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GETUG-AFU 15

Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial

Phase 3N = 385NCT00104715

Population
Men with metastatic non-castrate (hormone-sensitive) prostate cancer
Design
Randomized (1:1), open-label phase 3 trial in 29 centres in France and one in Belgium: ADT (orchiectomy or LHRH agonists, alone or with non-steroidal antiandrogens) alone, or with docetaxel 75 mg/m2 every 21 days for up to nine cycles. Enrolment October 2004 to December 2008.
Primary endpoint
OS
Arms
  • ADT alone (control, n = 193): ADT alone
  • ADT plus docetaxel (experimental, n = 192): ADT plus docetaxel 75 mg/m2 every 21 days, up to nine cycles
People
Gravis G, senior author Soulie M, GETUG
OSHR 1.01 (95% CI 0.75–1.36)Δ median OS+4.7 months
Show the numbers
Results reported for GETUG-AFU 15
EndpointAnalysisADT plus docetaxelADT aloneEffect
OSprimarymedian follow-up 50 monthsGravis 2013median 58.9 months (50.8–69.1)median 54.2 monthsHR 1.01 (95% CI 0.75–1.36)The 95% CI for the ADT-alone median is 42.2 to not reached. The abstract gives no p value.
Results reported for GETUG-AFU 15
EndpointAnalysisADT plus docetaxelADT aloneEffect
OSprimarymedian follow-up 50 monthsGravis 2013median 58.9 months (50.8–69.1)median 54.2 monthsHR 1.01 (95% CI 0.75–1.36)The 95% CI for the ADT-alone median is 42.2 to not reached. The abstract gives no p value.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.010.75–1.36
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%020406080100120140Months (modelled)
  • ADT alone (control)
  • ADT plus docetaxel (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsADT aloneADT plus docetaxel
0100.0%100.0%
3762.3%64.7%
7438.8%41.9%
11024.5%27.4%
14715.3%17.7%
Primary publication: Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, et al. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013;14(2):149-58. PubMedDOI

Appears in

Sources

  1. Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, et al. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013;14(2):149-58.

    PubMedDOI