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Addition of docetaxel to androgren deprivation confers durable OS benefit for metastatic prostate cancer


Nicholas James 2018

Nicholas W. James

BARCELONA, Spain — The addition of upfront docetaxel chemotherapy to androgen deprivation therapy conferred durable, clinically significant benefit for men with low- and high-burden metastatic prostate cancer, according to results of the randomized phase 3 STAMPEDE trial presented at European Society for Medical Oncology Congress.

“Docetaxel [in combination with] androgen deprivation therapy improves OS and failure-free survival in newly diagnosed metastatic prostate cancer regardless of metastatic burden,” Nicholas W. James, PhD, BSc, MB, BS, FRCP, FRCR, consultant in clinical oncology at Queen Elizabeth Hospital in Birmingham, England, and professor of clinical oncology at University of Birmingham, said during his presentation. “It should now be considered as a first-line option alongside [androgen receptor]-targeting agents for all [patients with de novo metastatic prostate cancer] regardless of stratification for disease burden.”

Previous results from the STAMPEDE trial showed upfront docetaxel improved OS for men starting long-term ADT after median follow-up of 3.5 years.

Clarke and colleagues reported long-term outcomes after a median 6.5 years of follow-up among 1,086 men with metastatic prostate cancer who were randomly assigned to the current standard of care alone (n = 724) or with docetaxel (n = 362).

OS served as the primary endpoint. Researchers also evaluated whether the benefit of adding docetaxel depended on metastatic burden, as previous trials had suggested.

Results showed that the addition of docetaxel to ADT significantly improved median OS (59.1 months vs. 43.1 months; HR = 0.81; 95% CI, 0.69-0.95).

Overall, 494 men who received standard-of-care treatment died, a 41% increase since the previous report.

Additionally, researchers found no evidence of a difference in OS benefit with docetaxel between men with low disease burden (HR = 0.76; 95% CI, 0.54-1.07) or high disease burden (HR = 0.81; 95% CI, 0.64-1.02).

The addition of docetaxel also improved failure-free survival (HR=0.66; 95% CI, 0.57-0.76) and PFS (HR=0.69; 95% CI, 0.59-0.81), with no difference in outcomes between the metastatic burden subgroups.

Further, docetaxel did not increase the rate of grade 3 to grade 5 adverse events after 1 year compared with standard of care (27% vs. 28%).

“This analysis does not support the presence of a volume effect on docetaxel effect in men with newly diagnosed metastatic prostate cancer,” James said. “Metastatic burden is, however, prognostic, which is consistent with what we have seen before.” – by John DeRosier



Clarke NW, et al. Abstract 844O; Presented at: European Society for Medical Oncology Congress; Sept. 27-Oct. 1, 2019; Barcelona, Spain.


Disclosures: Astellas, Clovis, Janssen, Medical Research Council, Novartis, Pfizer and Sanofi funded this study. James reports consultant roles with Novartis and Sanofi and consultant/speakers bureau roles with, as well as research funding and travel expenses from, Janssen. Please see the abstract for all other authors’ relevant financial disclosures.

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