On the Horizon
Ongoing clinical trials that have the potential to change clinical practice are looking at new strategies. One such trial is comparing the combination of palliative radiotherapy with the CTLA-4 blocker ipilimumab (Yervoy, Bristol-Myers Squibb) and the novel immunomodulator tasquinimod with placebo prior to docetaxel chemotherapy. Another trial is evaluating novel hormonal therapies, and still another is conducting a head-to-head comparison of cabazitaxel and docetaxel in the frontline treatment of men with CRPC.
"In these new studies, prednisone is omitted, so can we skip prednisone everywhere we use docetaxel?" asked Wojciech Dolata, MD, from the Allan Blair Cancer Centre in Regina, Saskatchewan, Canada, who was not involved in guidelines development.
In fact, he wondered whether the category 1 recommendation to use docetaxel with prednisone was included in the guidelines because of previous studies in which the combination was compared with mitoxantrone and prednisone.
"Prednisone was one of the first drugs studied in prostate cancer, and it never has had a survival benefit alone," Dr Armstrong reported. "Because it was available back in the 1940s and 1950s, it became the backbone or standard of care with which mitoxantrone was compared, and mitoxantrone required prednisone because it was thought to be unethical not to give prednisone."
"The strict interpretation of all the evidence has been that prednisone is used in the CRPC setting because we don't have any clinical trials without prednisone," he explained.
Dr Dolata told Medscape Medical News that although it is too early for most of the information he heard to influence day-to-day clinical practice, he is interested in the study comparing docetaxel with cabazitaxel in the frontline setting for men with CRPC, and hopes to include his patients in that or a similar trial.
Dr Armstrong reports financial relationships, including consulting fees, honoraria, research support, and speaker's bureau membership, with several pharmaceutical companies. Dr Dolata has disclosed no relevant financial relationships.
National Comprehensive Cancer Network (NCCN) 20th Annual Conference. Presented March 12, 2015