Prostate Cancer: Top Studies and Flops for 2013
Prostate Cancer: Top Studies and Flops for 2013
The approval of docetaxel for the treatment of mCRPC in 2004 effectively divided patients into 2 groups: those who were pre-docetaxel and those who were post-docetaxel. In subsequent years, we moved the needle for the post-docetaxel set by showing that cabazitaxel, abiraterone, and enzalutamide given in this setting can further prolong survival.
The approval of sipuleucel-T in 2010 was the first nudge in breaking down the barrier between pre- and post-docetaxel, as the data showed a survival benefit regardless of prior docetaxel use, but there was still no direct antitumor effect for pre-docetaxel patients. In 2013, the barrier between pre- and post-docetaxel was blown wide open when abiraterone was approved after showing that it could not only prolong overall survival, but also induce tumor regression and delay disease progression in chemo-naive patients.
"The use of abiraterone in the pre-docetaxel space became a reality in 2013," noted Dr. Sartor. "This has been a paradigm shift that has substantial consequences. For years we have been looking at the post-docetaxel space, and now are dealing with the post-abiraterone space."
Enzalutamide is likely to join abiraterone as front-line therapy, said Dr. Sartor. "The Data Monitoring Committee stopped the trial at an interim analysis because survival benefit was demonstrated, and the FDA will likely act on this trial's results in 2014," Dr. Sartor predicted.
All available data suggest that both of these drugs are minimally toxic, making them quite attractive to patients in the earliest stage of mCRPC who cannot or do not want to tolerate the toxicities associated with docetaxel.
A second big barrier was broken in 2013 when the alpha emitter radium-223 was approved after showing a survival benefit in patients with bone mCRPC regardless of prior docetaxel use.
The beta-emitting radioisotopes samarium and strontium have been available for a while but are used for palliation of bone pain. Radium-223 radically changes how radioisotopes can be used in patients with mCRPC.
Welcome to the "Post-Abiraterone Space"
The approval of docetaxel for the treatment of mCRPC in 2004 effectively divided patients into 2 groups: those who were pre-docetaxel and those who were post-docetaxel. In subsequent years, we moved the needle for the post-docetaxel set by showing that cabazitaxel, abiraterone, and enzalutamide given in this setting can further prolong survival.
The approval of sipuleucel-T in 2010 was the first nudge in breaking down the barrier between pre- and post-docetaxel, as the data showed a survival benefit regardless of prior docetaxel use, but there was still no direct antitumor effect for pre-docetaxel patients. In 2013, the barrier between pre- and post-docetaxel was blown wide open when abiraterone was approved after showing that it could not only prolong overall survival, but also induce tumor regression and delay disease progression in chemo-naive patients.
"The use of abiraterone in the pre-docetaxel space became a reality in 2013," noted Dr. Sartor. "This has been a paradigm shift that has substantial consequences. For years we have been looking at the post-docetaxel space, and now are dealing with the post-abiraterone space."
Enzalutamide is likely to join abiraterone as front-line therapy, said Dr. Sartor. "The Data Monitoring Committee stopped the trial at an interim analysis because survival benefit was demonstrated, and the FDA will likely act on this trial's results in 2014," Dr. Sartor predicted.
All available data suggest that both of these drugs are minimally toxic, making them quite attractive to patients in the earliest stage of mCRPC who cannot or do not want to tolerate the toxicities associated with docetaxel.
A second big barrier was broken in 2013 when the alpha emitter radium-223 was approved after showing a survival benefit in patients with bone mCRPC regardless of prior docetaxel use.
The beta-emitting radioisotopes samarium and strontium have been available for a while but are used for palliation of bone pain. Radium-223 radically changes how radioisotopes can be used in patients with mCRPC.
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