In an article, describing the data generated from a trial, published in Lancet Oncology it was shown that docetaxel chemotherapy (Taxotere), when added to the standard of care of hormone therapy (ADT), extended a man’s overall survived (OS). The trial concluded that docetaxel along with ADT should become the new standard of care for hormone sensitive metastatic prostate cancer. (1,2)
The primary objective of the trial (NCT00309985) was to determine whether overall survival would be longer for men adding docetaxel when they started ADT versus men receiving just ADT. The study was statistically highly powered being designed to ensure that it had at least an 80% power to detect a 33% difference in overall survival (OS) between the two groups.
The trial also evaluated some secondary objectives including PSA levels, the median time to disease progression, the median time to development of castration-resistant prostate cancer, and safety.
About 86% of the men in the combination group completed the six cycles of therapy, and 74% tolerated the chemotherapy and did not require dose modification. The median follow-up was 28.9 months. Median overall survival (OS) was 57.6 months versus 44.0 months for men receiving ADT and docetaxel or ADT alone, respectively.
When analyzing data for the subgroup of men who had high-volume disease, at the final analysis, median OS was again superior in the combination therapy group versus the ADT-alone group at 49.2 months and 32.2 months. Median survival for men with low-volume disease had not been reached in either study arm; however, all subgroups analyzed showed benefit with docetaxel treatment. A total of 85 men died in the combination group versus 114 in the ADT-alone group, all designated as prostate cancer deaths.3
Secondary efficacy endpoints also showed a benefit in the combination arm. The percentage of men receiving combination therapy who achieved a decrease in PSA to less than 0.2 ng/mL was significantly greater than those receiving ADT alone.3
Another advantage for the combination arm became apparent for the median time to the development of castration-resistant prostate cancer. Median time to development was 20.2 months versus 11.7 months for the combination and ADT alone groups, respectively and similarly for median time to clinical progression at 33.0 months versus 19.8 months for the combination and ADT-alone groups respectively. 3
The study reported treatment-related grade 3 or 4 allergic reactions in the combination therapy group along with grade 3 fatigue in 4%. Occurring at rates of 1% or less were grade 3 diarrhea, stomatitis, motor neuropathy, and sensory neuropathy. Neutropenic fever occurred in 6% of men in the combination group, and 2% had grade 3 or 4 infections with neutropenia.3
Docetaxel combined with ADT, prescribed as per the study protocol led to significantly longer OS than in men with metastatic hormone-sensitive prostate cancer who received only ADT.
1- Vale CI, Burdett S, Rydzewska LHM, et al. Lancet Oncol. 2015; pii: S1470-2045(15)00489-1. doi: 10.1016/S1470-2045(15)00489-1.
2- TargetedOnc.com. Metastatic hormone-sensitive prostate cancer should include docetaxel alongside ADT. http://www.targetedonc.com/news/metastatic-hormone-sensitive-prostate-cancer-docetaxel-adt. Accessed January 27, 2016.
3-Sweeney CJ, Chen YH, Carducci M, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. N Engl J Med. 2015;373(8):737-746.
Joel T. Nowak, MA, MSW wrote this Post. Joel is the CEO/Executive Director of Cancer ABCs. He is a Cancer Thriver diagnosed with five primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma, and the rare cancer Appendiceal cancer.