According to results from two clinical trials published in the New England Journal of Medicine, Taxotere® (docetaxel)-based chemotherapy regimens improve survival in patients with hormone-refractory prostate cancer. Taxotere® in combination with prednisone was recently approved for the treatment of hormone-refractory prostate cancer.
Prostate cancer is the most commonly diagnosed cancer in men in the United States besides non-melanoma skin cancers. The prostate is a walnut-sized gland that is located between the bladder and rectum and is responsible for forming a component of semen. Prostate cancer is stimulated to grow by male hormones, particularly testosterone. Therefore, patients may receive treatment, referred to as hormone therapy, to reduce levels of male hormones available to cancer cells. This removes the growth stimulus produced by male hormones and causes the cancer to shrink. Unfortunately, patients ultimately stop responding to hormone therapy after being on treatment for a period of time and are then referred to as having hormone-refractory or androgen independent prostate cancer. Once they become hormone refractory, patients have limited effective treatment options and prior clinical trial results have not been convincing as to the survival benefit of chemotherapy regimens at this stage of disease. One standard treatment option for patients with hormone refractory prostate cancer was the combination consisting of the chemotherapy agent mitoxantrone (Novantrone®) and the steroid prednisone.
The first clinical trial published in the New England Journal of Medicine was a direct comparison of Taxotere®/prednisone to the historical standard treatment of mitoxantrone plus prednisone. This trial included 1,006 patients who had hormone-refractory prostate cancer. Approximately half of the patients were treated with Taxotere®/prednisone and the other half were treated with mitoxantrone/prednisone. Patients treated with Taxotere® received therapy either once per week or once every 3 weeks at different doses. Patients treated on the Taxotere® regimen that was once every 3 weeks had superior outcomes to those treated with Taxotere® once per week. The average survival for patients following treatment with chemotherapy was nearly 19 months for those treated with Taxotere®/prednisone (every 3 weeks), compared to 16.5 months for those treated with mitoxantrone/prednisone. Pain was reduced in approximately 35% of patients treated with Taxotere®/prednisone every 3 weeks, compared to 22% of patients treated with mitoxantrone/prednisone. The most common severe side effect, low white blood cell levels, occurred more often in patients treated with Taxotere®/prednisone than those treated with mitoxantrone/prednisone.
The second clinical trial published in the New England Journal of Medicine included a comparison of a chemotherapy regimen consisting of Taxotere® and the chemotherapy agent estramustine to mitoxantrone/prednisone in hormone-refractory prostate cancer patients. This trial included 674 patients, approximately half of whom were treated with Taxotere®/estramustine and half of whom were treated with mitoxantrone/prednisone. The average duration of survival in patients treated with Taxotere®/estramustine was 18 months, compared with 15 months for those treated with mitoxantrone/prednisone. The average time to cancer progression was 6 months for patients treated with Taxotere®/estramustine, compared to only 3 months for those treated with mitoxantrone/prednisone. Severe side effects were more common in the group of patients treated with Taxotere®/estramustine, with the most frequent being gastrointestinal and cardiac; however, deaths related to treatment occurred in approximately 5% of patients, with no significant difference between the two treatments.
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These results indicate that Taxotere®-based chemotherapy regimens improve survival over the historical standard treatment regimen of mitoxantrone and prednisone in the treatment of hormone-refractory prostate cancer. The researchers concluded that these are the largest comparative trials to date that have demonstrated an improvement in survival for initial treatment of hormone-refractory prostate cancer, giving patients an effective treatment option for their disease. Patients with hormone-refractory prostate cancer may wish to speak with their physician about the risks and benefits of Taxotere®-based chemotherapy regimens as treatment for their cancer.
 Tannock I, de Wit R, Berry W, et al.Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer. New England Journal of Medicine. 2004; 351:1502-1512.
 Petrylak D, Tangen C, Hussain M, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. New England Journal of Medicine . 2004; 351:1513-1520.
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