STAMPEDE shows docetaxel benefit regardless of metastatic burden
medwireNews: Men with metastatic hormone-naïve prostate cancer (mHNPC) have improved outcomes with the addition of docetaxel to androgen deprivation therapy (ADT) irrespective of whether they have high or low burden of disease, indicates an analysis of the STAMPEDE trial.
Presenting the findings at the ESMO Congress 2019 in Barcelona, Spain, study author Nicholas James (University of Birmingham, UK) said the combination “should now be considered as a first-line option alongside [androgen receptor]-targeting agents for all de novo mHNPC patients regardless of stratification for disease burden.”
He reported on a stratified subgroup analysis of the multi-arm trial, which has previously shown a survival gain when patients initiating long-term ADT are additionally given docetaxel.
Axel Merseburger takes us through his top picks of the genitourinary cancer research reported at the ESMO Congress 2019, including updates on the STAMPEDE trial (5:33):
The current analysis used data on 272 patients treated with docetaxel plus ADT and 558 men given ADT alone for whom bone scans were available; stratification into low and high disease burden groups was based on the criteria used in the CHAARTED trial.
Failure-free survival (FFS) and overall survival (OS) results for all patients, obtained after a median follow-up of 78.2 months, showed that the improvement afforded by docetaxel was maintained with longer follow-up.
Importantly, there was “no evidence that the beneficial effect varies by metastatic burden,” said James, with a nonsignificant p value for interaction between treatment and disease burden for OS.
In fact, the addition of docetaxel was associated with an absolute increase in 5-year OS rates of 15 percentage points in the low burden group, at 72% versus 57% for ADT alone, and of 10 percentage points in the high burden group, at 34% versus 24%.
The results were similar for other outcome measures, such as FFS, progression-free survival, and prostate cancer-specific survival.
Describing the between-group differences as “highly robust,” James stated: “We have got a very convincing dataset that shows docetaxel improves survival in all patients.”
He added that to not give upfront docetaxel to men with a low disease burden if there is no other option “to my mind is a very big mistake.”
James also highlighted the discordance between these findings and those from the CHAARTED and GETUG-AFU-15 trials also investigating the docetaxel–ADT combination in the mHNPC setting, but which did show a difference by disease burden.
He suggested that these dissimilarities “may relate to high proportions of relapsed patients in low metastatic burden groups” in the CHAARTED and GETUG studies, while the STAMPEDE analysis primarily comprised (about 95%) patients with de novo metastatic disease.
These data also appear in the Annals of Oncology.
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