Docetaxel (Taxotere) appears to help improve overall quality of life and delay time for subsequent therapy in men with both non-metastatic and metastatic prostate cancer, according to a new analysis of STAMPEDE trial results.
Docetaxel (Taxotere) appears to help improve overall quality of life and delay time for subsequent therapy in men with both non-metastatic and metastatic prostate cancer, according to a new analysis of findings from the ongoing STAMPEDE clinical trial.
The findings suggest clinicians now may consider whether the evidence is sufficiently compelling to support docetaxel use in non-metastatic patients.
Adding docetaxel to androgen deprivation therapy (ADT) for advanced prostate cancer also was found to be cost-effective. Lead study author Nicholas James, MD, PhD, of the University of Birmingham, United Kingdom, said for men without metastatic disease, adding docetaxel to ADT reduced the risk for recurrence by 40%. It was already known that docetaxel prolongs survival in men with metastatic prostate cancer. However, an improvement in quality of life and reduction in subsequent treatment in non-metastatic disease was somewhat surprising, according to Dr. James, who presented the study findings at a presscast in advance of the Genitourinary Cancers Symposium in San Francisco.
The STAMPEDE (Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy) trial has enrolled more than 9,000 men with advanced (non-metastatic and metastatic) prostate cancer since October 2005. An analysis in 2016 showed that the 592 men in the trial who received docetaxel lived 10 months longer on average than men on standard therapy. For this investigation, the authors asked the trial participants to rate on a five-point scale (EuroQol EQ-5D) aspects of their health (mobility, caring for themselves, ability to perform daily activities, pain/discomfort levels, and levels of anxiety/depression). Docetaxel (75 mg/m2) was administered alongside standard of care (hormone therapy and radiotherapy in some patients) for six 3-weekly cycles with prednisolone, 10 mg daily.
For the men with metastatic disease who received docetaxel, their predicted survival was 0.89 years longer compared to that of men who received only hormone therapy, and quality of life was preserved 0.51 years longer. For men with non-metastatic disease, predicted survival was 0.78 years longer and quality of life was preserved for an additional 0.39 years with docetaxel.
“We already knew that docetaxel prolongs survival for men with metastatic prostate cancer,” Dr. James said, “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.”
Urologist Ganesh Raj, MD, PhD, of UT Southwestern Medical Center, Dallas, said this study has the potential to change the clinical paradigm.
“While the addition of six courses of chemotherapy can be associated with significant toxicity, the authors suggest that for this cohort of patients, the benefits of combining docetaxel with standard hormonal therapy and local therapy outweigh the risk, both in terms of overall survival and quality of life. The findings are provocative and may herald the use of multimodal therapy in non-metastatic prostate cancer,” Dr. Raj told Urology Times.
Mark Garzotto, MD, of Oregon Health & Science University and Portland VA Medical Center, Portland, agrees and said this study is particularly impressive given that there can be significant toxicity from chemotherapy treatment itself. However, he said men with non-metastatic prostate cancer are a very diverse group with a wide-spectrum of clinical outcomes.
“Characterizing precisely which patient populations will derive these benefits is of critical importance going forward,” Dr. Garzotto told Urology Times. “Additional questions that need to be answered include whether novel hormone agents can achieve similar or better outcomes as shown in STAMPEDE.”
Dr. James has received honoraria from and serves as a consultant/adviser to Sanofi/Aventis and several other pharmaceutical companies. He also serves on the speakers’ bureau for several pharmaceutical companies. His institution has also received research funding from Sanofi/Aventis and several other pharmaceutical companies. For full disclosures, click here.
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