Adding docetaxel to standard care does not improve metastasis-free survival or overall survival (OS) for patients with non-metastatic prostate cancer, according to results from the STAMPEDE trial published in JNCI Cancer Spectrum.
These long-term results from STAMPEDE show that adding docetaxel to standard care can improve failure-free survival (FFS) and progression-free survival (PFS) but not OS, metastatic progression-free survival (mPFS), or prostate cancer-specific survival (PCSS).
The phase 2/3 STAMPEDE trial (ClinicalTrials.gov Identifier: NCT00268476) enrolled 690 patients with non-metastatic prostate cancer. Patients were newly diagnosed or had previously received radical treatment without prior long-term androgen deprivation therapy (ADT).
The patients were randomly assigned to receive standard care alone (n=460) or in combination with docetaxel (n=230). Standard care consisted of ADT with or without prostate radiotherapy.
At a median follow-up of 81.2 months, there was no improvement in mPFS with docetaxel. The 5-year mPFS rate was 82% with docetaxel and 77% without it (hazard ratio [HR], 0.89; 95% CI, 0.66-1.19; P =.43).
Likewise, docetaxel did not improve OS or PCSS. The 5-year OS rate was 87% with docetaxel and 81% without it (HR, 0.88; 95% CI, 0.64-1.21; P =.442). The 5-year PCSS rate was 91% and 86%, respectively (HR, 0.84; 95% CI, 0.58-1.23; P =.373).
On the other hand, docetaxel did improve FFS and PFS. The 5-year FFS rate was 63% with docetaxel and 52% without it (HR, 0.70; 95% CI, 0.56-0.88; P =.002). The 5-year PFS rate was 78% and 69%, respectively (HR, 0.80; 95% CI, 0.61-1.06; P =.033.).
These improvements occurred without excess late toxicity, the researchers noted. After the first year, the rates of grade 3-5 adverse events were similar between the docetaxel arm and the control arm (30% and 28%, respectively).
“Overall, these long-term analyses of non-metastatic patients in STAMPEDE did not demonstrate a benefit to using docetaxel chemotherapy in terms of metastasis-free survival nor overall survival,” the researchers wrote. “There was good evidence upfront docetaxel resulted in men living longer before their disease relapsed and good evidence there was no excess of long-term adverse events for these patients.”
“The findings are consistent with trials addressing the same broad question and provide some evidence of modest benefit in favor of chemotherapy. These points will be worth considering altogether for selected men in this population,” the researchers concluded.
Disclosures: This research was supported by Cancer Research UK, Medical Research Council, Sanofi, Astellas, Clovis, Janssen, Novartis, and Pfizer. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
James ND, Ingleby FC, Clarke NW, et al. Docetaxel for nonmetastatic prostate cancer: Long-term survival outcomes in the STAMPEDE randomized controlled trial. JNCI Cancer Spectrum. Published online July 25, 2022. doi:10.1093/jncics/pkac043