Philadelphia, PA (PRWEB) December 09, 2013
Men suffering from highly advanced prostate cancer have new hope for longer survival times based on a recent clinical trial, the interim results of which were just announced by the National Institutes of Health. The findings suggest that physicians can immediately consider changing their clinical practice from the use of hormone therapy alone to a combination of chemotherapy and hormone therapy to improve survival.
Designed and conducted by the ECOG-ACRIN Cancer Research Group as part of the National Clinical Trials Network sponsored by the National Cancer Institute, part of the NIH, the clinical trial provides insight about the use of chemotherapy earlier in the course of prostate cancer treatment than is typically done in current clinical practice. Docetaxel, a US Food and Drug Administration-approved chemotherapy drug, was administered in combination with androgen deprivation therapy (ADT) when a man presented with advanced prostate cancer—cancer that had spread (metastasized). The trial showed that early application of both therapies is more effective than hormone therapy alone and is associated with an improvement in overall survival.
“Using the combination of docetaxel and ADT as initial treatment—and not waiting until progression on the ADT—has the potential to extend the life of men suffering from advanced prostate cancer,” said lead investigator Christopher J. Sweeney, MBBS, a Medical Oncologist at the Dana Farber Cancer Institute and Associate Professor of Medicine at the Harvard Medical School, both in Boston, MA.
The clinical trial enrolled 790 men with advanced prostate cancer that was hormone-sensitive (meaning prostate cancer growth depended on hormones) between July 2006 and November 2012, and has continued to follow their health status since. A recent planned analysis of the results showed that more men in the study who had received a combination of docetaxel and hormone treatment were alive after 3 years (69 percent) than were men who received only hormone treatment (52.5 percent).
Dr. Sweeney went on to explain that the benefit of the combination regimen vs. hormone treatment only was greatest (63.4 percent vs. 43.9 percent) in men with highly advanced prostate cancer, defined in the study as growth that has spread to the major organs (for example, the liver), spread to result in four or more bone lesions, or both. Researchers recommend that the new clinical practice should be restricted to men with highly advanced cancer because this patient group experienced the most benefit in the clinical trial, and docetaxel is associated with some toxicity. “This provides a new treatment option immediately for men whose prostate cancer’s growth has spread extensively,” said Dr. Sweeney.
While the immediate focus is to apply this treatment to highly advanced-case patients, a follow-up analysis of patients with less extensive cancer will be done to learn more about the effects of this regimen on them.
“Members of the clinical field of prostate cancer have awaited these results and are delighted that our hypothesis was correct that the earlier use of chemotherapy is safe, feasible, and improves how long a man lives with advanced prostate cancer,” said Michael A. Carducci, MD, FACP, AEGON Professor in Prostate Cancer Research at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, MD, and Chair of the ECOG-ACRIN Genitourinary Committee, which led the trial.
Dr. Carducci went on to explain that one of ECOG-ACRIN's primary research aims is to design and conduct clinical trials that have the potential to change clinical practice in the treatment of adults who have cancer. “Clinical trials, such as this one, give us the information we need to determine the most effective, life-prolonging therapy for our patients. This trial represents a building block from which to investigate further advances,” he said.
According to American Cancer Society estimates, more than 238,000 men will be diagnosed with prostate cancer and more than 29,000 men will die of the disease in the US in 2013. Five-year survival rates in men with advanced prostate cancer are significantly lower (28 percent) than those in men with less advanced disease (100 percent for both local and regional extent of the disease).
The name of the trial is E3805 or CHAARTED, which stands for ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer. Sanofi, Paris, the drug manufacturer, provided the docetaxel and supported this study under an agreement with ECOG-ACRIN. Docetaxel is currently FDA approved with prednisone for treatment of androgen independent (hormone refractory) metastatic prostate cancer.
About the ECOG-ACRIN Cancer Research Group
The ECOG-ACRIN Cancer Research Group is a multidisciplinary, membership-based scientific organization that designs and conducts biomarker-driven cancer research involving adults who have or are at risk of developing cancer. The Group was formed in May 2012 by a merger that combined the complementary strengths of the Eastern Cooperative Oncology Group (ECOG) in cancer therapy and the American College of Radiology Imaging Network (ACRIN) in cancer imaging. ECOG and ACRIN were two highly respected National Cancer Institute (NCI)-sponsored cancer cooperative groups. ECOG-ACRIN comprises nearly 650 member institutions in the US and around the world. Approximately 6000 physicians, translational scientists, and associated research professionals from the member institutions are involved in Group research, which is organized into three scientific programs: Cancer Control and Outcomes, Therapeutic Studies, and Biomarker Sciences. ECOG-ACRIN is supported primarily through NCI research grant funding, but also receives funding from private sector organizations through philanthropy and collaborations. It is headquartered in Philadelphia, PA, as is PrECOG, LLC, a not-for-profit company that partners with ECOG-ACRIN and industry to develop and conduct clinical trials in all areas of oncology. For more information, visit http://www.ecog-acrin.org or call 215.789.3631.
Androgen Deprivation Therapy
Androgen deprivation therapy (ADT) is a hormone treatment that reduces or blocks the level of male hormones (called androgens) to prevent them from entering prostate cancer cells. Androgens, mainly testosterone and dihydrotestosterone (DHT), come mostly from the testicles, although a small amount is made in the adrenal glands. Androgens regulate male sex characteristics and can stimulate prostate cancer cells. Lowering the level of androgens in cancer cells—or stopping them from getting into cancer cells—often makes prostate cancer tumors shrink or grow more slowly for a time. Hormone therapy alone, however, does not cure prostate cancer and eventually will become ineffective.