in patients with high-risk prostate cancer when compared to the standard treatment of androgen deprivation therapy alone.
When added to the standard hormone deprivation therapy AAP and docetaxel provided similar benefits to patients, with no difference in overall survival at the four year follow up between the two groups. AAP had slightly better failure-free survival and progression-free survival, less metastatic progression and fewer patients experiencing symptoms from cancer spreading to their bones. These differences were not statistically significant and the researchers stated that oncologists looking to determine which combination was preferable could find either choice acceptable.
“The individual trials suggested that abiraterone may have a larger effect on survival than docetaxel, but this did not translate into a clear advantage in this study. Both drugs provide a survival advantage over standard of care alone in men with high-risk prostate cancer beginning long-term hormone therapy,” said Nicholas D. James, chief investigator of STAMPEDE and consultant oncologist at the University of Birmingham and Queen Elizabeth Hospital in the U.K according to Prostate Cancer News Today.
Although not performing better in these trials and found to be less effective than in certain patients in other studies, historically Taxotere’s manufacturer, Sanofi SA, had been marketing the drug as having “superior efficacy” and benefits when compared to competing drugs. In 2009, the U.S Food and Drug Administration (FDA) issued a warning letter to Sanofi about this false marketing.
Lawsuits have been brought against the company not only regarding the misrepresenting of the drug’s safety and effectiveness, but also alleging that Sanofi illegally trained employees to promote Taxotere’s off-label use and paid kickbacks to health care providers who prescribed the drug off label, dramatically increasing sales in the early 2000s. The suits also claim that the company was simultaneously concealing the fact that the more potent and toxic drug can cause permanent hair loss from American consumers, who were warned a decade after patients outside the U.S.
There is currently a multidistrict litigation (MDL) IN RE: Taxotere (Docetaxel) Products Liability Litigation formed in the Eastern District of Louisiana. Since October of last year the number of cases in the litigation has grown from 33 to 1,491 as of Aug. 15, 2017 according to the Judicial Panel on Multidistrict Litigation (JPML). All of the suits in the MDL allege that chemotherapy drug docetaxel can cause permanent hair loss when other competing drugs do not carry this risk
This might be an important fact for oncologists to consider when discussing with patients which option is the best treatment for high-risk prostate cancer.
Prostate Cancer News Today