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Addition of docetaxel to standard treatment improves survival in high-risk prostate cancer
Adjuvant docetaxel-based chemotherapy improved OS and DFS among men with high-risk, nonmetastatic prostate cancer when added to the standard treatment of radiotherapy and long-term androgen suppression, according to results of a randomized, multicenter phase 3 trial published in Journal of Clinical Oncology.
Results also showed a reduction in the rate of distant metastasis with the addition of docetaxel to standard treatment for these men.
“These are promising results,” Seth A. Rosenthal, MD, FACR, FASTRO, radiation oncologist at Sutter Cancer Center and lead study author, said in a press release. “Physicians should be considering the discussion of this option with selected patients who are fit for chemotherapy.”
Previous studies demonstrated that chemotherapy with docetaxel improved OS among men with castration-resistant or castration-sensitive prostate cancer. Cytotoxic chemotherapy also may be able to target hormonally resistant cells.
Rosenthal and colleagues tested their hypothesis that docetaxel could improve OS and clinical outcomes compared with standard treatment among 563 men (median age, 66 years; range, 46-83; 87.6% white) with high-risk, nonmetastatic prostate cancer. More than half of the men (52.8%) had a Gleason score of 9 or 10, and 27% had cT3 to cT4 disease. Median PSA was 15.1 ng/mL.
Researchers randomly assigned the men to standard therapy with androgen suppression and external beam radiotherapy (n = 281) or standard therapy plus six cycles of docetaxel and prednisone concurrently with androgen suppression starting 28 days after radiotherapy (n = 282).
Median follow-up was 5.7 years.
Fifty-nine men in the standard therapy group died, including 23 of prostate cancer, compared with 43 deaths in the standard therapy/chemotherapy group, 16 of which were due to prostate cancer.
Results showed 4-year OS rates of 93% (95% CI, 90-96) with standard therapy plus chemotherapy and 89% (95% CI, 84-92) with standard therapy (HR = 0.69; 90% CI, 0.49-0.97).
Six-year DFS rates were 65% in the standard therapy/chemotherapy group and 55% in the standard therapy group (HR = 0.76; 95% CI, 0.58-0.99). Six-year rates of distant metastasis were 9.1% with standard therapy and chemotherapy and 14% with standard therapy (HR = 0.76; 95% CI, 0.58-0.99).
Both groups tolerated treatment well, with no unexpected adverse events.
“Longer follow-up may better define the results, although competing risks are always a concern.” Rosenthal and colleagues wrote. “Improved methods of risk stratification, including the emerging use of molecular profiling, may help to better identify patients who will benefit from intensification of treatment with [chemotherapy] in the future.”
The findings should prompt a multidisciplinary evaluation for all men with high-risk prostate cancer, Rahul R. Parikh, MD, and Biren Saraiya, MD, both of the department of radiation oncology at Rutgers Cancer Institute of New Jersey, wrote in an accompanying editorial.
“We truly need to identify the right patient, pathologic, clinical and molecular features to target the appropriate therapeutic approaches,” Parikh and Saraiya wrote. “In the near future, we likely will see the evolution of the prostate cancer treatment paradigm with biologics and personalized medicine as observed in many other cancers.” – by John DeRosier
Disclosures: Rosenthal reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures. Parikh and Saraiya report no relevant financial disclosures.