“This study is an important step forward for men with advanced prostate cancer, and adds to existing work the novel dimension of assessing quality of life and cost-effectiveness. The fact that these results were seen in thousands of men enrolled in a long-term study boosts our faith that the findings will hold up over the long-term,” said ASCO Expert Sumanta K. Pal, MD, moderator of today’s presscast.
ALEXANDRIA, Va. – A new analysis of the ongoing STAMPEDE clinical trial found that adding the chemotherapy drug docetaxel to hormone therapy for advanced prostate cancer improves quality of life and lowers the need for subsequent therapy. Docetaxel was also found to be cost-effective. These findings will be presented at the upcoming 2018 Genitourinary Cancers Symposium in San Francisco, California.
“For those men with prostate cancer that had not metastasized, adding docetaxel to hormone therapy reduced the risk for recurrence by 40%, which both improves quality of life and saves cost for treating cancer recurrence,” said lead study author Nicholas D. James, MD, PhD, a professor of clinical oncology at the University of Birmingham, United Kingdom. “We already knew that docetaxel prolongs survival for men with metastatic prostate cancer, but this improvement in quality of life and reduction in subsequent treatment, and therefore costs, in non-metastatic disease is somewhat surprising and may cause clinicians to rethink how and when they use docetaxel to treat prostate cancer.”
About the Study
The STAMPEDE (Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy) trial has now enrolled over 9,000 men with advanced (non-metastatic and metastatic) prostate cancer since October 2005 and has looked at nearly a dozen different drugs to treat the disease.
An analysis in 2016 showed that the 592 men on the trial who received docetaxel lived, on average, 10 months longer than men on standard therapy. This current report is a health economic analysis that looked at health-related quality of life and cost-effectiveness of the addition of docetaxel and prednisolone to hormone therapy, compared to hormone therapy alone (standard of care).
Using a standardized self-reporting tool commonly used in Europe (EuroQol EQ-5D), the researchers asked the trial participants to rate, on a five-point scale, five aspects of their health: mobility, how well they could care for themselves, their ability to perform their usual daily activities, their pain and discomfort levels, and their levels of anxiety and depression. Based on these reports, the authors were able to model changes in a man’s:
- predicted length of survival;
- quality-adjusted life years (QALY), a value that measures the quality and the quantity of life lived where one QALY is a year of perfect health; and
- incremental cost-effectiveness, which is also based on QALY as it assesses the cost-benefit of a medical treatment.
For the men with metastatic disease that had spread to organs outside of the pelvis (M1 disease), if they received docetaxel, their predicted survival was 0.89 years longer compared to men who received only hormone therapy, and the quality of life was preserved 0.51 years longer. For men with non-metastatic disease (M0), predicted survival was 0.78 years longer and quality of life was preserved for an additional 0.39 years with docetaxel.
“One of the key aspects we struggled with was how to truly measure quality of life,” said Dr. James. “How does one measure wanting to live a few more months to see a grandchild born even if the therapy results in difficult side-effects? Although there is a concern about side-effects, primarily nausea and fatigue, it is clear that avoiding or delaying recurrence outweighs the upfront toxicity of chemotherapy and adds enough to overall quality of life so that using docetaxel is beneficial.”
Adding docetaxel to the standard-of-care treatment regimen was also found to be cost-effective for both non-metastatic and metastatic disease. The investigators estimate that the annual cost of giving docetaxel in the United Kingdom is about 5,000 British pounds (roughly $6,750 U.S. dollars) per QALY gained. Researchers note that the potential cost saving benefit from delaying or avoiding recurrence in the United States should be the same, if not greater, due to higher drug prices in the United States.
Since STAMPEDE began, several newer drugs have come on the market, including abiraterone, an oral steroid synthesis inhibitor, which was approved by the U.S. Food and Drug Administration in 2011. Abiraterone has been tested in STAMPEDE, and the authors plan to report cost-effectiveness and quality-of-life measures for this treatment later in 2018.
The investigators note that docetaxel is still mandated for use by the National Health Service, but in other countries, including the United States, the choice between using abiraterone or docetaxel is less clear, especially since abiraterone is more easily taken because it comes in pill form. A course of docetaxel costs an average patient 5,000 British pounds a year, compared to 24,000 pounds for abiraterone.
This study was funded by Cancer Research UK and the Medical Research Council, UK.
View the full abstract.
For your readers:
2018 Genitourinary Cancers Symposium News Planning Team:
Sumanta K. Pal, MD, American Society of Clinical Oncology (ASCO); Daniel A. Hamstra, MD, PhD, American Society for Radiation Oncology (ASTRO); and Katie Murray, DO, Society of Urologic Oncology (SUO)
View the disclosures for the News Planning Team.
ATTRIBUTION TO THE 2018 GENITOURINARY CANCERS SYMPOSIUM IS REQUESTED IN ALL NEWS COVERAGE.
About the American Society for Radiation Oncology:
The American Society for Radiation Oncology (ASTRO) is the world’s largest radiation oncology society, with more than 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals who specialize in treating patients with radiation therapies. The Society is dedicated to improving patient care through professional education and training, support for clinical practice and health policy standards, advancement of science and research, and advocacy. ASTRO publishes three peer-reviewed journals, the International Journal of Radiation Oncology • Biology • Physics (redjournal.org), Practical Radiation Oncology (practicalradonc.org) and Advances in Radiation Oncology (advancesradonc.org); developed and maintains an extensive patient website, RT Answers (rtanswers.org); and created the Radiation Oncology Institute (roinstitute.org), a nonprofit foundation to support research and education efforts around the world that enhance and confirm the critical role of radiation therapy in improving cancer treatment. To learn more about ASTRO, visit www.astro.org, sign up to receive our news and follow us on our blog, Facebook and Twitter.
Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to making a world of difference in cancer care. As the world’s leading organization of its kind, ASCO represents more than 40,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of the highest-quality patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation. Learn more at www.ASCO.org, explore patient education resources at www.Cancer.Net, and follow us on Facebook, Twitter, LinkedIn, and YouTube.
About the Society of Urologic Oncology:
The Society of Urologic Oncology (SUO) was created in 1984 to enable qualified members primarily interested in the care of patients with malignant genitourinary diseases to meet for the purpose of discussion, development, and implementation of ideas to improve care. The Society and its bylaws conform to the guidelines and bylaws of the American Urological Association (AUA).
The purpose of the SUO is to develop educational and research initiatives and to study issues in urologic oncology and provide physician statements that represent a state of the art assessment of these issues to other organizations.
The Society also provides a forum for identifying the urologic oncologist as a physician with specific expertise in the study and treatment of genitourinary malignancies. In recognition of the multidisciplinary efforts involved in the study and treatment of genitourinary malignancies, the Society seeks to incorporate multiple disciplines in achieving these goals. The Society supports the activities of multiple disciplines in the common objectives of seeking an increased understanding and successful treatment of genitourinary malignancies.
The SUO seeks to improve the care of patients with malignant urologic disease and to provide a forum for the discussion of problems relating to malignant urologic disease. Our objectives include: 1) Stimulating research in and the teaching of urologic oncology, 2) Disseminating the principles of urologic oncology to the medical profession at large, 3) Bringing urologists into a Society whose work is entirely, or principally with malignant disease, 4) Being identified as the most qualified organization on matters relating to urologic oncology, and 5) Standardize fellowship training in urologic oncology.
Please visit our website or call (847) 264-5901 for more information on how to become a member.